Event ID: 692849
Event Started: 3/27/2007 7:50:57 AM ET

Please stand by for realtime captioned text.

Captioner is attempting to dial in, phone line is busy.

They turned to the Easter Bunny out word because "they wanted him to have been time." [ Laughing ]

So some lawyer for the government is running around, going inappropriate advertising. The might have to send a conflict of interest form that says I have no stock in the company. And going to move its more front and center just to cause that trouble because I don't have any stock. [ Laughing ] Want to thank hunt for leading a task force and for getting our report to the report doesn't look terrific and I want to commend the task force for a job well done trip and handed a copy firstly to the secretary and that was fun to do. Yesterday, we accomplished a great deal I am pleased about the task force that has been created. The challenge now is for that task force and Andrea and I and staff have already started to plan is the timing and timeline. We are going to ask Greg Dowling if the comes today, or we will call him on the phone -- let me be explicit here. What we need is to sit with you guys after an hour meeting adjourns and get a real sense of the time line for the department in terms of what it sees as what it needs. Then, we will piste up and perk out the committee's work based on on the deliverables to try to meet your timeline the messages we would appreciate you taking back to Sheila and to Greg and the secretary is that we've got the 664 days left in the secretaries of tenure. It he has taken next Wednesday off? [ Laughing ] And forgot about the Wednesday he has taken off. We want to make sure we are responsive to that.

That sounds fine, thanks.

So we will get that done. But I would like, what we are going to do before we leave today, if anybody during their spare intellectual moment wants to take a piece of paper and brought out what you think is the map. In your mind's eye, molecule creating an reagent. Molecule the get reagent, test kit be get laboratory, laboratory-eight, super power pharmaceutical company, laboratory-be, academic center and was a civilian, billion resources lambda three is one and a corner some are merely turning out one thing for a disease or condition. From there, it goes to room doctor and a genetic counselor decide do something with this or not. FDA and does something in the many who has in their mind the map. One page. Puts it right there and then. [ Laughing ] Morning has the map. And then, Maureen, because you are good, you take one color or a check mark and say, like CLEA, who got it. Mailed. Another one come on CLEA, not so sure FDA, nailed. Something else. Who knows! Open. Here are the human papillomavirus met things. So you can see where the holes are. If anybody has those things in there had and want to give it to Andrea that would be wonderful. Moving on. Don't do like I did yesterday. One thing I didn't do is I didn't order lunch. And they don't care. And so you either get it and by 10:00 -- by 9:30 if you don't order your lunch on the form, they don't care. Welcome again to Debra Leonard. Although she rotated off the committee, you never get to leave. She is now a serving and are genes patent tech Force the best taskforce tier and energy and November meetings we decided to pursue the study of the impact of gene patent licensing practice on patient access to genetic technologies. Consisting of several elements, data gathering and analysis, gathering public perspectives exploring international perspectives and ultimately returned to report to the secretary. The task force has been very active and our friend, Jim Evans M.D., PH.D.,.

It should be a great session. We have excellent people to help us understand this very complex and somewhat from up topic. In the interest of full disclosure, I want you to know that the DNA sequence on my tie is not a patented sequence. Sys is public meeting I won't show you my DNA boxer shorts. [ Laughing ]

Machine that mean we been talking about addressing for about three years on the committee since before I got to the committee. It is a topic I think perhaps second only to genetic discrimination raises a very strong passions. Unlike genetic discrimination those passions are from all ends of the spectrum. It is rare for somebody to get up and support it wholeheartedly. People have strong feelings about gene patents and in addition, to being something that evokes strong feeling it's highly complex topic come on one that many of us need a lot of education on. And the cornerstone of today's session for this morning really an as a series of educational talks from leaders in the field are going to help us understand the topics that are out there. I wanted to briefly review how we got to where we are and where we are going to written the task force and she patents and licensing practices consists of five of SAGHS the members and Andrea is going to be rotating off. Women number of extraordinarily helpful at hoc members and ex official members bers as well. Realized early on in this process that we needed a lot of help in understanding these issues and in dissecting the current landscape and the changing landscape of patents boss practices licenses executor. We were fortunate enough to persuade several people to help us I will be doing formal introductions later but Bob and Christopher on and had [ indiscernible ] nine will henceforth be known as Dr. C in keeping with yesterday. We were fortunate last night to meet these people after nine hours of meeting during the day, and we got to hear from I number of individuals listed here who had looked at specific aspects of patent law and patent and licensing practices with obvious reference to the genetics and gene tests. The history of this endeavor him dates back to March of 04 update that when Gene patents and licensing was identified as a priority issue for this committee. It was deferred to given the fact that the National Academy of Sciences at that point had an ongoing study that they have yet to report on a. By October of 2005 and insupportable just been released and a small group is formed to review that report and are thinking that it was entirely possible that the report would have done our work for us and we wouldn't need to pursue anything. However, in full committee in March of '06 the NAS report was summarized and reviewed and it was felt that more information was needed, specifically the NAS report spent on virtually all of their time looking at the basic science landscape and how patents and patent practices and licensing were having an affect and might have any effect on basic research. That differs from the charge of this committee and which is more associated with the public's health and the political access and those types of things during since the NAS report did not address those in detail, we felt there was more work to be done. In June of '06, we held an information session and decided to move forward with a study. We began discussions about the study scope and work plan. We establish the task force and that time there was somebody foolish enough to take on the chairmanship of that task force. In October of '06 we had our first meeting we hammered out with the scope was and began to develop approaches for addressing that scope. In November of whole '6 we decided at the full meaning to move ahead with an in-depth study come and in December of '06 we refined the proposed scope and developed an approach for a study. In February, we were still working on the scope and decided we needed some new blood and we were again lucky enough to get Bob Cook Deakin and other members of Duke University Center to develop a view relevant case studies and help us to tackle this rather daunting topic. Just last night in this room we held a special task force meeting where we heard some great presentations by the CGE dukes that addressed some of these issues and discuss next steps in the bar times. [ Laughing ] We wanted to review with to the current scope. This is just to review the scope. We are done wordsmith thing and when deliberating on the scope and one of the things I would emphasize with unconscious of in this whole procedure and in fact the various stakeholders would appropriately insist that we do sole, and isn't that we need to maintain a level of neutrality and openness about the positive and negative effects in current gene patenting. If one agrees the popular press and media one might think mistakenly, there are only negative things about patents that couldn't be farther from the truth. Needed to look at both the positive and negative effects of a patent team and I would emphasize licensing practices on our core concern, patient access to genetic testing and ultimately. I emphasize licensing practices because I think there is a great deal of feeling if there are problems with the current landscape of patents, lot and application and practice that we're in the permit is like are and how these things are licensed and how that are applied. We want to focus on gene patents for health-related tests including diagnostic predictive and other clinical purposes. It encompasses both clinical and patient access just to fill you in on the perhaps obscure nuances between bolstering what we mean by clinical access would encompass a providers' ability to order a test to get that test for their patience which in a way is an intermediary step to our ultimate concern which is patient and public access to these technologies and test. We are interested in considering the effects on transitional research. If there are things that in a bull or block the ability of such new technologies to reach the clinic and reached the bedside. This is a diagram of our study plan of how you would like to go about this process. In part one, we will concentrate on data gathering and analysis to get a view on where we stand at this point. That will consist of literature review, consultation case studies and perhaps additional research. Gaps are identified in the current body of literature and his answers that are out there and give there are tractable types of things that can be done in an expedient fashion, we would consider funding something on a modest scale to try to fill those gaps. That would have to be practical and public. We don't have three years to wait for new answers to come in. These are divided conceptually into parts but there's no reason to have to be done serially, that can be at least addressed in a parallel fashion. But what to gather public perspective. This is a topic more and more in the news, something the public has concerns about, probably more uncertainty and concerns, but we would like to solicit public perspective, compile and summarize those comments have a roundtable and public hearing about gene patents and analyze those public perspectives. Part three is to try to gain insight from International perspective stridden this is not a subject that the U.S. alone has grappled with and although we are obviously and extraordinarily different, policy and governmental framework and other countries that doesn't mean we might not be able to learned important lessons about how other countries might address these thorny issues. We would like to gather data on those from that perspective, identified experts and address those things at a roundtable and analyze and summarize those International perspective of this with the intent of a final report to the secretary. I would emphasize the building and the analysts are interested in a completely impractical set of recommendations. What we would like to do would be to identify and practical sings that we would recommend that would enhance the benefits of patent practice and licensing practice, and if identified, surmounted some of the obstacles and problems. The goals of today's session of basically educational. We want to provide the committee and everybody attending with a primer and we will assist in the development of study. We want to overview various forms of intellectual property the use of gene licenses by federal and private sectors and the history and the current a very much changing landscape of gene patent policies. At this point I'd like to recognize our first speaker and that is Jorge and Goldstein. He will delve into various forms of intellectual property and the confirmed by each year is the director of the biotechnology chemical group at Stern, Kessler, Godlstein & Fox. He has prepared and prosecuted patent applications for the U.S. and patent office's in the areas many. He has also an expert on intellectual property in strategy trade secrets licensing, research, contracts, federal licensing, due diligence and acquisition. He will be providing us a background on the loss, legal decisions and policies that have influence is deemed patent some role with respect to jean material and I would like to turn the floor over to Dr. Goldstein.

Thank you for inviting me to give this primer on intellectual property. I am a practicing attorney. I do this in my spare time as a hobby. What I am involved in day in and day out is presenting the divers parties before the Patent Office, before the courts, the four international tribunals, each of them arguing their case. I take a very passionate and strong belief in whatever party I am representing. [ Laughing ]

That doesn't always represent my views on the things and I have learned to write articles and gives lectures like this, disclaiming that anything I say has nothing to do with the positions I take in court and vice versa. I have given a great deal of thought and written a fair amount including some debates with people present your indirectly about gene patents and have been enrolled in the field since the late 70's, early 80's when the patent was first allowed an issue and when Cesar Millstein failed to get a patent this so I have put together a combination set of slides which includes an introduction to intellectual property, and then some higher-level thinking about the gene patents and the different types of gene patents and so on. What forms of intellectual property are there? What is a patent? How can there be patents on genes? Who owns your genes? That is an interesting question, but the press is all over of this stuff. There was an article written in the New York Times about a month ago in which it was actually gone further and started talking about who owns your disease. I have some strong ideas about who owns your jeans and who doesn't. Obtaining and forcing pectins. The patent system and how it fits with Gene patents and some conclusions and recommendations from my perspective. So why to have intellectual property? They're is a number of discussions and there is. Historical patterns originated in Venice in the 15th century and to attract and retain Curtises who were coming from the Middle East so they would say in Venice and teach but the nation's the art of a canal building and ammunitions and silk weaving and so on and wouldn't go on summer else. So but the nation's cooked up this idea called a patent and which they would give them exclusive rights to canal-building as long as a state and taught full disclosure, all that was in there already and it worked. So the idea was to protect ideas, expressions, and encourage disclosure, and some forms of intellectual property are forms of information and a source identification such as trademarks. The source of intellectual property in the United States is the constitution. Article one, section eight talks about promoting the product success of science by securing for limited times, 20 years from the filing in the United States and pretty much the rest of the broad the exclusive right to the respective writings and discoveries. This includes the right to have copy rights and patents. Just a general introduction to intellectual property from secrets, trade secrets all the way to Pattons and I will very quickly give you a specific example so you walk away with a sense of what the difference is between a trade secret, trademark, copyright and the different forms of patents. The classic example of a trade secret which everybody talks about is the formula for Coca-Cola. It is still a trade secret. There are presently industrial espionage litigation going on in the secretary at the Coca-Cola company tried to sell some secret that she thought was "the" secret. She's being prosecuted under various different statues including trade secrets. The formula for Coca-Cola is, indeed, a secret. And [ indiscernible ] and only two or three people know it. A trade secret is knowledge that confers advantages to an entity, say the Coca-Cola company. It lasts as long as the knowledge is kept a secret. The disadvantage is that a secret is hard to keep. Although, Coca-Cola has done well. You need to make sure when you go to court you can demonstrate that you have done the best you could to keep it. You can't stop someone else from independently discovering it or inventing it, or, in fact, it has happened much to the chagrin of people that the independent invention or independent rediscovery results and the loss of the secrecy. The disadvantages to the public is the knowledge of the form of Coca-Cola is not placed in the public domain so it stays with Coca-Cola and nobody knows about it and have a right to exploit it. If Coca-Cola to sit for 300 years a secret as long as they can keep it, no limit.

That is a trade secret. Trade secrets are enforced in state court term they're not dead appeared there is a federal espionage Act that protects the secret of them, but trade secrets are state-created. Trademarks. The classical trademark I will talk about is in the health scientist the trade mark for [ indiscernible ]. A trademark is something. It need not be a word, it could be a building like McDonald's, for example. It is something that distinguishes the goods and services from one company from those of another. The same [ indiscernible ] is called [ indiscernible ], and in J and J Europe had been selling [ indiscernible ] and a license and they called it a [ indiscernible ]. So the application apparently committed Lake causes everybody to know this is coming from the reliable source that they have taken it from for the last ten years and is not some other drug. It is not a different source. It's the same drug, but it's the source they have relied on. It's source identification. What can be traded market, a product like I just showed, a building like the golden arches, that's a trade mark. What is not always clear to people is that a sound can be a trade war. If you think about Intel inside, that little sound Intel has, that's a trademark of Intel to her is registered as a sound trade mark at the Patent and trademark office. A color can be a trademark. Brown or pink for insulation that you put in your attic for the winter. Is a color and color is in fact trade Markable. Trademarktrademark s give you a sense for a source. The advantages are they last as long as you use employer it to prevent others from using similar remarks tear it makes it quick and there's an advantage to the public to connect the source with a product. If you don't use it, you lose it. Next intellectual property section. Copyrights'.

Is a trademark for ever?

A trademark is forever as long as you use it and you do not abandon it. If the trade mark becomes the generic word, you lose it. For example, the Xerox is a trademark for copying using zero graphic methods, but when people say I want to Xerox something they are using it generically and the Xerox company is constantly reminding people not to use a Xerox generically because they will lose as a trademark. To Hoover in England there's a generic word for vacuuming. The Hoover company doesn't like that, and one of the dangers with a trademark becoming very famous is that you can lose it if you don't protect it as a trademark copyrights are yet a different form of intellectual the classic example here if you think about and Jim Watson's molecular biology of the gene, a copyright is a protection for an expression. It is not the idea but the style, the format in which the idea is presented. If you think about Watson's book, there are obviously an infinite number of ways of describing and writing a book on molecular biology. You can write a book on molecular biology without copying Watson's book, without copying his style, his chapter organization, where he puts the figures, the phrases and you are fine. You can write as many books as you want. But if you photocopy and the page of Watson's book, you are violating the publishers copyright. The idea is it is not to protect, the concept of writing, it's the particular way, format, a style that is predictable by copyright. The copyright is owned initially by the author and then by the publisher if the author is writing on behalf of. The expression can be independently created and not unique. It has to be capable of being fixed in a tangible medium. A whole bunch of stuff can be copyrighted and we are talking again about expression and not ideas. Literary works, musical works, sound recordings, dramatic works including choreography, including the NFL games, for example, is pretty dramatic. Pictorial graphic sculptures, motion pictures, architectural works. How about outside this classical field of literature or part? The best example of re quasi utilitarian application of copyright is the software industry. The problem was software copyright is while you can protect the form in which a particular flow of ideas is created, so you or your publisher only copyright on the code and how you have interpreted the flow of information, I cannot look at your code, figure out what is you are trying to protect and write my own code different than yours and I am not violating your copyright. That is why protecting software by copyright is a limited proposition. The best way to protect software is to protect the flow of the information and that is done by patents and the particular way in which you interpret the flow is done by copyrights. In the late in the 70's, early eighties there were papers that came out on the possibility of copywriting genetic sequences and my only answer is what I say there. I don't think so. The problem with copy writing a utilitarian objects is a lot does not allow you to use copyright to protect the function of the object. You need to be keenly aware of the limitations of copyright to just protect the style or the particular mode of expression and not the underlying idea.

How about copyright, is there a time for it?

It can be extended. It can be for the life of the author plus.

Why did the wiki mice -- Mickey mouse, right last for ever. The copyright is still in place?

I don't know, but I can look it up.

It is.

Which is a patented? At patent is the right to exclude. It is not the right to do anything, it is a right to exclude others for a limited period of time from a number of things such as make, use, sell it is a right granted by the government and the quid pro quo is the government gives you the right to exclude and you need to disclose fully the invention that he wanted to patent. If the quid pro quo is not met, and if you disclose it fraudulently or if what you disclose is an operative, the patent is invalid. Litigators let me go into court all the time trying to prove that a particular patent was granted by mistake, the patent office missed some piece or this was reproducible and it was not reproducible at all. The quid pro quo is private disclosure that would otherwise not become public like the disclosure of a corporation. Admissions who live for doing basic research and making it available to the public don't always understand the concept of the alternative is to keep it secret. Keeping things secret is -- the point of doing research is to make it available. For industrial and corporate scientists come secrecy is the norm. It is the daily -- their daily life. The concept of disclosing its to the public fully is a strange concept for corporate research and the patent says to them "if you disclose its, I will give you 20 years exclusivity. You'll be the only when that will be able to do this." You can talk about in DuPont for the Grand Canal, it is basically the same idea. What kinds of patents do we have? The classic patents that to all talked-about are so-called utility patents, 20 years from filing, takes about three years to prosecute sold 70 years of issuance. The invention must be useful, novel, not obvious. There are design patents which protect the design, look of something. Similar to copyright in some way in the sense there are probably many, many ways of designing a Speaker of a microphone like this, for example. If I have a particularly fancy 1 I could probably protect it through design patents. There are multiple ways of designing a utilitarian objects, and one of those can be protected by patent design grid for decorative design and planned patents which you don't have to worry about to much grid 20 years for filing an for a sexually reproduced plants. We're not for the talk about copyrights, trademarks, trade secrets, primarily a utility patents. What can be patented? Certainly, processes. Methods of producing compounds. Methods of using them in therapy and diagnosis. Instrumentation, machines. Manufacturers, things like plastics and paper. Particular chemical entities or genetic entities. Software can be patented. That's a relatively new one and is causing a great deal of consternation and especially in the financial industry that is giving him sued by inventors that have patented methods of calculating bond fund balances at the end of a day, for example pretty abstract ideas cannot be patented, that thematic equations, algorithms cannot be patented and laws of nature. This has become a controversial issue recently in the sense that it is being brought in to try to capture within the concept of the law of nature things like correlation between diagnosis. There was a case called the metabolite case in which that was tested but the Supreme Court said we shouldn't have granted, there's another issue you want to deal with the whole bio-tech patent was left holding their breath as to what was granted happen with diagnostic correlation patents.

He made a distinction on the copyright you can't copyright --

Where is the question?

Copyright does not protect the function of an object. Can you patent the function?

Yes. The patent covers the military aspect of what the object does -- utilitarian aspect. The copyright protection the form, the stock, the look of it. That's what patents are more powerful to protect the ideas than the copyrights. If I can patent the basic concept or idea that I developed, and then you can in body that in many different ways to rid and yet if you a copy of my idea I got you.

How about something with a function like an object or something like gene that is happen in nature?

