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Supreme Court decision, Diamond v. Chakrabarty, 477 U.S. 303 (1980), that launched the world's intellectual property system into the patenting of life forms, by authorizing the patenting of microorganisms. The U.S. Patent and Trademark Office (PTO) then, acting by internal decision, extended the Supreme Court's decision to plants and nonhuman animals.9 With the assistance of the Industrial Biotechnology Association, the PTO worked hard to build up its capabilities to deal with the backlog that emerged in the area.10

Congress has played only a passive and responsive role in this sequence. The PTO's extension of patent rights to plants has raised some concern in the agricultural community; its extension to animals raised concerns in both the agricultural and the animal rights communities. The result has been hearings, proposals for moratoriums, and suggested legislation to restrict these patents—but no actual legislation.11 Indeed the most relevant congressional action has been the passage of the 1983 Orphan Drug Act, which provides seven years of exclusivity, an equivalent of intellectual property protection, but enforced through the Food and Drug Administration's regulatory approval process.12 As of 1991, 9 of the 15 biotechnology-derived drugs on the market had such status, as did some 19 under development.13

At the international level, the process of adapting intellectual property law has been somewhat more thought out. During a large portion of the decade of the 1980s, there was an expert study organized by the World Intellectual Property Organization (WIPO)14 and, later on, a parallel study

9  

Ex parte Hibberd, 227 USPQ 443 (PTO Bd. App & Int. 1985) (plants); Ex parte Allen, 2 USPQ 2d 1425 (PTO Bd. App & Int. 1987) (animals). Note that there had also been special coverage procedures for many agricultural plants under the Plant Patent Act of 1930 (35 U.S.C. sec. 161-164) for most species of asexual plants and the Plant Variety Protection Act of 1970 (7 U.S.C. sec. 3231 et seq.) for most species of sexually propagated plants.

10  

Biotechnology in a Global Economy, supra at 210-214.

11  

d. at 216.

12  

Pub. L. No. 97-414, 96 Stat. 2049, Jan. 4, 1983. There is also a Drug Price Competition and Patent Term Restoration Act of 1984, which authorized the extension of patent terms for pharmaceuticals to compensate partially for time lost during the regulatory process, as part of an elaborate rebalancing of the relationships of generic and pioneer pharmaceutical firms, Pub. L. No. 98-417, 98 Stat. 1585, Sept 24, 1984.

13  

Biotechnology in a Global Economy, supra at 92.

14  

This was the Committee of Experts on Biotechnological Inventions and Industrial Property, whose First Session was November 5-9, 1984; Second Session, February 3-7, 1986; Third Session, June 29-July 3, 1987; and Fourth Session, October 24-28, 1988; Committee of Experts on Biotechnological Inventions and Industrial Property, various documents in series BioT/ CE. It is possible that there will be further meetings.



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