TRANSCRIPT: Meeting 2, Session 3

Knowledge Sharing, Innovation and Translating Research for the Public Good


September 13, 2010


Philadelphia, Penn.



Arti K. Rai, J.D.
Elvin R. Latty Professor of Law, Duke University School of Law
Center for Public Genomics, Institute for Genome Sciences and Policy, Duke University
Ashley J. Stevens, D.Phil.
Special Assistant to the Vice President of Research, Office of Technology Development and Senior Research Associate, Institute for Technology Entrepreneurship and Commercialization, Boston University
President, Association of University Technology Managers
David B. Weiner, Ph.D.
Professor, Pathology and Laboratory Medicine and Chair, Therapy and Vaccines Program, CAMB, University of Pennsylvania



Amy Gutmann:
In this session we are going to talk about knowledge sharing, innovation, and translating research for the public good, and we’re going to begin with Arti Rai, who is professor of law at Duke University and a nationally recognized authority on patent law, administrative law, and the biopharmaceutical industry. She has been engaged in discussions about knowledge sharing and innovation in the synthetic biology field for many years. She has also served as a peer reviewer for various National Academy of Sciences reports on intellectual property, and she is currently the chair of the Intellectual Property Committee of the administrative law section of the American Bar Association. Professor Rai, we are very happy that you could join us today.
Arti Rai:
I am really delighted to be here, and I want to thank the commission for inviting me, because I think this is a really incredibly important inquiry. Perhaps I would, since I have been studying synthetic biology for a while, but I am just very excited to be here and particularly excited to be on this panel about knowledge sharing and innovation for the public good. I think it’s exactly the right way to frame the inquiry, because the relevant questions are not just about patents, much as I love patents, and formal intellectual property in the form of patents. They’re broader than that. They’re questions that involve how to set up the entire innovation ecosystem, as one might call it, so as to yield the most public benefit.
So to get to one point immediately that has already been raised in several different contexts and the question of how the knowledge sharing and innovation questions in this area are different from or the same as knowledge sharing and innovation questions in other biological sciences, I think the way to think about it is as follows: many of the questions are the same as in other biological sciences that have a very significant information technology component, because there are lots of biological sciences that are not so pervaded by information technology but the various “-omics” — the genomics, the proteomics, and so forth — have a significant technology component. So we do have some precedent upon which to draw. That said, there are also differences.
I think one key difference from the standpoint of knowledge and information sharing is suggested by at least one definition of synthetic biology. As we have heard, there are multiple definitions. But I think this particular definition is very salient for thinking about knowledge and information sharing, and that is the definition that focuses on standardization. Some would say, I think Drew Endy among them, that standardization is the very essence of this field. That’s how it differs from prior efforts in that prior to synthetic biology there hadn’t been attempts to rigorously, and in a quantitatively predictable fashion, come up with standardized DNA and RNA parts that could fit together into modules.
That’s very interesting, not only from a scientific standpoint but also from the standpoint of innovation policy. Here’s why: Standardization and the law and economics and public policies surrounding standardization is probably the most exciting innovation policy question that legal scholars and economic scholars are studying right now. The national academies may actually launch a specific study on standardization in synthetic biology because it is so important. It involves intellectual property issues. It involves all sorts of other issues as well that I will get into.
Let me start out by talking about more conventional — and I say conventional in quotes because these aren’t really conventional in any sense of being very old. We are talking about a few decades old in terms of some of the more conventional knowledge and information sharing and innovation issues raised by synthetic biology. These are also raised by sciences such as by informatics and, as I suggested, the various “-omics.”
So for these biological sciences that have a very significant data component; data is obviously the coin of the realm. Per se, data is not protected by either patent or copyright. And unlike physical materials, such as knockout mice or cell lines, which are also the coin of the realm for some biological sciences, data is easy to replicate and disseminate. There are no real costs involved in that. So, one might imagine that we might see widespread data sharing in those biological sciences that have a very significant data component. Unfortunately, the available empirical evidence suggests this is far from the case. One major reason is just scientific competition. Outside of certain special large-scale genomic projects where NIH and other funders have mandated data sharing, very few scientists sua sponte want to engage in large-scale data dissemination, particularly prior to publication. And more importantly, perhaps even after publication, the available empirical evidence indicates that scientists are quite reluctant to share associated data that they believe they can use to extract additional publications.
There was a famous survey done by Eric Campbell and his colleagues at Harvard earlier, about five years ago, in which they found that almost half of all scientists who had asked for data associated with a published article had been denied such a request in the last three years. Almost half. So that’s extraordinary, and the evidence from my colleagues at Duke suggests that those numbers are only going up. So scientific competition is very, very significant, and is a real impediment to data sharing.
Now, commercial incentives may also play a role. Although data per se, as I mentioned, is not generally protectable by patent or copyright, making data publicly available can result in the inability to secure patent protection. So perhaps not surprisingly, the same evidence by Eric Campbell and others, including some of my colleagues at Duke, indicates that association of scientists with commercial activity significantly correlates even in various multi-variant regressions, even after controlling for other factors, with refusal to share data post?publication. So these are real, significant issues that are particularly important for areas like synthetic biology that are so heavily dependent on data.
I have mentioned patents in the context of data sharing perhaps being something people don’t want to do because it may result in the inability to seek patents. So let’s go to patents directly.
I think there’s several potential concerns regarding patents. One set of concerns that has long been mooted in the patent literature relates to the possibility of broad patents on what we might call fundamental technological platforms. There’s some history in the history of science and technology of restrictive licensing of these broad patents stymieing future innovation. Perhaps the most famous example is the Wright brothers’ patent on aircraft stabilization systems. That refusal to license on their part was really a major impediment to progress in the aircraft industry, and ultimately the US Government forced compulsory licensing of that patent, as did the US Government with respect to the AT&T transistor patent, which is an important component of integrated circuits.
So there’s some history of needing to have compulsory licensing in the area because there’s been — the owners of these patents have not licensed them in the most — in the manner that promotes technological progress the most quickly.
Some patent landscaping research that I did several years ago that was published in Texas Law Review indicates that we could be beginning to see some of the potential foundational patents in synthetic biology. It’s very hard to say that these are foundational patents because we are very early in the field, and often, as economists would say, ex ante — before the fact — you don’t know what constitutes a foundational platform in a particular field. But in the article, I point to several patents, including one held actually by HHS, a broad patent that HHS holds on the combination of a nucleic acid binding protein and nucleic acid sequence for purposes of setting up any kind of data storage or any kind — almost any kind — of basic Boolean algebra. So it’s a very broad patent and would cover a lot of what we have seen. Fortunately it is held by HHS. That’s not necessarily a problem. HHS is unlikely to assert it, and many of these patents that I mentioned in the Texas article, at least, are held by non?profit entities and unlikely to be asserted. So, perhaps more potential indication that there could be issues with broad foundational patents in this area rather than any sort of immediate concern.
