Evolving scientific norms and intellectual property rights: A reply to Kieff

Northwestern University Law Review

Volumn 95, Issue 2, 2001, Pages 707-713

  Rai, Arti Kaur ^a  

^a NONE

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EID: 0042868758     PISSN: 00293571     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (40)

1. F. Scott Kieff, Facilitating Scientific Research: Intellectual Property Rights and the Norms of Science - A Reply to Rai and Eisenberg, 95 NW. U. L. REV. 691 (2001).
2. Arti Kaur Rai, Regulating Scientific Research: Rights and the Norms of Science in Biotechnology Research, 94 NW. U. L. REV. 77 (1999).
3. Kieff, supra note 1, at 692 ("Rai begins her argument by painting a portrait of the basic biological research community before 1980 as a benchmark against which to measure the relative performance of that same community today.").
4. Id. at 697 ("The benchmark offered by Rai is a utopian vision characterized by specific prescriptive norms against intellectual property generally and patents in particular, but devoid of descriptive norms such as selfish behavior, which enjoys no frustration of the consensus set of abstract prescriptive norms.").
5. Id. at 701 ("Rai criticizes any theory of the patent system that focuses on the development of nascent inventions, like the commercialization theory.).
6. Rai, supra note 2, at 81-115.
7. Id. at 109 ("As might be predicted by law-and-norms theory . . . universities and individual researchers soon began to respond to the financial incentives of Bayh-Dole by rejecting communalism and increasing efforts to seek patents.").
8. Id. at 112-13.
9. See id. at 109 (noting that universities are seeking thousands of patents per year); see also id. at 115 ("[T]he post-1980 move towards greater intellectual property rights has clearly had a significant impact on the traditional norms of research science.").
10. Id. at 112-15. Gene fragments are also known as expressed sequence tags, or ESTs.
11. Id. at 147.
12. Kieff, supra note 1, at 705.
13. Rai, supra note 2, at 92 ("[A]ggressively competitive behavior that seems contrary to the norms of communalism may be tolerated when invention is at stake.").
14. See Patent Issues in Federally Funded Research: Hearings Before the Senate Judiciary Subcomm. on Patents, Copyrights, and Trademarks, 103d Cong. 11 (1994) (statement of Birch Bayh) (testifying that the number of patents granted per year to universities had increased from fewer than 250 in 1980 to almost 2700 in 1992).
15. Contrary to Kieff's assertion, see Kieff, supra note 1, at 693-96, I do not focus on prescriptive norms to the exclusion of descriptive norms. Indeed, if a norm community is functioning properly, descriptive norms should, in large part, comport with prescriptive norms. Moreover, departures from prescriptive norms should be punished.
16. Rai, supra note 2, at 92 (noting that the norm of invention led "scientists to compete vigorously to be the first to present an invention or discovery to the scientific community").
17. Id. at 95 (discussing the "cumbersome and complex" process for seeking patents on publicly-funded research prior to 1980).
18. Id. at 81-88 (surveying this literature).
19. See generally Kieff, supra note 1, at 698-705. The approach advocated by Kieff draws upon the work of Edmund Kitch. See Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265 (1977) (arguing for strong patent rights early in the development process in order to stimulate and coordinate such development).
20. See generally Kieff, supra note 1, at 698-705. The approach advocated by Kieff draws upon the work of Edmund Kitch. See Edmund W. Kitch, The Nature and Function of the Patent System, 20 J.L. & ECON. 265 (1977) (arguing for strong patent rights early in the development process in order to stimulate and coordinate such development).
21. Rai, supra note 2, at 80 & n. 17 (noting that the Article will compare current research norms with "full-blown intellectual property rights" - that is, "property rights on all invention that could be considered new, no matter how far removed from commercial application or easy to invent").
22. Id. at 136-37 (noting that the public domain should reflect a balance that includes development costs).
23. Id. at 120-35. A concern with transaction costs also lies at the heart of the critique of patent rights put forward by Michael Heller and Rebecca Eisenberg. See Michael Heller & Rebecca Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698 (1998). Molly Holman and Stephen Munzer have recently made the interesting argument that granting patents on ESTs of unknown function can create not only transaction cost difficulties, but also can distort research priorities and increase downstream development costs in a manner that causes a deviation from social welfare. See Molly A. Holman & Stephen R. Munzer, Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags, 85 IOWA L. REV. 735, 774-92 (2000).
24. Id. at 120-35. A concern with transaction costs also lies at the heart of the critique of patent rights put forward by Michael Heller and Rebecca Eisenberg. See Michael Heller & Rebecca Eisenberg, Can Patents Deter Innovation? The Anticommons in Biomedical Research, 280 SCIENCE 698 (1998). Molly Holman and Stephen Munzer have recently made the interesting argument that granting patents on ESTs of unknown function can create not only transaction cost difficulties, but also can distort research priorities and increase downstream development costs in a manner that causes a deviation from social welfare. See Molly A. Holman & Stephen R. Munzer, Intellectual Property Rights in Genes and Gene Fragments: A Registration Solution for Expressed Sequence Tags, 85 IOWA L. REV. 735, 774-92 (2000).
