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Pharmaceutical Patents Inter Partes Review (IPR) Proceeding Denial of Institution

Venable LLP

PTAB Director Discretionarily Denies Opdivo® IPRs Based on Settled Expectations of Patent Owner

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On July 24, 2025, the PTO Acting Director Coke Morgan Stewart discretionarily denied Amgen’s IPR2025-00601 and IPR2025-00602 challenging Bristol-Myers Squibb’s (“BMS”) U.S. Patent Nos. 9,856,320 (“the ’320 patent”) and...more

Jones Day

Discretionary Denial of IPR Institution Due to Advanced Hatch-Waxman Litigation

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In a recent decision, the Patent Trial and Appeals Board (“PTAB”) exercised its discretion under 35 U.S.C. § 314(a) to deny institution of an inter partes review (“IPR”) after applying the Fintiv factors, despite Petitioner’s...more

Jones Day

Physical Products Cannot Form Basis of an IPR

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On May 1, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) of U.S. Patent No. 11,140,841 in the case of Aardevo North America, LLC v. Agventure B.V. The patent in question, owned...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions: Mylan Labs. Ltd v. Janssen Pharmaceutica, N.V.,...

Mylan appealed from a Patent Trial and Appeal Board (Board) discretionary denial of institution of an inter partes review (IPR) proceeding. The Board declined to institute Mylan’s IPR under NHK-Fintiv, a multi-factor analysis...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Appeals from the PTAB and ITC: Summaries of Key 2021 Decisions

[co-author: Jamie Dohopolski] Last year, the continued global COVID-19 pandemic forced American courts to largely continue the procedures set in place in 2020. The U.S. Court of Appeals for the Federal Circuit was no...more

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