Kennedy Daniel C
Duke Law J. 2019 Apr;68(7):1433-68.
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.
在围绕高药价的争论所产生的喧嚣声中,有一个基本原则被忽视了,即如果没有通过市场独占权获得巨额回报的前景,制药创新就不会发生。生物制药专利目前正受到围攻,在双方复审(“IPR”)程序和哈奇 - 瓦克斯曼诉讼中都面临挑战。这双重攻击有可能消除生物技术创新所需的激励措施,尤其是对创新流程上游所取得的发现而言,从而危及新药疗法的开发。但一个引人入胜的解决方案出现了:援引部落豁免权,在专利审判和上诉委员会(“PTAB”)面前保护制药专利免受IPR的影响。这实现了两个至关重要的目标:促进部落自给自足,并鼓励对拯救生命和改善生活的新药进行投资。美国原住民部落与制药公司之间的契约伙伴关系不仅为部落提供了源源不断的版税收入,还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IPR程序中免受质疑。本评论文章是第一篇全面分析并倡导在IPR程序中援引部落主权豁免权的学术文章。