有希望的病毒对细菌耐药性的威胁:噬菌体治疗的不确定可专利性和替代激励的必要性。

IF 1.8 2区 社会学 Q1 LAW Duke Law Journal Pub Date : 2019-01-01
Kelly Todd
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引用次数: 0

摘要

噬菌体,或“噬菌体”,是一类高度熟练和适应性强的病毒,可以感染和杀死细菌。近年来,随着人们对日益严重的抗生素耐药性危机的担忧,科学家和政策制定者对开发利用噬菌体治疗细菌感染的新疗法表达了越来越大的兴趣。由于将新药推向市场所需的巨大费用,专利通常被认为是激励制药领域研究和开发的黄金标准。如果没有对开发商的前端投资提供如此强有力的保护,制药开发在财务上仍然存在风险和吸引力。不幸的是,最近最高法院根据35 U.S.C.第101条分析可专利主题的判例对噬菌体疗法是否有资格获得强有力的专利保护提出了质疑。为了使噬菌体疗法的前景成为现实,可能需要其他保护或激励措施。这样的框架可能包括商业保密、监管排他性、研究支持、替代支付模式,或它们的某种组合。
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The Promising Viral Threat to Bacterial Resistance: the Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives.

Bacteriophages, or "phages," are a category of highly adept and adaptable viruses that can infect and kill bacteria. With concerns over the burgeoning antibiotic-resistance crisis looming in recent years, scientists and policymakers have expressed a growing interest in developing novel treatments for bacterial infections that utilize bacteriophages. Because of the great expense associated with bringing a new drug to market, patents are usually considered the gold standard for incentivizing research and development in the pharmaceutical field. Absent such strong protection for a developer’s front end investment, pharmaceutical development remains financially risky and unattractive. Unfortunately, recent Supreme Court jurisprudence analyzing patentable subject matter under 35 U.S.C. subsection 101 has cast doubt on whether phage therapeutics would be eligible for strong patent protection. In order for the promise of phage therapeutics to become a reality, alternative protections or incentives are likely necessary. Such a framework would likely include trade secrecy, regulatory exclusivities, research support, alternative payment models, or some combination thereof.

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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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