Generation Patient Supports the Concerns Raised on USPTO Patent Challenge Restrictions During House Oversight Hearing
March 30, 2026
Last week, the House Subcommittee on Courts, Intellectual Property, Artificial Intelligence, and the Internet held an oversight hearing with U.S. Patent and Trademark Office (USPTO) Director John Squires. Chairman Darrell Issa (R-CA) raised several concerns about ongoing USPTO policies that are restricting public access to patent challenges. Generation Patient shares many of the concerns raised by Chairman Issa.
This blog overviews key concerns shared by Chairman Issa and other members at the hearing.
Restricting public access to patent challenges is contrary to congressional intent
In 2011, Congress created the inter partes review (IPR) to provide the public with an efficient mechanism for challenging invalid patents. For generic and biosimilar manufacturers, the IPR is often the most viable path to clearing the way for affordable alternatives. However, in recent months the USPTO has systematically denied IPR petitions under the notion of “settled expectations” and has proposed new rules to restrict patent challenges even further. Chairman Issa indicated that these recent departures from IPR practice are contrary to congressional intent.
Administrative judges have greater technical expertise for resolving patent challenges
35 U.S.C. § 6(a) requires administrative patent judges to have “competent legal knowledge and scientific ability.” In practice, this means administrative patent judges hold advanced degrees in fields like biochemistry and pharmaceutics. Judges in federal courts often lack the appropriate technical expertise. Chairman Issa highlighted this distinction, noting that IPR judges are better equipped to evaluate the validity of complex patents than generalist federal judges.
Ex parte reexaminations, which exclude third-party challengers, are insufficient
USPTO Director Squires indicated during the hearing that ex parte reexamination can serve as an adequate alternative for challenging patent validity. Chairman Issa pushed back given the closed nature of ex parte reexamination. Once a third party requests a reexamination, ex parte proceedings are conducted between the patent owner and the USPTO. The challenger does not have the opportunity to respond to arguments or present additional evidence.
Unexplained denials of petitions challenging weak patents
Other representatives criticized the systematic denials of IPR petitions in recent months and expressed concerns about how these decisions could raise costs for Americans. Among them was Representative Zoe Lofgren (D-CA), who expressed concerns about IPR denials issued without any written explanation to the American public.
Patent Priorities for Young Adult Patients
Millions of young adult patients across America depend on medications that can cost hundreds of thousands of dollars a year, and the patent system directly shapes whether they can afford the treatments they need to survive. We will continue to follow developments at the USPTO to ensure decisions include the experiences of young adult patients.
Click here to read the Generation Patient Patent Policy Priorities.
Luis Gil Abinader, Policy Director at Generation Patient. Contact: luis@generationpatient.org.