Sponsors (3)
The bill speeds generic and biosimilar market entry and reduces duplicative litigation—lowering drug costs and saving court resources—while raising the risk of reduced patent enforcement, lower innovator revenues/R&D, and uneven treatment for parties with pending applications.
Patients with chronic conditions gain earlier access to lower-cost generic and biosimilar medicines because the bill narrows which patents can be asserted, shortening pre-market litigation delays.
Generic and biosimilar applicants and small manufacturers face fewer asserted patents, reducing litigation costs and accelerating market entry, which lowers barriers to competition and can reduce drug prices.
Courts and health systems save time and resources by avoiding duplicative patent litigation over patents related by §253 disclaimers.
Manufacturers of innovator drugs could face earlier competition, reducing revenues and potentially leading to lower R&D investment and slower development of new therapies.
Patent owners may lose the ability to enforce some patents, which could reduce incentives for incremental pharmaceutical innovation.
Because the change applies prospectively only, existing pending applicants and current participants under 21 U.S.C. §355 and 42 U.S.C. §262(k) may remain exposed to multiple asserted patents until enactment, producing uneven treatment.
Based on analysis of 2 sections of legislative text.
Limits asserted patents in certain FDA‑related infringement suits to one patent per defined group of commonly owned, disclaimer‑linked patents.
Official title: Address patent thickets.
Introduced July 15, 2025 by Peter Welch · Last progress July 15, 2025
Limits how many patents a brand or patent holder can assert in certain infringement suits against generic drug, biologic, and biosimilar applicants and sellers by allowing at most one asserted patent per defined “Patent Group.” The rule groups patents that are commonly owned and that identify one another on obviousness‑type double patenting disclaimers, and it applies to new applications or licenses filed on or after enactment. The change is designed to reduce patent ‘thickets’ that can be used to delay market entry of generics and biosimilars.