Now, of course, even when there are patents, we could have enlightened owners — broad patents — enlightened owners licensing non?exclusively and broadly, and there’s good economic theory to suggest that you could do good and do well. In other words, you can make lots of money and also disseminate the technology widely even if you do hold a broad patent on a foundational technology. So the Cohen?Boyer patent is a seminal example of a situation where Stanford and UC Berkeley made hundreds of millions of dollars but also licensed their patent very broadly and nonexclusively.
However, there is the concern — and economic theory does suggest — that there are situations where it’s economically rational not to license broadly and nonexclusively. So that concern arises, and in some of the research I have done there is some evidence that certain nonprofit players, at least, Sangamo Biosciences being perhaps the most notable one — it has a wide array on patents on zinc-finger proteins, which are very important nucleic acid binding proteins. They haven’t always optimally licensed their technology. So there’s that concern.
Thus far I have been assuming that these broad patents are valid. I just came back from a stint at the PTO, so I can say this, I think, with some authority, that although the PTO tries to do a very good job of making sure the patents it issues are valid, there’s reason to believe and, then, in the information technology space — and the synthetic biology patents look more like information technology than they look like traditional biology — a lot of the patents are not of the best quality. In particular, some patents at which I have looked are probably broader than the disclosure in the patent warrants. In other words, a patent is supposed to show the person having, quote/unquote, ordinary skill in the art, how to make and use the patent.
These patents talk a lot about how to make these — these are particularly Sangamo patents — talk a lot about how to make the optimal nucleic acid binding protein, but don’t reveal the data set that would be necessary in order to do so. And various scientists with whom I have spoken say this is analogous to having a software patent and basically just saying it’s going to do X but not revealing the source code. So there’s inadequate disclosure in a lot of the patents, which is problematic to the extent that patents can be a very good thing for purposes of data sharing because the idea — the patent bargain is supposed to be a bargain in which you get an exclusive right in exchange for disclosing to the world how you did what you did. And if these patents are not fulfilling that bargain, that’s a problem for the progress of science.
And finally, we can have problems with patents that are associated with not just a few broad patents but lots of patents, so-called patent thickets. This is a real problem in the information technology industries in particular, where thousands of patents literally, in some cases, can cover a particular printer or a microprocessor or what have you. And to the extent that, again, synthetic biology aims to be like information technology and engineering in particular, we could imagine this happening in theory, at least.
My colleague, Bob Cook-Deegan at Duke, has estimated there’s something like 16,000 US DNA sequence patents out there, so there’s certainly a potential for these thickets. He estimates about 48,000 genomics patents in general. Thus far, the empirical evidence indicates that genomics has avoided patent thicket situations for two reasons.
First, academic researchers just ignore patents. They don’t care. And they don’t get sued, which is good from their standpoint, even though they could get sued because there’s no research exemption for academic researchers, just to be clear. All of you guys and gals who are doing research could be sued if you are infringing patents. For the most part it looks like you won’t get sued and you don’t care.
So that’s one thing. The second thing is, in the commercial sector people do sue a lot. But in the commercial sector, these tens of thousands of patents that Bob Cook-Deegan and others have identified, oftentimes it’s possible secretly to infringe those patents because you’re infringing in the research context but your ultimate product, your small molecule drug, doesn’t infringe, and the statute of limitations for suing you runs out by the time people know that you have infringed. So the commercial sector pharmaceutical companies do this.
But the problem is that if we’re going to have standardization in synthetic biology, standardization by definition is public. You can’t have standardization that’s secretly done because standardization means collective decision-making upon an agreed?upon standard. So this is where I think the real sets — the real concerns may lie in the future, because if we do achieve standardization on DNA parts or RNA parts of a sort that Drew Endy and others want to achieve, I think it’s fair to say that those parts will read upon a lot of patents. And they probably do right now read upon a lot of patents. I don’t know of anyone who has done a patent landscape of Drew Endy’s — of MIT’s — registry of standard biological parts, but I would suspect that they read on a lot of patents.
In the information technology industry, the way people have dealt with standardization and the reality of lots of patents on these standards is that they set up these standard?setting organizations (SSO) that get together and try to determine what the essential relevant patents are for the particular standard before they commit the industry to the standard, because you can imagine that without doing that, if you committed the industry to a particular standard and somebody came along with a patent on that standard, they could extract a huge sum of money after the fact, after the industry has already locked into that standard, far beyond what that patent might be worth as one of a thousand patents that reads on the standard.
So the idea is for the SSOs — and they have been blessed by the Department of Justice in doing this, to get together and make sure that they license or commit the owners to license on so?called reasonable and non?discriminatory terms all of the essential patents. Unfortunately, this process has worked to some extent but doesn’t work optimally, and so we have cases like one particularly famous case involving a company called Rambus that came in and was able to extract a huge sum of money on a patent it held, which it hadn’t really disclosed to the standard?setting body it was involved in, which was coming up with a standard for random access memory, RAM. So it’s potentially a really significant issue in synthetic biology that’s different from other areas of biological science, even biological sciences that have a large IT component and haven’t attempted to standardize in the way synthetic biology has.
So what are some possible options? Well, in the standards context in IT, there have been efforts in some context, at least, to either do these standard setting organizations, where you try to do ex ante licensing of the relevant patents or have alternatives that are either patent?free or where the relevant patent holders commit not to asserting their patents. So Linux, for example, is an open source software system where most of the relevant patent holders have committed not to asserting their patents.
So open source is one option, and that to some extent is what the MIT registry is trying, to the extent that it requires those who contribute parts to the registry to state that they won’t assert their patents if they have any patents.
Amy Gutmann:
Arti, I’m going to ask you to state the other options because of time. Otherwise we simply won’t have time for questions.
Arti Rai:
Okay. So open source is one option, sort of setting up an alternative, relatively patent?free system. The SSO is the other option. So let me conclude by saying I have been sort of relatively negative about patents thus far. I do want to make one very important point in favor of patents, and that is I would be reluctant to have any sort of system where we try to eliminate patents in this area, because I think they provide some very, very important incentives, and the key is to manage them properly, not to eliminate them. So, for example, I’m concerned about the ACLU v. Myriad case, which would try to eliminate very broadly patents on genetic sequences.
