Intellectual Property Rights and Research Tools in Molecular Biology Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996 (1997) / Chapter Skim
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PATENTING RESEARCH TOOLS AND THE LAW
PATENTING RESEARCH TOOLS AND THE LAW
Pages 6-16
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From page 6... ...
For many years it appeared that patents on living subject matter would violate the longstanding principle that one may not patent products or phenomena of natured But in 1980 the US Supreme Court held in the case of Diamond v. Chakrabar~y2 that a living, genetically altered organism may qualify for patent protection as a new manufacture or 1 The US Supreme Court relied on this principle in Funk Brothers Seed Co.
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From page 7... ...
expanded the categories of living subject matter that it considered eligible for patent protection to include plants3 and animals.4 During the same time period, the explosion of commercial interest in the field, and the concomitant emergence of commercial biotechnology companies, have amplified the importance of intellectual property in the biomedical sciences. Many biotechnology firms have found a market niche somewhere between the fundamental research that typifies the work of university and government laboratories and the end product development that occurs in more established commercial firms.
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From page 8... ...
The current belief is that if research results are made widely available to anyone who wants them, they will languish in government and university archives, unable to generate commercial interest in picking up where the government leaves off and using the results to develop commercial products. To make government-sponsored research discoveries attractive candidates for commercial development, institutions performing the research are encouraged to obtain patents and to offer licenses to the private sector.
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From page 9... ...
The anticipated advantages of being the first firm in the market with an innovation might be enough to motivate some firms to continue investing in R&D. But at least in some fields, the prospect of obtaining patent rights undoubtedly increases incentives to invest in R&D and to disclose research results somewhat.
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From page 10... ...
The utility requirement limits patent protection to inventions with practical applications, as opposed to basic knowledge. The meaning of this requirement has varied over the years from a minimal standard that the invention not be
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From page 11... ...
machine merely for philosophical experiments or for the purpose of ascertaining the sufficiency of the machine to produce its described effects." It is difficult to discern the scope of this exception with any precision, inasmuch as experimental use becomes an issue only in patent infringement actions, and patent holders are unlikely to file a lawsuit against an academic researcher whose use of the invention is commercially insignificant. Judicial pronouncements on the scope of the experimental use exemption address situations in which a patent holder has found a defendant's activities sufficiently annoying to be worth the trouble of pursuing a lawsuit; this factor has undoubtedly skewed the distribution of cases in which the defense arises toward cases with high commercial stakes.
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From page 12... ...
Bolar in the specific context of clinical trials of patented drugs by an amendment to the patent statute.ll As amended, the statute explicitly permits the use of patented inventions for the purpose of developing and submitting information under laws regulating the manufacture, use, or sale of drugs. But the amendment did not address the broader question of when the experimental use defense would be available outside of that very narrow setting.
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From page 13... ...
The obvious implications of discoveries in molecular biology for human health raise the stakes of striking the right balance between public access and private property, particularly when public attention is riveted upon the rising costs of health care. And it profoundly affects the interests of two different types of commercial firms young biotechnology firms and large, integrated pharmaceutical firms both of which are sensitive to intellectual property but for differ ent reasons.
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From page 14... ...
Research tools are not categorically excluded from patent protection (except insofar as they lack patentable utility) , nor is the use of patented inventions in research categorically exempted from infringement liability.
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From page 15... ...
Another risk is that patent holders will use a device employed by some biotechnology firms of offering licenses that impose "reach-through" royalties on sales of products that are developed in part through use of licensed research tools, even if the patented inventions are not themselves incorporated into the final products. So far, patent holders have had limited success with reach-through royalty licenses.
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From page 16... ...
Much depends on whether the holders of exclusive rights can figure out how to disseminate research tools broadly without undermining their value as intellectual property. These are difficult problems that defy facile solutions.
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