FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

Senate Bill Would Address ‘Patent Thicket’ Critics Say Stymies Biosimilars

March 14, 2019
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A bipartisan group of senators introduced legislation that would address one of outgoing FDA Commissioner Scott Gottlieb’s pet peeves — the “patent thickets” preventing biosimilars from getting to market.

Patent thickets, or the web of patents that protect biologics, are often used to block competition, in many cases through patents that are invalid or unenforceable, according to the sponsors of the Biologic Patent Transparency Act (S. 659), Sens. Susan Collins (R-Maine), Jeanne Shaheen (D-N.H.), Tim Kaine (D-Va.), Rob Portman (R-Ohio), Mike Braun (R-Indiana) and Debbie Stabenow (D-Mich.).

The bill would require drugmakers to make public the network of patents they use to protect the exclusivity of their biologics, which would allow competitors to more easily develop a strategy for developing their own versions.

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