Amy Gutmann:
Thank you. Ashley Stevens is currently special assistant to Boston University’s Vice President of Research in the Office of Technology Development and also Senior Research Associate the at University’s Institute For Technology Entrepreneurship and Commercialization. He is a leader in the field of technology transfer, and currently serves as president of the Association of University Technology Managers. Dr. Stevens has worked in academia and the biotechnology industry since 1982 and has been involved with both start?up companies and academic organizations, helping to turn promising scientific ideas into useful products and companies.
Welcome, Dr. Stevens. We’re delighted to have you here.
Ashley Stevens:
Thank you, and thank you to the commission for inviting me. I, too, am going to skedaddle to the podium.
Amy Gutmann:
Ashley Stevens:
Thank you. So as Dr. Gutmann said, I have been involved in the biotechnology industry since 1982, when I moved to Boston. I have been with two biotechnology companies, and I have been involved with academic technology transfer for 20 years now. So I really have lived through the growth of this industry. I have seen the transformation of Boston into a major center of biomedical research, largely based on the impact of spin?out companies from Harvard, MIT, BU, Tufts, and so forth. It’s coincidental that I am here with Jim, but I have been working with Jim Collins for many years in the commercialization of the synthetic biology technology and have greatly enjoyed that.
Perhaps because of this history of mine in the biotechnology industry, when Valerie first called me to ask me to come speak to you, my first reaction was, well, as I hear the debate on synthetic biology, I am hearing the same issues that have been discussed back in the late ’70s and early ’80s, and I think others have said that here today.
And so what I’m going to do is take you through how some of these issues have been managed over time. So, I’m going to talk a little bit about the Association of University Technology Managers (AUTM), make a couple of comments on the patent system, talk about patents and their impact on scientific research, and then talk about intellectual property in the biotechnology industry and the impacts of patents on scientific research, and then one or two specific thoughts about synthetic biology. And then I do — I know I will not have to time to get to them. I have data and statistics at the end of my presentation you might find interesting on technology transfer in the US.
So AUTM is the leading association representing technology transfer professionals globally. It has been around 30 years. We have 3,500 members in 35 countries. Our primary activities are professional development (educating practitioners). We provide services to mentors, in particular, a great deal of data collection — we are the definitive source of data on technology transfer — and then we do advocacy.
So first let me talk a little bit about the patent system. I think the point I want to make is that the patent system is continually in flux. It wasn’t until Microsoft was five years old that you could first get a patent on a piece of software — through the Diamond v. Diehr case of the Supreme Court. In 1982, we established the Court of Appeals of the federal circuit, which had a tremendous impact on strengthening the value of patents.
Through the 1980s, three landmark cases made biotechnology patentable. Chakrabarty established the patentability of microorganisms. In re: Hibberd on sexually reproduced plants, and then the famous Harvard mouse patent on genetically engineered animals. Then a decade later, we had the State Street Bank decision confirming the patentability of business methods. So I would say through the ’80s and ’90s we had a strengthening of the patent system, and then recently the Supreme Court has started to get back involved in the patent system in a big way. It had largely stepped back after the establishment of CAFC. And we’ve had a number of cases which have redefined, I would say, have limited the scope of patentability and certainly have reduced the economic impact of the patent system. For instance, Ebay v. Merck, the right to an injunction. That came out in, I think, May 26, 2006, about ten weeks after Blackberry had paid $615 million to be allowed to stay operating. And I think most people think that if Blackberry had been able to keep it off until after Ebay v. MercExchange, they would have saved about 500 to 550 million of the $615 million.
So our patent system is continually changing. Let me give you one particular example of how this impacts on scientific research. There were three patents filed, all around the 2000 time period, which attempted to claim all downstream drugs that modulated newly discovered biological targets. Two of these were from academic institutions, the University of Rochester, Harvard, MIT, and the Whitehead license to Ariad, and one was from Pfizer, a drug company. So these inhibitive Cox 2, the super aspirins, Pfizer’s was on the application of all inhibitors of PD?5 to treat male erectile dysfunction, and then the Ariad-Harvard case was NF?kappaB, a key modulator of the inflammatory system. These all claimed these targets through a method of treating people with certain disorders by modulating those targets. All three over the next decade have been ruled invalid for either enablement or written description. So I think this is an example of how sometimes overreaching patents might get issued but then when challenged do get shot down.
Let me talk a little bit now about patents in scientific research. The US technology transfer system has really been in place robustly for about 30 years since the Bayh-Dole Act of 1980, which allowed universities to freely elect title to the results of the federally funded research; obliged them to share the proceeds with the inventers; gave them pretty much complete discretion on licensing terms; required US manufacturers of products sold in the US; a preference for small business; and a non?exclusive license to the US government for its own use; and retained the ability to grant a compulsory license in the public interest, which has been invoked rarely, and there is currently a new invocation in play over the last couple of months.
If we look at the traditional scientific paradigm: ivory tower scientist does his scientific research, publishes a paper, and then gives presentations on those papers at learned society meetings. And I think what the new scientific paradigm is that in parallel with this, we have added a string whereby, simultaneously with the publication, and hopefully before it, we apply for a patent application. And then that patent application is used to create relationships with industry to take those inventions and to develop them.
And there has been involved a concept called the patent-paper pair — try saying that three times quickly before a presidential commission — created by Fiona Murray at MIT. She looked at fifty papers in Nature Biotechnology over a three-year period, found fifty percent of them had a corresponding patent. A more recent study, which looked at broad-based journals rather than the Nature Biotechnology, which perhaps inherently selects the science of commercial relevance, found a third of papers in biotechnology in a six-month period in Science and Nature had a corresponding patent. So, clearly the scientific community has embraced this parallelism of scientific research and then creating the tools to be able to engage with the commercial sector to commercialize.
The extent of faculty participation in this — this is data from the Thursbys at Georgia Tech. People like Jim Collins are in a small minority of faculty. About two-thirds of faculty never engage in the process in their entire career, and the rest is a spectrum in between.
So why do we have patents? As Arti said, and I won’t reiterate this, they are legally sanctioned monopolies to promote disclosure by inventors of the discoveries, and then they strike a deal with the government in which they disclose and in return get a 20?year monopoly on their use to allow the attraction of investment to develop the technology. Now, a patent, you have to remember, is exclusionary, not permissive. They let you build a fence around what you have; they don’t necessarily allow you to practice what you have in your own invention because there may be broader patents that encompass what you what have done. What they do allow you to do is to stop others practicing your invention without your permission, which is what we call a license. As Arti said, you are under no obligation to grant that license. You can keep the whole field to yourself, but they give you control over the development of the technology.
