THE WHITE HOUSE Office of the Press Secretary ________________________________________________________________________ For Immediate Release March 14, 2000 PRESS BRIEFING BY DR. NEAL LANE, DIRECTOR OF THE PRESIDENT'S OFFICE ON SCIENCE AND TECHNOLOGY POLICY AND DR. FRANCIS COLLINS, DIRECTOR OF THE HUMAN GENOME PROJECT The James S. Brady Briefing Room 12:45 P.M. EST MR. SIEWERT: Here to brief on the President's announcement today are Dr. Neal Lane, Director of the President's Office on Science and Technology Policy, and Dr. Collins, Director of the Human Genome Project. And Dr. Lane will begin. DR. LANE: Thank you, Jake. Ladies and gentlemen, I just have a couple of quick points to make before my colleague, Dr. Collins, makes his comment. And then we'd be happy to answer your questions. As you know, President Clinton and U.K. Prime Minister Blair announced their support today for making the raw, fundamental human DNA sequence information freely available to scientists around the world in order to stimulate the rapid development of genome-based health care products. Supporters for the Human Genome Project have long held that open access to such information will speed up the translation of that basic data into therapies that can cure or prevent disease rather than simply treating symptoms, as well as unlocking the mysteries of normal human development. Therefore in 1996, the three principal partners in the not-for-profit Human Genome Project -- which are the National Institutes of Health, the U.S. Department of Energy, and the U.K.'s Wellcome Trust -- adopted a policy requiring their grantees, all of their grantees, to deposit human genome sequence data into the public database within 24 hours. The President and the Prime Minister endorsed this policy, and call on countries and scientists around the world to adopt this approach. I want to make it absolutely clear that this statement has nothing to do with any ongoing discussions between the public and the private sector. Rather, it's made in recognition of the fundamental importance of the underlying science, and the need for a balanced set of policies. The United States and the United Kingdom have discussed the principles of this statement for many months, I can assure you, because I have been involved in those discussions. The statement does not require anyone to release information. The point of the statement is the development of the new generation of treatments, of preventions and cures will be greatly accelerated if raw genome data which is not patentable is widely shared. I want to also make it clear the statement is not about patents or what should or should not be patentable. Patent law dictates criteria for patentability and nothing in the statement supersedes these criteria. Intellectual property protection is a vital incentive to promote investment in product research and development. The statement also expresses the worthy goal of putting as much fundamental sequence data as possible into the public domain. This approach is the explicit policy of the government with respect to government funded research. It is also the approach taken by some in the private sector already. The statement applauds all who will take this approach from either the public or private sector. Now I would like to ask Dr. Francis Collins, who heads the government's efforts on the Human Genome Project, to comment briefly on the significance of today's joint statement. Then we would be glad to answer your questions. DR. COLLINS: Thank you, Neal. Good afternoon. I am happy to be here on what I think is a rather significant day, where a very important principle about access to the human genome sequence -- our common, shared heritage as human beings -- is being endorsed by the leaders of the free world. The Human Genome Project is an effort to decipher the sequence of the 3 billion subunits of DNA. Running ahead of schedule and under budget, this audacious project, and it is audacious, will complete a working draft of the human genome sequence in the next few months. Already, the sequence of close to 2 billion subunits of DNA have been determined and placed into gen bank, which is the publicly accessible database that you can go to on the Internet. Any scientist, anywhere in the world, can access the sequence and use it to help them answer their research questions, and they are doing that thousands of times each day. The Human Genome Project is a decidedly international effort, with contributions from the United States, the United Kingdom, France, Germany, Japan and China. In the United States, as mentioned, the project is supported with public funds by the National Institutes of Health and the Department of Energy. Why does this matter, this project? Well, all disease -- whether we're talking heart disease, breast cancer, or mental illness, or a long list of the ills that afflict us -- have genetic contributions. Having the entire sequence of the human genome available to all will accelerate the process of understanding the connection between genes and disease. The sequence of the human genome will thus be the foundation of biological research in the 21st century, and will lead to a new era of individualized preventive medicine, where your own risks can be used to adjust your own plans about how