Bear with me for a minute. As long as you take it out of nature and introduce some sort of intervention and make it is separate from nature you can patent it. Patton's encourage disclosure. They encouraged investments. They can prevent others from using the invention as a trade secret. That's interesting if I were to reDiscover the formula for Coca-Cola and it is not public and I got a patent, Coca-Cola would have to stop using the form electorate if Coca-Cola wanted to patent it now it to be too late. They're is a trade law that says you have to choose secrecy or patents. You cannot keep your inventions or discoveries a secret for 25 years and when it is about to be discovered, you patent it. That is called an estoppel in law, it means you can't do it. Whereas if I were Matt discover it by myself and I patent its, the fact that it is secret is not against me. They're is a risk in keeping things things a secret. If I was Coca-Cola's patent lawyer 65, 70 years ago when -- he came to me and said should I keep a secret? I would have said no. A set I swear I will be able to keep this a secret for 65 years, I would have given him that advice. Thank God it didn't come to me, right? He did much better I don't believe secrets can be kept that long especially in a product that is going to be drawn up by billions ions of people. Common sense. And disadvantages of patents. To the corporate how scientists the patent needs to pretty much laid out a blueprint of what the intention is. The formula, the Coca-Cola from the, the process of what goes in it. It is expensive to obtain. It is even more expensive to litigate. Litigate can cost 2 million to $3 million. When people say to me how much is going to cost me to litigate this? My rule of thumb is about 8 million a year. How many years? 2 to 3 years and you can multiplying that by two or three. Is a multimillion dollar business to the gate patents. You may need to seek patents in many countries. Idea of a patent in the U.S., people could go abroad and bring the data entered there is case law that says you could do it drug screening internationally and send the data in by Internet and bring in data is not a [ indiscernible ] of a screening patent. The technology is developindevelopin g very quickly, patents are a limited appeared in consumer products patent is have a limited use. No talk about patents on a genes Terry patents on naturally occurring materials claim isolated and purified molecule's. There is lots of legal -- adrenaline and purified form was patented in 1912. Insufficiently pure form that was the word of the patent claim. In 1977, in a case called [ indiscernible ] there was a patent of cultures of struck a myiasis grid the critical words that need to go into the patent plan. In 1979 strawberry flavor in compositions were patented where acid derivatives were the one set of compounds give strawberry flavored to the strawberry and they were isolated and purified and compositions containing them. A composition contained [ indiscernible ] acid reached on a strawberry, right? But if you put it substantially. [ indiscernible ] acid, that is the way it is construed that it doesn't read on a strawberry because say strawberry as a composition of matter is a natural and the flavoring compound that is not isolated and purified put in there. In 1980 the famous case from GE, made a common bacteria that was able to grow and metabolize a whole set of hydrocarbon fractions patented. The thinking went up to the Supreme Court and the Supreme Court said in a famous statement that is to reproduce by patent lawyers in the biological sciences "anything under the sun made by a man can be patented." I am sure today the Court might say anything under the sun made by a person or man or woman, but those are the days, 1980. That is used by patent attorneys of lot. "anything under the sun." Meeting if the hand of man has intervened like Pierre find the Star break extract, that it is patentable. Let's look at what a jean patent actually looks like. A gene patent ultimately is a gene claim, a patent contains a whole bunch of disclosure at the beginning and then there is a number of numbered claims at the end of the patent. And claim one of engines is reproduced in this slide. That's the double 08 patent issued in '87 and that patent has actually expired the DNA patent is gone. Although it has made subsequent violence and has patents on all kinds of other things it was a four, $5 billion market and they have held tight. That let no one in because of these patents. What is claimed it is -- I am going to use this one appeared purified and isolated DNA sequence, that is the critical wording, it has to be purified and isolated. This sequence and codes people, it is selected from two and some parts of this claim. The first one is a DNA sequence actually set out in the patent. Is a vigorous fight and six are the complementary strengths. That happens to be the human gene sequence. That [ indiscernible ] as all biotech patent lawyers doesn't want to just protect the particular human gene sequence, it wants to protect all of the genes to machines that come from other species, a modified in some way from the human gene, otherwise the patent could easily be avoided. It is not that difficult to envision the possibility of changing a few basis here or there or maybe a neutral and non-impacted mentation and developing an alternative. If you have a patent limited to just the one sequence the patent could be easily avoided. What is really critical in this claim is DNA sequence under it stringent conditions to meet sequences defined A in. Also, to the occasional variants of the basic human gene. It is interesting how is defined. It is defined by habitus Asian under stringent conditions which I defined in the Patent and it's test to see what inferences and what doesn't. This little primer question, who owns your genes? I would like a buddy to walk away from here and reading to see how wrong he is. He's a great novelist and I love his books, but as far as policy is concerned, I think he should just keep on writing fiction. Close your genes? If they are in your body, the genes are yours. On the other hand, if you are in the hospital or your doctor's office and blood has been taken, the law has been clear for many years and there was a case that confirmed it and 99 game at the University of California, the famous [ indiscernible ] case, once your genes are extracted from your body they belong to the hospital. So the act of extraction changes legal ownership of the jeans, of the genetic material let's say look, before people my lab I want to own my genes. They will say are you crazy? This is not crazy. What happened, is that this and discovered that his jeans and his cells had been isolated and used sed commercially to produce some material and he got pretty upset that people were exploiting them. Let's assume you do a deal with the lab. If you do a deal with a lab it and change by contrast the operation of law which is what the more case said. You can walk home with the test tube of your genes. And if I ever patent on you're isolated genes, and you have this little test tube that you go home with and the art yours, but if I got a patent on them because they are now isolated can you commercialized at? The answer is no. You on your genes but I of the intellectual property on your genes. Just like if you own a copy of [ indiscernible ] book of Internal Medicine, I own the intellectual property it is yours but the copyright is mine, you can go to the grave with that book budget cannot reproduce it, sell its, too stupid it make copies of its. So there's a big difference between owning the book and on and the copyright. Only the genes and owning the patent. You own your genes but I may all the right to exploit them. Can I use my patent on the isolated genes? That's a trick question. I hope in of the answer? Of course not, patents are only isolated genes they're not your chromosomes. How easy is it to obtain a gene patents queue queue by this I mean isolated. They're is a number of standards in the patent office that go from the genetic sequence that you disclosed needs to be useful and fertility is one of the most difficult parts to overcome when he or trying to obtain a gene patent. In has to be substantial, credible and specific. You need to have a written description of the gene and berries of the gene in order to get scope. You need to reproduce the invention. Indeed for the gene to be novel, namely and has not been published an isolated farm, this sequence and another publication before you filed. It cannot be obvious. The standards roughly are much harder to overcome at the utility of written description that at the obvious nests and of things. In the indebted states as I come up with a new sequence for a jean well-known but I've modified the sequence RI have a variant of it, I can get it. There is no very high, very strict standard in order to obtain a gene sequence patterns in the U.S. tour in Europe they took a different turn early on and they can demonstrate if there are methods and incentives to make these variants the gene is obvious. In the U.S., the Patent Office is not allowed to represent evidence available to isolate this new Jean-Pierre approaching was unknown, genes and other species were isolated. That does not work in the U.S. Works very well in Europe and demonstrates clearly how in here and the U.S. went in very different directions. The Europeans are not happy in the direction we took and there's a lot of criticism in the academic literature about the direction that our court to appear in the essence of a patent right to is the right to exclude and the right to exclude which is the essence of a patent includes the right to an injunction. I can go to court and get the court to stop you from using, exporting, offering its sees I direct to extract damages if I have been heard had my marketing by your copy that infringes my claim and I can demonstrate I lost profits for the market is diluted I can I get my lost profits are get reasonable royalties. I can leverage the ability to get an injunction to be able to obtain licenses. The right to enjoin in the U.S. has historically been very strong. The interesting news for this group I think is that there has been a recent Supreme Court case where the right to enjoy and has been cut back from what it has been historically. Until very recently, until this case, this debate case, any any activity that for this the institutions business objectives is an arrangement and can be enjoined and this applied even shoot Duke University, those of you from Duke note this like the palm of your hand. He had a laser that he had patented what it was at another university he was using it to teach and he got unhappy and left Duke and found out that Duke was continuing to use this patented laser. He sued them. Duke said what are you talking about? On an academic institution. You cannot tell me to stop. The court said yes, against you. Sorry, Duke. As far as you are a business objectives are supported by this infringement, namely you teach, that is your objective. You're not a state university. You're not immune. Is an infringement and may have to stop. You can't imagine the brouhaha this cost. They went to Congress and they respond and still are paired when I talk to university officers still don't want to talk. It is something we don't want to deal with the experimental use defense is essentially nonexistent. That's another thing to note here. Clinical use of a drug that is generating data that will go to the FDA and to the statute and a Supreme Court case clinical research is in fact and a suspension of a patent. The pharmaceutical company is doing clinical work and they are using a patented drug, they are free to do so until the clinical work and and they go to the market. The question is how early does clinical work start. This preclinical work still cover it? Early experimental research still covered by this immunity. Now, the right to exclude has recently been cut back. It used to be if you proved there was an infringement and the patent was still valid at the end of litigation, an injunction came in and automatically you got an injunction. It is no longer automatic. It's pretty clear from the Supreme Court case and from lower court cases in the last six months to a year that for example a patent holder that does not manufacture, Norris, is not in the marketplace may not readily get readily get an injunction. Health is a major public policy concerns and the courts have noted over and over again in injunction litigation so the patent lawyers who does not want the invention has a patent, frames it, likes looking at the Patent and maybe a offers licenses every now and then, maybe not. That is not an antitrust violation to not licensed a patent right. Nowadays patent holders who are not working the invention who are not licensing the invention that's a test case has not yet come up, I not be able to get injunctions. That actually opens the door in the U.S. for the first time to serious thinking about compulsory licenses, licenses forced on the patent holder by order of the court. Compulsory licenses have been [ indiscernible ] for decades and decades. The East Bay case has opened the door and is not possible to at least right academic articles that compulsory licenses are coming and I have already seen a few cases.

I think we are running short on time and I want to make sure, this is so great, I want to make sure we get as much as possible from you, if you could within the next tennis or so finished up and what we will do is bring Doctor Goldstein back for questions.

Okay. The door has opened and I think the next few years are going to be interesting especially in health care patent litigation. I've already talked about full disclosure time limited expressivity capitol information for technologies are frisky outlook. The idea privatizing that would be in the public domain. Helps promote investment if the technology stays in the Commons, the basic idea is nobody would put money to protect it so maybe it might die and the comments and might not make it into the market. But there are patents and there are patents. The patent system is created as a one size fits all system. I think careful thinkers of the system and the long always distinguished, even though the law doesn't, between different industrial sectors through the [ indiscernible ] like the pharmaceutical industry is the classic poster child for a good, strong patent system. Major investments and long delays at high risk of failure and the products have a very long life. This is not what the consumer products industry no major investment necessary at the end of the spectrum is business methods and don't require high risk investments. The product life are relatively short trip a lot of the inventions and developing a new business methods like a computerized method of compiling fund balances at the end of the date don't need patents and the application is sort of an afterthought. As like the Supreme Court said we don't see why not is not like a patent is necessary to promote good smart Wall Street financiers from calculating balance funds. Where you can contrast that with the pharmaceutical industry and in the middle of it is usually placed the semiconductor industry, copying is still a risk, but there is a ticket problem in the semiconductor industry. It is estimated if you want to put to a new duty on the market or a CD player or and I-Pod, I-Pod is a registered trademark of Apple Computer grid I'm not trying to use it generically I'm so paranoid about using I-Pod. If you want to put DVD player or one of these a miniature and Goldstein players on the market is estimated indeed thousands of patented grid for a complicated high-definition television set you may need 19, 20,000 licenses. There's a real ticket and this is the industry or patent laws have come out from because people cannot move without patent rules. Our isolated the human genes like the synthetic drugs are are they like business methods? What role to patents play in genetic patterns? The answer, which is what lawyers always have as an answer is it depends. It depends on the function and the use of the gene and who are the potential defendants. Let's sort of think of gene patents and three different categories because I think it is useful at least to put some taxonomy and gene patents. There are DNA patents called protein drugs. They tend to be in the biopharmaceutical companies. At the other and our DNAs encoding targets, like molecular receptors used for drug screen. The potential defendants in this category tend to be institutions and small research companies that are doing screen for these receptors and in the middle just like the semiconductors are diagnostic probes through these are not DNase that our used for say. The potential defendants are mixed bag. They include diagnostic companies that are putting kits on the market and they include the medical community was doing political work, maybe research. If you think about gene patents and these three different categories, things become clearer are they more like synthetic drugs are more like business methods the PPA? Gene, if you said that they cannot get it patent on gene that impose a protein being used as a therapy, as a drug that need FDA approval of the house lot application time and high risk, they would probably not spend any money and it could very it will be that PPA gene would be the discovered and they're probably wouldn't be much in the pharmacies in the United States and therefore DNA in coding drugs, protein drugs are I think a lot more like synthetic drugs than business methods. Patenting the gene, not the protein words the innovator, the risk is high. I've mentioned this factor already and in fact there is case law that suggests that the patent has already been construed pretty nearly so that subsequent generations are not covered by the PPA original. At the other end is the receptor. If I isolate the DNA I can get a patent on it, but the research applications are the most important applications here. We're not talking about the receptor as a protein been sold as a drug in the marketplace. We're talked about it being used as a research tool. The commercial application is much lower. Development risks and costs are not high. These are used primarily as research tools and for stability is iffy, you can use it abroad, bring in the data, preclinical [ indiscernible ] as I described before. It's difficult to ascertain with the damage is. How much money can get from you if I take you to court? What is it worse for you to be doing research? Nine tie in ten years from now and say if you discover that Blockbuster because you use my receptor in vitro to do screening even though you are ten generations away I still want a cut of that blockbuster that is called a reach-through royalty and lots of controversy about this. Certainly, they put money into the research they don't like research patents being licensed exclusively and hold up research and there is a clear his sense that patents tend to impede the dissemination of research tools. Now, that is very important because big front steps into a debate that carried a lot of weight. Lot of people talk about patents and then they go where searchable patents are no good. I am fighting with them all the time in the middle sort of like semiconductors are genus are called diagnostic probes. There are still manufacturers who put kids on the market and they want patent protection. Indeed receiving and of these patents don't just included the manufacturers, but also end users. They're is a lot of debate in the literature and lots of evidence that developing improvements in genetic tests has led to large fragmentation of the patent field just like Sunday conductors and there is a clear sense who can perform the genetic tests may well interfere with good practice. In my taxonomy patents are like semiconductors and I think there is a problem with them. The perceived value depends a bit on who is talking. Academia which is sort of the middle one feels that as far as DNA encoding protein drugs they like patents. If they discover the gene you can be sure they want to have an exclusive right to license exclusively to some pharmaceutical company. On the other hand as far as DNA coating receptors they feel for research tools like to patent them but they're having a lot of trouble licensing they're not that many takers and reach-through royalties don't talk well and if you're talking to big-from what they love -- they hate receptor pectins they don't want to pay stock royalties. They're a small status. Everybody agrees that therapy drugs are good things to have, the biggest difference is in the IT research and of things and there are set ups that make their living from isolating research tool genes and patenting the minute you say to them that DNA patents should not exist they're not going to like it. In thinking about it and diagnostic patents I have [ indiscernible ] their number of academic research groups that fought about this in great detail, following the model of consumer electronics one could think of creating in the diagnostics field, not in the other field tools that use internationally recognized standards to define what tools publish what patents belong and which ones don't which are essential and which ones are not. You hear pools being discussed as the panacea for solving all of these problems. It is not. They have to be thought through very carefully and in the biotech industry, I will leave you with the final conclusions, no one other than you owns your genes. But they may own patents on the isolated version of your genes and provide commercial exclusivity. There are different categories and they need to be thought of in a different way and whenever you recommend did not throw the baby out with the bathwater. Post-eBay, I think there is real possibilities for compulsory licenses. Patent pools, I believe in the diagnostics field they can route but you may have to start working with international health organizations to create standards decide diagnostic standards are applied in the house, they could be applied in the health field. And define an experimental and clinical research without undermining all research tool pass. There was an issue of academic medicine years ago that had a lot of this that I'd recommend for an excellent survey on human gene patents, so much has happened that it is already out of date but as an introduction it's pretty good set of articles. Thank you.

Thank you. That was wonderful. [ APPLAUSE ]

That was a fantastic forever. We are going to wait for questions until the next two speakers have gone ahead and spoken. I wanted to turn now to Ms. Claire San Francisco. We're going to hear from two speakers representing the federal sector and the private sector. Claire San Francisco is from the technology office and will begin by describing the federal perspective and is responsible for the oversight licensee portfolio. Clare?

I will try to be fairly brief I know we have a long morning ahead of us. Today I'm trying to talk about how the NIH handles licensing not unlike many in the medical community NIH is concerned about certain licensing practices, brought expose of licensing of gene patents for a diagnostic application. The bottom line is if there are real problems and there do seem to be some examples of problems in this field, think the focus should be at the level of licensing and not at the level of patent. That will be might take-home message. Here's the reality. We are in the age of homo-economic. A little bit about the NIH. What I want to emphasize here is we are big. We spend 10% of our 26, $27 billion budget internally on campus. A lot of the policies I will be discussing only apply to the intramural program so some of my views I will say why are we doing this in the extramural Program and the simple answer is the grantees don't want us telling them what to do. The time has come to consider taking some of the policies and having the grantee community at least voluntarily adhere to it but there is no mandate they must follow some of these policies. I will start by discussing some of they NIH policies. The research tool is a great example if there is a low public health priority we don't patent. We will patent if there is a high public health priority even if there is no commercial interests. We every large portfolio and in neglected and rare diseases. We try to achieve a balancing act. If you have to much IT are restricted license the monopoly he will hinder future research. Inventions such as the genes that encode for proteins that could have therapeutic use you will not get appropriate commercialization. We try to achieve this balance. Here again here or intramural this is what we do on campus. We always focus on the public health benefits for this and financial benefit to us is our last concern. And that all sounds great. We can afford to be altruistic. We have a big budget. This is not the reality for the university. You have to be aware of that. We try hard to never give a license for more than the company realistically needs. We do preferential [ indiscernible ] are narrow exclusive licensing and try to optimize the number of new products that hit the market and the best way to do that is to do multiple licenses. We insist that the availability of technology for research and maybe extend it to research and clinical, but we [ indiscernible ] research ourselves but free also want other non profit.

So what are the mechanisms we use? We use a very standard mechanisms. Our one anomaly is the quarter of research and development agreement. We actually give our collaborator an option in this room. Most of the time we do not-exclusive but if you work with us to get an exclusive option. Even in that case we are careful to make sure the scope of the license matches the scope of the research plant. We don't give people more than they need to commercialize. We to the opposite of academia. We give up mostly of non-exclusive, and occasionally co-exclusive. If you exclusives when it comes to their critics are vaccines. Even those can be quite by disease indication by technology platform we try to parse it out so we can give multiple licenses. We're very really give a a broad license. Here are statistics prepared by met separately opposite of what academic desperate 80 percent of our licenses are non-exclusive if you look at the Association of technology manager survey data UC and academia is mostly exclusive licenses. We don't really know the nature, some of them maybe there'll but the way bottom does the survey you can't tell. I want to emphasize that difference.