So let’s look a little bit at intellectual property in the biotechnology industry. I would posit that the intellectual property in biotechnology is profoundly different from that in the traditional pharmaceutical industry. A small-molecule drug typically has two or sometimes three layers of patent protection. You can see this in the FDA’s orange book, where manufacturers have to list the patents that protect their drugs. There is always — or usually — a composition of matter. There are generally methods of treating specific indications, and then there may be a formulation patent. You may see a billion-dollar drug protected by one or two patents alone.
Biotechnology, however, is characterized by many core discoveries being made and patented in academia and by the existence of platform technologies that translate specific genes and protein discoveries into marketable products, and there’s intense licensing activity in the biotechnology industry. And products do carry substantial royalty burdens.
Let’s say that you have discovered a composition of matter of a gene in a protein and you apply for a patent. If you want to just use it as a screening patent, you don’t need a license to Cohen-Boyer before that expires. If you want to use it therapeutically, you need a protein expression system. If you want to use it in gene therapy you need a delivery vector. If you want an RNAi, then you need access to the Tuschl and the Craig Mello-Fire patents. When you look at the biotechnology industry, there have been numerous technology patent platforms that are owned by universities. I list some here. Arti already mentioned Cohen?Boyer, but we have Riggs?Itakura, which was key to bacterial production of DNA. And then we had Axel, key to mammalian cell production of DNA. The Cabilly patents on monoclonal antibodies, the Thompson stem cell patent for Tuschl, Mellow-Fire RNAi patents. There have also been substantial technology platforms that have been owned by companies. The Cabilly patents were actually done by Cabilly at City of Hope, but Genentech had control of them and did the licensing. We had the Mullis patents of Cetus on PCR, the Queen patents of protein design labs on the humanization of monoclonal antibodies, and the Ladner patents on phage display owned by Diax. These have been licensed, and licensing if a very, very fine-tuned weapon. You can do highly nuanced license agreements and transfer infinite degrees of scope of rights to the patents.
So why do people license their technologies? Either because they can’t or won’t develop a technology. A University, it’s not part of our mission to develop technologies and sell products. A small company may have inadequate resources to take the product to market. The invention may not be insufficient to market a product itself. It may be a platform technology that needs additional inventions to productize it. So you do a deal where somebody takes a majority of the risk and returns the majority of the return, and the inventor receives a small part of the return. In other words, five, or ten, or twenty-five percent of a big pie is going to be worth more than a hundred percent of a small pie.
And licensing platform technologies has been highly profitable. Genentech, $250 million from Cabilly in 2007 alone. Protein Design Labs, a similar number from the Queen antibody patients in 2008. Cohen?Boyer made $254 million for Stanford and the University of California-San Francisco over its lifetime. City of Hope got a $500 million jury award against Genentech just for Riggs-Itakura. Axel made Columbia $800 million over its lifetime.
I think one of the other questions that I discussed with Valerie was the issue of do patents inhibit research? Certainly, as Arti alluded to, a lawsuit, Madey v. Duke, did establish that universities are in the business of doing research and the patents must be respected. However, infringement suits are highly expensive, probably a minimum of $5 million, and there’s rarely sufficient economic value in basic research to justify enforcement actions, so I agree with Arti giving you the measure of comfort that she did in her remarks.
Another thing to remember is that only issued patents can be enforced, and cutting-edge research builds on prior work which takes place well before patents can be issued. And we have robust material transfer systems in place. The universal biomaterial transfer agreement treaty has over 300 signatures now, and academic institutions license their patents with explicit disclaimers concerning blocking patents. We leave insuring freedom to operate entirely to our licensees.
There has been overreaching use of patents. There have been attempts to use patents on research tools overly broadly, to reach through and claim rights to discoveries made using these tools on things like the Harvard mouse and the CRE-LOX patents in this respect. But I want to point out to you that these were all made — these assertions were made by companies. One company, actually, seemed to be a slow learner, not academic institutions.
Another issue that’s raised is do patents encourage secrecy? This is, I think, a big misunderstanding. Patents require complete disclosure of the best known way of practicing the art as of the date of filing. That’s what we call “best mode.” Patents are another form of publication. We’ve had examples where professors filed patents, couldn’t get the paper accepted, but the patent was their ultimate claim to priority. US patent applications have been published after 18 months of filing since 2001. And as somebody has alluded to, scientists are secretive about the interim results of their research until they reach a publishable conclusion. In 1993, I had the privilege of working with Richard Kolodner, who was pretty sure he was on to the discovery of the hereditary colon cancer gene, and his challenge was to get the materials to prove that fact without alerting a certain researcher further south of what he had found. And the race was on. The word leaked out, and we managed to beat that guy by only two weeks. So until things are publishable, scientists are very protective of their discoveries. Availability of provisional patent applications since 1995 has facilitated patenting without delaying publication.
So if I can take one more minute, I want to ask the question, is there anything fundamentally different about the intellectual property aspects of synthetic biology? Some is certainly being developed in the private sector, private foundations such as Venter. Some is being delivered in academia, such as the University of Wisconsin’s recent patent application on the reduced gene set E. coli, which I think will have probably more commercial relevance than Venter’s microplasma.
I think the scope of what is patentable subject matter will be determined by the patent office and the courts, and I think we should have confidence in the robustness of those processes.
And I do want to leave you with the thought that the intellectual property regime, I believe, is sufficiently robust to handle the challenges. Arti did talk a little bit about standard setting. There’s been little in the way of standards and patent pools in biotechnology, but very interestingly MPEG LA, which is the original independent patent pool operator and standard setter, has recently announced a patent pool on gene patents, genetic testing patents, which I think is a very interesting development in the expansion of novel mechanisms for intellectual property management.
Thank you.
Amy Gutmann:
Thank you very much. Thank you. We are now on to our third presenter, and he is David Weiner [phonetically pronounced Wee-ner]. Am I pronouncing that correctly?
David Weiner:
Weiner [phonetically pronounced Wy-ner].
