Sponsor
Patrick Ryan
Representative · D-NY
Representative · D-NY
The bill aims to lower drug costs and strengthen patent quality checks—speeding patient and taxpayer savings—while increasing revenue pressure, legal uncertainty, and potential reductions in incentives for brand-name drug innovation.
Patients (including those with chronic conditions), Medicaid and Medicare beneficiaries, and taxpayers will likely see earlier access to lower-cost generic drugs and biosimilars because presumed disclaimers shorten effective exclusivity periods, reducing out-of-pocket costs and program spending.
Small businesses and other patent-system stakeholders may benefit from improved patent quality because USPTO review and potential new guidance could reduce issuance of low-quality or duplicative patents, strengthening overall patent system integrity.
Innovator (brand) drug companies will face weaker protections for later-listed patents, reducing expected revenues from follow-on patents unless they can prove distinctness.
Brand and generic firms will likely face increased litigation and uncertainty over what counts as 'patentably distinct,' raising legal costs and business uncertainty for both sides.
If courts apply the presumption broadly, R&D investment incentives for follow-on and incremental improvements could decline, potentially slowing incremental pharmaceutical innovation over time.
Based on analysis of 2 sections of legislative text.
Creates a rebuttable presumption that later‑expiring patents on the same drug are disclaimed for certain FDA‑linked patent challenges and orders a USPTO review of examination practices.
Official title: To amend title 35, United States Code, to prevent double patenting, and for other purposes.
Introduced January 31, 2025 by Patrick Ryan · Last progress January 31, 2025
Creates a legal presumption that when a patentee holds a later‑expiring patent on the same drug or biological product, the patentee is treated as having disclaimed the extra patent term in certain FDA-related patent challenges unless the patentee proves the later patent claims a patentably distinct invention. The bill also directs the USPTO Director to review and report on patent examination practices that allow non‑distinct or term‑extending patents to issue, with recommendations delivered to the House Judiciary Committee within one year of enactment.