to avoid illness and stay healthy. To ensure that this information is available for researchers to develop such diagnostics, and also the new generation of therapies that we all hope for, this fundamental information about the sequence itself must be placed in the public domain for all to use freely. I applaud Prime Minister Blair and President Clinton for endorsing the importance of immediate and free access to the sequence of the human genome. Thank you. And I think we would be, now, glad to answer your questions. Q The key issue here, it seems to me, is whether genetic patents can be applied for and received. We do have companies that have applied for thousands of genetic patents, or begun the process of applying for them. Are they going to be able to receive patents or not? DR. LANE: As I said earlier, this statement really in no way is intended to change patent policy, or changes patent policy. I'm sure you know the Patent Trade Office has recently issued guidelines on how they would deal with requests for patents on genetic material. And it's clear that they require a certain level of utility. This statement does not address that set of issues at all. I think the patent policies and patent decisions are up to that office, and what this statement emphasizes is the importance of making available the raw, fundamental human genome data that I think no one disputes is not subject to patent. That's what this statement has to deal with. And this statement further goes on to say that it is important, of course, to protect intellectual property in cases where we are talking about a gene-based invention. Q Beyond strongly encouraging data release every 24 hours, is there any either carrot or stick approach that the administration could pursue, or is interested in pursuing, on an international level? DR. LANE: I think the existing policy of the public-private partnership that we have with the U.K, the Human Genome Project has, as its policy, that the fundamental data must be released in 24 hours. This statement is simply to encourage all researchers in the public or the private sector to make their data openly available. It has no implications with regard to further steps. Q Really, what some of us who are in the news business are trying to figure out, the news is you're actually encouraging others in the private sector to do what you're already doing? DR. LANE: That is the essence of the statement. It has worked well. It is also the case that many in the private sector have already made clear that they believe this is an important thing to do. What we have done in this statement is to come together, our two countries, and say perhaps to a larger audience of researchers, that making unencumbered -- giving unencumbered access to the raw fundamental human genome data is important and we commend those who have decided to do that and we encourage further efforts in that direction. Q Could I just ask you, in terms of the patenting office, these guidelines that were recently issued, has that been the guidelines that they have always used in looking at these patent applications or the process of the patent application? As I understand it, that that has not necessarily been the case and that there has been a debate within the patenting office and that President Clinton, by issuing the statement, is basically coming down on the side of hands-off the sequencing but allowing any therapies, et cetera, to be patented? DR. LANE: I think you would have to direct your question to the Patent Office. But what I think is clear is that everybody agrees that the raw, fundamental sequence data of the human genome is not patentable. I think discussions have to do with what level of utility does one need to demonstrate in order for that information to be patented. And I think the specifics of that, you would need to address to the Patent Office. Q So how much of a utility are you saying needs to be -- DR. LANE: This statement does not address that. This statement simply acknowledges that the protection of intellectual property of gene-based invention is very important. It is not in any way intended to change patent law or patent policy. Q You seem to go out of your way without ever saying the word -- I have the feeling that you have sort of a disclaimer in there -- that today's statement had anything to do with the squabble with the Celera folks. But having said that, whether this statement was in the works long before the break-off in talks last week with Celera -- I accept what you say about that -- nevertheless, the break-off in talks from your point of view did have to do with a difference over philosophy, right, of sharing? And I gather you felt you felt that the Celera folks were not adhering to the kind of policy that the Prime Minister and the President are advocating today? DR. LANE: I think today we're focusing on the statement and what its impact is and what its implications are. And let me just again say the statement does not have anything to do with ongoing discussions between any of the companies and the public project. What I will say in connection with your specific question about Celera is that, in my own conversations with Craig Venter, my understanding is that he agrees with this statement. In other words, there is not anything in