Amy Gutmann:
Weiner. I knew there were two options. I had a 50/50 chance. I got it wrong. David Weiner is a Professor of pathology and laboratory science at the University of Pennsylvania. He is a world-renowned leader in immunology as well as in gene vaccines and therapy. His laboratory helped to found the field of DNA vaccines. He is the recipient of numerous NIH grants. I take it that’s by way of some disclosure, but it’s good disclosure, an adviser to both the FDA and the NIH, and a key player in many start?up biotechnology companies. He currently serves as chairman of the scientific advisory board of Inovio Pharmaceuticals. Welcome.
David Weiner:
I am also going to use the podium.
Amy Gutmann:
Welcome up to the podium.
David Weiner:
I greatly appreciate the invitation to be here. I thank the panel for allowing me to come and speak with you, and it’s an honor to follow such distinguished individuals, who actually know something about what they’re talking about. I’m from Brooklyn, and really my background in any of this is questionable, as my three daughters often tell me.
I’ll share with you some thoughts. When Valerie called and asked me to participate, she asked me if I could talk a little bit about my experiences based on a basic researcher who has interacted with different branches of the government, as well as industry, on some of my possible background relevance.
So the points for discussion I sort of summarized up here. So my first point is one that several speakers have already brought up. I don’t believe that synthetic biology, as pointed out, is new. It’s really an extension of molecular biology and biotechology. And the Venter paper of cloning a one million base pair genome sequence into a microbe is an achievement because it’s completely synthetic, but it is the natural organism sequence and it actually had to be specifically labeled for them to tell the difference between that sequence and the native microbe sequence. So in many ways, previously we’ve engineered bacterial viruses in animals, and we actually performed the sequencing of the human genome project with much larger pieces of synthetic material than this.
And there is a system in place that I would argue is a highly successful engine for including oversight and safety of developing new drugs, diagnostic, agricultural food safety products, job creation, and significant value for the American public. I’d also like to highlight that current drug development costs, approximately, for a therapeutic is at least a billion dollars on average or more and take 10 to 15 years or more years to accomplish. In fact, vaccines take longer than this, and that’s an important issue when we talk about patents.
And there are safe harbor provisions that protect developers during the active patent period in order to allow them to compete once the patent has expired. And therefore, patent effect is relatively limited in many senses for new therapeutic development. I’ll go into that a little more on following slides.
If a company cannot be allowed to have levels of patent protection — and I particularly enjoyed the last two presentations that talked about limitations of patents — then this will not serve the American public, as drug development cannot be supported by industry. Without a patent, no large pharma is going to consider investing a billion dollars to go forward. They have to feel they have ownership of something, and we have to enable them to do that. This, of course, serves Americans in many ways with products, jobs, and it’s very important in US competitiveness. Just because we make this change, the rest of the world might not make this change, and we have no controlling over that.
Industry is currently under a great deal of pressure, both biotech and pharma, and industry’s supportive measures and further enhancing incentives, I think, is particularly important at this time. And this commission, dealing with these issues, I think you’re stepping exactly into that realm as well.
So my own personal background is in the area of DNA vaccines. I want to point out these are actually synthetic vaccines, and therefore I never really considered them the same way we talked about today. But it is an area of completely synthetic, computer-designed gene sequences from pathogens that can be delivered as pure DNA sequences.
The scientific advantages of that are, again, when we try to engineer something we try to improve safety and effectiveness, and so it’s the safety of a non?live with the effectiveness of live vaccines, and there’s lots of advantages to that. This is an example of the synthetic delivery into an animal model, and this green is the expression of that gene in living animal. And actually these vaccines have gone into tens of thousands, at least, humans already by different groups and companies. And so we have a lot of experience with this as far as safety in people.
So synthetic biology allows a rapid construction of nucleic acid sequence in a laboratory and can be used to transform cells, engineer them, and create safer and new organismal phenotypes, and the reason Venter work increases the size of the synthetic sequences for this can be argued. Bacterial chromosomes are actually very large pieces. Yaks are extremely enormous pieces. And in fact if I just took an example from someone on the panel, Col. Michaels, who led the HIV vaccine program that showed us the first possible signature of an effect of HIV vaccine of 30 percent in humans. They used the recombinant pox virus system that actually encodes a genome of 108 base pairs, a hundred fold larger than what we’re talking about in Craig Venter’s work. That was put into tens of thousands of people with, as I understand, a very excellent safety record. And so there’s really been this type of manipulation going on, in fact in humans, for a considerable period of time. The pox virus field started in 1982 publicly, I believe.
So synthetic biology is a continuation of the evolution of molecular biology, and we have been engineering for years recombinant viruses, bacteria, vaccines, yeast recombinants is an entire field of recombinant vaccines. And many of these have been in humans for considerable periods of time, and we’ve been generating new phenotypes for decades. Synthetic gene sequences are in routine use in laboratories and in animal products and in the clinic for some time.
I might point out we tend to overestimate our own power here. Nature is by far dramatically superior to anything we’re doing. I’m pointing out — I have an example here of two different in?bred dog species, and these are all derived from the wolf. If we talk about cows, cows now can produce liters and liters of milk. They can’t do that naturally. We have chickens that have breasts larger than the entire rest of the bodies, and all of this is done by reassortment and breeding of tens of thousands of genes naturally by mating.
If we talk about in the natural world, malaria, for example, is delivery of hundreds or thousands of different genes from a single parasite into our body. So nature really has the upper hand here, and we’re still playing with just a few gene sequences.
Oversight is clearly important, and for many years — since, as I’m arguing here, it’s not very new — there’s been a lot of discussion in the US of safety and how to move forward in people, animal, laboratory studies, plants. And I also want to point out this is a worldwide issue. And, really, that’s of significant importance now. And we need to, of course, continue to watch this and all important areas of science for developments that present unique issues.
So some broad strokes on patent and biotechnology, which certainly the last two speakers are much more capable of addressing than myself. Academics and not?for-profits have the ability to do basic research in patented areas, as was discussed. And the human genome, I want to point out, has been sequenced and all open reading frames have been identified, and this is about research from about ten years ago. And human genome sciences, of course, cloned all the open reading frames from messages about the same time.
So most of those are not new issues, therefore. New research may uncover forms of genes that are particularly associated with disease, but these may take years or decades of work, and then a patent around this specific application and the way we use it is, of course, seeming worthwhile.
The average new therapeutic drug will take more than ten years to develop, vaccines much longer. HIV, the quest has been more than 25 years. The polio vaccine took more than 40 years, for example. Flu took also a similar amount of time after validation of a particular gene target. So a patent is filed, there will be about three to five years of research, and then maybe industry will jump in. This is not changed dramatically by synthetic biology. And so if you put these numbers together, you can see the patents do not dramatically impact therapeutic development in a negative fashion. In fact, they are enabling. They give industry a way to move forward to allow them to bet large amounts of money and resources, and they create jobs.
