생의학 복합체 시대 창의적 연구의 소유권: 스탠포드 대 로슈 (Stanford v. Roche) 판결을 통해 본 미국 공공기금 기반 특허의 소유권 논쟁
Who Owns Creative Production in the Age of the Biomedical Complex? Stanford v. Roche and the Controversy Over the Ownership of Government-funded Inventions
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본 논문은 미국의 공공기금 기반 특허의 소유권을 둘러싼 대표적 법적 논쟁이자 2018년 바이-돌 법(Bayh-Dole Act)의 개정을 가져왔던 스탠포드 대 로슈(Stanford v. Roche) 소송을 살펴볼 것이다. 2005년 미국 스탠포드 대학(Stanford University)은 공공기금 지원을 통해 HIV 진단 기술을 개발했으며, 이에 관련된 특허의 소유권이 바이-돌 법에 의해 우선적으로 자신들에게 양도되었다며 다국적 제약회사인 로슈(Roche)를 상대로 특허권 침해 소송을 제기했다. 본 논문은 이 소송에서 나타난 미국의 공공기금 기반 특허의 소유권을 둘러싼 법적 논쟁을 분석하며, 이 논의의 기저에는 21세기 생의학, 생명공학과 제약산업 영역에서 어떻게 기술 혁신을 장려하고, 사적 이익과 공적 이익 사이의 균형을 추구할 것인지에 대한 새로운 해석이 있었음을 보일 것이다. 이를 위해 본 논문은 특히 미국 연방대법원 판결을 앞두고 제출되었던 산업계, 학계, 정부와 벤처투자산업과 같이 다양한 이해관계자들의 법정조언서(amicus curiae brief)들을 분석할 것이고, 이를 통해 1980년대 이후 생의학 분야의 상업화와 생명자본주의의 성장으로 대학과 정부, 그리고 생명공학과 제약산업과이 활발한 기술이전, 협력연구, 그리고 전략적 계약과 고용, 창업을 통해 네트워크로 연결된 생의학 복합체가 등장했다는 인식이 나타났음을 보일 것이다. 스탠포드 대 로슈에 대한 2011년 대법원의 판결은 무엇보다 이러한 생의학 복합체의 등장으로 인해, 공공 연구자금에 기인할 발명의 경우에도 창의적 발명가가 특허를 소유한다는 점을 명확히 하고, 그 소유권 귀속의 불확실성을 제거하는 명확한 계약을 강제하는 것이 혁신과 공공이익을 극대화하는데 중요해졌다는 논의를 반영한 것이라 할 수 있다.
Abstract
Ownership of creative production in biomedical science and technology has emerged not merely as a legal and technical question but also as a matter of key public policy and ethical issues in the recent historical nexus of commercial biotechnology and academic capitalism. This article analyzes a controversy between Stanford University and the Roche Molecular Systems over the ownership of PCR-based HIV diagnostic patents. It pays a particular attention on the amicus curiae briefs submitted before the U.S. Supreme Court case, Stanford v. Roche, in order to shed light on the changing landscape of the controversy over the ownership of government-funded Inventions. The private industry, academic community, and government officials put forward their own interpretations of the Bayh-Dole Act as a way to find an optimal balance between economic innovation and the public interest in the age of the biomedical complex. The 2011 Supreme Court decision, 563 U.S. 776 (2011), which held that the Bayh-Dole Act did not affect an inventor's ownership right, reflects the need to reaffirm and clarify an inventor's ownership right in the highly risky, unpredictable, and collaborative biomedical enterprise.
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