专利流氓-为什么生物和制药处于危险之中

Robin C. Feldman, N. Price
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引用次数: 7

摘要

专利流氓——也被称为非执业实体、专利主张实体和专利货币化实体——是立法和监管改革议程上的重中之重。然而,在现代辩论中,生物制药业明显没有被提及。尽管生物制药典型地以专利为中心,但传统观点认为,生物制药在很大程度上不会受到巨魔的威胁。这篇文章从理论上和描述上都表明,传统观念是错误的。特别是,这篇文章对5所主要大学的生命科学持有量进行了开创性的研究,以确定这些大学是否对货币化者有吸引力。这是一次有意的简单搜索,而不是一次详尽的搜索。尽管如此,我们还是确定了数十项可以用来对抗当前行业的专利。这些专利包括药物有效成分的专利;治疗方法;鉴别新药的筛选方法;制造方法;剂型;辅助技术可以部署在一个“小贩的袋子”的方法。本文描述了我们发现的专利类型,包括每种类型的示例。在决定是否进行这项分析的过程中,我们为潜在的危害是否大于潜在的益处而失眠。如果不进行改革努力,我们的工作只能为那些愿意效仿的人提供一个方便的路线图。然而,零星的轶事证据表明,货币化正在向生物制药领域转移,生命科学领域的恶意攻击是可以预测的,而且还处于起步阶段。如果在问题扩散之前实施改革,立法者和监管者就可以在问题变得根深蒂固、造成太大伤害之前遏制这种活动。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Patent Trolling — Why Bio & Pharmaceuticals Are at Risk
Patent trolls — also known variously as non-practicing entities, patent assertion entities, and patent monetizers — are a top priority on legislative and regulatory reform agendas. In the modern debates, however, the biopharmaceutical industry goes conspicuously unmentioned. Although biopharmaceuticals are paradigmatically centered on patents, conventional wisdom holds that biopharmaceuticals are largely unthreatened by trolls. This article shows that the conventional wisdom is wrong, both theoretically and descriptively. In particular, the article presents a ground-breaking study of the life science holdings of 5 major universities to determine if these might be attractive to monetizers. This was deliberately a light, rather than an exhaustive, search. Nevertheless, we identified dozens of patents that could be deployed against current industries. These include patents on active ingredients of drugs; methods of treatment; screening methods to identify new drugs; manufacturing methods; dosage forms; and ancillary technologies that could be deployed in a “peddler’s bag” approach. The article describes the types of patents we found, including an example of each type.In deciding whether to undertake this analysis, we lost sleep over whether the potential for harm outweighed the potential benefit. If reform efforts are not undertaken, our work could do no more than provide a handy road map for those who would follow. However, with scattered anecdotal evidence suggesting that monetization is moving into biopharmaceuticals, life sciences trolling is predictable and in its infancy. If reforms are implemented before the problem proliferates, legislators and regulators could cabin the activity before it becomes deeply entrenched and too much harm occurs.
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