The difference is extra mural votes are grantees can do what they wish under patent and licensing they can control their own invention commercialize them. They're is a famous research tool policy NIH put in place with sometimes ask for acceptable profit-sharing plan. And we have a new guidance document that came out a few years ago called "NIH best practices for the license of genomics practices." We asked grantees to adhere to but it's not a requirement. This document came out of the genome Institute, Francis Collins idea. We were actually doing all of these practices for over a decade but nobody on the outside New that's how we read having the license and and gene patent. We tried to put it down in writing and distributing it to the community. We do a declaration of an exceptional circumstances where we tell our grantees you have no by Bill rights. As he can imagine, the university's head of these and fight against this, but in some project it's necessary that the and product such as full length and D and a's of all available or in the case of create a library of knocked out mice. There were a patent attached, but couldn't really get them out there. Occasionally we will completely take that away but that is Terry rare. The academic research enterprise really is the source of many of the platform technology of the new products commercialized by industry. The companies are and licensing from academia that means to controls the licenses? Who is writing the license agreements? Universities. The companies can ask, but is the universities of control how the licensing is done. So if genetic inventions were no longer patentsable had to sublicense or give aid license to interested parties but would affect the industry. It would be in no one's interest to put diagnostic companies of business. There is probably wheys to be more thoughtful and careful and licensing so you don't create monopolies or problems with pricing because one company has a lot. Other than genetics probably the most hated and diagnostic company is a scene appeared here is a list of patents just from off the mob ' is website. They have created a large collection of patents for various no logical disease conditions. But if you take a closer look and say where these patents come from, what you will see -- this slide is from my friend David Ledbetter. If you look at the patent come take a look, I those mostly companies? No. They are academic institutions. There is one for Athena. Keep going down the patent. Mostly academic entities. Keep going. Academic entities. There is another one from Athena. One more from Athena, everybody else universities and so on. A few companies, Mostly University spirit of those dozens of patents licensed by Athena only three today develop and-house. The rest day in-license. Nobody else can do these genetic tests except Athena. That policy of not sub-licensing. If you want that tests done you have to go to Athena. Then, I'm going to use some data from Bob Cook deacon and his colleagues. The Duke group published a couple of years ago, they did a licensing survey and specifically looking at DNA patents and who owns them. University of California is number one. A number two is the U.S. government, NIH. NIH owns the second number of gene patents. The one circle in red our universities for Top 30 DNA patent holders but they also signed a new white paper that has come out from the premier technology transfer organization. The Association of University technology manager came out for weeks ago a very nice white paper which is Technology neutral but does mention gene patent and diagnostic and a number of the universities will hold the largest number have signed on. It is kind of like in the future, you can't do anything about the legacy patents, but I think it is a good start on the doing this because they are altruistic? They're doing this because universities are getting terrible press. There's a lot of push to change and criticism for how university's art licensing patents. They thought let's voluntarily do something proactive before the NIH are pieces of legislation will force us to change how we do business. On a should also mention that 4 0 to 65% of all of the DNA paste patents filed by universities were made using government funding. By their own disclosure in their patents, over half of the DNA patents discovered by universities were founded by government funds. What does that mean? That means the NIH or government had a policy telling them how to license he would catch about half of these. Is evidence of the issue jean taxes have gone mainstream. I'm embarrassed to admit I some time reading this flimsy publication called parade magazine and I choked on my coffee back in November gene patents are putting your health at risk. Parade magazine. We have to have an intelligent discussion and has already been mentioned, Michael Crichton's book for he has in the back of the book author notes. Awful. Stop patenting of human genes. Number five [ indiscernible ] by Dole back to 1980 legislation that gave universities to own a their own inventions. That is extreme. That would put a complete halt on many industries basing their businesses on inventions coming from universities. I will go click through some of this. Just to point out that gene patenting came to the floor once the human genome project got going. There has been a lot of reports, I want to point them out, how $0.6 a it is the tech industry is to perceptions or concerns about not being able to have sufficient patent protection. When Bill Clinton and Tony Blair announced the working draft of the human genome project one of their spokes people have answered a question that made it sound like there would be no longer and the ability to patent genes. And the stock market that day to.

Jorge, 30% plunge in one de just based on that statement. There has been some proposed pieces of legislation trim this one from 2000 to was pretty good, there was also a [ indiscernible ] report and in 2003 we finished the human genome project. By the time we figure this all out there is no gene for us to patent and all of the early genes have become off patent. Trees and the problem will take care of itself but it will take another five or ten years. And then we have the NIH best practices which is a good document. We didn't for with OECD needed essentially, the recommendations are identical. Emphasize non-exclusive licensing, making sure you retain a research use provision for everybody, not just yourself. Very much in line with the was a convergence of opinion. And then the autumn came up with a white paper this month which is not specifically about gene patents but the recommendations are almost identical to some of the other reports. My bottom line, stop worrying about gene patents. Focus on taxes. Is the licensee and that really matters to this unlikely that patents will be revoked even though there is a bill to try to do just that the figure would be very important to develop alternative feasible strategy to ensure maximum access including clinical labs and research labs as Dr. Gold stain already pointed out pretty tough to get a gene patent. Very tough in Europe and Japan there is at least I hire brought for getting these patents and they tend to be more narrow the focus on a licensing to do a lot better. I will take a minute on this old bill because I think it is a far better proposal then Dr. Weldon who is from Florida. His new bill proposes a complete ban on human gene patenting but it's not retro active. His previous Bill was nice. What they did is they did an analogy to the surgical technique from ten years ago. They proposed to exempt from patent infringement individuals will use [ indiscernible ]. If it added political in here you would pretty much cover everything and they said he should exempt medical practitioners. This was kind of a good idea. I thought the concept was good. Unfortunately, Dr. Wilson decided to propose a new bill in 2007 that would prohibit the patented of human genetic material. This is silly because there's really nothing left. It would be very hard to find a new human genes that hasn't been published and it doesn't address the key public health concerns of what has been license. People are concerned about the same example. In my ten or 15 years of doing this I hear the same five examples repeated. Hemochromatosis, can advance disease. It is the same ones. I there any new ones? Is it just these few to get exceptional. I think it is the same ones over and over and we have to look at that. If 99 percent of the people are played by the rules that's a good thing. Again, this is to show you society's come along Kinmen Bordon '99 on this issue all in line with all the other policy documents I mentioned. Here's our strategy in summary. We publish a lot execute non-exclusive licenses, give limited fields of use, mandatory sub-licensing and we have developed this Best practices Guide for use by ourselves and by our grantees, again not required by our grantees. Our grantees are not required to follow these. We always include provisions to ensure continuing unavailability for all others for research purposes, not just ourselves. Here is a summary. I won't go through it in detail. It is the same concepts over and over again and all of these documents. The one thing they do emphasize is commercial development and to monitor and enforce terms. Was the licence is signed everybody is happy. You have to go back, follow, if a company's not appropriately using ID you need to take back the license. This also requires staff but it is very important. The NIH is doing this in a rigorous way, many universities are not. Here is the white paper from autumn. I think it is sensible and the balance. It is Technology neutral. It deals with licensing of inventions in general. How to serve the public and make sure you're still encouraging [ indiscernible ]. It is signed by big-name universities. They're not afraid to lose money. It is being endorsed by several different groups and are hoping to get more folks in there and is in response to negative press but so what, it's silly goods thing. In this document they emphasize should not hinder clinical research, professional education and training and you should be able to do independent validation of the test even if there is patent coverage through licensing of a single gene for diagnostic may be counterproductive. They're finally saying it and putting it out there. And I will finish off with proposed remedies. We can pass legislation to have compulsory licensing. Not a terrible idea. We can all some work on a [ indiscernible ] redemption. He can also tie and non-infringement benefit. Patent pools I think these are difficult but it's also an option, there is antitrust issues that could be hard to sell, encourage Class licensing and a new open source movement which are kind of interesting as well. I think the best possible remedy and I want to emphasize this is my personal view is I think as a start it U.S. government grantees to follow some of these guidelines and if they have a chance to renegotiate licenses that come up for renewal they should think about it. We're going to get a lot of letters, but it's not a bad idea. He needed data to see how big the problem is. If the problem is there he mights have to have the grantees at least adhere to some of these practice which now a large number of entities agree is the way to go. But he do need some data. I was a problem of NIH. Here are your options you to follow our best practices or the autumn white paper, they are nearly identical and I think we will go very far trip to conclude, there has been policy development which has been removed in and had the bad news is this is taken about 20 years. It's great start. I like the idea of being broader but I do grid by the time this policy or legislative fix are put in place many of the gene practices will have expired on the proposals are only granted be for licensing going forward and not retro active with the legacy problem which is probably where the problems lie. I will stop there. It thank-you. [ APPLAUSE ]

That was wonderful. The extraordinarily practical kinds of things you need to hear and consider. Next I would like to introduce Lin Sun-Hoffman, Ph.D. J.D., she is a Senior patent Attorney from Applera file systems. Previously she worked at some Applera Managing Captain preparation and prosecution on gene patents as those other gene related diagnostics. She also worked as a patent at USPTO examiner. She's here to enlighten us about the private sector side of this equation. It's great to hear from you.

Think you. Can you hear me? I am from the industry. I guess like most of you and work with academic NIH government. I spent last seven years as in-house counsel. First I work for [ indiscernible ] which is a Jim nomack company and did a lot of a gene patent filing. Recently a move to another division applied file system which is a research tool company. I see both of the gene patents. Before I start and there is a little disclaimer here my personal view does not represent the company view. First from my aspects the typical Jim patent claim you click method for making of a protein and for screening and also you claim antibody based on this gene. And also in addition, with the gene patent you have a method for diagnosing a disease by monitoring a gene expression or a protein expression and also a method for treatment of the disease by targeting that gene was antibody a small molecule. That was typical claims in the patent. Why do company uses gene patent. He probably know this background many needing a target to screen they have libraries adjust to screen the compound. For biotech company is developing the podium like platform using a target to develop an antibody treatment. He would have the different proteins that expressed in different disease stage so you develop target for the treatment by antibody. Here there is a couple of example in the treatment, protein and an testing and these are all target to specific protein. Ford diagnostic company Applera also has the diagnostic with mutations associated with certain genes. This is another type of use for the gene. And also both Speaker talk about [ indiscernible ] is also for diagnostic purposes. For the research company we use them as friends, primers and putting race for using. And the gene patent holder this academic and U.S. patent there the majority holder and there is some industry. People probably familiar with inside and HGS Applera, these have a lot of patent issue assigned to them. And I use Claires side, that's the survey to reiterate that the majority patent are academics and government from a company's point of view, we want access to a patent especially like a research tool company. What we do a big search, whether those of Jean has patent issue. And Majority and patent are in the public domain. The earlier one in the public domain, no one can patent. Once you did a search there is no freedom to offer its that is patent counsel. We just license or design around or try to negotiate some kind of other deal with other patent owners. Here, again, the academic and the U.S. The government they are the majority owner sys of the gene patent. So companies, the licensee are [ indiscernible ] developers they try to obtain the license, just like Clare stated the, the majority research company getting their first research information from the academic NIH. From my experience seen how we usually get the license that those are not exclusive from academic and from U.S. But as clear stated, now more and more academic, they want to have exclusive license so they can make more money off that because we are in more research area so that more tend to be non-exclusive license. But they had [ indiscernible ] company as a patent owner a is owned a company [ indiscernible ], vague license them where they develop them self our license is right inside an internal develop those genes themselves. Some of those only develop exclusively, I was told they do license to the academic for steady [ indiscernible ]. The type of agreement we have is straight license agreement. From industry point of view [ indiscernible ] target has some huge development value. In the early stages is really not exclusive. Or is there is some internal development we have a collaboration our agreement with a pharmaceutical company.


[Replacement captioner attempting connection to audio line. Please hang up phone so that audio connection can be re-established.]

[Time is 9:00 a.m. CT. Replacement captioner dialing 1-301-985-4641. Need somebody to hang up phone on event end so that audio connection can be re-established. If there are any questions, please contact Caption Colorado at 1-800-590-4197.]

[Time is 9:10 a.m. CT. Captioner still unable to re-establish audio connection with 1-301-985-4641. If this information is incorrect or there are any questions, please contact Caption Colorado at 1-800-590-4197.]

[Time is 9:16 a.m. CT. Captioner unable to re-establish audio connection with 1-301-985-4641. If this information is incorrect or there are any questions, please contact Caption Colorado at 1-800-590-4197.]

It is free easy for somebody to say this kind of institution is just a research. Merck is just outsourcing their research. So lets sue them as well. So I think a lot of these lines we are hoping to draw between academic researchers versus non academic research are all very busy anyway. I think my view that I described it a little bit in the talk is that ultimately if you are dealing with micro array diagnostics or if you are dealing with multiple mutations or multiple snips for a particular disease the of the solution is not just any old patent polls which have problems because of [ indiscernible ] issues as Clare mentioned and other problems and other such issues, but carefully defined patent polls where international health organizations like WH0, APHO or the SNC, the American College of Medical Genetics [ indiscernible ] ethnic panel for cystic fibrosis is to have the following seven mutations. These petitions the to meet every universal test that works for cystic fibrosis. I'm sorry?

[ indiscernible ]

Then the patent owners, which in our fields -- the patent owners and the Consumer Product electronics know that they cannot put the product on the market unless the talk to each other. It is impossible. They depend on each other. One has the patent on the chips and the other has the patent on the CDs and the other has the patent on electronics. There is no product unless they talk to each other and they are used to talking to each other. In our fields companies don't talk to each other. There is this long history and tradition of exclusivity in the pharmaceutical industry. And I find this over and over and over again. So for them to sit down and start talking about cross licensing are forming a pool for diagnostics, it is played out in left field. It some international association was to come in and say this is the test. You need these by [ indiscernible ] and this too bad that three patented by three different people, but any one of those is not the standard of care. It is going to force, I think -- that is my proposal. It is going to force people in this industry that don't talk to each other to start talking to each other and to start to cooperative the more. That is my view.

And the other solution is either compulsory licensing or exempting, you know, clinical practitioners from a patent infringement. There is a dichotomy because the very same universities that have a clinical lab at the half of the market in these troubled their transfer offices busy transferring these things and by two licenses. So you can't say don't suit our lab but by the way we would like a lot of money. It is bill problem. The other thing with cystic fibrosis is you have some people who actually said to the tech transfer office, please license this not explicitly and that is how it was handled. I have seen the presentation and if every did it the way [ indiscernible ] handled we would not be here.

The other point I want to make it is probably easier at NIH to suggest that academic institutions follow the NIH guidance document. And that is a the a bit disingenuous because the NIH place by a different set of rules. You don't have a mandate to try to make money and your bills are paid by the taxpayers. Private institutions especially live under these, perhaps come on realistic but nonetheless expectation that tech transfer will potentially make money for the institution. And that is the motivation for doing this. And so you cannot tell them to adopt a different set of standards that says, don't worry about the profit motive. Simply give everything away as much as you can and be reasonable about it because it is just a different game.

But to be fair, the University of California, exquisitely licenses the [ indiscernible ] patent and make a fortune because they did hundreds of licenses. So it is not always unprofitable to lessons in this manner. A lot of people to don't realize that and it is unrealistic for every tech transfer office to cover its costs are to be a profit center. Universities must learn that.

These are not controlled experiments. Reasonable minds and regional institutions differ on strategy.


Okay. We have a little bit of time left with three people on the list. Andrea, Julia, then Sherry.

Mine are more comments because mine were basically raised. I am a though skeptical of patent pools. Because there is that were voluntary in there. An academic does not know how to play nice in the sandbox. Industry cooperating with each other because they need each other, academia tends to be this all for me and all for me. So I am a little skeptical of the patent pools and how long it would take to get a patent pool together for one diseased even if you eventually could. The second point is what was raised by Andrea. This is not going to be a problem that goes away. It is not that everything is out there and it is going to go away because I am aware of the older ones that you were mentioning. The last two and a half years I have moved up to a higher level and not the rookie running a laboratory. Andrea mentioned in the last six months there have been three cease and desist letters. It is not stopping in is having it very large impact on diagnostics. While we talked here and we have -- you have a mandate to look at research issues related to genomics, this task force has decided to look at clinical access and patient access. And so I think you need to focus the discussions on those aspects of the impact of gene patents on clinical access and patient access to the use of this information for health care. And the conclusion of the evaluation of the NAS report was that much of the research issues have been addressed. So I think maybe we should not continue -- we should focus the discussion more on the clinical and patient access issues.

Okay. Julia and then Sherry.

I have a comment about the micro array that's because when you do those to put all the scenes there and many of the heart many covered by existing and to -- patents. If you do a micro array you cannot possibly could to every single gene and like every single patent application. So how do you -- how are people balancing these two things, they need to do things and all existing patents that are behind all of the genes that are in a micro array?

I can put two cents in there. With those micro array we to a freedom to offer search and then go to the company to talk to them. Usually the license is pretty low, but sometimes we cannot find the genes that -- it is impossible to search every scene. So far we get letters from universities where they have time to go through all of these websites to find out which genes are there, but it is hard to detect most of the time. [ indiscernible ]. That is not a big issue in the industry at this time.

But you are right in the sense that everyone up the gene sequences needs to be cleared to be used commercially. You have a million different sequences up there, and if even one of them is patented, I would take it out out that the NRA or go get a license or stop the whole project. And all three of those have happened. People many times well proceed towards developing Micro array and find out that two or three of the genes they want to use our are licensed somewhere else and either they take them out for the whole project stops.

You mentioned earlier that one suggestion is for the NIH guidelines for liberal licensing to be made mandatory for grantees. I wondered if you could explain the legal authority that NIH has to do that and what mechanism would be used, like a regulation. And let me just tell you but I am struggling with. By using a parallel example, in the area of research with animals NIH clearly has the authority to regulate what happens with animals while the research is being conducted. But what if there was a lucrative market for post research animal petting or something, how could NIH control that after the research is financed and is a great commercial activity that no longer convulsive research?

That is an excellent question. Essentially we make a condition to grant. In other words we say you cannot make the money unless you will say that you will at least to narrow is this is or nonexclusive and we probably have to write in some reasonable exceptions are some sort of a venting process so that we don't to be up to much. But as far as legal authority we probably don't really have -- it would need to be changed to be really able to do it, but we could make it a condition of the grant. So essentially we are not making you do it. Is just if you want our money you have to do it.

Has had the analysis being done to answer the question of whether you have the authority or not?

I think we can get the authority but we don't have it right now, but I don't know that definitively.

As far as the research tools policy, we were able to make that a policy and did not have to change in the laws. We were able to answer to that is a condition of grant. That was the analogy I was thinking of. Unpopular though it would be.

Okay. We are already behind a bit and I am going to pull a read on you and curtail part of the break. That's me back in five minutes. I want to thank the speakers.

Reed would never do that. I don't understand.

[ applause ]

[ break ]

If you want a ride to the airport or need transportation you need to go to Abby or you will be walking. Because they do not care. Like I did not get any lunch yesterday, I'm telling you, man. They don't care. Secondly -- I am just teasing. Now she feels bad. I am just teasing. They care. They love everybody. I'm sorry. Number two -- they are going to take my money away. Congratulations. She is not here now. I have waited all this time. Okay. We will do it later. Debra Leonard, would you please to -- we are so pleased you are here and you are going to do public testimony. Because you have to go to the trained people to public testimony. Because one of the things you are going to publicly testimony on is the topic dejoir among other things we are happy to have you public testimony.


