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剖析一片显而易见的意大利蒜味腊肠薄片:科学、专利判例法以及早期生物技术领域在促红细胞生成素(EPO)形成过程中的命运。

On slicing an obvious salami thinly: science, patent case law, and the fate of the early biotech sector in the making of EPO.

作者信息

Rasmussen Nicolas

出版信息

Perspect Biol Med. 2013 Spring;56(2):198-222. doi: 10.1353/pbm.2013.0016.

Abstract

This essay reconstructs in previously unavailable detail the 1980s race to clone and market what would be biotechnology's most important product to date, erythropoietin or EPO. The scientific contest continued into the U.S. courts, which were charged with deciding competing patent claims to the natural substance as a drug. Through case law in the new domain of recombinant DNA, the courts imposed a de facto policy that shaped the business and scientific environment of small biotechnology firms so as to narrow research efforts and assimilate the sector to the established pharmaceutical industry. However, alternative dispensations in patent law were possible at the time, and the public's interest might have been better served.

摘要

本文以前所未有的详细程度重现了20世纪80年代克隆并推销促红细胞生成素(EPO)的竞赛,促红细胞生成素是迄今为止生物技术最重要的产品。这场科学竞赛一直持续到美国法院,法院负责裁决对作为药物的天然物质的相互竞争的专利主张。通过重组DNA新领域的判例法,法院实施了一项事实上的政策,该政策塑造了小型生物技术公司的商业和科学环境,从而缩小了研究范围,并使该行业融入了既定的制药行业。然而,当时专利法存在其他分配方式,公众的利益可能会得到更好的保障。

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