Reaping the Benefits of Genomic and Proteomic Research Intellectual Property Rights, Innovation, and Public Health (2006) / Chapter Skim
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1 Introduction
1 Introduction
Pages 19-31
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From page 19... ...
1 Introduction T he advent of the molecular era in biology in the 1940s and 1950s, and in particular the development of the tools of recombinant DNA in the mid 1970s, made it possible for scientists to isolate individual genes and determine their chemical composition and ultimately to sequence entire genomes. The ability to map and sequence genes has not only advanced our fundamental understanding of how genes are assembled into genomes, it also has yielded highly detailed knowledge of the structure of evolutionary trees, increased our understanding of genetics, and led to the development of new diagnostics and therapeutics for diseases such as hypertension and cancer.
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. The scale of the rush to protect the rights to new genes is reflected in the fact that by 2001, before the HGP was even completed, just two biotechnology companies alone had filed more than 25,000 DNA-based patent applications for both full-length genes and gene fragments (Service, 2001)
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From page 21... ...
Domestic and international patent policies treated DNA sequences as "compositions of matter," much like any other chemical formulae. Thus, the areas of biological discovery emerging from the HGP and related efforts -- from gene sequences to proteins -- are potentially patentable subject matter as long as the invention meets the standard criteria of novelty, utility, and nonobviousness, describes the invention ("written description")
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From page 22... ...
. These universities licensed the use of the technology widely and nonexclusively to private companies for relatively modest fees, and freely to universities and nonprofit research organizations; thus, the existence of the patents is not believed to have impeded research materially.2 However, not 2Columbia University has a new Axel-Wigler patent that it is seeking to exploit and that is the subject of a lawsuit with companies that have refused to take a license for it.
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From page 23... ...
The principal quid pro quo was simple: Although Harvard would own any patents that might arise from Leder's research, DuPont would be entitled to an exclusive license on any and all such patents. Over the next two years, Leder and his collaborator Tim Stewart developed a so-called oncomouse -- a mouse genetically engineered to be highly susceptible to certain types of cancer.
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SCIENCE AND COMMERCE Many research scientists who work in public institutions are troubled by the concept of intellectual property protection for DNA-based information, because it seems to be in conflict with scientific norms that dictate that science will advance more rapidly if researchers enjoy free access to knowledge. However, use of the patent system means that there will be less of an incentive to resort to protecting knowledge by making it a trade secret.
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has generated controversy that creates new challenges for reaching the appropriate balance between the two realms. In recent years, the controversy has shifted from debates about whether patents on genes, gene fragments or sequences, single nucleotide polymorphisms, haplotypes, or proteins are fundamentally inconsistent with the norms of research science -- that is, whether patents on such inventions should be allowed at all -- to more nuanced questions about what types of research discoveries should be patented and how proprietary research tools should be disseminated to preserve the benefits of intellectual property, while at the same time minimizing interference with the progress of science and the delivery of medical services (NRC, 1997)
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. If the inventor has a full description and an enabling disclosure adequate to support broad claims, licensing issues become more complex, and the possibility for litigation increases.
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must be fully encouraged. Thus, the data must be in the public domain, and the redistribution of the data should remain free of royalties." In 1996 an international group of public and private sector scientists who were engaged in genomic DNA sequencing passed a unanimous resolution -- commonly referred to as the "Bermuda rules" -- that "all human genomic DNA sequence information, generated by centers funded for large-scale human sequencing, should be freely available and in the public domain in order to encourage research and development and to maximize its benefit to society." Thus the publicly funded HGP established norms of behavior for the genome community that promoted openness.
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in a suit against Duke University has undermined that presumption, finding that research is part of the "legitimate business" of the university and is not protected "regardless of commercial implications" or lack thereof.6 It would appear that researchers and their institutions now must pay closer attention to the intellectual property issues involved in their current and future work. This "experimental use exception" litigation indicates that many aspects of the law governing patent rights to biological materials remain unsettled.
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The Court of Appeals for the Federal Circuit recently affirmed a USPTO rejection of patent claims to ESTs, noting that the USPTO utility guidelines comport with the court's own interpretation of the utility requirement. Meanwhile, some important differences remain between the European and Japanese patent offices regarding the standards applied to biological material applications; and these differences, too, are likely to have effects on the conduct and possibly the location of research.
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The committee also sponsored a survey of research scientists (described in Chapter 4) and conducted its own research on the patent landscape and licensing practices in biomedical research.
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INTRODUCTION 31 ORGANIZATION OF THE REPORT Following this chapter, the committee provides an overview of the science of genomics and proteomics and discusses policy developments in these fields. Chapter 3 addresses the specific intellectual property issues raised by genomics and proteomics and their interpretation by USPTO and the courts.
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