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