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噬菌体疗法对细菌耐药性的潜在病毒威胁:噬菌体疗法的专利可获性不确定及替代激励措施的必要性

The Promising Viral Threat to Bacterial Resistance: the Uncertain Patentability of Phage Therapeutics and the Necessity of Alternative Incentives.

作者信息

Todd Kelly

出版信息

Duke Law J. 2019 Jan;68(4):767-805.

Abstract

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.

摘要

噬菌体,即“phages”,是一类高度熟练且适应性强的病毒,能够感染并杀死细菌。近年来,随着对抗生素耐药性危机日益加剧的担忧,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现出越来越浓厚的兴趣。由于将一种新药推向市场的成本巨大,专利通常被视为激励制药领域研发的黄金标准。如果没有对开发者前期投资的这种强有力保护,药物研发在财务上仍存在风险且缺乏吸引力。不幸的是,美国最高法院最近依据美国法典第35编第101条分析可专利主题的判例法,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,可能需要替代性的保护或激励措施。这样一个框架可能包括商业秘密、监管独占权、研究支持、替代性支付模式或它们的某种组合。

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