Companies that embark on product development are protected by safe harbor provisions. The safe harbor provisions extend beyond mere research and development of drugs equivalents to include basic experimental research on new drug candidates and other products that require regulatory approval. And, as stated above, therefore these have a limited — a clear effect — but a limited effect on ultimate therapeutic development.
So the major points are: companies cannot justify the hundreds of millions of dollars of investment necessary to undertake a new therapy or vaccine development without being able to establish patent ownership position with their management. Otherwise, what are they working on? And biotechnology is a worldwide pursuit. We do not control patenting in other companies. Further curtailing US patents in this area will likely put US at a competitive disadvantage.
And so I list here some of the positive impact of this patenting and biotech. Some are very obvious. Over the last 30 years lifespan in the US has increased an average of 2.2 months per year. We are sort of the first generation ever to almost be guaranteed to see our grandchildren. That was not true of the generation that fought World War II, for example. These are enormous benefits.
There are more than 200 biologic medicines and vaccines that benefit millions worldwide. There are an additional at least 1200 biotech diagnostic tests being used in clinics around the world. We live longer, more active lives. There are many advances I cite here: immune disease, cancer treatment, and Viagra allows individuals a sense of — well, you can fill in the rest of that yourself.
It is perhaps the most active area in the pharmaceutical industry. More than 600 new drugs for Alzheimer’s, cancer, immune disease, and many, many others — heart disease — in development currently. The current system, including regulation, created hundreds of thousands of jobs directly plus more indirectly, as typically bioreviews claim that we get two for one jobs from the outside community from the inside job. And these jobs are very high paying, so this is particularly important.
Increased investment by the private sector has really been spawned by these patents. Development of hundreds of billions of dollars improves food safety and in fact this leverages the initial NIH public funds. So if we think the actual cost of developing a drug is about a billion and NIH cedes five or ten labs to do research at a few million, you can see that the leverage here is enormous, an enormous benefit to the American public.
Examples are very straightforward. HIV was a death sentence in 1990. Now in the US it’s more of a chronic disease. Breast cancer survival has dramatically improved. We can go through the list. There’s new vaccines that didn’t exist. The HPV vaccines are threatening to wipe out wonderfully this cervical cancer, which are tremendous accomplishments. And we can go on and on with the autoimmune disease drugs, for example. Clearly this is an extremely important and valuable area for the United States.
But current economic conditions are significantly problematic. The biotechology industry is under tremendous economic pressure. Raising capital is difficult for a variety of reasons. The large pharma situation is scary and difficult. Consolidation — just consider this: in the last few years we have gone from seventeen major pharmaceutical companies to just down to eleven. Think of the loss of jobs, because when they consolidate they don’t stay the same size. They usually shrink down to the exact size they were before. This limits research outlets for academic and NIH research, small biotechs, and it limits the number of new drug programs. It’s estimated somewhere between fifty and a hundred programs are lost during the mergers per company. So think of what a loss that is to the American public.
If you talk about vaccine manufacturers, the situation is even more dire, in my estimation. In the 1980s there were 27 considered large US vaccine companies; today we just have two: Pfizer and Merck. We don’t even have a large company that makes the influenza vaccine that we were so concerned about last year, and we have a relatively limited license to MedImmune for that flu vaccine that doesn’t cover all age groups.
It is important to continue to allow reasonable protection and further incentivize and enhance U.S. competitiveness in the area.
So my final thoughts are, in place, as an example of a highly effective government-regulated system that engages the private sector to leverage public investment, which has resulted in the creation of new therapeutics, diagnostics, agricultural products, biosafety products, and these have significantly enhanced the quality and quantity of American lives with an excellent record of safety. It continues to provide a significant job creation and drives billions in private investment to an area of value for US citizens.
Current systems — including patent protection, limited scope of patent allowance, safe harbor provisions, long drug development time lines — provide incentives and stability and allow for continued new therapeutic development, which is important for the US economy.
Elimination and further limitation of patent protection areas has the high probability to eliminate much industry incentive, which would lower the US competitiveness because we would be the ones doing that, not our competitors. Due to significant economic pressure in the biotech and pharmaceutical industries, additional incentives are particularly important.
So I will stop there, and I thank you very much for allowing me to present today.
Amy Gutmann:
Thank you very much. Let’s thank our three presenters.
Amy Gutmann:
So we have much food for thought here about the way in which patenting affects the public good. Anita Allen, since you are one of our certified law professors, would you lead off with a question?
Anita Allen:
Thank you. I think what we heard just now is a very pro?patent perspective from Dr. Weiner, and a somewhat skeptical but also pro?patent perspective from Professor Rai. Arti, you were very helpful in pointing out some of the problems, but you did in the end say that you think we should not eliminate patents but should rather manage them. And then we also heard a very optimistic point of view from Mr. Stevens.
No one is saying let’s not patent or let’s be extremely cautious in patenting. Instead, I think we’re hearing let’s figure out how to capitalize on our already robust patent system and then let’s also try to manage. So my question is really going to be mainly directed at Arti Rai, which is about, well, how do we manage?
If the system is as robust as Stevens says and as wonderful as Weiner says, but you think we should be managing the system, what specific things would you have us do to make sure that we can benefit from the patent system in the ways that were described but not harm issues of access and justice that I think you have in mind when you express your skeptical cautions?
Arti Rai:
Right. So I think that in terms of management there are two primary mechanisms. One is the grant of the patent has to be over valid territory. In other words, we should make sure that the patents granted by the PTO are high quality. I fear, unfortunately, that in general in the biological sciences they have been of high quality, according to the internal standards of the patent system. But as we get more and more into fields where the biological sciences resemble information technology things get a little more dicey. There’s a lot of complaint in the information technology industries, basically Silicon Valley, about the quality of the patents issued in the IT industries covering software patents, telecommunications patents. Lots of momentum for that reason — or at least there was some momentum for that reason — to have significant patent reform, particularly by those industries. So that’s one thing. So that’s high quality.
The other point set of mechanisms that have to be emphasized — and maybe this is even more the remit of this particular committee, because high quality patents, presumably the patent office should try to be — and I think they are. Dave Kappos, the head of the patent office, is trying to do that — is thinking about licensing. And there are many different actors in the licensing landscape. There are universities, and universities need to manage their intellectual property and the public interests. And I think more the most part they have done a pretty good job, but I think everyone recognizes that there could be — there are situations where universities have perhaps exclusively licensed in situations where they shouldn’t have exclusively licensed.