here that you read today that I believe that particular company would take exception with. Q Could I just follow that up for a second? As I understood it, what broke off the conversation was that they wanted over a period of years to be able to use -- if they were going to cooperate with you, they wanted exclusive use for, well, years, to be able to employ it exclusively and you folks said, I don't think so. DR. LANE: This statement does not address that particular issue, I think. And I don't think it is appropriate here to talk about the particular negotiations between the two parties. What this statement has to do with is encouraging -- making the raw, fundamental genome data available, so that the researchers have it and can advance research. Everybody agrees that's not patentable. And my understanding is that the private sector is quite supportive of this kind of approach and this sort of statement. How a company might choose to make its data available, freely available, is not addressed in this statement, and I think would be something that the company would have to work out. I couldn't speak to that. But the principle that the statement addresses, I think, is clear. And I expect the private sector agrees. Q But in conversations with Mr. Venter, you were driven, you were motivated by a philosophy that's being espoused today by the President and the Prime Minister, right? And yourselves? DR. LANE: Well, my view has always been that such fundamental data should be freely made available, because that's how you advance the science. And if the data has no obvious utility, then my understanding has always been that it does not satisfy the requirements of patentable information. And I don't think there's any dispute about that. I think what particular companies do is something that those companies will need to work out. And there could be contractual arrangements or other ways in which a company would make its data available. The principle is what we want to emphasize here. And we certainly, the President wants to encourage all of the researchers, public or private, who are involved in human genome research, to make this information freely available so that the research can go forward. The President has made that very clear in his February interview. Q Well, is Celera not releasing its information now, claiming that there is utility in it? Or it's not available now, is that right? DR. LANE: My understanding is, the Celera data is not currently available. DR. COLLINS: Not the human data, no. DR. LANE: Not the human data, but -- Q And they're trying to patent it? DR. LANE: But in conversations that I have had with Craig Venter, he has made it clear that it is certainly their desire to make this raw, fundamental data available. So I think it's only a question of how and in what time frame. And I can't -- you'll have to ask him about his view on that. Q What is England bringing to the table in this agreement that hasn't already been on the table? DR. LANE: I think what the U.K. brings to the agreement is simply the expression that our two governments are in complete agreement on the principles that are expressed in the statement. The Human Genome Project was a project that involved some important partners, but a small number of partners -- NIH, DOE and the Wellcome Trust. This statement is broader. It applies to all researchers in the public or private sector, and encourages them to do what the Human Genome Project has already agreed to do. Q So would you deny that this statement wasn't designed to encourage Venter and Celera to get back into talks, and to formulate a formal agreement on how they will share their information, when they will share their information? DR. LANE: The statement is for the purpose of encouraging everyone in the public and the private sector to do everything they can to make the raw, fundamental genome data as available as possible, as accessible as possible, and as fast as possible. So it applies to everyone. Q By basically publicly saying that your definition of what the Patent Office will approve or not approve, or what should be patented or what should be controlled, should not be the human sequencing? DR. LANE: I have stated that there is no disagreement that the raw, fundamental genome data, which -- I'm going to give Dr. Collins here a chance to say something, so perhaps he could tell us what that is, actually -- that that be available, that that's not patentable by our current patent law. And this statement is to, therefore, encourage that that be made freely available. So it's not to change anybody's idea about what should be patented or shouldn't be patented. And it does not force anybody's hand to do anything. It's to encourage that this raw, fundamental data be made available as rapidly, as openly, as accessible as it can be. Can you comment on this? DR. COLLINS: Maybe I could add something. It's important to keep in mind when we are talking about making the sequence of the human genome accessible to all, it is not just a matter of patenting that's being referred to; it's also immediate release of the data. We are at the moment, in the international sequencing consortium, producing about a million base pairs, roughly every three or four hours. So there is a lot of data coming out here in a