I forgot my hat.

For those that do not know depending upon what see is talking a lot put on one hand or another and she has a whole collection of them.

And just in case you are confused, I am not Bob Cook. Dear Dr R., number -- members of the committee, good morning. I am a [ indiscernible ] and I am speaking to you now as a member of the Association for molecular pathology. I will forgo the a coalition of the mission. The purpose of these comments is to provide the perspective on three issues relevant to the stars to the [ indiscernible ] and the concerns of AMP. The first is the proposed federal legislation is to oversight of genetic testing. As you have heard in other public cost estimate recently two bills have been entries into the U.S. Senate liting to the regulation of laboratory developed test. Senator Kennedy has introduced a bill entitled the laboratory testing permits Act and Senator Obama as introduced a bill until the to genomics and personalized Medicine act. AMP agrees with the intended goals of these bills which is to protect public health by entering saved diagnostic tests. However, we are deeply concerned that these bills if enacted into law which have unintended negative consequences including some really restricted access to genetic testing services by the public as well as decreased innovation and implementation of novel to the test. As in other areas of medical practice laboratory medical advances by implementation steps as defamation becomes available. And we started believe that the same the tentacles can be achieved by strengthening mechanisms and a strong collaboration with the power sector. The purpose of raising these issues with us is to ensure that this advisory committee is aware of these bills and the potential negative impact that may result for genetic testing services. Furthermore AMP asks to request that the Secretary of Health and Human Services convene a meeting to engage key stakeholders to maybe affected by these bills with members of Congress and relevant regulatory officials to reach a common understanding of the purpose of the legislation and the best ways of achieving these goals without unintended harmfull outcomes. The second point of concern is the assessment of reimbursement for testing testing Services and I feel like a broken record here. That was not in the official comments. AMP members performed genetic tests and other type of molecular tests for the best and the patient care and continue to struggle with the economic reality that the reimbursement levels set for the CP T codes used for genetic testing are less than the cost to perform these tests. Report uncovers and reimburse the issues and made recommendations to the Secretary that we can develop a plan to address this issue, AMP is not aware of any action taken today. We applies -- to plot report and recommendation and asks that they follow up to determine if action betaken to correct the inadequate payment levels for these codes. And finally the third point is on gene patents and patient access. We ask that you continue to give full consideration to the negative impact of appendixes of licensing and enforcement practices on genetic testing. We are encouraged by the approach that they're taking to investigate the impact of gene patents on patient access to genetic testing. We want to assure that scene patent enforcement continues to limit the test, molecular policy levers can perform [ indiscernible ] their patience. We encourage you to carefully consider and develop recommendations to the Secretary of Health and Human Services, but will address the clinical impact of these practices. We remain available to assist with or provide additional information for your thoughtful deliberation and important work. On behalf of AMP I think the committee for your time and for listening to the concerns.

Thank you very much and those comments are well received. I to -- we have one comment. Let me just say people and the it CMS comment. So I am pretty confident that that will be added to the list of things that CMS will be responding to, and I feel their is a pretty good pathway to try to get CMS comments back to us on your matter as well as the other ones that came up yesterday.

Let me bring the microphone closer so I can project. Anyway. One thing that strikes me about today's comments and actually to comments from yesterday, there are different organizations that represent not only the laboratory, but also aggregate groups and individuals that brought to our attention the legislation but be -- that is being introduced at the Senate right now. We also have received key charge from the secretary to look at this oversight and I heard yesterday that the secretary's office is looking at issues of oversight. So it seems to me that with these groups they're asking us to look at this issue and ask the Secretary to engage the stakeholders in some kind of coordination among the different groups to make sure that [ speaker unclear - audio low ]. And we hear from the stakeholders. So what I think that maybe we want to consider at this committee is writing a letter to the secretary asking this specific question [ speaker unclear - audio low ].

I think we had Chris yesterday who was representing the office of legislation. He could not be on the call with us. Craig Burton. In so I think that what we might want to do was say, if you could take back to Craig Burton this point. Can I get a sense from the committee that is to see what we are looking at is -- and correct us. We want to be assured that the administration is doing everything that it possibly can in terms of its coordinated activity between the various bills that are in play to try to give us the best calculus for success.

And make sure the stakeholders are involved in the discussions to make sure that there is -- that the consequences to this development are a flotation of this.

So I think that just because -- and unless the committee would like to guide me in a different way, given that we had a conference call yesterday with the senior person representing the office of HHS for legislation with the two key congressional staff people who clearly all knew each other and we're all talking, if we could get a strong sense that what you heard here, I think that would be faster than trying to read the letter and have it go through whatever the heck the process is that it has to go through.

Would it drive the message stronger if we write a letter?

I -- I say we follow up with the letter. Andrea will draft the first draft of the letter. And get the draft to Sarah who will then expeditiously get it to me and we will forward it to whom? [ indiscernible ]. No, you don't have time. Yes, if you want in on this you better get to Andrea and help her draft it.

Look what you sparked.

Preliminary to having a meeting of the various stakeholders on the bills, do you have somewhere your specific questions or concerns about the two bills?

The Kennedy bill has very broad implications for all of the clinical laboratory practice. So they don't restricted to genetic tests. Any laboratory developed test is included in this process. So what you need to understand is that is far reaching way beyond genetic testing. So the breadth of that is very scary to clinical practice. The other bill actually incorporates much of what this committee has been deliberating on in the various sections. It does -- it is much more reasonable in allowing a process to be developed on oversight of laboratory developed test, specifically, but there are many other sections. But looking at the laboratory developed test process for oversight of those tests it is much more to look and develop a process which would allow stockholders input. So that Bill is probably more reasonable up teetoo. I think that was AMP analysis.

So I think that is important, and your comments are respected. I want to make sure that we don't -- I want to be clear about the committees sense of expectations. As I understand it I think that what the Andrea recommendation is is that we are encouraging the secretary's office to be in -- to continue their process of collaboration between the two bills, sponsors and stakeholders so as to address the chances of a bill going by. I think we are being studied in not trying to get into which bill is better or the other bill. Although Kevin's question is for the inappropriate. I just want to make sure that there is no sense in the committee that you would be disappointed if we did not way as to which Bill had greater merit. I think that is not our role as an advisory committee to the secretary. Good. Thank you.

Turned it over to me.

With glee. Hand to the committee's credibility.

Well, I want to introduce now Bob Cook-Deegan. It is really a pleasure. The secretary's committee is rare fortunate to have [ indiscernible ] and the services of Bob and his group and try to help us grapple with these issues. His team is working on the patient access study. Bob is the director of the Center for genome, epics, Law and Policy at the Duke University Institute for genome Sciences and policy. Previously he was director of the Robert Wood Johnson Foundation Health Policy at the Institute of medicine. And I will turn things over to Bob.

Thanks, Jim. Is my microphone on? Can you hear me in the back? There. I can hear it is making noise now. I am going to make the walk you through a premiere on intellectual property. I am going to try because Jorge and Karen others have covered a lot of this territory. I would just pulled out some lessons. Before I do that I wanted to and all assistance to do so much work. They gave a presentation to a subset of your task force last night. Julie as a postdoc / legal scholar. Chris is the actual teacher of the course that presented last night. The students on the left and the Julia and I have been helping out with that project. Shuba is the posts doctor had to the early this morning. She is running the class tonight. Basically what we were asked to do by your committee is to turn the data and the resources that we have at Duke on the question that is facing your committee which is about access. And I think one reason that Sarah and your committee turn to us is that we have a research group that has been funded by the National institutes of Health, national genome Research Institute and the Department of Energy to study the role of intellectual property and informational flow in the innovation process into genomics. It is the Center for genomics. It is called that because we are in particular he had what is the distinctive role for having lots of information about genetics and to number is available to large numbers of people all over the planet to the Internet at relatively low cost. What does that do for the innovation system and how does that interact with the intellectual property system. This is subclass of things that we have been looking at although we have really not looked specifically at [ indiscernible ]. Here are the factors you are contending with. What are the meeting variables that affect access that much relates to intellectual property? One is prize. The whole idea of a patent is that you get more control over your prize because you can prevent other people from using and most important selling the thing that you made, your invention, on the market. It can also be associated with control of the invention. You will see some examples of that in the diagnostics arena. You can actually impose conditions of the people testing because you had sold control over that intention. For example, in diagnostic testing for Alzheimer's disease there was a big controversy. Well, as in the diagnostics said, we will only do the test if the condition says a signed statement that says, this person as far as I am concerned has dementia and therefore this is a diagnostic test. That was to prevent screening. They could do that because they had exclusive rights to the 32p that govern testing for Alzheimer's disease. Another factor that entrenches regulatory approval. If we get heavier into this game of other testing in mending test or for these more complex Micro array and multiplex tests then obviously that has an influence on the overall market to end this contract with the FDA in ways I will explain. And finally reimbursement is a big deal. You just heard about that. Who pays how much a pair pace for a service matters a lot. And some of these examples I will work through depending upon how the rules fall out, if those developing tests are expected to approve the equivalent of safety and efficacy Ford said the test before they get paid, that is if CMS says they aren't going to pay for tests until yet proven clinical utility and you have to pay for it and it will cost more to develop these tests and there will be a higher demand for having intellectual property protection before take the step down the road toward getting any new test on that particular condition. This is not data available to you yet. These are the cases -- and I really am not going to good too deeply into them, but we are doing a comparison of breast and colon cancer testing because they are clinically similar. The patent landscape is different because the married of genetics has control over breast cancer and the patents that are relevant to bracket testing were as the intellectual property for colon cancer testing is more diffuse and it is mainly owned by academic institutions. It is being -- it is available through a much larger number of laboratories. I will go to each of these cases but we will some information on describes the condition and chemical decision tree and would exclusively at the role of the intellectual property on access to the degree of we can find it. I will say one summary is a will be very hard to give you crisp clean information that keys in only on the question of access. The best we can do in some cases is to look at utilization which is how many people actually use a test which is only used -- this proxy for access. What you want to know is how many people who should be getting access to something are as a fraction and how many people who should not be using a test are. Is for it hard to do that, but people go as far as we can with these case studies. I will now shift gears and I really want cover those case studies because you will get more information. This is the team does pull together a lot of the teeten. There'll be a lot of data and I apologize for that, but these supplies will be available to you and we have preferences for most of the data. You can recover and look at it at greater length when you need to. Just to reiterate some of what happened in this morning, basically a patent is this ability to prevent others from making, using or selling your invention. You have to disclose your invention in sufficient detail that somebody else can use it, and the patent system works because the court system of national governments becomes a tool for defending your rights. You get the patent rights and the courts will defend your right. So they are subsidizing your exercise of that right. Why are patents called patents? It is because the idea is you must disclose a lot of information. That was the tit-for-tat that was set up in the Constitution of the United States. So we have in our project in the been looking at technologies. None of the things that you see on this list here, these are things where we are trying to pull together what the story is. I have carted them into things that are unpainted, things that are patented by academic institutions and things that are patented by private-sector interests like firms. Most of these are patented [ speaker unclear - audio low ]. Some of these we are just getting started on a summer yet better stories for. So -- let me step back. And let me step back even one step beyond that which is what are we doing in the first place? Everything you have heard about this morning is all the hassles and transaction costs and price increases associated with patenting. So why are we doing this in the first place? There are two justifications for having [ indiscernible ]. One is because if he just do something useful for the world you should get a reward. Therefore if you are contrary to to viable to society he should make it a bit of money. This is the idea that actually goes back to Robert Locke and it was his idea that Thomas Jefferson stole and put into our U.S. constitution. And that is where the idea of progress and science and useful arts came from. It was a very straightforward translation of Lockean [ indiscernible ]. In the area that we are talking about, one is it does what we just said. There examples of that are in our stories. Terri is working at Cetus and discovered PCR. The patented it of the budget which related. They made about $300 million of the intention when it was sold. It was sold in parts and the rest of it went to come around. At deal went through in part because of the $300 million which enabled it. And then they made about $2 billion of a PCR. How have they done that? Because your read as for doing PCR are a little more expensive. Every time you buy one of the Terra cycling machines you are paying people feeding money back to host an interest in directing. Why are we doing that? Does somebody did something awfully useful. It is a piece of analytical -- is a fantastic method and everyone uses it ever. $2billion sounds like a lot, but if he you spread it out over many years and bundle it with sorts of other things the system, that's it. The same thing for. I know you have heard about that, but that was the discovery at Stanford University. They made about a cover to the quarter of a billion dollars the that the but it had any impact on the in price of any of the price that generated most of the income. That is one thing that the patent system test. He do something useful and get money out. There is another thing that the courts have tended to focus on more recently which is that if you have patents or you have the prospect of getting patents in the future, that induces a investment in companies. For example when investors were deciding back in 1985 excuse me, 1991 and '92, should we invest in this thing called myriad Genetics you think those investors were thinking, if they can get patents on some useful commercially a voluble things then be broken some money back from our investment. This is a theory that is contingent upon be able to carve out a collection of property and sell it for profit. The same thing was going on his human genome Sciences with this order during sequencing. We have stories like that going on. In the chart that Clare showed you will see that in sentiment geosciences have a highly disproportionate share of the gene patents that are held. The reason for that is they did this sequencing. In part they were expecting to get patents that they could sell on the market. Either they would make products or they would get ravenous when the people bit product based upon the stuff that they discovered. There is the third thing that the patents to the does a lot of work in drugs in particular. We have case examples of that in biotech. That is if a product after you have discovered it and made an important discovery if it still costs a lot of money to take to the market, say you have to prove safety and efficacy of your product you have to patent the thing up front, but then you have to prove that it works and that it is safe which costs tens of millions of dollars and sometimes hundreds of millions of dollars. If you will make that at best and improving his sick before you get on the market you need something to protect your investment in the discovery in the first place this is the work that the pad and distilling. The solving what the Cowboys called the free rider problem. What happens if he did not have patents and the situations? He spent the money to prove something is safe and effective in a generic manufacturer walks in and says the did you put this thing on the market taken remanufacture your parking -- your product at a cost of production without having to do the R and D expenditure to prove it is safe and effective and therefore those price are in theory not ever to happen unless there is some other way to pay for safety and efficacy testing. The baby have construct the system where those costs are borne by the inventor or by the company who will market the product, and that is the way it will be. You need something that will protect that investment. Patents are not the only way to do that. [ indiscernible ] is another way see that. Some background numbers and then I will shoot through a bunch of did decide to give you a flavor. I want me to memorize quizzes at the end, but here are some numbers. These numbers are as current as I can make them. There are about 44,000 U.S. DNA patents. I'm sure you understand this, but hasn't lot is national law. You can get a broad white patent, but that means you have to go country by country. In places like Europe you can get a Europe white patent, but it you ever have to defend it you have to go country by country. It is litigated in each national patent system. Said the U.S., as you will see, as a whole lot more activity than other systems. There are about 44,000 DNA patterns. What do I mean by that? That is something that at least mentions DNA or RNA in its claims. You describe your invention and then say claims. The claims are what Jorge was talking about. The picket fences that define the boundaries of your invention. It you walk onto my territory we are going to hit you. And the claims are what define that boundaries on. If you mention this than we are pulling it into a data set that is called the DNA patents database and that is just a collection of terms that are specific to nucleic acids. It is about 25 or 30 terms that we tested one at a time for sensitivity and specificity and we think it works pretty well for capturing DNA patents. There is a subset of those patents that are sequence patents that mention DNA sequence specifically. And the number drops from 44,000 down to something on the order of 16,000. These numbers are very inexact, but it gives you as least an order. So what is the difference? The difference is things like [ indiscernible ]. Like PCR, like butter [ indiscernible ] patents. Promoters and in answers might be sequence base were they might be too short strip sequence. And then finally within six patents is a subset that is a gene patent. In the gene patent is usually for a complete DNA that is full length, the messenger RNA. The picture that contains the DNA in the cell line that would produce the things that that team makes. Said that is usually a package. And that is the protecting patents. There is it a bit of wobble in these terms. You have heard the figure of 4,000 state from the tense and worried paper. Actually, of those 4,000 about 1,000 of them are only on my progress and things like that. Sir your classic tin pans actually account for 3,000 of those. The thing to notice on this side is of the 16,000 sequence patents that exist worldwide most of those are only in the United States. Show you a graph any minute but here are the raw numbers. There are only got 750 that have been issued in Europe, and only 500 of those have issued in Japan. Those are the three big markets. So this is actually kind of real strange situation.

Do you have any idea how many of those gene patents are diseased genes Association patents?