This is not synthetic biology, but in the case of diagnostic patents, which is what’s happening in the ACLU v. Myriad case, the breast cancer gene patent case. I see that mostly as a problem of bad licensing on the part of certain public sector institutions, exclusive licenses where they didn’t have to be exclusive licenses. So we have to be vigilant about that set of issues. We have to be also vigilant, if and when we get standardization, and I’m not sure we will. That’s the hope, that we’ll get standardization. Really look at what the IT sector did correctly in terms of setting up standard setting organizations and patent pooling but also where those mechanisms have not worked perfectly, where there have been situations of holdup. And I think on the whole there haven’t been that many, but there’s a lot going on in the IT sector in general in terms of thinking about how to make these mechanisms work better, and I think if we get standardization in synthetic biology, that thinking should translate directly.
Anita Allen:
If I could just ask you a couple of quick follow?ups. One is, is there any reason to think that the products of synthetic biology should be not patented? I mean, issues analogous to the ones we have been presented with, business methods or animals and so forth. That’s sort of one — I think a lot of what the anxiety is about is maybe we’re going to be creating a life form and then slapping a legal protection, which is inappropriate somehow for the kind of thing that it is. And another thing is — but you do think that we should manage it. Who is the "we"? That’s really very important question. Who is the “we”? Is it the government? If so, what part of government? Is it some kind of private-sector management that ought to be going on, especially when it comes to sort of the norms of licensing and so forth?
Arti Rai:
Yes, I think it’s a little bit of both. I think the government does have a role to play, including this commission has a role to play in setting up norm expectations for licensing, for example. And I know this is going to be a question that’s discussed in the context of the biosecurity panel. For example, this is not exactly IP, per se, but it could have relevance for IP considerations as well. I take it there’s going to be some decision reached in the not-too-distant distant future about a standard for screening gene sequence orders. There I think the government, for example, has a larger role to play in making sure that’s the appropriate standard. It’s appropriately rigorous, and I suspect that next — tomorrow, perhaps, we’ll have a discussion about whether the government’s approach has been appropriate rigorous.
So definitely the government has a role to play. And also in modeling best practices of its own licensing. So HHS — I mentioned HHS has a patent — which it hasn’t asserted, thankfully, because I think that that’s not the sort of patent that should be asserted. So the government can model best practices with respect to non?assertion and also with respect to licensing. Because NIH has in particular, for purposes of synthetic biology, already has a significant patent portfolio and is likely to accumulate more patents.
So I think it’s a dynamic interaction between the government and the private sector. In general, I’m not a huge believer in very stringent top?down regulation. I think norm?setting is probably the better way to go.
Ashley Stevens:
If I can make a couple of comments.
Amy Gutmann:
Excuse me for this interlude. If anybody in the audience wants to ask a question or make a comment, please come up to the microphone, okay?
Ashley Stevens:
I want to reiterate that I think we should avoid the temptation to meddle with the patent system. (A) That takes an extraordinary long period of time. The US Congress has been trying to reform the US patent system for six years and it still seems to be stuck. International treaties take typically eight years from signing to implementation, whereas licensing behavior can be changed much more quickly.
I would remind the panel that in 2001, with the conclusion of the human genome project in sight, President Clinton and Prime Minister Blair, made a 201?word statement that they were going to stop patenting of the human genome, and this led to a secular decline in the finances of the biotechology industry that probably still has not been reversed today, even though they back?tracked very quickly in what they had meant by that statement.
Now, Arti did talk about standard?setting, and this has been one of the roles that AUTM has been active in recently. About six years ago, we established the nine points to consider when doing licenses, which talk about some of the things you should look at when coming to a license agreement. And a year ago we set a statement of principles and guidelines on how to include protections for global health when licensing health care inventions. We are currently working with a bioindustry organization on a set of guidelines for licensing genetic tests because this is a subject of some controversy lately.
I do want to make one comment, and that is it is very dangerous to exercise hind vision. One could criticize the University of Utah for exclusively licensing the BRCA1 and BRCA2 genes to Myriad in 1995. They did it because they thought it would lead to a more robust and better breast cancer gene. I actually started the work that led to the cloning of those genes.
When I decided to license the hereditary colon cancer genes non?exclusively, I did it because I wanted to get the maximum commercial impact because I wanted every offerer of tests to come up with — to be able to offer our test. So looking forward 15 years, I may have — I’m probably considered to have come to the right conclusion but for the wrong reason, and the University of Utah is considered to have come to the wrong conclusion but for the right reason. It is very easy to look back and be smart.
Amy Gutmann:
Now, because we haven’t yet engineered eyes behind your head, I just want to say there is a line now of — we’re very welcome — of people — not you, but Ashley. So I will ask the presenters to swivel and let’s take questions. And introduce yourselves. Just say your name and where you’re from.
Al Giovenella:
I’m Al Giovenella. I’m from the University of Pennsylvania. With drugs in a lot of other countries there’s virtually little or no patent protection and it makes things uncompetitive for us here. I was wondering is it reasonable to assume that for genes and for the synthetic microorganisms that that patent protection will be about the same as drugs. It will vary greatly and it might not have — in some countries you might not have very little protection?
Amy Gutmann:
Thank you.
Arti Rai:
Well, I have been looking at this issue in the context of genes specifically just because the ACLU v. Myriad case raises the question of the patentability of genes. Interestingly, with the salient exception of certain developing countries like Brazil, most other countries have fairly robust patent protection for genes. With respect to the products of synthetic biology — I mean, one of the things that’s interesting about synthetic biology is it’s not just pharmaceuticals and medical products. There will be lots of other types of products that will be produced. But my guess is unless, you know, court decisions cut back patent subject matter significantly, we in the US and for the most part abroad will have fairly robust protection.
Amy Gutmann:
Thank you.
Ashley Stevens:
There are nuanced differences between patent systems. You can’t get a method of treating patent in Europe, for instance. The different timing rules can sometimes result in different groups winning the prize. But I think in the developed world by and large it would be comparable scope.
Amy Gutmann:
Thank you.
Ellen Bates:
Ellen Bates from Los Angeles. My question is more to the standardization on the international front, because I understand we’re seeing a lot more development abroad to avoid the problems and expenses that we’re experiencing here.
Amy Gutmann:
You know what I’m going to do? I’m going to take the next question as well. That way you all can look — you can use your microphones more easily. Yes, so, standardization on the international front. Yes?
