Hostname: page-component-848d4c4894-x24gv Total loading time: 0 Render date: 2024-06-01T23:53:14.529Z Has data issue: false hasContentIssue false
  • English
  • Français

Conflicts in the Biotechnology Industry

Published online by Cambridge University Press:  01 January 2021

Henry T. Greely
Get access Rights & Permissions [Opens in a new window]

Extract

True revolutions turn the entire world upside down, in ways expected and surprising, profound and mundane. The revolution spawned by advances in molecular biology is no exception. Most of the attention has gone, deservedly, to the possible effects of these advances on medicine, on society, and on our understanding of what it means to be human. But the revolution has already had effects—large and small, good and bad—in other areas. This paper analyzes one aspect of the industry created by that revolution in molecular biology–biotechnology. Specifically, it surveys the various kinds of conflicting interests, both real and perceived, that develop among commercial enterprises, government, and institutions in biotechnology; and it examines the legal implications and public policy concerns of these conflicting interests.

The paper focuses on three different kinds of conflicting interests that confront private and public enterprises competing or collaborating in the biotechnology industry: (1) those among businesses involved within the industry; (2) those in relationships between industry and government; and (3) those in relationships between industry and universities. These types of conflicts raise very different issues, but each stems from circumstances unique to the young biotechnology industry.

Type
Article
Information
Journal of Law, Medicine & Ethics , Volume 23 , Issue 4 , Winter 1995 , pp. 354 - 359
Copyright
Copyright © American Society of Law, Medicine and Ethics 1995

