奇怪的同床共枕:美洲原住民部落,大型制药公司,以及他们联盟的合法性。

IF 1.8 2区 社会学 Q1 LAW Duke Law Journal Pub Date : 2019-04-01
Daniel C Kennedy
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引用次数: 0

摘要

在围绕高药价的争论的嘈杂声中,人们忽略了一条基本原则:如果没有市场独占性带来的巨大回报,制药创新就不会发生。生物制药专利目前受到围攻,在多方审查(“知识产权”)程序和Hatch-Waxman诉讼中都受到挑战。这两方面的打击可能会消除生物技术创新的必要动机——尤其是对创新管道上游的发现——从而危及新药物疗法的发展。但一个令人着迷的解决方案出现了:在专利审判和上诉委员会(“PTAB”)面前,援引部落豁免权来保护药品专利不受知识产权保护。这有助于实现两个至关重要的目标:促进部落自给自足,鼓励投资于挽救生命和改善生活的新药。美洲土著部落与制药公司之间的合同伙伴关系不仅为部落提供了源源不断的特许权使用费收入,而且通过援引长期确立的部落主权豁免原则,使生物制药专利在知识产权诉讼中不受质疑。这份说明是第一份全面分析和倡导在知识产权诉讼中援引部落主权豁免的权利的学术报告。
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Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance.

Lost in the cacophony surrounding the debate about high drug prices is the fundamental principle that pharmaceutical innovation will not occur without the prospect of outsized returns enabled through market exclusivity. Biopharmaceutical patents are currently under siege, subject to challenge both in inter partes review ("IPR") proceedings and in Hatch-Waxman actions. These twin assaults threaten to eliminate the incentives necessary for biotechnological innovation--particularly for discoveries made upstream in the innovation pipeline--thus imperiling the development of new drug therapies. But a fascinating solution has emerged: invoking tribal immunity to shield pharmaceutical patents from IPR before the Patent Trial and Appeal Board ("PTAB"). This serves two critically important objectives: promoting tribal self-sufficiency, and encouraging investment in life-saving and life-improving new drugs. Contractual partnerships between Native American tribes and pharmaceutical companies not only provide the tribes with a steady stream of royalty revenue, but also insulate biopharmaceutical patents from challenge in IPR proceedings through the invocation of long-established principles of tribal sovereign immunity. This Note is the first piece of scholarship to comprehensively analyze, and advocate for, the right to invoke tribal sovereign immunity in IPR proceedings.

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来源期刊
CiteScore
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期刊介绍: The first issue of what was to become the Duke Law Journal was published in March 1951 as the Duke Bar Journal. Created to provide a medium for student expression, the Duke Bar Journal consisted entirely of student-written and student-edited work until 1953, when it began publishing faculty contributions. To reflect the inclusion of faculty scholarship, the Duke Bar Journal became the Duke Law Journal in 1957. In 1969, the Journal published its inaugural Administrative Law Symposium issue, a tradition that continues today. Volume 1 of the Duke Bar Journal spanned two issues and 259 pages. In 1959, the Journal grew to four issues and 649 pages, growing again in 1970 to six issues and 1263 pages. Today, the Duke Law Journal publishes eight issues per volume. Our staff is committed to the purpose set forth in our constitution: to publish legal writing of superior quality. We seek to publish a collection of outstanding scholarship from established legal writers, up-and-coming authors, and our own student editors.
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