Unidentified Speaker:
This isn’t a question. This is comment left over from the last speaker.
Amy Gutmann:
Please introduce yourself. You can make a comment.
Unidentified Speaker:
I guess we could consider this a temporary recess. My comment has nothing to do with synthetic biology. This is left over from the last meeting. They ran out of time. This concerns rather leftover matters, ethical matters which were significantly evaluated and acted upon but which have not yet been completed and with cruel and inhumane consequences.
I am here to urge you, the commission, to put on your agenda for a very near future meeting the subject of the need to recontinue, to restart, and complete a government-wide federal policy change to protect citizens for the very first time from non?consensual US classified human research experimentation. President Clinton in March 1997 ordered a government-wide federal policy change to accomplish that, but that policy change was not completed before he left office. President Clinton ordered this policy change after the federal advisory committee on new radiation experiments. You had Dr. Faden here; she was chairman of that. They recommended that such protection was truly needed. Specifically, in their final report of October 1995, Recommendation 15A, that advisory committee recommended the adoption of a federal policy requiring the informed consent of all human subjects of classified research and that this requirement not be subject to exemption or waiver.
The Bush administration took no known action, neither to cancel nor to examine nor complete this important policy change. Wouldn’t you want to live in a country where specific federal regulations or laws to protect citizens from nonconsensual military intelligence or other classified research experimentation, secretive tests on humans? Yes, no? This is not a hypothetical problem. That’s why I’m here.
Our US government today is conducting nonconsensual experiments. Most notorious among ongoing nonconsensual classified US human research experimentation by the US government is ongoing research development and testing and evaluation of real-time electromagnetic signals, monitoring, and assault of the human body and brain day and night, typically for years and years with no apparent end in sight on each nonconsenting, innocent US citizen. There are 300 or 500 or probably more innocent US citizens targeted by this ongoing program. In some cases, they are also targeted by recorded low-tech harassment.
Among the victims these days are now more numerous females and males in their regular child-bearing years. Due to this crime, hundreds of innocent citizens are being denied their day?to?day liberty, their careers, their preferred education, and for many the human right to found a family. As you know, your commission’s purview includes bioethical issues related to advancements in science and technology. Neuroscience applications — this involves that — and protection of human research participants.
Please realize that the Office of Human Research Protections in HHS is not currently an appropriate forum for this matter because that office only regulates HHS-related experimentation research, even though OHRP, part of HHS, was designated by President Clinton as the lead agency in coordinating — joint rule making when he ordered it originally. Today in 2010, the rule making apparently needs to be reordered as restarted by President Obama. Therefore, your commission is the most appropriate and specific forum for this issue. Thank you.
Amy Gutmann:
Thank you. We’ll accept that as a public comment, and you should feel free to submit the entire text to us.
Unidentified Speaker:
Yeah, you have that text from the prior meeting.
Amy Gutmann:
Okay. Okay. Thank you. Thank you for that.
Let’s go back to the international and standardization question. I don’t know who would like to take a stab at that.
Arti Rai:
I wanted to clarify what the question was referring to. Are you talking about —
Nita Farahany:
While we’re addressing standardization, I have a question on that, so if you could just —
Amy Gutmann:
Nita Farahany:
So, Arti, you mentioned that one of the goals of synthetic biology is to move towards standardization and that this has implications for how we think about patents and the application to the system. If could you elaborate in your answer to this as well in what ways you think this will make this unique relative to other fields of genetic sequencing and how standardization, if we do ultimately end up in that direction, how we should be thinking about it differently.
Amy Gutmann:
And, Arti, don’t feel you have to keep turning. Just use the microphone. Then everyone can hear you. Okay? Thank you.
Arti Rai:
I did want to get some clarification on the international piece, though, because I wasn’t entirely clear on — are we talking about a situation — I mean, there are a couple of different international pieces to this standardization puzzle. One is the question of whether research gets moved offshore because implementation of particular research would infringe upon patents in the US. There’s some evidence of that. Wes Cohen has —
Amy Gutmann:
Do you want to clarify?
Ellen Bates:
Well, we know that it does. I mean, I’m an attorney, and we finance deals out in LA and we move them to China. That’s it. We move them to India. It’s cheaper, you know, and then we have the issues that come with maybe a misunderstanding or a deliberate misunderstanding or an inadvertent misunderstanding on standardization. So that has its own implications. So I’m asking you to address that, because we started the meeting with an international perspective, and I’ve seen it go provincial.
Arti Rai:
Right. So, I mean, there is evidence of off shoring in order to avoid patents, which does suggest that that not all entities, even in the biopharmaceutical sector, think our current level of patenting in the US is optimal for their purposes. But that may or may not mean we should reduce the current level of patenting. In terms of — and, you know, you guys should feel free to expound on that as well. In terms of, Nita, your point — I mean, it’s really hard to say because the technology is so inchoate right now exactly how all of the issues in the IT sector with respect to standards are going to, if at all, have an impact in synthetic biology, but at least looking very cursorily, for example, at the registry of standard biological parts, if there’s ever a reason to believe that that reads upon thousands of patents.
I don’t want to state a legal opinion, but I think that that’s probably the case. And given that that’s an academic inquiry right now, I don’t think that’s a problem at all. But if that type of standardization was to be agreed upon by commercial companies so everyone knew that they were implementing those standards, that’s when you get the potential, as has happened in the IT industry, for major lawsuits. And that’s what we’re seeing in IT.
Nita Farahany:
Because the standard products infringe on other patents that already exist or —
Arti Rai:
Yes, exactly.
Amy Gutmann:
Tim Trevan:
Tim Trevan from the International Council for the Life Sciences. This doesn’t deal with the patent side of the international management of this field, but I don’t know if now is the right time to report on this or whether in biosecurity and biosafety session, but there are two efforts of standardization of how gene synthesis corporations should go about their businesses in terms of best practices. In the United States, you have the International Gene Synthesis Consortium, and in Germany you have the International Association Of Synthetic Biology, both of which have come up with best practices in the industry for how to go about the process of assessing orders both in terms of what the order is against the database of knowledge about the genes and a check of the client themselves as to whether they have a history of having a justifiable use for that technology. And then, of course, it deals with record keeping and whom to contact if there are suspicions.
So there are international efforts, and I would very much urge the commission in its work to maintain an international perspective and outreach to other international efforts.
Amy Gutmann:
We’ll take that as a welcome suggestion and an occasion to thank the panelists again, and we’re going to take a lunch break and reconvene at 1:45. Thank you, Arti, Ashley, and David, very, very much.

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