No. Nobody has looked at that. Nobody has looked at actually maybe I will come back to that at the very end get it is one of the [ indiscernible ] think about doing as a tactical step. To summarize what I think is a fair summary of but most scholars -- and we our academic. But here are some things that most people who study this business would save the kind of agree that these are generally true. We think the peasants to induce investment and private sector activity. That is, there is more R and D going on because of the prospect of having a patent. These companies exist precisely because they expect to make money. One of the ways is by having patented things. It does create assets for startup firms. It does solve the free rider problem, at least in some situations. And we have many examples. The patent system generates income for universities like the contents or the actual pence generated $790 million for Columbia. So the universities are making streams of revenue of of the patented materials. There are some other things that we agree are inherent in having a patent system. They make it more expensive because you are charging more and because there are a hassle costs and transaction costs associated. There is more of a bureaucracy. If you're going to keep track of things and account for them it will cost more money and create friction in the system because any time you're counting things and have to account for them there is going to be friction. In a way it is tax on innovation. And the request and I think that has been building and the service of a lot of the exchange this morning is does it really come up the efficiency of the R and D system if you have too much clutter if you have to clear up the press before you can do any real work. And we have a problem and it is an efficiency problem. There are some things that do not happen in the real world because of these encumbrances. So in the example of PCR it seems pretty clear that some environmental uses did not happen because EPA and the enormous or researchers don't have NIH but it's and could not afford to go out and use PCR for looking into zillions of plants in many many ecosystems. They just could not do it and the difference between a patented and patented technology may have meant that certain areas of research just did not happen. That said which happens if you look at some inventions that are patented for some that were not? What we have here is three examples of a preliminary chain reaction which was patented by Cetus. This is PPR322, the contractor that was a second generation which was developed at the University of California San Francisco. On patented but absolutely could have been. It was a beautiful piece of engineering. Then we have Maxim and Gilbert sequencing that absolutely could have been patented. Had we know that? Because there was a DNA sequencing method that was patented in 73 that was a lot less coverage than this. So it could have been patented. It wasn't. This was by a guy who went on to form teenine corporation, not a guy who headed patents. Also at the time this was discovered dates is to not think about doing things that way. The question here is does the fact that something is on patented like these two dimensions affect the adoption curve? To a first approximation you will see that the curse look pretty similar. So what can we conclude from that? Not a whole lot because we don't know how much use of PCR there would have been. What we can say is at least it was not catastrophic. There was a lot going on. It was little more expensive than it otherwise would have been but does not seem to have completely driven the innovations system to a halt. Now, one of the things that is distinct to genomics is that it was a very compressed period of very rapid investment in a lot of companies, and this is their market capitalization. So these are publicly traded firms that not only get started but actually went to public markets and put their start up for trade. So you can count what they do. One of the things you can count is how much they are worth and you can see here is the 20002001 public speech about three months after the announcement of the draft sequence in June of 2000. And then it went down by a factor of five and is beginning to build back up. You will see at one point there was almost $100 billion in value in these companies. That is what investors thought they were worth, but in fact that dropped precipitously and it shows you the volatility. This shows you the Big 15 firms on that list. There are about 75, 77 firms on that list. Of the Big 15 have continued to increase their R and D despite these fluctuations in their overall market value. You will see they are spending their money on R and D, but they are also spending their money on plants and equipment. And the fact that the trend is going up faster suggest they are also spending money grabbing new talent from the from pharmaceutical industry. They are pulling people to their businesses that get paid more. So the curve is a little steeper. This is the general landscape. This is the most general category I gave you and it shows you the very rapid slow rise from [ indiscernible ] right here. This is when it became okay to patented living thing. You will see there are some patents that happened before then without any controversy. It really took off at a steady rise during the early 90's, the East and then it took off exponentially for a while from 94 to 99. For three years in a row it dropped and then last year it went back up again. I have not shown you those figures. The figures on for this year are it a bit ahead of last year. This is not a permanent drop-off and looks like it is beginning to reverse. This is a striking slide. This is how many sequence patents, the subcategory of those patents are for sequences that have been issued by the different panting offices around the world at different times. The U. S was always it will hire. There were a fair number not been issued. Japan is black and Europe is white. They always where the white hats in the Penn came, it would you see here though is since 96, after that exponential rise that you saw in the previous draft there are a lot of patents being issued in the United States and no place else. This is what that looks like year by year. You see the slow and steady increase. The reason they are dropping at the end is not because it is going away but rather because those things are counted. Those are probably things that are still under examination in the patent offices around the world and therefore those curves will probably come up some level that is higher than right now but it just has not happened. The only definitive data on this camp from reading all over the patents that were issued and the United States from 1980 to '93. And Steve McCormack and I read these by hand and could them in one of the things because did was to haunt them. What you see here is a very anomalous pattern. A the a bit over half are owned by for-profit firms of one sort or another. Usually it is 3% academic ownership or less. Tele-Communications, widgets, as France. This is an anonymous the high representation but here is the data from the European group, a really Nasby's of analysis that came out last November by the Science Policy Research at the University of Sussex. What you see is the fraction of patents going to private sector interest, that is private firms has been going up with each successive time. Which is what you expect to happen. If you add these things at the bottom which are the private sector interests you see that their function of these patents going up. Now, this is slide taken from the Jensen and Murray paper. I apologized for the low quality. It is from Science magazine and I just pulled it right out. The news here is that this fraction that clear alluded to, these are Gene patents. How did they define that? They found all the patents the confined that it's a confirmation and then they married it to the database if the NIH that is the best curated Jean database. So this is the stuff that biologists to to characterize their chain. They dump the information at the National Library of Medicine and compared the sequences and patents to the sequences and will characterize jeans and asked where they massed? That is how they came up with this collection of 4,000 some teams that are patented and the 82% or so that are not patented. So now that on patented set is a combination of things that will never be done to it and things that are not yet patented. And we don't know the relative proportion of those. Nobody on the planet knows that. Academic institutions on the most DNA patterns and this shows you what to do with those. These first two, we did not know what was going on. The university's actually don't administer a certain number of patents that the on. They give them to somebody else. So we don't have any data on those. The zero licenses for about 30 percent of the patents which means somebody pay to get a patent and the never licensed it. That happens about 30% on average. Most of the patents were licensed once. Does that mean is exclusive? No. You can have a non this is license to a single licensee but that has a lot of overlap with not excessive licensing and there are really interesting patents and this collection, these 45p that have been licensed more than nine times which are the actual patents on code transformation come on production of the protein on the base sell, it is the common border patterns and being able to detect forcibly label cells that to the registrar developed at Stanford. Those our classic pants that had been nonissues of the licensed, usually as a source of income that has not really gotten in the way of the innovation process very much like the PCR story except a little cheaper. So now what Sarah asked me to do is to say, okay, what are peasants during and then what could governments or other stakeholders to about this? What are the policy papers that are at your disposal to make terrible walk through some things going on, some things you might think about that you could do and just to give you an idea of what is going on in the real world that your report is going to interact with. One is there is patent reform being contemplated in both the house and Senate, a bill that made it, there were hearings in both the house and Senate last year. It sounds like there is even more energy behind this because the intellectual property interest of Telecom computing and supper businesses are fed up and are putting a lot of muscle behind trying to get patent reform which is really what is driving the patent reform. The biotech and pharmaceutical constituencies have, for the most part been three happy with the way things are. It is oversimplification to say that they -- I think it would be happy if there was no reform but I think they may have accepted that there might be reform and therefore if there's going to be reform there are certain things they want to see happen. But this patent bill is going to probably be going through with the next year were to during the hundred and send Congress and this is something where there might be provisions that would be relevant to your work. A bill was dropped in about a month ago by heavier the Sara from Los Los Angeles and represent the will and who is a physician from Florida. This is bill that would say from here forward there will be no sequence based Patten's. So that Bill has been introduced. There is one co-sponsor, Pete Stark, and we don't know what is going to happen with that beyond what I just said. He saw mention in Paris talk of the rivers bill, plunders run from this in. She was squeezed out because she was forced into the same district but John Dingell who run the same primary. So her bills died with her candidacy. And nothing happened in the 108th Congress, but that idea is still perking in the background and could be brought to life again. There are also the commission practices and that is doing a lot of work. That is stirring a lot of work. If you look at the difference between the U.S. and Europe and most of that is not the rules because we have the same patent criteria for the most part in both sides of the Atlantic. So something is going on in the way the patent office's are handling these inventions that is quite remarkable and tells you that there are levers to pull. You heard mention of a research exemption which does not exist under U.S. law. The Duke started is history about 100 yards from where I parked my car every day. That case is now over and we give him back his pre electron laser. So this case you won't be hearing about any more. We have done our damage. But there is talk in the wake of this of creating a statutory research exemption under U.S. law. There were some proposals and it is not currently on the table. But you will see that in Belgium and France they actually passed Research exemptions that are pretty substantial. And there are many research exemptions and other countries that allow you to do research on the invention. These are actually exceptions that allow you to use the invention. As well as do research on it, much broader exemptions. Finally you heard Jorge and clear both alluding to compulsory licensing. What does that look like? Basically in Belgium the king of Belgium decides to with the better off -- our house would be better off if we could use this wonderful invention that somebody made. It does not take away all the rides, but it takes the exclusive right away from the patent holder and basically says as the king of Belgium I am acting on behalf of the people and we are better off. People pay you but we demo please and not what you want. It reduces the press coverage that a patent holder has. So patent holders tend not to let this stuff but that is what has happened in Belgium and France. And it is under hot to speak because India passed a new patent law that went into effect last January. It is being actively to get it right now. Many to helping countries that have to adopt the new Western rules of patenting have built compulsory licensing into their statutes precisely because they want to keep public health at the forefront.

That compulsory licensing you are implying comes with reasonable royalties?

Yes. It is supposed to come with reasonable royalties. That is one of the issues. I don't know if you are covering it, but the Thai government to step in on AIDS drugs and says we are going to force compulsory license. Thereof to rate was .5% which most of these colors in this field think is too low. And if it is challenged -- it is going to be challenged in the broad court system and it may be too low, but if it was 5% there would not have been much of a squabble. So it is supposed to be fair and reasonable, but what that means to the court system depends. But, yes, it is not an absolute right to override the patent rights. Rather you are supposed to still give the investor some return for their invention. In the patent reform system, this is probably more detail than you believe need to know but these are the two things that have gotten the most attention in the patent reform bill in the U.S. The most -- one is the U.S. is the only major country in the world that has this rule that in the you as if there is a dispute between two people that have Kropotkin's at the same time the courts are supposed to figure out what we call an interference proceeding to actually invented it first. Whereas in other countries the patent office just says, okay. You have to prove that you invented it which is much easier to do. You can't steal something and then patented, but if you invented it yourself and prove that you did not steal the idea, meaning they can't prove that you did, then it is the first person to file a patent application, just an administrative simplification. So for the sulfur and computer people that this is driving the budget because they have patens all of the world and they want the U.S. to shift to the same rules as other countries. The interference proceedings are extremely expensive and you have to hire a very very special lawyer and there are only a few people in the borough to do this stuff. If you break any of the rules about evidence for case blows up in your face so you hire these people at very high prices. Everybody was like to get rid of those transaction costs except for the lawyers. So the U.S. might switch to a first investor to file. Interestingly universities are kind of in love with the first inventor criteria and let the U.S. law as it is. So there has been hostility with to this change within The University community. Probably most importantly as illustrated in the case study that Julie will be presenting, there is an opposition process that does not exist in the U.S. You guys and the patent up the spread to consider this other stuff when you gave up those claims, and that means that if you have to do that within a certain time, and once that has happened it stars a proceeding to basically look at the patent again in light of the new information that has been contributed by outside parties, and this is what happened to the bracket patents and led to the dramatic narrowing of the Parker won patent from the entire team to just the mutation that is highly prevalent in some Jewish families. That is how it was discovered and that is how its claim is structured in the European union. It is a narrow path and compared to the patents in the net States. One little sidebar here is that the coin Boyer patent kind of went through this kind of process and is not completely unprecedented but was because Stanford brought that on itself by openly prosecuting their own patent. What they did that? They thought they were going to get sued and would have trouble keeping the cats heard it and therefore they openly prosecuted the patent. So a lot of prior art was but to the attention by a flurry of articles that happened just before the decision was going to be made and the Patent Office issued the patent anyway. So the court looking at that case would say they did consider this stuff and this is not just a patent, this is pattern that busted some scrutiny that is much more serious than normal. So what are the tools at your disposal? There are all sorts of stories in the scientific community of things being patented and Santos not liking it and beginning to push back and say we are just not going to get those licenses. Initially PCR licenses came with restrictions and scientists would not sign up. They made a lot of noise and complained. They wrote nasty articles. They would yell at the officers and you know what, it's changed. The policy change sent a this is up their licensing restrictions. The director of NIH took an active interest and negotiated a much more liberal licensing strategy which then became the template for other universities to use as their licensing strategy. It gave the scientific community access to very valuable technologies and it didn't require a lot being passed. It just requires some of the negotiation and some people yelling at each other in public and low and behold the policy changes. Moreover Harold farmers and Francis Collins as well as Bruce Alberts when he was the head of the National Academy of letters to the patent office sink you guys are being too sloppy. Stop it. They made a lot of noise and lo and behold in conjunction with a very important court decision the patent office began to increase the level of scrutiny of gene patents specifically. He would not know that from the patent numbers. But the fact is that there are a lot of patents that might have come through Linda otherwise that did not. Finally there are all sorts of rules that had been alluded to. These are where most of these guidelines Clair is alluding to, the OECD licensing guidelines. The autumn guidelines, the NIH best practices guidelines and the residual guidelines are all in this practice is but there are also some rules that the site security has imposed on itself about sharing of data and materials that interact with intellectual property. So the large sequencing centers agreed in '96 when we have a -- when the sequence the think of DNA of more than a thousand base pairs beat-up that on the Internet. They just count themselves to an informal contract saying they would do that. That matter. What does that to? It means that if permission is up there and if you discover a gene based on the sequence and that is the only thing you have done be you're going to have a hard time getting a patent because that is that in the public domain. It does not make it impossible but the have to do something beyond to sequencing. The consortium, this is the group was trying to find variations in the human genome. They sat down and said the only way we can make sure this stage in the public domain is people file patent applications and characterize each spelling difference in the human genome long enough of we are sure nobody else can patent it and then people walk away from the pack. So it was expensive, laborious but crafted as a strategy for keeping things in the public domain. So if you get a grant now from NIH you say you will play by those rules. There is the best practices document that came out a couple years ago and the licensing guidelines were just officially sanctioned last year. There is the University statement that Clare directed towards and was in your packet for the meeting here. This came out mainly from Stanford. A lot of the problems that you are addressing would not exist of those guidelines were being followed. It is really that simple. And if you could get practices to adopt those guidelines you have a legacy problem. You have all these patterns and buses that had been signed that won't go away, but moving toward a lot of the problems would be solved at the skies were being followed. Finally when you get a grant you have to have a data sharing plan. We had to have one for our grant. Well, we make certain promises. The sign a piece of paper that if we don't do it somebody could do something about it. That is a tool that could, in theory, be used to make sure that information is out there and flowing freely and that it is being used for the purposes for which it was generated. The problem with that is enforcement. How does anybody actually know? Well, they don't, but that is a tool that is out there. Right now we only have informal mechanisms. How would we know? We do know if somebody is a bad actor or if they are stupid enough to say in public what they are doing which sometimes they do, but most of the time you don't know unless you have a systematic way for monitoring what information is being shared. So Sarah did ask me to review some of the empirical data. You have one of the experts, probably the single most important study on this list is the survey that their colleagues to it. What clinical labs for doing and what it demonstrated is that some folks have stopped offering tests that they used to offer or have decided never to offer in the first bus test that they might otherwise have agreed to offer but for the patent situation. That tells you that the provider level there are certain to have backed away from certain kinds of diagnostic testing. It does not necessarily tell you about access because if somebody then goes -- in the case of married for example if the same patients that would have sent their samples to U Penn or the idea of clinic in Virginia or to encore bed when it was operating if instead they are sending them to marry there might not be an access problem. It might just be they are paying more money. We don't know that and it is very very hard to get data that is sufficiently refined to be able to tell. There are two poster children that to almost all the work and is probably the reason this committee excess. In the survey of the literature that was done by the upper to group, Julie as colleagues at the University of Alberta have done a valley nice servant of who said what about the Bronco and all these other cases on the poster Children of the behavior and D in a licensing. Reckitt is way way way far and had the case that matters to most and have the most negative publicity and is mentioned in almost every policy report. You saw some of those from the U.K. and U.S. and Ontario. They're is a report from the Australian law reform commission. They all mentioned record. They me mention can the. They may mention Alzheimer's testing, but they all mention the practice case. Now a key things that will come out in the case study is the think you need to understand is the pet story is would carry the day. Essentially it is only offered as a genetic test by myriad and the reason for that is because they had a very strong patent positions and drove the other providers out of the market using their patent position which is not what has happened in any other terrorist action. In the U.K. The National Health Systems said it pushed back and said we won't play but those rules. In Canada one province, one health minister in one province Curry publicly said they are not going to put are your rules and overtime since married had a lawsuit and has not one has not prevailed, the other provinces have pretty much follow that province that was Ontario in not paying attention to the patents for all intents and purposes. They are being ignored. And it is testing as usual. In Istria a license to an Austrian firm that said, hey, Health Systems in the provinces, you can use this and we will not issues of the lessons. It is a very different patent situation. This is a very unusual case. It was a relatively inexperienced licensing office. This is my interpretation. It was some combination of secrecy, the trail and overpricing. This was a bad outcome, and it led to an out-of-court settlement with I hope all the parties are happy with. We don't know the details because that is what happens when you settle out of court. Here are things going on that are actually a big deal and I think these are more powerful than patents and predicting access to tools in the future. One is coverage and reimbursement in the key question here is, if it becomes able that you have to prove that your test is actually useful in a clinical decision path and it will be part of a clinical guidelines, for example, if you have to prove that as a company before you put something on the market or before you could pay for it by the Paris, that will be a pretty heavy burden. And it does mean the patents will be a more important part of the game and it will get even worse if you not only have to prove that it works but worth paying for. And that may be the direction that things go. If the FDA gets in the game the other for the single machine or full the multiplex test, that is a regulatory hurdles that everyone will have to go through and that would increase costs and also increase the importance of the intellectual property associated with those tests because then you have to solve this free rider problem I talked about before and have to prove your thing is useful before you can make any money off of it meaning that it is going to cost more to develop these tests. Finally the push back is one of the ping test of what I am talking about today. The biggest push back in the bracket cases came from the monopoly power of the patent holder bumping up against the monopsony. That is when you control -- when you are the only buyer. So monopoly works against people and they are atomized buyers but there -- when there is only one other buyer they can be issued as hard as you can because they control the market. When monopolies monopsony the dynamics are completely different and that may be what happens in some diagnostic tests. So a few things to say about the examples I have given year. Many of them are relevant. That is the thing to notice her. The technology is moving very rapidly in the direction of many genes being associated with any given condition. Many alleles for each gene and meeting to be able to have technologies for looking at what is happening to those genes. It is not just measuring inheritance but also measuring something in a tissue or a state variable. What is happening is it is cancer or not cancer? That is the direction that a awful lot of DNA analysis is going. That is a completely different game. The technologies are chip, micro or Ray, analytical our rhythm. This is a much more complicated thing and it begins to feel a little bit like making DVD machines were making a really complicated a cumulative technologies that require multiple components that were alluded to earlier. It is a completely different game from the case discussed. So those could prove to be out space is rather than the norm. And we have already said enough, I think, about married and the Fina to indicate that those are the two cases in the gene patenting game that have the biggest effect on diagnostics that I am aware of. Mike Watson might know of cases that I do not, but these are the two that we keep bumping into in our work. Finally, what is going on in the big picture about gene patenting that might influence you're thinking as you make this report? There are a bunch of opportunities to be taken that even given the current patenting situation might have led to different outcomes. If be hit years has changed among the stakeholders. One is if some of these patents began to be challenged. It instead of just being a license fee we heard the dynamic of how the company thinks about, should be actually pay for the slices are not? If it is $8 to pay the license because you don't want to spend a million on a lawsuit. But is the dynamic going on there? We have a prisoner to long. One big stakeholder who has a very strong stake in defending their intellectual property and you have a lot of other players who have a much lower stake in seeing the friction go away. You are willing to tolerate a certain amount of friction especially if you have to take a big risk to solve the problem for everybody else. It seems possible that the would be pushed back that happens from time just for example I mentioned this because these are patents held by my Own University, do it. If in during the clinical trials under federal funding if the university decided to do that clinical trials of had said, no, we will not play by your rules, they could have, in three, taken this to court and I don't want to predict how a judge with look at a federally funded invention funded by NIH being licensed to a company that then goes back and is being used primarily for a clinical trial being paid for by a in ACRI and other parts of NIH and saying, you absolutely have to honor this patent because there is that little provision that says the government has certain rights and interests in these dimensions. It is not clear to me that this is out of bounds and is arguable. You could get lawyers to line up on the other side which is why nobody pushes back. The risk is that you might lose and he might spend a couple million dollars and at the end you are still going to have to buy the license and pay that $8 per test. Deborah had this experience with Myriad. Actually, it was not Debra but the your city of Transylvania where it became a bone of contention whether providing bracket testing under NCI studies was considered research or not. Could there have been pushed back against Myriad on that case? I think there might have gained -- being. It is arguable that the outcome might have gone the direction of saying, that is research and it is not of the research exception. Because there were federal adventures associated with the additional invention. It looks like, as are headed to, spring cord is itching for a case. It looks like the Justice would just like to have a case to chew on, and if that happens then suddenly the rules are very different. That is how we got into this game. This was a five to four decision were one vote changes and then the rules change to talk. It is an earthquake. Finally has I had already illustrative these stories for broadcast in Canada and the U.K. suggest that patents are not necessarily the most important thing. When you're dealing with a health system which we don't believe have in the U.S., we have atomized buyers and sellers and buyers but in other systems that have a more coherent policy making framework it turns out that maybe the patent situation is not going to be the thing that determines the outcome nearly so much as what it pays for and under what conditions. Finally, state and because we are doing this gigantic experiment. We have delays of intellectual property on on this side of the agenda and are on on on the other side of the Atlantic and in Asia. And I have no idea -- this is a game that is just beginning to play out because there is a 20 or 30 your litigation cycle. Insulin was patented and conned in 1967. Since the case that finally decided that took place in 1997. There was 20 years of fights going on before we knew what the answer was to the original planning case. So there is a 20-year cycle. Most of these bands began to issue in '94. What does that tell us? It tells us that at about seven or eight years from now people begin to see whatever litigation to drop that is likely to be the time when this stuff hits the fan. I have already hit all these points and I have a bunch of data size if you have questions, but I'm not quite to hit you with all the sides. Just a bunch of affirmation I wanted to make sure was available. You already have a question.