hurry and all of that is getting put onto the Internet on a 24-hour basis. We will, by this summer, have 90 percent of the human genome in what's called a working draft form. Now, if you were to look at that data, what you would see is a series of A, C, G and T. That is the four-letter alphabet that DNA is written in. And staring at it, you would have very little idea what that particular piece of DNA does. Even with our most sophisticated computer analysis, we can only guess at what some parts of the genome are doing, and most of it still remains to be figured out. The argument here is that the way we are going to get it figured out, is if any scientist who has a good idea has immediate access to that. So this exhortation, which is I think is what this statement is, is that this raw, fundamental data, which is going to take years to sort out, ought to be accessible immediately to anybody, with no barriers. And the possible barriers are numerous. But the idea is, get it out there as fast as you can with absolutely no restriction on how you use it. The analogy has been used that this is like the periodic table of the elements for human biology. We are determining here right now, in a rather historic way, the 100,000 entries in that periodic table which are the human genes. They will have variance, sort of equivalent to isotopes in the periodic table. But that, of course, if you think about the analogy, tells you how early we are in the process of understanding how it all works -- just as I think you would argue that, having had the periodic table for chemistry in some way only available to some people or with patents filed on parts of it, wouldn't necessarily have been good for that field. I think you can make the same argument here for genome. We are very early in the process. We need to figure out what it means. Q Dr. Lane, following up on your statement that nothing was forced on this, nonetheless, there are a number of technology stocks that are now taking a hammering on Wall Street. Because the analysts think that this agreement puts the breaks on the ability of these companies to sell their data. What would your reaction be to that? DR. LANE: I think the statement speaks for itself in that regard. It is not the intention to in any way inhibit the private sector from doing what it should do, what's important that it do to make sure that the necessary technologies and products are made available to improve people's health. Our view, the President's view, the Prime Minister's view here is that by doing what is encouraged here, by making the human genome data freely accessible, that is going to advance research, but it's also going to make more widely available the very information that some companies may need in order for them to add the utility and make their products. So the expectation here, I think, is not that this in any way holds back that market or those opportunities, but it really ought to help it go forward. So this is not just about making pure science work better; it is about getting this information into the hands of those people who can put it to use to derive new treatments, new cures for debilitating diseases. Q Nonetheless, those stocks are going down. Those stocks are going down today, rapidly. That's causing a reaction on Wall Street. DR. LANE: I have no information on that. I see no reason to connect the two. Q Celera is one of those stocks that's going down, it has fallen almost $14, to $97, just since your announcement this morning and Joe Lockhart's comments this morning. Did you all have any communication with Celera and tell them you were doing this today and, if so, what was their response? DR. LANE: I have not myself had conversations with Celera. But our understanding is that Celera is supportive of this statement. Q Did they know specifically what you were going to say and how you were going to say it? And were they invited to join you? DR. LANE: No, I'm not aware that they were told in advance what this statement would say. But we have discussed the existence of a statement before -- those discussions I referred to earlier. Q Was there a choice made within the administration not to include them here? If they're supportive of your proposal, wouldn't it make a stronger front? I mean, it would obviate all these questions we're asking you about why are you at odds with Celera? DR. LANE: No. The statement was worked out with the U.S. and the U.K. That's certainly what I gave most of my attention to. And the fundamentals that are in this statement, we have every reason to believe, in fact are supported by the private sector as well as the public sector. So there's nothing in this statement that is in any way intended to inhibit the private sector from its work. DR. COLLINS: I might add to that, that in fact there is a private sector enterprise called the SNPS Consortium, which is formed by 10 pharmaceutical companies, that have for the last year been working together in collaboration with academic centers to put information about variants in the human genome into the public domain as rapidly as possible. So here's a good example about how the private sector is very much in support of what is stated in this particular joint statement today: that this fundamental, basic information ought to be available