Tu SS, Rai AK, Kesselheim AS - Law360
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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Costa E, Kesselheim AS - Journal of Law, Medicine, & Ethics
Kirby-Rivera L, Feldman WB, Kim M, Kosmopoulou G, Kesselheim AS, Tu SS - Journal of Law, Medicine, & Ethics
Eisenkraft Klein D, Kesselheim AS - Health Policy