That is all right. That was easy.

Can you clarify the government's March and rights? Does that require going to the courts and through litigation to the government to do that or can they just say, we are going to allow the use of this in these situations?

Let me be clear. There are three aspects that are related that are completely different. They have three different procedures. What is the rights I alluded to. Basically if you have got -- if your intention to rise from federal funding the government very clearly -- for example the and I is into relapse can make, use and sell the invention from any university that -- you discover something as a valuable and patented. NIH intermural Laos unquestionably could use that for free. They are government and part of the dree Department that sponsored the research and can use it for free which is built into the statute and they don't have to do anything. That is a boon for royalty free paid-up license to use that invention. If $1 of that when through federal funding. That is just built in. There are two other provisions. Clare alluded to one of these like with the mouse part of collection NIH did this declaration of exceptional circumstances and said this is a special case were funding this work in order to create a resource will be clearly available. Patenting is just getting into a year. NIH makes that determination but it actually has to go to the Department of Commerce to ask for permission because that is officially have been arrested by the Department of commerce. If in SF and in I ate in the early in the quarter and the defense had little more flexibility in how they could go about doing that he might see more use of that kind of a provision. Universities hate that because that is a reduction of their autonomy. But that is a possible angle. The third thing you alluded to is Martin. Margin is something. There were four persons written in that said if any of these four conditions for maps and the government can step in, even though we gave you your passion rise. The government has decided that this is a really weird case and one of those provisions is public health. They can at that point march in and grab back the election a property that give away. That is very different from these other two situations. They never actually done this. If they decide they're going to march into the patent holder as an appeals right built into the statute. It has never gotten to that level. NIH has always decided we are not going to Larkin. That can be opened by statute.

What are the four conditions? You mentioned one is public health.

I don't want to quote them. Public health is the one that has done all the work in all of the cases that I am aware of. There are three other provisions. One is probably that they are not working the patent address of the enough.

[CAPTIONER TRANSITION]please hang up phone and reanswer.

... spending faster than anybody else. They were not losing patent rights because they never got the patents. They were filing patent applicationings, really bizarre, that go on for pages and pages, phone-book sized, where the last 600 pages are sequences of pages, they have no idea, but wanted to dump it into the patent system to keep somebody else from patenting it. Then they would dump it into the public domain, very sophisticated, expensive strategy can only be used every once in a while.

Question: To clarify, you mentioned briefly the FDA, one of the benefits of patenting to an Inventor is to avoid the free rider, and you mentioned data exclusivity, the FDA could be used for the same ends, could you elaborate.

Being built into the trade agreement, hotly contested provisions, basically what you can do is, FDA can in certain circumstances say we will only consider data that are contributed by the party testing this product or service, which means that if somebody else later wants to make the product or service they cannot use the data the first party -- somebody gets approved, diagnostic test on the market, assume it's a -- test, something like that. They show they can measure what they are measuring, accurate, does what they say if does, approved by FDA, on the market, somebody else comes along saying we want to do the same test. You are mandating, FDA, saying we have to prove these things to you, well, we want to use the data they contributed and show we are testing the same they are. No, you have to recreate the data they produced as a first approved entity. Therefore you get rid of the free rider problem getting everybody generating the data, economists hate that, but it solves the problem.

Question: True that 510 K --

That's specific to devices, Jorges would know more. In the -- if you introduce a new drug into a new jurisdiction, we are building into trade agreements, after approval of FDA, you have negotiated exclusivity, depends on administrative decision by an FDA or FDA equivalent. I don't know what triggers it in the FDA.

Yes, I am from FDA. I must tell you I have never heard of this provision, been operating in FDA for 15 years without knowledge of this provision. The 510 K program doesn't lendz itself well to -- the -- program does, to a certain extent, advantages to sponsors to fielding a class product, putting more burden on competitors, making it difficult, not impossible to do product-to-product comparisons. The construct is not familiar with the the working level outside of the usual way we do business, to bifur cate the data requirements for the first to classes of -- product.

The person written most about this is Becky Eisenberg, if you want to go down this pathway, she wrote a piece, the mechanism used to get Tack rin on the market. Unpatented drug, a period of data exclusivity for Warner-Lambert to test for Alzheimer's disease. Not a common thing. In theory, it exists. In a way the pediatric extension is a data exclusivity situation, so it's an idea floating around out there. If you wanted to go down the path I would get Becky in here and ask her to talk about what she's found out about it.

Okay, great. Thank you very much.


In the next few minutes we are going to have an update on the progress, status of the SACGHS, by Bob Cook-Deegan and his -- before that, I want to go ahead. Do we have the slides? I wanted to refresh, you will have to release the password -- I am not privileged with the password information. They know who to trust.

I wanted to review for you all the structure of the study plan, you have seen this slide before. Again, part one, the items in red are things that are being pursued by the institute there at Duke. Literature review, consultations, case studies, the conceivable need for additional research, tractable, identifiable. Part two, public perspectives, staff is beginning to put the nuts and bolts together for that. Part three, gaining international perspectives. I would like to introduce Chris conover, who works closely with Bob, Chris is an assistant research professor of public policy, studies at the Terry Stanford institute at Duke university. Chris and Bob will give us an update, then we will have committee discussion of the study plan.

Chris Conover: I will be brief and you will be happy to know I don't have slides. I gave you the backgrope for the work on center, this flurry of e-mails I alluded to, Sarah, just before Christmas, basically saying could you guys help out, given you have the tools you have, apply them to the problem we are facing for advisory committee. I fired off an e-mail, won't say anything more than that except so say it seemed like a good opportunity to show the -- for real world decisions, good proxy to make a decision about something, spending time and energy to figure out something. I figured well, we better make our stuff available to that group. Sarah cc'd Francis Collins and -- I knew the right answer. So we were very happy to help out.

One of the mechanisms I thought of immediately is the mechanism Chris will talk about, what happens at wonderful universities, access to students who are bright, have to take courses. One of the courses we teach is described by Chris.

Chris Conover: I am director for health policy certificate program at Duke. As part of that certificate, the certificate is like an interdisciplinary major that any Duke graduate student can wrap around whatever degree they are pursuing. In the capstone seminar, the last course they take as part of certificate sequence they are supposed to bring everything together, do a first-rate policy analysis is the way we put it in the syllabus. This was a great opportunity, as Bob said, for all the reasons he described, but I will describe the group of students that take this class. It's very interdisciplinary, this year we have students that are representing the business school, law school, medical school, and even the school of the environment. We have mid-career people who are pursuing a masters of art and liberal studies, very diverse mix of people and leads to very interesting discussions when we talk about policy issues.

So we are doing this study in basically two tracks. We are doing a literature review where we -- you didn't show that -- okay. You are going to describe the process?

I was going to describe about the case study, that's all.

Chris: We have a conceptual model of the process of innovation starting from basic research going all the way down to test actual patients. As Bob said earlier, the issue in terms of access is trying to figure out who should be getting these tests and are they actually getting these tests in the real world. Are there either price issues or other delays, time issues, that result in decrements to access. We are looking at underutilization and overutilization.

A little update on what we are doing, this is a poor taste of what you will get later. The model of genetic test development, relying heavily on a report done by the lo in group on the development of diagnostics, Lou in, belt way bandit that does terrific work in health technologies, a report on how does new diagnostic work, applying to the more specific case of genetic tests. Students doing literature review on genetic tests specifically at each of these stages.

The other thing we wanted to do, usually drives policy, you collect and count things when you can, and you usually can't. Any of the numbers you really care about, because people don't collect them the way you want to interpret them, and you collect stories. We are trying to do systematic stories, called case histories that would be thing that's we think we discuss in the literature, for example. And give an insight into how the stories came about. These are the case studies that the students converged on. We got help from Mike Watson, gave us heads up in the last two cases. We wanted to find squeaky wheels in some cases, have a representation of different kind of diseases and comparisons where we might get some insight. There's no perfect controlled experiment, we can get some approximations, breast conser versus colon cancer, roughly equal rev lance, genetic testing falls the same place more or less in the clinical decision nodes, and fame I willial cancer, five to 10% in both cases roughly. Genetic testing is similar. In one case, myriad, secured access, exclusive rights to most in the U.S., not abroad, not the thfert to use them for useful purpose. In U.S., both. Shut down the alternative providers, bracket testing. That contrasts with colon cancer, ownership of genes is mainly different companies, a few thrown in as assignees or coassignees. Licensings, many more providers of tests, we can look at prices. The students, Christy, medical student at Duke, public policy degree, called up the labs that offer the colon cancer testing and breast cancer testing, said what do you charge, simple methodology. Next case is -- versus cat a vans, both with dire outcomes, clinical outcomes. Where the intellectual property in both cases to nonprofit institutions, can a advance, controversy -- the other trying to figure out the intellectual property case, discovered the seminal gene -- but trying to track down and figure out the story.

Cystic fibrosis you know about, generally oversimplifying, a case of relatively liberal licensing, by the institutions that did the gene discoveries. Not terribly controversial.

Hem a Tom a cro sis, an article written, I suspect you read, written for Nature, discover indeed a baby biotech, discovered at Mer Cador, went belly up, sold IP to progenitor, went belly up, sold to large firm, belly up is not a technical term. Intellectual property started at a genomic start-up from the first generation, subsequently sold up the food chain, interesting story, fairly common trait. Last two cases are ones Mike Watson had a big say in helping us think about. These are cases where there are many genes where there's intellectual property, some of which is being libberally licensed, some isn't, a pool might emerge, if the world were a perfect place. The funny thing about people as compared to DVD machines, the frequency of their allele differs, and the frequency of a particular gene test is going to be different -- they are going to have different powers. Not all patents are going to be equally valuable. A particular condition, you will think it's more valuable than the less frequent. In a patent pool the easiest thing is throw it in, count, give out the money according to that. If you have a hold-out who thinks their patent is particularly valuable it complicates the formation of patent pool. The kinds of cases where if you want to make the world a wonderful place where everybody could get access to technology at low cost, these are places you have to have lots of genes, lots of alleles of the genes on a single diagnostic test, test it all, require aggregating all the IP.

If you are going to have an aggregation problem these are cases where that might show up. Where we are in in these cases, started to -- the patents, sounds easy, sometimes easy to identify the patents. Making sense of how they do work in the real world is really complicated, that's where we are now. We're trying to identify the patents and read the claims, figure out which piece is absolutely essential, which piece could you throw away without worrying about it. We are hoping to go as far down the path as we can and feed that back to your committee in the next couple of months.

It's very disturbing and almost refreshing in a way to hear you say how complex looking at the patents related to a disease are, because that's what every physician has to do at every academic institution if they want to do testing, it's not what physicians should be doing. It's interesting to hear an expert having problems doing this.

I am not an expert, Jorges might be. I am a scholar, the opposite of an expert.

Other specific questions?


Before we move on to the committee discussion for the last 20 minutes or so? Thank you very much again.


We have four specific questions to go over with regard to this morning's session to get committee input on the first one, remembering this was essentially an educational session. Did this session this morning provide sufficient background information on the basics of gene patents and licensing practices? Are there gaps that you all feel you can identify that we need to fill at the next session? Are we deficient in our background at this point?

I will take no comments as a lack of deficency. Going once, going twice. Okay. Well, I would really rather not debate scope, we have a debate that gets to scope, the last thing.

Next one, similar to first question. Did this session provide sufficient background information on the key policy developments related to patenting and licensing processes. Would you identify any specific pieces of information or gaps we need to fill before going on?

Great. I for one feel much better after this session. I feel like we've really had a series of speakers who were able to lay these things out for us. The study methodology, it's difficult, and I think Bob really summed up the changes broadly in the policy realm. We're interested ultimately in patient and public access. We even use clinician's access as a rough proxy for that. That said, it's problematic, if not impossible to really get at that specific question of patient access. What's been identified through the task force meetings, consultation with Bob's group and all, really is trying to get at the best types of information that are out there, but also the types of case studies that might allow us to distill data out of it on the impact of patents. We have focused on performing case studies via Duke collaborators, public perspective and comment, then trying to also glean lessons from the international perspective.

Do you -- is there a sense among the committee that we are on the right target with regard to this methodology?

Pursuant to the questions that came up in the earlier morning session, it seems to me a piece of information were lacking, a finite challenge, although I know Bob would scream at me for suggesting that. If there are "only 3 or 4,000 gene patents" the question is what percentage relate to a disease and we clone the gene for protein -- my thinking about all of this would waver significantly if there were 200 patents related to human disease versus 2800 related to human disease. That's finite. Someone would have to go through, look at the claims, either claim a method for diagnosing disease or they don't. I think we are missing that.

I guess what you would postulate then, if it's a very small percentage there's less evidence patents are having much impact.

Except your own point earlier was that this is where science is going, to make these gene disease associations and that's what's going to be patented more and more in the future. Even if it is a small percentage, I don't know knowing the percentage of the 3000 will influence this group, could be a larger or smaller tip of the iceberg.

I would think there would be a cost benefit situation. Something to be done in an afternoon, I doubt it, very interesting, and useful information. The question is how costly would it be, something we can take up with Bob in a task force meeting, explore that if the exitee wants us to do that. Committee --

When Bob put his slide up about factors effecting access Sarah and I had a little discussion. There was price, hassle, regulatory approval, but Sarah and I were talking, there's also to some extent availability. Availability of tests, which gets to some of the stuff John and Mildred and I did about how broadly is the test available, which gets to the sole provider of a medical service, how many of those really are there, if you take into all the ATHENA patents and myriad. I am not aware of too many sole provider situations. That's the worst way of looking at -- the worst examples of availability. Then there's also the issue of how a patent holder restricts the use of the patented information. For the example of CMC 1 a, the exclusive license of that patent would not do prenatal testing. They were deciding medical practice. Are there examples of access because of the way the patent is being utilized, used in various ways. These are all proxies, but additional proxies you may want to take into consideration when looking at these various cases.

I think it's worth having availability as a separate thing. I think of that as related to the hassle factor, it's a different thing, maybe use that word. Classic words of the IOM definition of access.

I think of hassle as the laboratory director getting a cease and desist letter, having to spend hours with the university lawyer, patent lawyer they are bringing in to consult with -- that's to me hassle. Or being proactive, having to look up what the patent holders are, whether they will enforce against you before you do a medically relevant test.

Not what we originally thought, those are -- I was thinking of what has led to the outcomes in U.K. and Canada as much as anything else. When myriad says you have to send the results to us, the relationship from counselor to -- you have to ship it off to someplace, handle the information, you have to create new data structure, relationships, put in the mail, and it perturbs the system, as much as anything else, and the price, the buyers say we don't want to play that way. Not making an exception because vu a patent on it. That's what I was thinking.

There may be a lot of definitions of hassle, and maybe you need to refine --

I got it.

Can I comment for a second on Hunt's thing, I think it would be good to have a discussion at the whole committee after the dust has settled a little. I showed the list of thousand patents where we hand coded them, tookis about a year, I will never do that again. It's a fair amount of work, but a deneumerrable set of things, we coded all of those patents. One thing we are thinking about, the set from 1980 to 93, 38 categories, c DNA, mammals, humans? Diagnostic method, probe, categories having to do with diagnostics. Each box in there, could go back to those original thousand, say diagnostic or not, get the pioneer cases. The other thing we are thinking about doing, I don't think if it's possible. You have a set of patents, there's new semantic computer -- say, here are 60, 80 patents, all of which we know have diagnostics in them, we hand-coded them. Go find out, find the other patents that kind of look like these. Pull those, look at those, see if it's doing a good job. If it is we might have a set of -- it will just look for word that's show up, do a lot of work in patent claims to do that. Don't know if that's technically possible, might be possible to do this sort of thing quickly. The problem is, if you look at, for example this European study, there were actually 1.9 million sequences that were claimed at one level or another that resulted in the 16,000 ,000 sequence based patents. How do you go from -- to -- a lot of things show up early in the process, never get issued as claims. Two, a lot of those things are things like probes, snips, some of which are diagnostically relevant, but not genes. You would miss all of that if you only look at gene patents that meet certain criteria. That could be a pretty big deal for microarray testing, stuff like that. We just don't know.

I think what we could do if we have permission of the full committee, discuss in a task force meeting, decide on the cost of that.

One more comment on that, if there are going to be policy changes that are considered it might be useful to know what the legacy would be, in other words what are the ones that would be out there, not considered and that could make a tipping point in terms of how the policy might be crafted. The other thing in terms of looking at access issues, that I didn't hear. I know there are a lot of pairs that are dealing with issues of contracting with specific reference laboratories and how things are happening related to tests -- only as sole source. I know at least anecdotally -- a way to look, see the impact in a captured population of impact on access.

Reminds me of one data resource I should have mentioned. Out of these case studies, we are trying to think about what data could we mine to get this. Alexander Shields at Harvard is an incredibly good health service says researcher, trying to come up with algorithms to map to -- for a lot of the tests you would care about there aren't specific CP c codes, but you might be able to take data, narrow down, the equivalent, you get the bracket test or doafnlt might have developed algorithms, United Healthcare health set, get utilization set, loose proxy, but suppose they have data from Denver and Atlanta, we could time sequence that according to the months after the direct to consumer ads happen, uptake in utilization, look like bracket test being, impact of intervention.

Or if you could compare the -- colon and breast --

We are trying to see what we can do with data sets out there. Alexandria has all the -- she would be available to you.

If that algorithm is put out I hope it's not copy brighted copyrighted or patented.

We have one more potentially controversial issue between you and lunch. Kevin, Deborah?

Kevin: Maybe you could give a sense, it's come up a couple of times, the ideas of differences in the international arena, compared to the United States. I am curious to know, granted in the patent landscape, nations tend to operate somewhat individually, but still there's gotta be international pressure there is, or tendencies, dynamics, somebody might have the pulp of to give a sense of where things might go. We advise the secretary of this country, but obviously, as you pointed out, things are not going to be happening in isolation, vacuum. If something is available overseas that will be cheaper, I presume that's where the market will go. We won't be able to make decisions in a vacuum, it will potentially put us in a very uncomfortable position. I was looking for more, better sense of international trajectories in what will happen.

