Op-Ed: Congress Must Repair USPTO’s Inter Partes Review Process

Tu SS, Rai AK, Kesselheim AS - Law360

  • Innovation Incentives and Competition

Summary:

Recent administrative changes at the USPTO, including centralized institution authority, unexplained discretionary denials, and non-merits-based decision criteria, have sharply constrained access to inter partes review and are now spreading to ex parte reexamination, leaving fewer viable mechanisms to challenge potentially invalid patents. Congress should enact legislation requiring written explanations for all denials, subjecting those decisions to judicial review under the Administrative Procedure Act’s arbitrary and capricious standard, and reestablishing IPR’s core function of removing erroneously granted patents to protect competition and the public interest.

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Recent Work from PORTAL

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The Impact of Semantics in Medicines Regulation

Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Simple graphic of magnifying glass examining papers to signify reviewing research publications.

Delisted Patents on Pharmaceuticals, 1998-2024

Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics

  • Innovation Incentives and Competition
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Delays in Access to Generic Semaglutide Point to Key Missing Pieces in Canada’s Drug Approval System

Eisenkraft Klein D, Kesselheim AS - Health Policy

  • Innovation Incentives and Competition
  • Regulation and Clinical Evidence
Canada approved its first generic semaglutide nearly four months after market exclusivity expired, with delays arising from the absence of clear standards for demonstrating equivalence between fully synthetic generics and the brand-name product. Regulators should publish equivalence standards so manufacturers can build the required evidence into their initial submissions, helping lower-cost alternatives reach patients sooner.
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