National Institutes of Health U.S. Department of Health and Human Services
NHGRI Roundtable on Genetic Patenting
National Human Genome Research Institute (NHGRI)
Marriott Wardman Park
December 4, 2002
The National Human Genome Research Institute (NHGRI) has held an almost two year long planning effort to help guide the institute into the new era of genome research that will follow the completion of the Human Genome Project (HGP) in the spring of 2003. As part of this process, the NHGRI has sponsored a series of workshops and roundtables focused on specific scientific, health and social issues topics. On December 4, 2002, the NHGRI held a roundtable to discuss genetic patenting. The purpose of the roundtable was to explore the ramifications, now and in the future of the patenting and licensing of genes, single nucleotide polymorphisms (SNPs), haplotypes and other types of genetic and genomic data (including compilations of such data in the form of databases) for research and health care. Attendees included a group of experts in patenting and licensing, along with stakeholders from industry, consumer organizations and research institutions.
Alan Guttmacher, the NHGRI deputy director, opened the roundtable by welcoming the participants and describing the NHGRI planning process and some of the concepts that have been proposed for the future, including the possibility of sequencing a genome for $1,000. He suggested that the ability to sequence a genome for $1,000 would change the practice of medicine. However, a fundamental question is how to provide access to genetic information and inventions without inhibiting the commercial development of new products and services by the biotechnology and pharmaceutical industries.
As background for the roundtable dialogue, several individuals gave brief presentations. Lawrence Sung discussed the future of the "research exemption" and the implications of the recent Madey v. Duke decision. In Madey, the Federal Circuit Court of Appeals essentially ruled that university scientists must obtain permission before using patented technologies. Robert Cook-Deegan presented information on licensing and its impact on health care delivery. He presented data from a project funded by the NHGRI and the DOE regarding the creation of a database of DNA patents and a new survey on licensing practices at U.S. and Canadian academic and non-profit institutions. John Iwanicki discussed the pros and cons of federal patenting legislation, including the concepts that the patent system promotes investment and rewards routine discovery, but sometimes discourages innovation.
Following the opening presentations, all those gathered for the roundtable considered the three primary discussion topics: (1) Is there a problem with genetic patenting and licensing today? If so, what can be done to fix it? (2) What are the implications for the future? and, (3) What is the role of the NHGRI?
The key points were as follows:
One of the purposes of the patenting system is to provide an incentive (in the form of a time-limited monopoly) for the full disclosure of inventions (in the written description section of the patent) so that others can learn about the invention, make and use it after patent expiration and/or try to "design around" the patent (creating additional inventions). All these activities foster scientific and technological progress. However, when someone patents a genetic sequence, he/she can exclude others from making, using or selling any tests based on detection of the gene and/or particular mutations in the gene. This means others cannot design around it and cannot verify the patent results. Consequently, this makes the patent on a gene much more powerful and valuable than many other patents.
The NIH policy on research tools has been in place for several years. This policy encourages the sharing of research tools developed by grant recipients with NIH funds. The policy also addresses patent issues and gives guidance on how to handle research tools in terms of patenting and licensing. In the NIH Office of Technology Transfer, complaints regarding the sharing of research tools/access to materials outnumber complaints regarding infringement on patents. Access to materials may be an increasingly important issue in the future. In the past, universities usually exchanged materials freely with other universities, but now, in the increasingly frequent situation in which a university has established a for-profit company (or a working relationship with one), transfer of materials often does not occur.
For research exemptions, e.g., research use of patented materials and/or inventions by non-licensees, there is the need to define research use versus commercial use. Most academic research does not have a commercial outcome as an initial goal. This is in contrast to industry, where the shareholders and other stakeholders understandably expect research to have a commercial outcome.
One solution for patent infringements may be payment of a portion of earned royalties. While these might not equal what the patentee would obtain via a lawsuit, patent lawsuits, on average, cost about $10 million, take about five years to process and ultimately inhibit future scientific developments.
There was concern that Madey v. Duke would have a serious negative impact on university research. With Madey v. Duke, the court shattered any illusion that just because research is not commercial one could proceed with indifference toward patents. If upheld, Madey may force universities in the future to choose between violating the patent laws or stopping certain research. Concern was expressed that it would be difficult to craft a legislative research exemption that would not affect some research sphere.
Patent pools have been created, in reaction to multiple patent lawsuits within an industry, to bring licensing costs down, to establish universal standards, or to resolve intractable non-access problems for potential commercial users. In particular, they relieve a situation in which no one can manufacture a particular product without licenses from at least one other organization. If it would be possible to discourage exclusive licensing of genetic patents, it might be possible to encourage pooling of genetic patents. However, there is the question of whether patent pools would alleviate the possibility of exclusive licensing.
The NIH guidelines for research tools should definitely make universities contemplate how they license, because they do not want to breach the guidelines.
Rather than limiting access to information, a patent actually provides a wealth of information. Patenting has an important societal role and the patent system provides an incentive for research.
Legislation regarding genetic patenting is unlikely to pass until issues surrounding genetic patenting start to affect health care costs and consumer groups get involved. The U.S. government has generally argued that patents are good for all technology, and that there should be no discrimination against any one field or area of potential patenting. This would make it difficult to carve out criteria specific to genetic patents. One cannot solve the existing problems with carve outs for genetics, but carve outs might prevent potential future problems.
It would be helpful to have a survey of university compliance - or non-compliance - with the NIH research tool guidelines; specifically, are there licenses that violate the research tool guidelines and, are there research tools from NIH-supported research that are not made available. This survey could offer information about whether to convert the guidelines into legislation, whether the guidelines, if implemented fully, would address the problems without the need for legislation, or whether guidance is needed in other areas.
The discussion paper, "The Ethics of Patenting DNA," by the Nuffield Council on Bioethics, is thoughtful and presents potential solutions to patenting issues.
Potential Action Items
Regarding genetic patenting, NHGRI and/or NIH should consider the following:
The NIH should explore crafting a Bayh-Dole - like specific research exemption, e.g., Federal grantees and contractors give the government royalty-free research-use licenses to all inventions that they make using government funds. This would not solve all problems, but might set a good policy standard.
The NHGRI, in partnership with the NIH, should proceed with the development of licensing guidelines, using the NIH guidelines on research tools as a model. The NHGRI should support research that is designed to develop licensing guidelines aimed at scientists and technology transfer offices. However, the development of initial guidelines should not be delayed pending such research.
The NHGRI should be careful not to focus solely on gene patents, but should consider prospectively what issues will arise for other types of pre-competitive data, such as SNPs, haplotypes, expression array data, protein structures, protein-protein interactions and so on.
The NIH could perform more of a broker role in establishing guidelines for patents on various types of genetic and genomic data, as the NIH has done in negotiating obstacles in stem cell research. The NIH is a big player here and can use its muscle to determine the terms of exchange for letting research go forward.
The NIH should consider the development of ground rules for assuring that basic classes of information are protected in a way that does not restrict their use. These would be enforced via the grant making authority, similar to the existing ground rules on research tools.
The NHGRI should fund research on intellectual property issues related to genomics research. The Federal Circuit pays attention to what the patent office does. If the NIH and the NHGRI make strong statements they will also get attention. Even though the NHGRI cannot lobby, research performed by the NHGRI can inform decisions.
The NHGRI should consider doing a "what if" exercise on existing databases to think through what would happen if a private entity appropriated one. If this occurred and later refinements were made, these refinements might not be made publicly available.