News & Analysis as of

Patent Litigation Inter Partes Review (IPR) Proceeding

K&L Gates LLP

First Denial Based on USPTO’s New Discretionary Denial Factors

K&L Gates LLP on

Earlier this year, Chief Judge Boalick issued guidance on the USPTO’s recission of “Interim Procedure for Discretionary Denials in AIA Post-Grant Proceedings with Parallel District Court Litigation,” explaining how the Fintiv...more

Goodwin

Recent PTAB Developments for Regeneron’s Aflibercept Formulation Patent

Goodwin on

Earlier this month, a Patent Trial and Appeal Board (“PTAB”) panel denied institution of two petitions that were filed separately by Samsung Bioepis (IPR2025-00176) and Formycon (IPR2025-00233) for inter partes review (“IPR”)...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Cardiovalve Ltd. (Fed. Cir. 2025)

One of the assumptions, or promises, or hopes, attendant on the inauguration of post-grant review proceedings (particularly inter partes reviews) under the Leahy-Smith America Invents Act was that, as in European Opposition...more

Volpe Koenig

“Settled Expectations” as the New Gatekeeper for PTAB Discretionary Denials: Why Late-Stage IPRs Are Getting Harder to File

Volpe Koenig on

When Acting USPTO Director Coke Morgan Stewart denied institution in Dabico v. AXA Power IPR2025-00408  Paper 21, much of the commentary focused on the result....more

Alston & Bird

Patent Case Summaries | Week Ending June 13, 2025

Alston & Bird on

Fraunhofer-Gesellschaft zur Förderung der angewandten Forschung e.V. v. Sirius XM Radio Inc., No. 2023-2267 (Fed. Cir. (D. Del.) June 9, 2025). Opinion by Lourie, joined by Dyk and Reyna....more

McDermott Will & Emery

CRISPR Clarity: Enablement Is Analyzed Differently Under §§ 102 and 112

McDermott Will & Emery on

In a decision underscoring the distinct standards governing enablement under §§ 102 and 112, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial & Appeal Board’s finding that a prior art reference was...more

Vinson & Elkins LLP

File Early or Risk Denial: iRhythm IPR Institution Denial Underscores the Importance of Filing IPR Petitions Sooner Rather Than...

Vinson & Elkins LLP on

On June 6, 2025, the Acting Director of the United States Patent and Trademark Office (“USPTO”), Coke Morgan Stewart, issued a decision denying institution of five inter partes review (“IPR”) petitions filed by iRhythm, Inc....more

ArentFox Schiff

Federal Circuit Narrows Scope of IPR Estoppel, Resolving District Court Split

ArentFox Schiff on

The Federal Circuit recently clarified in Ingenico Inc. v. IOENGINE, LLC that inter partes review (IPR) estoppel does not extend to physical systems described in prior art patents or printed publications....more

A&O Shearman

Federal Circuit Affirms Patent Trial And Appeal Board Decision, Finding Claims Of Patents Covering CRISPR Guide RNA Technology As...

A&O Shearman on

On June 11, 2025, the United States Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board (PTAB) decision invalidating two patents owned by Agilent Technologies. The patents at issue, U.S. Patent...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

Alston & Bird

Intellectual Property Litigation Newsletter | June 2025

Alston & Bird on

Welcome to the Intellectual Property Litigation Newsletter, our review of decisions and trends in the intellectual property arena. In this edition, we learn that unilateral assertion is not industry standard, the IPR...more

Venable LLP

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

Venable LLP on

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

WilmerHale

Federal Circuit Patent Watch: An Enabling Anticipatory Prior Art Reference Need Only Enable a Single Embodiment of the Claim

WilmerHale on

Precedential and Key Federal Circuit Opinions - ALNYLAM PHARMACEUTICALS, INC. v. MODERNA, INC. [OPINION] (2023-2357, 06/04/2025) (Taranto, Chen, Hughes) - Taranto, J. The Court affirmed the district court’s claim...more

McDonnell Boehnen Hulbert & Berghoff LLP

Agilent Technologies, Inc. v. Synthego Corp. (Fed. Cir. 2025)

An argument could be made that one of the most significant Supreme Court decisions in U.S. patent law in the last thirty years was Dickinson v. Zurko.  In that case the Court held that the Federal Circuit was bound by the...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: 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

Proskauer - The Patent Playbook

Discretionary Denials in Action: iRhythm Technologies Inc. v. Welch Allyn Inc.

The U.S. Patent and Trademark Office (“USPTO”) Acting Director’s recent decision to deny institution of inter partes review (“IPR”) in iRhythm Technologies Inc. v. Welch Allyn Inc. offers valuable lessons for both patent...more

Irwin IP LLP

Seeing Double?  Similar Claim Terms Could Be Trouble  

Irwin IP LLP on

When prosecuting a patent with similar language across various claims make sure your claim terms have different meanings, otherwise, during litigation you may lose the strategic opportunity to keep some claims valid if others...more

Morgan Lewis

Meet the New Discretionary Denial Factor on the PTAB Block: Settled Expectations

Morgan Lewis on

USPTO Acting Director Coke Morgan Stewart recently issued a decision discretionarily denying five petitions for inter partes review (IPR) filed by iRhythm against patents owned by Welch Allyn based on a factor that had not...more

Fish & Richardson

Ingenico v. IOENGINE and the Diminishing Role of Sotera Stipulations

Fish & Richardson on

In Ingenico v. IOENGINE, No. 2023-1367 (Fed. Cir. May 7, 2025), the Federal Circuit resolved a long-standing split among District Courts in favor of petitioners regarding inter partes review (IPR) estoppel under 35 U.S.C. §...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: Biosimilar Litigations - June 2025

Venable LLP on

Biosimilar Litigations include litigations relating to biosimilar/follow-on products of CDER-listed reference products. Litigations between biosimilar applicants/manufacturers and reference product sponsors as well as...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: 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

Volpe Koenig

When an IDS Comes Back to Haunt You: Lessons from iRhythm v. Welch Allyn

Volpe Koenig on

Patent attorneys are well-versed in the function of the Information Disclosure Statement (IDS) during prosecution. We understand that listing prior art in an IDS satisfies the duty of candor, helps insulate patents from...more

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