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Biotechnology is not the only industry affected by the revolution in genetics. The pharmaceutical and the agricultural industries are also affected. For these established industries, genetic manipulation remains peripheral, though very interesting. As is noted in the text, the nature of those industries also affects the nature and extent of the conflicting interests they experience.Google Scholar
The paper deals largely with conflicting interests rather than “conflicts of interest.” Although some of the discussion concerns conflicting interests that give rise to conflicts of interest, full discussion of such conflicts of interest awaits another paper.Google Scholar
Even identical twins, triplets, and so on will have accumulated mutations in the DNA of their cells that make their genomes slightly different.Google Scholar
See, for example, Ortho Pharmaceutical Corp. v. Amgen, Inc., 882 F.2d 806 (3d Cir. 1989); and Re Joint Ventures Between Baxter International Inc. and Nestle SA, [1992] 5 C.M.L.R. M33.Google Scholar
This history is ably recounted in Witt, M.D. Gostin, L., “Conflict of Interest Dilemmas in Biomedical Research,” JAMA, 217 (1994) 547–51, to which my discussion is indebted.Google Scholar
Pub. L. No. 96–517 (1980) (codified at 35 U.S.C. § 200, et seq. (1994)). The act was amended in 1984 to extend its coverage to national laboratories operated by universities or nonprofit organizations. Pub. L. No. 98–620 (1984).Google Scholar
Presidential Memorandum to the Heads of Executive Departments and Agencies—Subject: Government Patent Policy, Pub. Papers 248 (Feb. 18, 1983).Google Scholar
Exec. Order No. 12,591, 3 C.F.R. 200 (1987), reprinted in 15 U.S.C.A. § 3710, app. at 256–58 (West Supp. 1992).Google Scholar
Stevenson-Wydler Technology Innovation Act, Pub. L. No. 96–480, 94 Stat. 2311 (1980) (codified at 15 U.S.C. § 3701, et seq. (1994)).Google Scholar
Commercialization of research was further encouraged by the Federal Technology Transfer Act of 1986, Pub. L. No. 99–502 (1986) (codified at 15 U.S.C. § 3701, et seq. (1994)), which authorizes federal laboratories and agencies to enter into Cooperative Research and Development Agreements and requires agencies to provide cash bonuses and royalties to employees at federal laboratories who create patented inventions.Google Scholar
Stanford University Office of Technology Licensing, “Inventions, Patents and Licensing” (as amended 1994). In 1993, the University of California system earned $45.3 million from technology transfer; Stanford, the largest single campus recipient, earned $31.2 million. The total for all universities was an estimated $318 million. United Press International, “UC System Cashes in on Technology,” Mar. 28, 1995.Google Scholar
Horwitz, J.R. Chua, J. Noel, M., “Nucleosides. V. The Monomesylates of 1-(2′-Deoxy-beta-lyrofuranosyl)thymine,” Journal of Organic Chemistry, 29 (1964): At 2078.CrossRefGoogle Scholar
Ostertag, W. et al., “Induction of Endogenous Virus and of Thymidine Kinase by Bromodeoxyuridine in Cell Cultures Transformed by Friend Virus,” Proceedings of the National Academy of Sciences, 71 (1974): 4980–85; de Clercq, E., “Suramin: A Potent Inhibitor of the Reverse Transcriptase of RNA Tumor Viruses,” Cancer Letters, 8 (1979): 9–22; Furmanski, P. et al., “Inhibition by 2′, 3′-Dideoxythymidine of Retroviral Infection of Mouse and Human Cells,” Cancer Letters, 8 (1980): 307–15; and Waqar, M.A. et al., “Effects of 2′, 3′-Dideoxynucleosides on Mammalian Cells and Viruses,” Journal of Cellular Physiology, 121 (1984): 402–08age>.CrossRefGoogle Scholar
Mitsuya, H.I. et al., “3′-Azido-3′-deoxythymidine (BW A509U): An Antiviral Agent that Inhibits the Infectivity and Cytopathic Effect of Human T-Lymphotrophic Virus Type III/Lymphadenopathy-Associated Virus in Vitro,” Proceedings of the National Academy of Sciences, 82 (1985): 7096–100.CrossRefGoogle Scholar
Pub. L. No. 97–414, 96 Stat. 2049 (1983). The Orphan Drug Act of 1983 was intended to encourage drug companies to produce small market drugs in the United States. Orphan drug status gives firms a number of advantages, the most important of which is a complete monopoly on a covered drug's marketing in the United States for seven years from the date of approval. For a general discussion of the background on the Orphan Drug Act, see Asbury, C., Orphan Drugs: Medical Versus Market Value (Lexington: Lexington Books, 1985).Google Scholar
Burroughs Wellcome applied successfully for a “use” patent, covering not the substance of zidovudine (which had been known and in the public domain since Horwitz's discovery in 1964), but its various antiviral uses.Google Scholar
Farley, D., “Benefit vs. Risk: How FDA Approves New Drugs,” FDA Consumer, 21 (Dec. 1987–Jan. 1988): At 6.Google Scholar
See Barr Laboratories Inc. v. Burroughs Wellcome Co., 40 F.3d 1223, 32 U.S.P.Q.2d 1915 (Fed. Cir. 1994), cert. denied, 1996 U.S. LEXIS 471 (Jan. 16, 1996). The federal government, university scientists, and industry have recently resolved a similar dispute over patent rights to BRCA1, the newly discovered breast cancer gene. The federal government had questioned the fact that the patent application did not list its researchers as co-inventors. The parties settled, with an agreement that expanded the list of co-inventors and provided a 25 percent royalty share to the government. See Eliot, M., “NIH Gets a Share of BRCA1 Patent,” Science, 267 (1995): 1086.Google Scholar
Leary, W.E., “U.S. Gives Up Right to Control Drug Prices,” New York Times, Apr. 12, 1995, at A23. See also Anderson, C., “NIH Panel Rejects Pricing Clause,” Science, 265 (1994): 598.Google Scholar
See, for example, Witt, Gostin, , supra note 5; Rodwin, M., Medicine, Money, and Morals (New York: Oxford University Press, 1993); Kassirer, J.P. Angell, M., “Financial Conflicts of Interest in Biomedical Research,” N. Engl. J. Med., 329 (1993): 570–71; American Medical Association, Council on Scientific Affairs and Council on Ethical and Judicial Affairs, “Conflicts of Interest in Medical Center/Industry Research Relationships,” JAMA, 263 (1990): 2790–93; and Emanuel, E.J. Steiner, D., “Institutional Conflict of Interest,” N. Engl. J. Med., 332 (1995): 262–67.Google Scholar
Final Rule, Objectivity in Research, 60 Fed. Reg. 35,810 (July 11, 1995).Google Scholar
Booth, W., “Conflict of Interest Eyed at Harvard,” Science, 242 (1988): 1497–99.CrossRefGoogle Scholar
See generally Emanuel, Steiner, , supra note 23.Google Scholar