composition of matter under Section 101 of the US Patent Code. Characterizing Chakrabarty's invention as "a new bacterium with markedly different characteristics from any found in nature" and "not nature's handiwork, but his own," the Court indicated that Congress intended the patent laws to cover ''anything under the sun that is made by man.'' With this broad directive from the Supreme Court, the US Patent and Trademark Office (PTO) 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. To survive financially in this niche, biotechnology firms need intellectual property rights in discoveries that arise considerably upstream from commercial product markets. This creates pressure to patent discoveries that are closer to the work of research scientists than to ultimate consumer products.

Another contemporaneous development that has contributed to the prevalence of intellectual property in biomedical research is the passage of the Bayh-Dole Act and the Stevenson-Wydler Act in 1980, and a series of subsequent acts that refine those statutes and expand their reach.5 These statutes encourage research institutions to patent discoveries made in the course of government-sponsored research. For some institutions involved in health-related research, this represented a 180° shift in policy. A generation ago, the prevailing wisdom

3  

In 1985, the PTO held that plants were eligible for standard utility patents, and not merely the more limited rights provided under special statutes for the protection of plant varieties. Ex parte Hibberd, 227 USPQ2d (BNA) 443 (Pat. Off. Bd. App. 1985).

4  

The PTO held that oysters were patentable subject matter in Ex parte Allen, 2 USPQ2d (BNA) 1425 (Bd. Pat. App. & Int. 1987). Shortly thereafter, the Commissioner of Patents issued a notice stating that the PTO would consider non-naturally occurring, non-human, multicellular living organisms—including animals—to be patentable subject matter. US PTO, Commissioner's Notice, Official Gazette of the Patent and Trademark Office 1077:24 (April 21, 1987). The notice hastened to add that PTO would not consider human beings to be patentable subject matter, citing restrictions on property rights in human beings. The first patent on a genetically altered animal was issued in April of 1988 to Harvard University for the development of a mouse bearing a human oncogene. US Patent No. 4,736,866 (April 12, 1988). The decision to extend patent protection to animals generated considerable public controversy and has been the focus of numerous hearings in the US Congress. Restrictive legislation has been proposed from time to time, including a moratorium on animal patenting, although no such legislation has been passed. More recently, the patenting of DNA sequences has emerged as a new focal point for aversion to patents in the life sciences, but no new legislation has been enacted.

5  

These statutes are codified as amended at 35 USC §§ 200–211, 301–307 and at 15 USC §§ 3701–3714.



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