Sponsors (4)
The bill makes it easier for generics and biosimilars to enter the market—likely lowering prices and improving access—at the cost of narrowing method-of-use patent enforcement and creating legal uncertainty that could weaken innovation incentives and disrupt past or pending patent disputes.
Patients with chronic conditions and generic/biosimilar manufacturers: allows applicants to seek FDA approval and market generic drugs and biosimilars without facing method-of-use patent infringement suits when they comply with labeling disclosures, accelerating market entry and likely lowering drug costs and improving access.
Hospitals, health systems, and drug applicants: clarifies legal definitions around labeling, promotion, commercial marketing, and biologic terms, reducing litigation uncertainty for applicants, hospitals, and courts and lowering compliance and dispute costs.
Patent holders (companies and researchers): lose enforcement tools for method-of-use claims, which may reduce returns on some patented indications and could weaken incentives for certain kinds of drug innovation.
Patients and consumers: manufacturers could narrowly tailor labeling to avoid infringement while still directing off-label use, potentially undermining patent protections and exposing patients to promotional practices that skirt the original patent scope.
Small businesses, hospitals, and litigants: retroactive application may reopen settled cases or alter pending litigation outcomes, creating legal uncertainty and potential costs for parties and courts.
Based on analysis of 2 sections of legislative text.
Creates a statutory patent safe harbor for certain generic, 505(b)(2), and biosimilar approval, labeling, and on‑label promotion while excluding communications that reference patented uses disclosed to FDA.
Creates a new patent safe harbor that protects certain acts by generic drug, 505(b)(2), and biosimilar applicants and by firms marketing generics or biosimilars when those acts are limited to FDA‑approved labeling and uses the statutorily required patent statements. The safe harbor shields filing, seeking FDA approval, describing products as generic/therapeutically equivalent, and promotion consistent with approved labeling from infringement claims for method‑of‑use patents, but it does not protect promotion or labeling that references patented uses that were identified to FDA. Applies similar rules to biologics under the BLA biosimilar pathway, defines key terms by cross‑reference to FDA/PHSA definitions, and makes the changes retroactive and prospective for conduct and litigation before, on, or after enactment.
Official title: 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 January 9, 2025 by John Wright Hickenlooper · Last progress January 9, 2025