Sponsors (4)
The bill reduces litigation risk and increases predictability for biosimilar/generic applicants — potentially speeding competition and lowering costs — at the expense of narrower immediate enforceability of innovators' patent portfolios and added procedural disputes and uneven treatment for pending cases.
Biosimilar and generic applicants (small biotech firms) face fewer patent infringement suits because reference product sponsors can initially assert at most 20 patents, reducing litigation costs and regulatory uncertainty.
Biosimilar/generic applicants are less exposed to surprise infringement claims because the bill limits late-filed and unrelated manufacturing patents, improving predictability for manufacturing and launch planning.
Innovator/reference product sponsors keep the ability to protect clinical uses because method-of-use patents are exempted, preserving incentives for certain clinical R&D.
Reference product sponsors and innovators may be unable to fully protect their patent portfolios because the cap can prevent asserting all relevant patents, potentially reducing enforcement power and returns on R&D.
Giving courts discretion to increase the cap for 'good cause' invites litigation over what constitutes good cause and appropriate disclosure, adding procedural complexity and legal costs for both sides.
The rule applies only to future 262(k) filings, so pending biosimilar applicants receive no retroactive relief and a temporary patchwork of differing rules and outcomes may persist.
Based on analysis of 2 sections of legislative text.
Caps the number and types of patents a biologic reference sponsor can assert against a 262(k) biosimilar applicant and clarifies which patents regulatory submissions can implicate.
Official title: Amend title 35, United States Code, to address the infringement of patents that claim biological products, and for other purposes.
Introduced March 13, 2025 by John Cornyn · Last progress July 21, 2026
Limits how many and what kinds of patents a biologic reference product sponsor can assert against an applicant seeking licensure of a biosimilar or interchangeable biological product. It also clarifies that certain regulatory submissions can be treated as acts of infringement for patents claiming the biologic, uses of the biologic, or methods/products used to manufacture it. The new patent-cap rules apply to biosimilar (42 U.S.C. 262(k)) applications filed on or after enactment and include procedural rules for court review of requests to exceed the cap.