Divisional Patent Minefields: Navigating Big Pharma’s Patent Extension Strategies

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Copyright © DrugPatentWatch. Originally published at https://www.drugpatentwatch.com/blog/

The article “The devil is in the divisional: an analysis of divisional patents, deadlines, declarations and suggestions for future practice” by Mieke Filler provides a comprehensive analysis of the strategic use of divisional patents in the pharmaceutical sector to delay generic and biosimilar market entry.

Key Points

  • Pharmaceutical companies strategically employ divisional patent applications and litigation to extend patent protection and delay competition from generics and biosimilars, even though divisionals are legally permitted under patent laws.[1]
  • Divisional patents allow companies to secure broad and long-lasting patent portfolios by claiming different components of the same invention in separate patents, creating a “minefield” of patents that generics must navigate.[1]
  • Tactics like filing multiple divisionals, withdrawing patents before adverse judgments, and replacing them with new divisionals create uncertainty and prolong litigation, dissuading generic entry.[1]
  • The article discusses the limitations of existing safeguards like divisional filing deadlines and the double patenting prohibition in curbing misuse.[1]
  • It analyzes the role of Arrow declarations, a judicial tool that can provide relief to generics against divisional infringement, but notes inconsistencies in its application across cases.[1]
  • The author suggests potential solutions, including reintroducing divisional filing deadlines, clarifying the double patenting prohibition, establishing clearer principles for Arrow declarations, and considering the abuse of process doctrine to address divisional misuse.[1]

[1] https://academic.oup.com/jiplp/advance-article/doi/10.1093/jiplp/jpae046/7693785
[2] https://www.bakerbotts.com/thought-leadership/publications/2021/october/on-the-interface-of-intellectual-property-and-antitrust
[3] https://www.bakerbotts.com/~/media/files/thought-leadership/publications/2021/october/medicines-for-europe-position-paper-on-divisional-patents-mar-20211.pdf?hash=82CB8F9CFD49A2B2099711E363E79DD6E00B46F9&la=en
[4] https://www.aipla.org/list/innovate-articles/revisiting-divisional-patent-applications-the-plurality-of-inventions-debate-in-india
[5] https://www.iam-media.com/review/the-patent-prosecution-review/2024/article/israel-deep-dive-national-prosecution-processes
[6] https://www.managingip.com/article/2c6zuwss3s78xp9byrr40/expert-analysis/special-focus/divisional-patent-applications-in-india-the-power-of-a-comma

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