Limits the number of patents that brand-name drug companies can assert in lawsuits over biologic medicines and biosimilars. Caps patent claims at 20 per case, with no more than 10 from newer patents, and broadens what counts as patent infringement. Applies these limits to new biosimilar applications.
Changes affect brand-name biologic manufacturers, biosimilar developers, and the courts handling these disputes. Fewer patents in a case can streamline litigation and reduce delays. Biosimilar makers may face clearer rules when entering the market, while brand-name companies face tighter limits on how many patents they can use in a single lawsuit.
The bill passed its first chamber and is now before the second, which must pass identical text before it can go to the President.
Learn about the legislative processBegan: Mar 13, 2025
Completed: Mar 13, 2025
Began: Mar 13, 2025
Completed: Apr 10, 2025
Began: Apr 10, 2025
Completed: Jul 21, 2026
Since: Jul 21, 2026
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