魔鬼在分部:对分部专利、期限、声明的分析以及对未来实践的建议

Mieke Filler
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摘要

本文认为,在制药领域,分案专利申请和诉讼被战略性地用于拖延仿制药和生物仿制药进入市场。欧洲专利公约》和《1977 年专利法》为这些做法提供了合法依据,但英国最近的判例法表明,滥用这些做法会导致故意混淆现有的保障措施。尽管如此,专利法不应是被动的。重新引入分案申请时限并缩短合规期将为缩短分案申请时限提供切实可行的行政措施。此外,进一步明确双重专利禁令的实施将减少成功获得的实质上相似的分案专利的数量。本文还详细讨论了箭式声明,最后简要分析了滥用程序原则是否适合处理分割滥用问题。
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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The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice
This article argues that divisional patent applications and litigation are strategically employed in the pharmaceutical sector to delay generic and biosimilar market entry. These practices are given a legitimate basis in the European Patent Convention and the Patents Act 1977, but recent UK case law shows that their misuse results in deliberate obfuscation of existing safeguards. Nonetheless, patent law should not be passive. The reintroduction of the divisional filing time limit coupled with shorter compliance periods would offer practical administrative steps for shortening the time frame within which divisionals can be filed. Moreover, further clarity surrounding the implementation of the double patenting prohibition would reduce the number of substantially similar divisional patents that are successfully obtained. This article also discusses Arrow declarations at length, before concluding with a brief analysis of the suitability of the abuse of process doctrine for dealing with divisional misuse.
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