News & Analysis as of

Patent Litigation Inter Partes Review (IPR) Proceeding Patent Invalidity

Goodwin

Fresenius Files Two IPRs Against Regeneron Aflibercept Patents

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On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however,...more

Knobbe Martens

Applicant Admitted Prior Art Can (Sometimes) Show Obviousness

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SHOCKWAVE MED., INC., V. CARDIOVASCULAR SYS., INC. - Before Lourie, Dyk, and Cunningham.  Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2019-00405. In inter partes review...more

A&O Shearman

Non-Application Of Interference Estoppel By PTAB In An IPR Institution Decision Found To Be Unreviewable

A&O Shearman on

On July 22, 2025, the Court of Appeals for the Federal Circuit concluded that the Patent Trial and Appeal Board’s (the “PTAB”) decision not to apply interference estoppel and, therefore, to institute an inter partes review...more

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

What Should the USPTO Consider Changing for Implementing Post-Final Written Decision Estoppel in Ex Parte Reexamination Based on...

The estoppel provision of 35 U.S.C. § 315(e)(1) had largely prevented requesters from challenging claims of a patent via ex parte reexamination after an inter partes review (IPR) that resulted in a final written decision...more

Jones Day

Inventor Testimony of Reduction Date Leads to Denial

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The Patent Trial and Appeal Board (PTAB) denied institution of an inter partes review (IPR) brought by Par-Kan Company, LLC against Unverferth Manufacturing Company regarding U.S. Patent No. 8,967,940 (“the ‘940 patent”). ...more

ArentFox Schiff

Overcoming the ‘Settled Expectations’ Doctrine: Guidance From Intel v. Proxense

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Last month, we provided an overview of the Patent Trial and Appeal Board’s (PTAB) application of the “settled expectations” doctrine, articulated in recent PTAB director-level decisions. Interim Director Coke Morgan Stewart...more

McDermott Will & Emery

Applicant-admitted prior art may inform but can’t be basis for IPR challenges

McDermott Will & Emery on

The US Court of Appeals for the Federal Circuit clarified that while applicant-admitted prior art (AAPA) may be cited as evidence of general background knowledge in inter partes review (IPR) proceedings, it cannot serve as...more

Jones Day

“Settled-Expectations” Analysis May Leave Some Petitioners Feeling Unsettled

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As discretionary denials are on the rise and institution rates are declining at the PTAB (link), recent decisions from the PTAB have introduced the notion of a patent owner’s “settled expectations” as another reason for the...more

A&O Shearman

Federal Circuit Invalidates Patent For Angioplasty Catheter Based On Applicant Admitted Prior Art

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The Federal Circuit recently issued a precedential decision in Shockwave Med., Inc. v. Cardiovascular Sys., Inc. (CSI), affirming-in-part and reversing-in-part the Patent Trial and Appeal Board’s (PTAB) decision, and...more

Proskauer - The Patent Playbook

PTO Creates New Expectations Regarding Discretionary Denials

On the heels of the U.S. Patent and Trademark Office Acting Director’s recent decision to deny institution of iRhythm Technologies’ inter partes review petition, the PTO has now issued additional decisions clarifying the role...more

McDonnell Boehnen Hulbert & Berghoff LLP

Shockwave Medical, Inc. v. Cardiovascular Systems, Inc. (Fed. Cir. 2025)

Received wisdom is that inter partes review proceedings are limited to prior art as defined by patents and printed publications.  But in recently decided Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., another prior...more

Venable LLP

Spotlight On: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - July 2025

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Etanercept Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Actemra® (tocilizumab) / Tofidence™ (tocilizumab-bavi) / Tyenne® (tocilizumab-aazg) / Avtozma® (tocilizumab-anoh) -...

Venable LLP on

Tocilizumab Challenged Claim Types in IPRs: Claims are counted in each IPR, so claims from the same patent challenged in multiple IPRs are counted more than once. Within each IPR, claims are counted only once, whether they...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

Venable LLP on

Pegfilgrastim Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost® (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) / Stoboclo®...

Venable LLP on

Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

Venable LLP on

Trastuzumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Humira® (adalimumab) / Amjevita™ (adalimumab-atto) / Cyltezo® (adalimumab-adbm) / Hyrimoz™ (adalimumab-adaz) /...

Venable LLP on

Adalimumab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Spotlight On: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - July 2025

Venable LLP on

Rituximab Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Morgan Lewis

‘Settled Expectations,’ PTAB’s New Discretionary Denial Factor, Gains Additional Footing in Dabico

Morgan Lewis on

Acting Director of the USPTO Coke Morgan Stewart recently discretionarily denied institution of an inter partes review (IPR) based on a new consideration, “settled expectations,” that is, the length of time that the...more

Venable LLP

Spotlight On: Lantus® / Lantus® SoloSTAR® (insulin glargine recombinant) / Basaglar® (insulin glargine) / Semglee® (insulin...

Venable LLP on

Insulin Glargine Challenged Claim Types in IPR and Litigation: Claims include those challenged in litigations and IPRs. Claims are counted in each litigation and IPR, so claims from the same patent challenged in multiple...more

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

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On June 9, 2025, the Patent Trial and Appeal Board (“Board”) issued a Final Written Decision (“FWD”) in Merck’s IPR2024-00240 against The Johns Hopkins University’s (“JHU”) U.S. Patent No. 11,591,393 (“the ’393 patent”),...more

Knobbe Martens

Finding Common Ground? — Federal Circuit Clarifies IPR Estoppel

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INGENICO INC. v. IOENGINE, LLC Before Dyk, Prost, and Hughes. Appeal from the United States District Court for the District of Delaware. IPR estoppel does not preclude reliance on public-use evidence that is substantively...more

Jones Day

Delegated Rehearing Panel Sends Lifeline to Mercedes-Benz

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A Delegated Rehearing Panel (“DRP”) recently modified the PTAB’s construction of the claim term “workload” and remanded, giving Mercedes-Benz USA, LLC (“Petitioner”) another opportunity to challenge a processor patent....more

Jones Day

Federal Circuit: RPI Arguments Must First Be Raised at the PTAB

Jones Day on

Apple Inc., et. al v. Gesture Technology Partners, LLC (March 4, 2025) (Moore (Chief Judge), Prost and Stoll) (on appeal from the Patent Trial and Appeal Board) [WAIVER; OBVIOUSNESS] ....more

White & Case LLP

Federal Circuit Reinforces Standard for Prior Art Enablement in CRISPR Dispute

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On June 11, 2025, the U.S. Court of Appeals for the Federal Circuit decided Agilent Technologies, Inc. v. Synthego Corp. (No. 23-2186), addressing enablement of prior art references for disputed CRISPR-Cas9 gene-editing...more

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