Sponsors (7)
The bill makes it easier for generics and biosimilars to gain approval and be marketed for non-patented uses—speeding access and lowering drug costs—while narrowing method-of-use patent enforcement and adding compliance and legal-uncertainty trade-offs for innovators and health providers.
Patients with chronic conditions will gain faster access to generics and biosimilars because applicants can seek FDA approval and market products for non-patented uses without facing method-of-use patent infringement liability.
Patients (and payers) may see lower drug costs because greater availability of generics and biosimilars for non-patented indications increases competition on price.
Generic and biosimilar manufacturers (including small businesses) and health systems face reduced litigation risk and regulatory uncertainty because the legislation clarifies the statutory safe harbor and related definitions.
Patent holders (innovators) lose the ability to assert method-of-use patents against certain approvals and marketing, which may reduce expected returns on R&D and could weaken incentives for future drug innovation.
Manufacturers and health systems may face increased compliance complexity and costs because they must maintain separate labeling and marketing restrictions to avoid infringing patented uses.
Patent holders could see limited remedies and unsettled outcomes in ongoing litigation because the law's retroactive application to pending and prior conduct may curtail available enforcement actions.
Based on analysis of 2 sections of legislative text.
Establishes statutory safe harbors that protect certain ANDA/505(b)(2)/biosimilar filing, marketing, and labeling acts from method‑of‑use patent infringement claims when applicants follow FDA listing and labeling rules.
Official title: To amend title 35, United States Code, to provide for a safe harbor from infringement of a method of use patent relating to drugs or biological products.
Introduced December 5, 2025 by Benjamin Cline · Last progress December 5, 2025
Creates a new patent safe-harbor that protects certain actions by generic drug, biosimilar, animal generic, and 505(b)(2) applicants and sellers from being treated as patent infringement for method‑of‑use claims that were previously listed with the FDA. The protections cover filing applications that include the required patent statements, marketing and promoting the approved product with its FDA‑approved labeling, and describing the product as generic or biosimilar so long as labeling, promotion, or marketing do not reference the patented uses that were identified to FDA. The law applies retroactively to existing and pending conduct and proceedings.