Speech, Drugs, and Patent Infringement

D. Bloomfield
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引用次数: 1

Abstract

The modern law of induced patent infringement contradicts the Patent Act and violates the First Amendment. As currently applied, the law unconstitutionally restricts speech, discourages the entry of generic drugs, and helps keep medicine prices high. Under current doctrine, a generic drugmaker is liable for induced infringement if its drug label so much as hints at using a product in a way that is covered by a patent. This is true even when there is no evidence that prescribers read generic drug labels and in cases when only an in-depth inquiry into the language of the label might promote infringement. As I show, this doctrine flies in the face of a simple reading of the statute. And by restricting lawful and non-misleading speech for such an attenuated purpose, it also violates the First Amendment. Modern patent inducement law should be revised because it unconstitutionally prolongs drug monopolies and undermines a key statutory path to generic competition. Revisiting the roots of inducement doctrine also leads to the surprising conclusion that method-of-use patents—a cornerstone of pharmaceutical intellectual property—are weaker than generally supposed.
语言、药物和专利侵权
诱导专利侵权的现代法律与专利法相矛盾,违反了第一修正案。按照目前的适用,该法律违宪地限制了言论,阻碍了仿制药的进入,并帮助维持了高药价。根据目前的原则,如果仿制药生产商的药品标签暗示其产品的使用方式属于专利范围,那么仿制药生产商就应对诱导侵权负责。即使在没有证据表明开处方者阅读仿制药标签,以及仅对标签的语言进行深入调查就可能促进侵权的情况下,情况也是如此。正如我所展示的,这一原则与对法令的简单解读背道而驰。由于限制合法且非误导性的言论以达到这种弱化的目的,它也违反了第一修正案。现代专利诱导法应该修改,因为它违宪地延长了药品垄断,破坏了通向仿制药竞争的关键法定途径。重新审视诱导原则的根源也会得出一个令人惊讶的结论,即使用方法专利——制药知识产权的基石——比通常认为的要弱。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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