Let me make two generalizations about that. You have seen the data that show where an ought outliar case, what I am about to say, blindingly obvious, but may overwhelm the difference, if we are talking about access to care we are also an outliar. What is it causing that? I doubt it's patenting. We have limited access to all sorts of goods and services in the U.S. for certain populations. The specific sets relevant to intellectual property is really difficult in dealing with systems of care whose dominance of -- how we structure the system. There's a really profound problem of interpretation that we will confront when dealing with access. The fact is many many U.S. citizens, access is a complicated problem. The bottom and top have pretty good access. The people right above the working poor, we don't have data on those populations, trying to mine that. We will try to do that. Not sure how important intellectual property is when you have a profoundly unfair system you are starting with.

One last question from Deborah.

Deborah: You think you are moving to last item. I want to go back to the previous one -- can you go back to the policy. I know that all the speakers today have brought up a lot of policy options, wot I but I don't have a clear sense of them. The task force needs a list of NIH, diagnostic, medical, e xemptions, tech transfer. Who would do those --

That's on my agenda. I completely agree as we move forward we have to keep in mind all of the different possible remedies to issue that might come up as problems.

From the data you have given, Bob, you have given the source of how much it cost necessary s in U.S. Could you talk about how much it cost necessary s in Canada, Europe, if a patient could get ought outsourcing --

Yes, we are doing -- easy to get -- not always easy for health systems to know how much it costs them to do -- in other places it's a completely different model of how tests get done, but you can get an idea of how much a lab needs to get paid to do a service, some idea of what they would charge. Very rough. Talking about one significant -- better than we usually do in the patent business. We may be able to give you limited information there.

Great. Okay. I am going to move on. We have four full minutes to discuss this controversial issue. It does indeed have to do with scope. Should the scope of our study be broad to cover the -- now, let me just review for you briefly what the scope says. That we are undertaking a study of the positive, negative effects of current gene patenting and licensing practices on patient access to technology and ultimately the public's health. I will give you my view: That it's very difficult to address that scope without also addressing the scope of gene patents on human pathogens, hepatitis c, pathogens with profound impact on human health, and genetic fests genetic tests are useful, employed, it's hard for me to exclude those from our scope.

Not everybody feels that way. Deborah?

Is it possible not to include pathogens as the focus of everything we are doing, but consider always when we are looking at the policy options whether or not pathogens would be covered by whatever options we're looking at? Because we will have to consider the broader impact of whatever policy suggestions, recommendations we're making to the Secretary. We could always keep it as a back question in our heads without actually asking Bob and the students to take another case study.

I agree, not interested at all in expanding the amount of work. I think keeping that, though, on the table is to me legitimate. Mark?

I was going to say a couple things. In the rapid diagnostic area I would look at this as similar to other types of rapid diagnosis for pathogens, not that dissimilar. The targeting area is probably going to be, go through the typical pharmaceutical type of approach, gene targets, pathogens to affect -- keep it on the back burner, what will emerge related to pathogen/host interactions, then will that really get into issues that are going to prevent moving knowledge forward that way?

Other comments? Hunt?

I was going to concur. I reread the charter. It's very hard to exclude it given we are focusing on technologies, not genetic disease per say.

Then if the committee approves, what we will do, we will keep that within our scope, within our purview. However, I agree we don't want to derail the deliberations by focusing on that exclusively. Agreed?

All right.

I think we can adjourn to lunch, then.

I don't know where Reed is. Great. I have other changes I want to make.

Be back here at what, 1:45.

[Break for Lunch.]

Captioner hanging up phone line for audio. Will redial in prior to 1:45.

Captioner attempting to redial.

captioner attempting to redial. Please hang up audio number and re-answer. Thank you.

thanks! Caption in call with music on hold.

Please stand by for real-time relay captioning.

Did Mark quit yet?


I have done it twice.

There's no coffee, they don't care. Just don't care.

We will deal with the rules around refreshments. Staff is under draconian prohibitions.

We will do something.

The solution to this is in the future.

I would not suggest anybody do what the chairman did, crawl on his belly, look up, at other people's food.

That's off the record, yes?

Oh. Are we on yet?

Three cameras looking at you.

I was speaking meta forrically.

The session is now back in order.

Thank you all very much. I do I want think I don't think we have more public testimony, we will be able to move forward.

Can we at some point, if our ace team could put up on the board at some point soon our strategic agenda. That's really what the rest of the afternoon is all about. Really all about the strategic plan.

In June I asked the members and the exfish oweios to study -- a couple of colleague says s have been really helpful, made suggestions. As we launch into -- and by saying we are revisiting the strategic plan doesn't mean you have to change it, or do anything. You have a lot on your plate, don't feel compelled to act because it's on the agenda. A normal review. I am not trying to downplay, or the doctor formally known as -- your presentation, but I want you to know you don't have to change anything if you don't want to.

We will now hear two proposals, I will start with Steve on the importance of analyzing the economic consequences of the genomic innovations.

This proposal links closely with what you will hear from -- and figure out how they fit together.

You have the proposal in tab 7, I won't read the whole thing, some of it restates the obvious. We know that all the innovations we have been talking about have the potential to improve the health of Americans and are likely too have a fairly broad impact on the healthcare system and the systems that support it. One of the major problems we face in the country today is the extraordinarily rapid rise in the oifer all cost of healthcare, consumer 60% of GDP, twice the rest of the country, one of the major drivers of that increasing cost is technological innovation. Genomics today is a tiny part of the increase, but will probably play, has potential for playing a larger role in the future.

As I look at the charge associated, we have the advisory committee, seemed like the economics is one of the major social consequences we probably should be looking at within our charge. So looking at technological innovation, it's impact on the healthcare system, although we have a robust environment we know almost all of the technologies out there in the aggregate increase costs. There are very very few that in the aggregate really save money. Many of the new technological innovations provide great value, and we as Americans have embraced them. But nonetheless there are few that save money in the aggregate. We open genomics will be one of those leading to prevention and huge amounts of healthcare costs.

But that may not be the case if what we have is a plethora of new therapies targeted, cost of diagnostics, management and potential for costly drug therapy or other kinds of interventions.

If we think about, try to imagine the future, it's important to think about how that process potentially is going to get managed and considered to have rules of the road going forward. If you take the premise as correct, that the costs are likely to increase in terms of healthcare costs that's not necessarily a bad thing. Other benefits at societal level as well. We can go through a long list, but obviously support a vibrant research and development enterprise, commercial enterprises to the extent we are healthier, more productivity, better quality of life. There are many aspects of the economics that bear thinking about.

One reason to bring it up, the economic consequence of genomics in particular, haven't been put in the broadest context, we have the opportunity to do that. That's a big topic, economic consequences of research going way beyond the mandate of our group. On a quick scan of who is doing this, we didn't, couldn't find any other groups that were taking this on, we could be more thorough in the future to look, but not a problem being, informing the -- dialogue.

What we were -- I was going to propose to the group to examine the issue, preliminary basis, scan of the, if you will, the economic consequences of environment. Look at a number of issues, explore the issues we think should be addressed. I identified a few that occurred to me at least. Who will, should pay for innovation, the downstream costs. How are we going to afford that? Who is going to benefit? Industry, employers, academia, healthcare payers. How can the costs be managed to optimize the use of available resources, allocate wisely? How will these technologies be paid for when developed?

What are the rules of the road particularly for insurers, if one is investing in development of technologies what's the assurance they will actually get coverage?

Is this going to be based on some level of certainty of net benefits, incremental benefits, other issues, issues that I think we could elicit some of the stakeholder's perspective and get a better perspective on how to go forward.

There are a lot of ways to use the research money available, how to be allocated, basic, applied research, better use of technology, translation into practice, establish proof of concept, more for prevention, more therapeutics, advice we can provide along those lines.

As a first step I proposed the creation of a very small exploratory group from those of us on the advisory committee, our colleagues, to begin to prepare an issue brief we can bring back in July that will flesh out this domain in a little more broadly, and talk about where we can provide, have the greatest opportunity to contribt. If there's agreement to proceed to some type of white paper that we would put together as a product of the committee itself.

Reed V. Tuckson: Thank you Steve. Let's keep the notes squared away, come back and discuss both of them together. That's terrific. Thank you. Now, if we could hear from Gurvaneet Randhawa.

Good job.

I am impressed.


Thank you.

And Mur iNE. Whoever.

Thanch you, we are in the unenviable position of being the last people holding you up in this room. We will try to make it brief. I have one slide in front. Formal title is inthe greating genomic in clinical practice, one can call it the slide from Dr. G. I have, in this slide, highlight, maybe not at 30,000 foot level in a slide you saw yesterday from Wylie Burke of the different phases from discovery to outcomes, impact on outcomes. In this slide, I have taken more of a 10,000 foot above the ground view where moving from the top left corner is initial discovery done in the biomedical research labs, also in the genetic epidemiologist, largely in NIH, CDC, first cause in a disease, causal link, correlation, in vitro experiments, data from animal model and from humans. Now we move from the phase of academia and federally-funded research to more of the phase where products get developed, this is more the private sector, pharmaceutical and diagnostics industry. For convenience I have put two pathways here, research and development of there a therapeutics, and diagnostics, one can add vaccines, pharmacokinetics, we have phase one, two, three trials, for diagnostics it's more observational studies. The examples we have heard haven't gone through the FDA regulatory approval, but for the most part things do undergo regulatory approval and then are available for clinical use.

Now, that is actually where most of the things need to happen before we can start thinking of using this routinely in clinical practice. The next box below is what I call a small box of outcomes research. This is a huge number of studsy designs.

This group of study designs can come from different databases, health plan databases. Medicare, Medicaid claims databases, electronic health records, another source, and of course we can launch new prospective studies.

What I have below the box is three mechanisms of arc we can use to -- one is traditional grant mechanism closely modeled on NIH, the auto 1, auto 3 grant mechanism. And the program called CERT, centers for education research on therapeutics, cooperative agreement program. And the newly started contract based program called the DECIDE network. This is newly created, started to look at comparative effectiveness of drugs and devices in diagnostic tests. The next phase after we have all the data from different studies. To synthesize the data, through evidence based practice center, the EP c program, we heard yesterday Dr.Berg chairing the -- panel, about evidence based -- working closely with the re-Program to have evidence reports through EP c program. Examples, genomic test nothing cancer, cytochrome in depression, for s SR i use, and the other reports, on hn PC c and -- profiling. Just with the e gap program we have other collaborations, it's new testings, other evidence, ongoing, family history testing through another part of CDC, division of cancer prevention control.

We have mechanisms to look at many topics, the theme is the same. That is, there's not much evidence. That came clearly through yesterday, and I think the challenge we have is not how we handle the evidence, which of course is a daunting task by itself, but how to get the evidence in the first place. How research comes in it. But to go through the whole process, the evidence reports are closely paired to decision-making, the dm in the next box. Decision making can be for guideline development, the gd in the initial above the box, or coverage decision-making through Medicare, Medicaid, health plans, insurers, ascertaining whether there's enough net benefit of introducing something in the clinical practice. There's a whole slew of questions that need to be addressed. What are the benefits of the new therapy, the harms, the net benefit, the added value. Most of the times things are not done in a vacuum. You have an existing test, existing therapy, what's the added value of this new test, new therapy to what we already have here. Finally, what are the costs, coast effectiveness. Once the decision makers look at all these aspects the disiz gets made to cover the test, recommend using the test, then we have next set of challenges, how to implement the decisions, if you heard issues about access to care, changing behavior from early adopters to late adopters. Finally, the routine phase of clinical use. All of this is, trying to simplify the diagram, other steps one can think of, for example could be a feedback loop from the routine clinical use to see, as part of post marketing surveillance, we achieving intended benefit or not? The public health dimensions that -- will address, not part of this slide. The only reason to have this slide is so we can focus on what is the discussion about right now. It's on outcomes research, that small box right after availability for clinical use. I think it will be useful for us, and I am grateful this coinsiedzed with the secretary's charge, if the committee decides to have a work group, to give guidance on what are the current gaps that we have in evidence that can be used to make decisions. What are our mechanisms of creating the new evidence needed to make the decisions, if the existing mechanisms are good enough, how can we better link them, if you are already collecting enough data for diagnostic tests, outcomes, therapies, and the problems reside in different databases with different entities can we better link them, or modify databases, or create new ones. How would we adopt electronic medical rossereds, records, health records, some limitations for using them. A whole set of issues that could be teased out, would be useful for us as we go in the future to think of this as a cross-cutting issue starting with genomics as beginning point, can be adopted in other non-genomic set beings to identify the outcomes.

One, in terms of Piggiebacking initiatives, we are collaborating with national public office, the evaluating the existing strengths and weaknesses to obtain outcomes of genetic tests. We could use that ongoing project as point to build and come up with a set of recommendations, next steps to be feasibly adopted by federal agencies and improve public/private partnerships. That was the essence of my message here and I will turn it over to -- [captioner TRANSITION]

Please hang up phone line and I will transition with next captioner! Thank you.



I would like to highlight five boxes there. Not to overrun the highway with more cars but starting with the upper left-hand side which is to put in at a big focus, the role of the Public Health Sciences, large studies, these are where the action starts. We do not need to sell that in this session. The second thought was designed as a collaborative movement and to make sense of gene disease associated. It becomes so chaotic that you need a systematic review and better analysis of the field. We have made a lot of progress in highlighting what we know and what we do not know about gene disease relationships from a public health perspective. The third process, which you have heard about ad nauseam over the last few months is EGAP process would sit in the middle of the FDA research. It is a synthetic out research to figure out what we know and what we do not know about the various outcomes and the characteristics of genomic--the is that utilization of. You have heard a lot about this. I do not want to belabor the point. It was a structure that was designed to be a public / private partnership to highlight what we know and what we do not know to move things along the translation of the way, so to speak. The fourth box is the infrastructure over which the a clinical pathway of drugs and their pigs and genomics will have to go through. If you heard from--clinical practice is a very state Pacific. The example of newborn screening is an example of where the policies around genetic information that all newborns will have to go through. This is a very weak base right now in genetics at the state level and community level. People are trying to figure out what it all means. Public Health will have to play a role when things began to move down that translation high. Finally, when things become part of routine, clinical use, people always ask the question, what is the impact? Who is using it, do we have disparities? Is it costing more? Have people outcomes and health outcomes been affected by this? Right now, it is very sad to say from my perspective that the bulk of the investment and what genomics and that's did studies, the big signs, big Therapeutics. It becomes atrophied around the corner as we move towards a real translation. This reminds me of a recent article that was published in the German not too long ago. There were two articles published at the time. One is about community-based research and practice based research. Westphal and his co-workers talked about the blue highways, the usual meaning of translation in the NIH window is to move it from the bench to the bedside. That is the usual term and translation. Really, that only covers part of the translation. You need to move in from the bedside to the top practice. This paper, they talk about depth T2 got T2 is systematic reviews. This is what we have done what EGAP is to develop that infrastructure and the model process that try to tackle T2. What is it for use? T3 is doing the research that disseminates, and implements and looks at outcomes and utilization. That is T3. Nobody really have a handle on T3 right now. There are very few studies and far and between. We have done a preliminary analysis of some of the cancer genomic pubs that include economic analysis is that Steve mentioned earlier. The number of articles published on BRCA1 and genes got dramatically as we move down to a utilization and outcomes on patients and families and not outcomes. There is no data because there is no funding behind it. To finish up, this joint proposal, and I think Steve and thus did not coordinate our approaches, but it really talks about the overarching concern about the evidence of a genomic applications and outcome research broadly defines as not to include the number of parameters that are crucial to measure and have a real good translation of this technology into improving the population's health. What we would like to do is open this up for discussion to see whether or not this committee wants to wait and in a good way like to have weighed in on many other topics.

Thank you the three of you. I appreciate in. Steve, from our earlier conversations, he sees the synergy of these as well. We might want to entertain as best as a as a bundled [indiscernible]. People who have gotten together and tried to move this forward. I will ask each of them individually. What we are beginning to see as I engaged in this strategy here is that-and try to tie it back to what the Secretary it is sort of pushing through and what the whole health care system is pushing through. If we look at the major paradigm, and I am just rehearsing what is obvious to everyone, it would look at the major paradigm in healthcare delivery today, it is the sense that no one can afford to continue to pay for everything coming down the pike, just use willy-nilly. It is a very clear momentum around transparency and transparency at around what is the performance of the delivery system, both in quality and an efficient use of how their assets but that is what is really there. Outside of the field of genetics, where we have more history and where you have larger numbers of patients in the population, we have been able to begin and health care, the revolution as it were, to develop, to translate science into guidelines, the guidelines into performance measures, performance measures that lead you to be able to evaluate quality and efficiency in the use of assets, make that information available to the public for more informed choices about where they go for their health care to meet individual needs, the old Met personalization of Medicine. I think if I understand what is happening here is to say it, okay, we recognize en genomics, particularly in diagnostics but also Therapeutics, that this has not had the benefit yet, because it is still a newer field of having the level of research that allows the the specificity of clinical guidelines development that then is translated into real outcome measures for performance that then allows us to all know whether or not these precious health care assets are being used in a way that advances the performance of the healthcare system, both in terms of quality and effectiveness, and thereby ultimately makes it more difficult to make sure that individual care is tailored to meet the individual needs of each unique person. I think-That is what I foresee as the genius of these two that are coming together. Am I completely off base in that analysis, Steve?

You are right on target. The other side of this is understanding the a value proposition, if you will, on the health care delivery site. Out [indiscernible]. There is some better expectation that we allocate those resources where we will best be able to benefit those given the resources that we have both on the health care side as well as the R&D site. Muin, you used population based a couple of times. Given what Steve has said I as one observer, am curious about the depth level of analysis that you are thinking about here and the level of analysis of the effectiveness of this of the it community, the state, and the city, the county, the community, or is in the level of analysis between the patient and their doctors?

To use the analogy of the road, this is where my tires hit the road as far as I am concerned about where things are going. First of all, cost of guns and medical outcomes of two sides of the same coin. They are inseparable. To separate them into two groups would be an artifice. I would concur with the idea of bringing them together. The second point I would make that in additional to the R&D that Steve just mentioned, this is also an opportunity to really work around other identified priorities within the healthcare system to find out where we can make our biggest impact. I would like to mention something that we are doing at our place around from of Cumadin. This has been a fairly hot topic. We are looking at to see if it did the outcome. We did a cost outcome study so that we were able to capture all costs out with the Medical outcomes do comment on both of those. The reason to choose it is if you look from a patient safety perspective, you have 2 million a year that are not related to the use of Cumadin. There is a huge target to work around understand all of the different aspects of this. Those are the types of Delegates that I think that we need to identify. The one thing, and if we were to go back to the first slide is that we talked about things emerging and then being translated into practice, but the example of that Muin used as aspirin, we have known that it works for 30 years. We still cannot get people to use it. There are a lot of medications already out there in use that would probably benefit dramatically from applying this type of genomic--it is also thinking about what are the targets that are already existing so that we can go after, if you will, retrospectively.

That is a terrific comment. Muin in terms of --

I think to use the term population health instead of medicine or public health, they typically think of public health agencies and state health departments. There are nights and the treaties on the future of the public's health not, not one of them not too long ago in which they talk about population health umbrella is the one weren't medicine and public health at agencies and others in the private sector coming together now, there are very few things and not genomic paths that are under the Public health system. A newborn screening and some of the Internet services, but I see the implementation of genomics will be in our health care delivery system. If we deliver a population health umbrella to desert them in primary care or in a well defined community, which could be an HMO organization or groups of them at can develop the actual measures that we have used in other areas.