to all. They not only believe in that, they've been putting their own resources into making sure that happens. I think that's a very strong indicator. So I would not think it's at all appropriate to look at this statement as something which the private sector would be opposed to. This, for the most part, strongly endorses the positions they have taken in the recent and distant past. DR. LANE: Let me repeat again, in my own conversation with Craig Venter, he made clear to me their desire to make the raw, fundamental data available, for all the reasons that we say. Q Dr. Collins, could you specify precisely what you would like private companies to do, on what time frame? And could you address as part of that the companies that over the last few years have built CDNA libraries of human genes, which of course does not include Celera. DR. COLLINS: Well, Justin, this is a statement which comes not from me, but from the President and the Prime Minister. I think the statement says that there is an exhortation here to take basic, fundamental information, where the utility of that information is not all that clear, and immediately place it out there where every scientist can get access to it. So the statement seems to exhort private companies to do so. And, again, many private companies are being formed on the expectation that that will be the case, because it is now going to be their business plan to add value to that information, to annotate it, to figure out what functions mean. And that is an enormously important part of the future of genomics. Much of what we learn about how the genome functions, and the ways in which it will ultimately benefit human health are going to be done in the private sector, and we encourage that and celebrate that. Q Do you include the CDNA libraries in this request that people make their stuff public? DR. COLLINS: Again, it not being my request, I think the wording of this suggests that all raw, fundamental information ought to be available to all. The NIH has a new program to develop a complete set of full-length CDNAs, and that is being done with the understanding that all of that data goes into the public domain immediately in the same fashion as this. So, certainly, from the NIH perspective, that would include CDNAs. Q Dr. Collins, there is a proposal circulating from the SNPS Consortium recently that it's supposedly initiated by NIH and the Wellcome Trust that specifically states that the information that would be generated on gene sequencing through this proposal would not be made public right away and, instead, would be held only to be seen by genome research centers of NIH. Is that true? DR. COLLINS: Jamie, that is an incorrect interpretation of the discussions that have been going on. You may know that the SNPS Consortium, from the outset, has adopted a policy to try to make sure that the single nucleotide polymorphisms -- I see a lot of people wondering what the heck is a SNP. Well, it is a variant in the human DNA sequence where I might have a T and you might have a C, and those are very interesting because some of them will turn out to correlate with illness. The policy of the SNPS Consortium, this group of 10 pharmaceutical companies and the Wellcome Trust, and now IBM and Motorola have joined as well, they wanted to be very sure that the SNPS discovered in that effort would end up completely, freely accessible. They go through a process, which I could not accurately describe to you, that ends up using a mechanism called an SIR, which basically makes it absolutely the case that those SNPS cannot be claimed as intellectual property by themselves, or anyone else. These pharmaceutical companies don't get to see the data a minute before anyone else, so this is done in an altruistic way, basically saying this is good for the community. But that process, that pipeline, requires a matter of three to five weeks to be accomplished. If there were to be a collaboration of this sort, the process of SNP protection -- because they have followed that all along -- would be expected to stay the same. But the sequence itself would not be delayed in any way that is not concordant with the Bermuda rules. Q But wasn't the proposal funded -- initiated, I'm sorry -- initiated by NIH and the Wellcome Trust? DR. COLLINS: This is still under discussion. There's been no decision to fund any proposal at the moment. Q Just to kind of further clarify the key point, is it your opinion that Celera has at any time attempted to patent raw genetic material, as you call it, and that's the stuff that can't be patented? DR. LANE: I certainly am not aware of that. I mean, are you aware of that? DR. COLLINS: -- publicly have stated, back in the fall, that they had filed provisional patents on 6,500 gene sequences. Q Right. Is that the raw material that you're talking about, and that in your opinion cannot be patented? DR. COLLINS: I don't know the contents of their patent application, and neither does anybody else, so it would be inappropriate for me to try to guess the answer to that. Q One reason that some of us keep asking questions about Celera is we keep reading these news reports that Celera's going to be ahead of your project in coming up with a completed gene sequence. Now, that may or may not be true, you can address