Pharmaceutical Companies Extend Drug Patents Using Method-of-Use Strategies Post-ANDA.

Pharmaceutical companies employ various strategies to extend patent protection for their drugs beyond the initial expiration date, particularly in the post-ANDA (Abbreviated New Drug Application) landscape. These strategies, often referred to as “patent hacks,” aim to create barriers for generic drug manufacturers seeking to enter the market. Key methods include pursuing method-of-use patents, patent stacking, patent landscaping, and seeking patent term extensions. A common tactic involves securing patents for specific methods of using a drug, rather than the drug’s composition itself. This allows companies to obtain new patents with expiration dates different from the original patent. Furthermore, pharmaceutical firms create a “patent thicket” through patent stacking, a process that involves filing a series of patents that build upon each other, complicating the patent landscape for generic drug manufacturers. Another approach, patent landscaping, includes analyzing the patent environment to find potential weaknesses and pinpoint opportunities for patenting new innovations related to the original drug. Finally, companies also utilize regulatory pathways to extend a patent’s term beyond its original expiration date.

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Source: https://www.drugpatentwatch.com/blog/how-to-win-post-anda-drug-development-patent-hacks/ Fri, 04 Apr 2025 16:32:39 +0000

Author

Mark Chiang