25. I follow the conventional account in defining transaction costs broadly, so as to include the costs associated with identifying potential buyers and sellers, negotiating deals, measuring performance, and enforcing agreements. See THRÁINN EGGERTSSON, ECONOMIC BEHAVIOR AND INSTITUTIONS 14-16 (1990).
26. Kieff, supra note 1, at 693-704 (arguing that "the basic biology research process, like any process, can be viewed as one that requires inputs and generates outputs, and experience shows that patents on inputs generally do not prevent the production of outputs").
27. SNPs represent those areas in which human genomes differ by only one base pair from one another. SNPs can be found in the coding or noncoding regions of DNA. SNPs in the coding regions are known as cSNPs. The discussion in the text focuses on SNPs of the cSNP variety.
28. It is important to distinguish between ESTs and SNPs of known function and those of unknown function. To determine the function of an EST or SNP, the researcher has to make a significant research investment. Thus, ESTs and SNPs of known function are not properly considered upstream research.
29. Kieff, supra note 1, at 699-700.
30. John Doll, The Patenting of DNA, 280 SCIENCE 689, 690 (1998).
31. Kieff, supra note 1, at 702-03.
32. Id. at 703.
33. Although norm communities are typically made up of private actors, scientists within the National Institutes of Health and other research agencies should probably be considered to inhabit the same norm community as their academic counterparts. These federal scientists interact closely with the academic research community. Indeed, many of them come from this community. Expanding the norm community to include federal scientists, however, raises thorny questions about the distinction between norms and law. This is particularly true because federal scientists can make policy, even if they have limited legal authority to enforce that policy. See Rai, supra note 2, at 147-49 (discussing policy decisions by Dr. Francis Collins, Director of the National Human Genome Research Institute, to encourage public release of early-stage genome research). I thank Rebecca Eisenberg for pressing me on this point.
34. See Peter G. Gosselin & Paul Jacobs, Patent Office Now at Heart of Debate, L.A. TIMES, Feb. 7, 2000, at A1 (noting that PTO was responding to a "drumbeat of concern" by scientists from the National Human Genome Research Institute as well as university scientists).
35. See REVISED INTERIM UTILITY GUIDELINES TRAINING MATERIAL 50-53 (2000). This handbook for PTO examiners interprets 35 U.S.C. § 101 (2000).
36. Martin Enserink, Patent Office May Raise the Bar on Gene Claims, 287 SCIENCE 1196, 1197 (2000).
37. See Nicholas Wade, 10 Drug Makers Join to Find Genetic Roots of Disease, N.Y. TIMES, Apr. 15, 1999, at A27. The major research universities that took the lead in the public human genome project are also taking the lead in generating the data for the SNP consortium. Technically, the SNP consortium is filing provisional patent applications and then releasing the information into the public domain. So long as the consortium files a provisional application before another entity files a patent application, the consortium can preempt the subsequent patent application. For a discussion of preemptive publication as a competitive strategy for private sector firms, see Gideon Parmochovsky, Publish or Perish, 98 MICH. L. REV. 926 (2000).
38. See Nicholas Wade, 10 Drug Makers Join to Find Genetic Roots of Disease, N.Y. TIMES, Apr. 15, 1999, at A27. The major research universities that took the lead in the public human genome project are also taking the lead in generating the data for the SNP consortium. Technically, the SNP consortium is filing provisional patent applications and then releasing the information into the public domain. So long as the consortium files a provisional application before another entity files a patent application, the consortium can preempt the subsequent patent application. For a discussion of preemptive publication as a competitive strategy for private sector firms, see Gideon Parmochovsky, Publish or Perish, 98 MICH. L. REV. 926 (2000).
39. Unlike the interests of the biotechnology industry as a whole, the interests of large pharmaceutical companies do converge sufficiently for a cooperative strategy such as the consortium to be possible. However, even the consortium itself might not have been possible absent the facilitative role played by the Wellcome Trust, the U.S. National Human Genome Research Institute's partner in the public genome sequencing project. See Wade, supra note 35, at A27. A similar public-private initiative to sequence the mouse genome, and to release the results of that sequencing into the public domain, was recently announced by the National Institutes of Health, several pharmaceutical companies, and the DNA chip maker Affymetrix. The sequencing will be done at Washington University in St. Louis, the Whitehead Institute at MIT, and the Sanger Centre in the United Kingdom. Public-Private Project to Deliver Mouse Genome in 6 Months, 290 SCIENCE 242 (2000).
40. Rai, supra note 2, at 120-35.