that if you will. But beyond that, everybody -- a lot of people seem to think whoever comes up with the completed gene sequence, it'll be a better, more accurate one if the two of you work together. You were not able to reach an agreement. So can you address, are they going to finish their work ahead of you? And, two, what was the stumbling block in reaching your agreement? DR. LANE: Let me make one comment, and then Francis can join me. The situation now, of course, is that all of the raw, fundamental data for the human genome that has come out of the Human Genome Project -- Partnership is available. It's there in gen bank. And so any of the companies have access to that. They can put that together with whatever they have -- Q They have access to your material, but you don't have access to theirs? DR. LANE: That's correct. And that's, of course -- I mean, we're a public entity, and it was part of the agreement to make that data available. And we believe it's the correct thing to do. We're trying to encourage everyone, all countries and all sectors, to do this. So when you ask the question, they're ahead of us, or are they ahead of us? It's not, I think, quite the same, in that we already have the availability -- they already have the access to the data that have come out, has come out of the public -- Q Sir, the second part of my question is what really broke off the agreement? What was the stumbling block? DR. LANE: well, the statement really is not about the discussion and I would just as soon we didn't go into the nature of those negotiations. Q But the value on Wall Street has always been getting there first. I mean, whether it has been, you know, the one gigahertz processor or air conditioning in cars. Getting there first has always been the issue. And I think the private sector might think that that has been kind of taken off the table, especially with this announcement today that, you know, you're really encouraging that it be made available. DR. LANE: Let me repeat what I said earlier. My understanding is that there is nothing in the statement which lays out these two fundamentals that they would disagree with. So this statement, in my view, does not take anything off the table. It only addresses data that is not patentable. That's the only kind of data we are talking about here. And we're encouraging that that be made available so everybody can be first, so you can get that fundamental information out there so the researchers can take it and push forward, and the companies can take it and add value and make whatever products that they wish to make. Q I would have a different question related to science and technology. Since the President is going to India, he is going to talk a lot about science and technology. If you have spoken with him or any advice for him as far as his visit to India? DR. LANE: We are very -- he, of course, is very much looking forward to this trip. We are very excited that science and technology will be a very important part of it. Science and technology is an area in which the United States, among others, on which the United States and India have had a longstanding, good partnership.
Some of the most outstanding scientists, engineers in the world are from India, many live in this country, many are in India. So there is much for us to talk about while we are there. Q You are not going with the President? DR. LANE: I'm going with the President on the trip, yes. Q One last question. Dr. Collins, you have been very involved in these talks with the private sector. Would you hope that this statement would bring them closer to an agreement on exactly when and how all the information that everyone has -- including Celera -- will be shared. DR. COLLINS: Again, this statement has been in the works for many months. It is not the intention of this statement to try to push any particular hearer in one direction or the other. This is a statement of, I think, a fundamental principle that humankind would be best served if all of this information is available as soon as possible. And it's really not for me to guess how that might be received in various quarters. Q Given the fact that the private sector has said that they would have the genome map by this spring, it does make us all wonder why the timing and why now? I mean, it sure looks suspect. It looks like you're pushing them to an agreement. DR. LANE: Let me repeat what I said earlier. This has been under discussion for many months. The first discussion I'm aware of, of this statement, was carried out by myself and Sir Robert May, who is the Prime Minister's Science Advisor, and Lord David Sainsbury, Minister. And those were very informal discussions. We consulted with our people on this side and they consulted with the people in the U.K. and thought it would be a good idea to issue such a statement, just to make clear to the world where our two nations are on this issue. It just took a while to get the statement put together -- for reasons I think you can understand. And we want to get it right and we want to be sure these are fundamentals that move us forward for the reasons that are so clear. We want to make people's lives better, and this statement lays out principles we think will do that. Thank you very much. We appreciate it. END 1:15 P.M. EST