Obviously, you have thought about this. It is okay not to have the answer to these dumb questions of mine. That is what the committee might start to grapple with it. If you take what Mark set and use the example of Cumadin, it is very easy to get your arms around something that says, at the end of the day, we know that there are X number of preventable hospitalizations or extra length of stays in hospitals that result from misadventures with Cumadin dosing that more specific information about whatever tests work, it better guidelines and better performance by the clinical community and using that information in making therapeutic decisions would ultimately result in savings. You can pretty well get your arms around that and have the benefit. If you tried to think of a prevention or a health enhancing initiative, maybe it would be at something in the area of newborn screening. I do not know. I am trying to think of what would be the analogous example that would help us to look at it beyond the area of clinical intervention.

Prevention is the key is that ties both medicine and public health. Hot without this technology, to have the promise for developing earlier, faster and more personalized intervention, whether at the average student level or at the diagnostic or health promotion levels, the use of family history, for example, early diagnostic tests, whether they are done in a screening model or not, they can be part of the health care delivery system. That is what we are talking about here. Developing an approach that says, we are going to introduce these things using the best available evidence. Where are going to measure success and how much it costs. We will figure out the best way to introduce them. About the end we will measure their impact and the utilization of the population, keeping in mind there are large health disparities between the haves and have-nots. Out that is a very strong emphasis for public health not to step in. What I am afraid of is at the end when we start measuring successes and failures, we see it that the gap in health disparities may enlarge rather than narrow, which is what we want to have happen.

We have Steve, G and K.

Even at the population health level, we have used some of the tools at a population level based on what the effectiveness is and the cost effectiveness ranking, as you know for preventive services, because they are not all created equally. Big used in the guidelines as well as the Fed decides. They get used again metrics. They are meant for population based change. When we are talking about things that are critical, the approach and the economic approaches really help us deal with things that are at a population level so that banks that provide the most value art and likely to get done.

It will then be in -the it terrific Fitzgerald. What ever you were going to say, would you also say, at this level of your thinking, what are you more focused on the committee trying to find and identify priority examples for which there ought to be outcome measures that are informed by the guidelines that are what ever, so that you start to introduce those things in the system, or are you are doing more for an analysis of stores to look at the robustness of the research enterprise that allows whatever comes down the pipe to happen. What is your level of specificity of engaging this topic?

I will start with the question first and ended the comment I was going to give. Eight in the short answer, yes to both. On the one hand, we need to focus on the infrastructure and research enterprise and the delivery Enterprise and see how we can get-build a more robust infrastructure to get outcome data. It is hard to do this in an abstract without having some concrete examples and say, here are four or five different kinds of examples which give us a spectrum out of what kind of the challenges we are facing current fleet and how we think the next step will have to overcome these delegates. Now, but the comment that I was going to make was, again, an example of where clinical health and Public health have intersected. No one can scream for BMI in a clinician office. But if they are equipped to give the counseling and time as well as deal with the Community intervention that might be available to an obese person to lose weight, and access to better exercise programs in their community, if there are counselors and nutritionists that will advise that on their nutritional intake, are prevented examples where it is not solely in the clinical and the main, it needs to be interfaced with the broader health community.

Before it Dr. Fitzgerald comes on, I embrace what you are saying. It makes sense. I am struggling a little bit on that last comment to try to get down to the level of the regularity of around the it research informed guidance that leads you to a guideline that leads you to a performance measure, that leads you to have the outcome of some of what you-if I was going to fight the obesity I'd and I was going to worry about, as we were talking about off line about the availability of food in the grocery stores in minority communities. I do not think that gets to me at this particular domain. Can you give a little more about where you see the focus of the Science in the prevention of obesity?

I will refer to my companion here.

Kevin, I will not get you.

The example of obesity is a great example. A few months ago, there were a number of genes discovered that some variant may increase your risk of obesity. There is the same for what I'd done to diabetes. People are rushing to develop a diagnostic test to try to offer people, based on that test you have a risk of obesity. You go from that T1. You have identified the gene and start during the clinical trial. You say, what is the added value of this diagnostic test? Are there any specific gene based intervention that we should have? We have not done the clinical trials, we do not know the parameters of the test. If we do this in a community, it will take away from this. Suppose it meets all of these standard tests of evidence dates and you have a test that you are now beginning to deploy in the population, so you now move to T3. USA, who is using at? Is it helping people? A genetic test for obesity does not stand alone because of the gene environment interaction that goes along with obesity. The matter of which a genetic test for obesity is introduced on this translation highway is very complicated. It is not just got out T1 or T2 of record as of whether you offer it as a screening test for the whole population or in a primary care or a medical geneticists office. That is a translation process without the research that goes along with it. Out that is what we are asking the committee to grapple with, and help us move along.

It just to give this the first example, the obesity example, where this might be helpful. When the preventive Services Task Force discovered in terms of the intervention with people with high BMI, it found that you needed to have medium to high intensity counseling. out if you can identify genetic populations that are-that will lead to more intensive interventions than the average resident population, those kind of studies can be done in the public health or community setting. That is where the evidence would come in, not from an individual providers.

Let me let jump in real?

I think something like that could be done right now. There is a test. There is some outcomes for patients. They either did the test, did the counseling. Lot we can go through some of that data first and see how it goes.

Actually, we know very little. That is what happened at the NCI meeting that I attended in November.

From where I worked, I know that there is the database that has that kind of information, within the institution database. I can not do them. You are actually right on the money. Clearly, what we are hearing here is as, there is this court, currently, it appears that there is an inadequate data base that is not yet fully translated into effective guidelines by which we are able to evaluate performance and a hold Gunnison-to keep them accountable for how they use the tests. What we are hearing on the encouraging side is that there might be loads of information that could be used to play this game out. Can use it and talk about what will happen and what would be the benefit?

If there is a mechanism for these people do write it, that would benefit from what they are doing and would probably publish it. Right now, it is sitting in a database in someone's office.

Right now we will go to Sherry Jim.

Are you on this point, exactly?

If not, I will go to Kevin and then you. We will go to heaven. I want to keep some of these balls clearly in front of us. One of the things that I want to get you to work around what you mean and what you do not mean. Part of this is, if we do this, it will be a long term and is itself. That is why I keep asking questions about the entire database, carving out money from the NIH and put it into this. What did you mean about the research infrastructure? The part of it is that you have a secretary that is down from 665. He is putting his eggs in a personalized health care basket. The question is, in some ways, I am not trying to push you in a direction in terms of multiple ways of doing this, do you say to the Secretary, we want to participate in delivering it to you on your watch a few low hanging fruit efforts where we can claim a credit for having pushed forward the evidence of -based assessment that allows the transparency of individualized appropriate decision making, or, at some diagnostic, some particular intervention, and that is the beginning of now moving this field into the mainstream of the yen and day out from the clinical care delivery, just like everything else is being dealt with? I want you to keep that concreting and your head, and whether or not you want to embrace it, I am not advocating it. Let's go to Kevin and then surely.

Just to answer that point, exactly, and just to give it some S.p.A., time to come up with recommendations that were not only abroad, but in some ways concrete remedies were numb to areas where we continually but it up against an area where there was not any. In a sense also, we can say that this is a very logical next step in this committee is development and movement. Go back to the secretary and say this is leading us to where we want to go, which is development of best practices, which is what we call for any way.

I think I am struggling with the same thing that you are, Reed, which is what can this committee do? What can this committee get their arms around that would be useful and helpful to the kinds of questions and concerns that have been laid on the table? There are levels of analysis that can be done on these questions. This group tends to do its best work around the policy analysis and at that level, not on the research questions, which really gets down to the various agencies, and the large panels of research experts that they have a. I know we ought sprinkled in the group, research experts, but we tend to pull to the policy level at a committee. The suggestion that I want to weigh on the table based on the discussion that we have had thus far is really a study with four points for consideration. The first point is, that the group would make the case for why did the analysis are critically important for public health not clinical care and for the economic of the public health and clinical care. You can use the examples ... that were talked about to illustrate those points. You can get into some specific analyses of some specific cases and make it come alive for the audience, but do it in such a way it out of why these are important and what is clearly missing. To do the needs analysis of what databases and information is out there and what is missing? What is not available to the community to do these kinds of T3 analysis? MN to lay on the table for the department, based on that needs analysis, what are the kinds of questions that the department really needs to address glugs what kind of questions do they need to invest in to ensure that you are doing the kind of research so that you can ask and answer these kinds of questions. The final piece is, how do you get the different components of the department to work together in order to accomplish and answer those questions? CMS have a role, NIH, has a role, CDC has a role of. I think that this group has been very good at helping the Department see how the different pieces and components can play together to try to look at some very big questions.

We will come to Jim. Let's just review of those as issues. The first of all, where we are based on Kevin's comment, we are starting to get to a consistency consensus of understanding what we want to achieve at a conceptual level. We have now been advanced here by saying, okay, maybe our role is to make the case for why this is important, why T3 level of analysis is important. Find some representative cases to make it, alive and make it come alive. That is a legitimate role, citing a bright light on this. Then, secondly, do the it needs assessment 48 what do we have that can answer these questions and what we do not have. There is a database in an institution like yours, but there is not a lot of data that Muin feels comfortable about. We will say your is what is there and here is what is not there to raise the question. The question is that the needs to answer and say that DHS needs to invest in. This is what you need to resolve and salt. Lastly, to identify the major players in the department who need to be a part of this effort and create some template that helps facilitate interagency coordination that allows them to get at it. Did we get to your point? That is terrific. As people make their comments, they would you are going to say, but reacted the a specific proposal that is there. Jim?

My discussion is-Well it is sort of related to T3. Apple listening to everyone, does not do things that struck me. One is cost effectiveness and the other is a probability. In terms of cost it up the mess, we do not take cost into consideration. It can take billions. A lot of insurance companies do not take crossed into consideration. Why is that technology has been recommended to a second committee, they do. Even though it is great, it will cost much and we will not cover it. If there is some way that that cannot late-I think that would rally. The issue. The second is the probability. CMS has said, when we look at genetic testing, one of our concerns is, it's as if the test and so that someone has an increased probability of a particular genetic disorder. How much is at in terms of quantifiable on how? For example, based on a family history, you might say someone, based on a population of a thousand patients, there might be a chance that the person have a today the disease because of their forebears. A specific genetic test might increase the from 20% to 22% or maybe 70%. Where does that patient all in terms of assets from? Are they going to stay at 1% of will it be moved up to 99%? If there is some quantifiable way to add the increased probability of well as the family history in terms of a particular disorder, that might help to push the hot issue of trying to get the it dust covered.

If we take the shari out line and say, again, those are important point, the probability example is more where you can use and not do make the case of why the T3 is important. You might take your cost effectiveness deal and the second point that she made, which is, do we have enough animation. Do we have information to actually answered the cost effectiveness question. If we do not, we need to identify that. That would prop up as a need for information and research. I think the bulk of your points fit into the four points that have been laid out. We have Muin and then Alan.

II think maybe Reed, you talked about the timeline for HHS, given that it is none two years or less. Of the zero secretaries initiative with a personalized health care did nicely with at. I have not talked to him in particular. He does not want to stop with T1. He wants to move this technology to improve the out populations held health. Do not forget T2. You will never get to T3 unless you go through T2 barbecue need to use systematic based prophecies. It is a huge construction. Right now people go around it without the evidence for its effectiveness of T2 and T3, but I am advocating for is a post T1 a [indiscernible]. The real translation.

Thank you.

Jim was suggesting we to the state terminology it. I think that Steve, Gurvaneet and Muin have identified some big issues. I very much liked the the statement by Sherry about where we are headed. I would add to that, and what I think was implicit and Sherry's comments. All of us around this table would like to completely remake the nation's research and clinical care systems that might be a little bit beyond the scope of the committee. We have been most successful when we focus on the genetics, genomics portion of this. If we try to overreach, we will get in trouble. There is plenty that we can do in this area while focusing on that. We might be able to get our way through the nation's healthcare hot and research at.

I think can we are not coming in agreement with each other. We think that this is important. I feel confident enough as your chair to suggest that there is a worthy effort for people to go and think through. What I would suggest, what I would hope that the committee would do as it sits down and we will populate that committee in a moment, would be that, first of all, it using the four points from Sherry are very useful for organizing some of this. I think that you need to be, a unit to give us some good it ought, as you look at your illustrated cases, being a specific about those which get to the level of prioritized specificity, like, hemoglobin [indiscernible]. Is Dr. Smith ordering them or not? Is the diabetic care delivered consistent with the best possible standards? That is a level of-you can get your arms around it and it is real specific. That is where the momentum is moving today, but really nuts and bolts. Time to find the examples that move this field into that level of granular to on the clinical care such delivery site. You have to be a pretty specific about trying to grapple with some of the larger more population base issues that are outside of the relationship between a patient and their doctor. Who is the edible unit for these measures when you move beyond a recent, Dr. Decision making? You want to be thinking about where that is. You want to be giving some good thought to whether it is-It is probably the way that Sherry solve it, it makes this question less important. Whether we are trying to identify, again, or are urging or fine examples of what we want to do that speak to the question of whether it really is requiring that a different or some kind of an investment in the research dollars in the of the structure that allowed you to answer these kinds of questions. If you are identified needs, you have to have the science that gets to that need. That is not a simple issue, obviously, as you all know. I do not thank you should be by that issue.

The funding, they are doing comprehensive from transitional from research to clinics and back again. They should have a lot of that information.

That is some homework to do. I think we would like you on the committee, quite frankly. I would want you to consider, as a subcommittee, the point that while our committee will hopefully transcend-and we have transcended any particular administration, and or secretaries, I think we owe it to our Secretary of the moment to try our best, especially when we have one that has reached into us in such a dramatic way in saying that I care this much about personalize the ascent to try to tie the theoretical constructs of this to his effort that says, I bought things that allow individual human beings in America to have a care that is delivered cost effectively with quality that is reported transparently so that they can match their care delivery infrastructure to meet their individual human needs, their aunt or sliced Madison. I want to cut it in that sense, where he is putting his efforts and, we want to without to the greatest extent possible. We have a three co-chairs. We need one out of the three. Steven gets to be the chair. Muin and Gurvaneet, they are part of the committee. They aren't co-conveeners with you. Mark, are you sure?

I do this everyday.

Mark, you are there. The other piece I forgot it is, I've been like for you to consider dropping a guideline to this out reach into a receptor site vault. [ LAUGHING ]

On Andrea's committee. She has and that oversight for how guidance is made in terms of whether the right test was the chosen. Clearly, there is a connection here. We want to make that explicitly.

That is exactly what I was the thinking of. Since I am already on Andrea's committee, and my role on that committee is on the perspective of a health care delivery, that would be the natural link.

Because of the rule that no good deed goes unpunished.

Greg Feero of our staff.

It looks like Greg have a unanimous consent.

I will bring it to him. [ LAUGHING ]

You're such a nice guy.

Okay. Done. To the suburbs started and is it that people. A round of applause.

Can I get stabbed to put up the strategic plan? I thank you have already now busted the thanks on energy. --busted the bank on energy desk. [ LAUGHING ]

I want to just review with you, briefly, your strategic plan and make sure that you, at a committee are comfortable now. The vision statement has been scared away. With discrimination, there is nothing more we can do other than making a terrific recommendation. We will be following up with [indiscernible], he is not here, but he will be calling in.

Someone is supposed to call the legislation. We will send a letter also.

Wait a minute. Bat is the bill. --that is the bill. You are talking about GINA. We are talking about the Kennedy bill. , education and training. We did ask someone to do something on that. It was the nursing people.


The nursing people are supposed to give us, how are you doing? Yours going to send us something, right?


I think what we need to do, and you will do that. Will invite the leadership to the table. I am not interested in 1959, 1970, who did what. The bottom line is not, not one question, straightforward, no fooling around, a recent, informed assessment of the quality, of the level of preparedness of the professions it being able to handle the genetic information coming forward. We should probably take a third somebody or other. We will figure that out. If anyone has an idea of a good handle this stuff.

Do you not only one that brought question answered but some updates and our resolution was put forward in 2004, do you want to know if we are in a other plays and making progress?

If you have figured someone that can get the sense of what is going on, maybe they are to a stream. Maybe you can figure someone who it does CME.

Bruce would be the it one to talk about. He published the peas in a genetic medicine at about the readiness of [indiscernible].

Let's take that name. Let's get someone from the American Board of Medical specialties. That is the way to do it. We have nursing. She is going to come. You will come to the meeting, aren't you? We have the boards and we will get Bruce.


Basically, what we will do is ask the ABMS to send us a representative who cannot speak to us from a obstetrics point of view, but also a ABMS point of view.

You also want to include someone from the laboratories.

To be considered. Someone who says, we are getting nothing but quex in here, and you need to know it. We will think about that.

Okay. That is a a very good idea. To get one of the big players, the big laboratories in and ask them to curve of the level of crap in that you're over year.

To do what commercial?

Yes, commercial. Let's bring Paul back in here, Paul, right?

Next covered and reimbursement. We will have, we will have a CMS briefing on where they are on this, or someone presenting CMS at a superior organizational level. Someone will come in here and tell us something about the reimbursement. I am not concerned about that. That will be an easy one to do. Direct to consumers marketing --


Do you have an update? Update. What we are doing, we will be doing a lot of these things probably will need to be short and no fooling around. One of the things that I think we'd do well, and we have done it to death is lots of presentations. We are going to take up a little bit, with your permission, and staff and I will work hard with the presenters to say we want you to answer a question. We do not need to know about the history of your field, just answer the question. But I? That way we can fly faster.

Are we becoming a court of law here? 81 a yes, no answer? [ LAUGHING ]

This is the dragnet rule. Nothing but the facts, ma'am. That means the challenge is on us to know what we are asking these things. We need to say to ourselves and the people coming to us, based on our responsibility to the public, what is the most important thing? The clear on what we think we need to know, and being very specific. That is what I think we need to do. We need to raise our game. Large studies. Done.

Make your comments public bite June 1st. We will have an update. Gene pending?

We are moving along.

We want to start Art two in the July, if we can? That will be it public comment solicitation and maybe a roundtable of some point.

Just think about it for a minute. The things on the left side art thanks, Bank, Bank. We are on it. We are using our role and response ability. The pharmacgenomics and is ongoing. It will be with us. The people on subcommittees will be using their time on that. The gene patenting is on going. has been reinvigorated, lots of time, lots of energy on that. It will take up a lot of our bandwidth. We created a new one today. It is there to be discussed.

What are we going to call it?

I have an idea. Is a fairly-why don't we call it to inflation.

You cannot say translation. T3? [ LAUGHING ]

You are not just talking about translation. You are talking about measurement and Viacom downtrend outcome. Is there any member of the committee that deals like they do not see their face in the class picture? Is there anyone who feels like their issues are not being addressed? I did on this committee and am willing to travel all of the way to College Park because I have been caring about this and they keep ignoring me. I am furious with that Chairman? Everyone is okay? Update. I want to do not want last thing. I would like the staff to stand up, please. Stand up. Come on. We have to stand up, all of the it staff. We just want to speak for all.

To all of these Ex-Officios, we appreciate it and to all of the committee members. It has been a great meeting. Take care. [Relay event has concluded.]