{"title":"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。","authors":"Daniel C Kennedy","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":47625,"journal":{"name":"Duke Law Journal","volume":"68 7","pages":"1433-68"},"PeriodicalIF":1.8000,"publicationDate":"2019-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Strange Bedfellows: Native American Tribes, Big Pharma, and the Legitimacy of Their Alliance.\",\"authors\":\"Daniel C Kennedy\",\"doi\":\"\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":47625,\"journal\":{\"name\":\"Duke Law Journal\",\"volume\":\"68 7\",\"pages\":\"1433-68\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2019-04-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Duke Law Journal\",\"FirstCategoryId\":\"90\",\"ListUrlMain\":\"\",\"RegionNum\":2,\"RegionCategory\":\"社会学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"LAW\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Duke Law Journal","FirstCategoryId":"90","ListUrlMain":"","RegionNum":2,"RegionCategory":"社会学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"LAW","Score":null,"Total":0}
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.
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.