Sponsors (4)
The bill narrows and clarifies which patents can be asserted in biosimilar litigation—speeding competition and improving predictability for applicants and courts—while constraining reference sponsors' enforcement scope and introducing new litigation and procedural risks for developers and health systems.
Subsection (k) applicants and patients with chronic conditions: Patent-assertion limits (max 20 patents total; no more than 10 patents issued after the §262(l)(7)(A) date) reduce the number and strategic use of patents that can delay biosimilar market entry, likely accelerating competition and lowering costs.
Subsection (k) applicants and courts: Narrower definitions of which patents are eligible to be asserted (product, use, manufacturing) provide greater predictability for applicants and courts, simplifying litigation planning and regulatory decision‑making.
Courts and litigants: Allowing courts to increase the patent-cap for good cause preserves judicial flexibility to accommodate genuinely complex cases where more patents are needed, reducing the risk of unfairly truncating valid claims.
Subsection (k) applicants and hospitals/health systems: Expanding §271(e) to cover manufacturing-method and product claims increases litigation exposure and legal uncertainty for biosimilar developers and providers.
Reference product sponsors: Restricting sponsors to asserting at most 20 patents in §262(k) suits may limit their ability to protect legitimate patent portfolios and could weaken incentives to invest in improvements or lead to strategic shifts in enforcement.
Patients with chronic conditions and subsection (k) applicants: Exempting treatment/indication-use patents from the cap allows sponsors to continue asserting method-of-treatment patents for particular indications, which can still delay biosimilar access for those uses.
Based on analysis of 2 sections of legislative text.
Places a 20-patent cap (max 10 newly issued) on initial patent assertions by brand biologic sponsors against biosimilar applicants, with defined exceptions and judicial flexibility.
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 the number of patents a brand biologic sponsor can assert in lawsuits against biosimilar applicants and narrows the types of patents available for early infringement claims. It caps initial infringement assertions at 20 patents (with no more than 10 newly issued patents), defines eligible patents, allows courts to increase the cap for good cause, and excludes method-of-treatment patents from the cap. The rules apply to biosimilar (42 U.S.C. § 262(k)) applications submitted on or after enactment.