Sponsors
The bill aims to speed competition and earlier access to lower-cost drugs by presuming certain later, non-distinct patents disclaimed and improving USPTO procedures, at the cost of reduced enforceable patent terms, higher litigation and administrative burdens for patentees, and potential dampening of incentives for incremental innovation.
Patients (including those with chronic conditions and low-income individuals) could gain earlier access to lower-cost drugs and biologics because improper patent extensions on later-expiring, non-distinct patents will be less likely to delay generic and biosimilar entry.
Generic and biosimilar manufacturers could face fewer delayed market entries, speeding competition and potentially lowering prices, because later-expiring, non‑distinct patents will be presumed disclaimed unless rebutted.
The USPTO review and recommended procedural changes could improve patent examination quality and reduce issuance of overlapping or improperly granted patents, strengthening the patent system's integrity over time.
Patent holders (especially holders of later-expiring patents) will likely lose enforceable patent term for those patents unless they can rebut the presumption, reducing expected patent value and returns on investment.
Patentees may face increased litigation burdens and costs because they must prove patentable distinctness by a preponderance of the evidence to overcome the presumption, raising legal expenses and uncertainty.
If USPTO examination standards tighten or reinterpretation raises the bar, inventors and small businesses could find it harder to obtain or maintain patents for incremental improvements, potentially reducing incentives to innovate.
Based on analysis of 2 sections of legislative text.
Creates a presumption that later-expiring patents on the same drug/biologic are disclaimed unless the patentee proves the later patents claim patentably distinct inventions, and tasks the USPTO with a one-year review of exam practices.
Introduced January 31, 2025 by Patrick Ryan · Last progress January 31, 2025
Creates a legal presumption that later-expiring patents claiming the same drug or biological product as an earlier-expiring patent are treated as having disclaimed additional patent term unless the patent owner proves the later patents claim patentably distinct inventions. Also directs the U.S. Patent and Trademark Office (USPTO) Director to review examination procedures that allow multiple patents to extend exclusivity for the same drug/biologic and to report recommendations to the House Judiciary Committee within one year.