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2.5
Theoretical perspectives
Intellectual property law and policy developments
The reason for Hilgartner’s focus on legal mechanisms of commercialisation is that the commercialisation of biotechnology research and development in the final quarter of the twentieth century was closely linked with the evolution of US intellectual property law and policy. The trend towards stronger intellectual property rights in biological innovations began with the decision of the US Supreme Court in Diamond v. Chakrabarty.56 Before 1980, the policy of the US Patent Office was to refuse applications for patents on living organisms.57 The basis for refusal was the long-standing ”products of nature” doctrine, which specified that although processes devised to extract products found in nature could be patented, the products themselves were not patentable subject matter because they were not inventions.58 Accordingly, when Ananda Chakrabarty applied in 1972 for a patent on a living bacterium capable of consuming oil slicks, the application was refused. Chakrabarty appealed, and in 1979 the case reached the US Supreme Court. In June 1980, by a close majority, the Supreme Court held that Chakrabarty had a right to a patent on the microorganism under the existing patent law. The majority noted that the relevant distinction was not between living and inanimate things, but between products of nature and human-made inventions; patentable subject matter included ”anything under the sun that is made by man”, including living organisms produced using genetic technology.59 Through the 1980s, further decisions consolidated the policy reversal initiated by the Supreme Court in Diamond v. Chakrabarty. In 1985, the US Patent and Trademark Appeals Board awarded a patent for a type of genetically engineered corn, holding that the general availability of plant patents had not been restricted by the passage of legislation granting specific plant patent and plant variety rights protection.60 In 1987, it confirmed that, in principle, patents could be granted on nonhuman higher animals.61 By 1988, the Patent Office’s willingness to grant a patent to Harvard University on ”any nonhuman mammal transgenically engineered to incorporate into its genome an oncogene tied to a specific promoter” – exemplified by the famous (or infamous) oncomouse – indicated that the turnaround was complete.62 A second significant development in US intellectual property law and policy was the passage in 1980 of the Patent and Trademark Law Amendments Act (P.L. itself, or to the distinction between public and private sectors of the national economy, than to the construction of an infrastructure that allows specific techniques or tools to be transferred from local to extended networks. Private companies may be part of such an infrastructure. 56 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980). 57 The only exception was statutory: the Plant Patent Act 1930 allowed patenting of plants that could be reproduced asexually. See Kevles (1998), p.66. 58 Kevles (1998), pp.65-66, citing Ex parte Latimer, 1889 Dec. Com. Pat. 123. 59 Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) quoting SEN. REP. NO. 1979 (1952). 60 Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. & Interferences 1985). 61 Ex parte Allen, 2 U.S.P.Q. 2d 1425 (Bd. Pat. App. & Interferences 1987). 62 Leder et al., Transgenic Nonhuman Animals, United States Patent No. 4,736,866,12 April 1988.