News & Analysis as of

Patent Infringement Patents Patent Litigation

Volpe Koenig

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

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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

McDermott Will & Emery

No Blank Check: Vendor Can’t Claim Declaratory Judgment From Customer Lawsuits Alone

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The US Court of Appeals for the Federal Circuit affirmed a district court’s dismissal of a declaratory judgment action, explaining that declaratory judgment jurisdiction does not “arise merely on the basis that a party learns...more

McDermott Will & Emery

Radio Silence Alone Doesn’t Prove Equitable Estoppel Defense

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The US Court of Appeals for the Federal Circuit reversed a district court’s summary judgment grant based on an equitable estoppel defense, finding that the accused infringer failed to show that the patent owner’s silence or...more

Sheppard Mullin Richter & Hampton LLP

Navigating Declaratory Judgment: Mitek’s Bid to Head Off USAA’s Patent Claims

This case addresses declaratory judgments of non-infringement in relation to subject-matter jurisdiction and the district court’s refusal to exercise discretionary jurisdiction. Background - In June 2020, Mitek Systems,...more

Vinson & Elkins LLP

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

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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

Venable LLP

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

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

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: 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

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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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Mitek Systems Inc. v. United Services Automobile Association

Mitek Systems Inc. v. United Services Automobile Association, Appeal No. 2023-1687 (Fed. Cir. June 12, 2025) In our Case of the Week, the Federal Circuit examined the limits of declaratory judgment jurisdiction for a...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

Fenwick & West LLP

Key Takeaways: Strategies from the First Two Years of the UPC

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The Unified Patent Court (UPC) represents a transformative development in European patent litigation. Fenwick’s Ryan Johnson teamed up with Bird & Bird’s Boris Kreye and Chris de Mauny to explore important considerations and...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

Venable LLP

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

Jones Day

Federal Circuit: Plans for Future Activity Created a Substantial Risk of Future Infringement

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Restem filed a petition for inter partes review of U.S. Patent No. 9,803,176, directed to stem cells obtained from umbilical cord tissue and isolated through a two-step process to create a specific cell marker expression...more

Fish & Richardson

Texas Round-Up: May 2025

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Below are summaries of two claim construction opinions issued out of the Eastern District of Texas in May 2025....more

BCLP

Federal Circuit Clarifies Limits of Prosecution Disclaimer in Patent Families

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In Maquet Cardiovascular LLC v. Abiomed Inc., 131 F.4th 1330 (Fed. Cir. 2025), the Federal Circuit addressed whether the prosecution history of one patent in a patent family can limit the scope of claims in a different patent...more

Lathrop GPM

Claim Construction Matters: Federal Circuit Decision Highlights the Significance of Lexicography in Patent Drafting

Lathrop GPM on

A precedential ruling by the U.S. Court of Appeals for the Federal Circuit on June 4 affirmed that Moderna’s mRNA-based COVID-19 vaccine SPIKEVAX® does not infringe two patents owned by Alnylam Pharmaceuticals, upholding a...more

Jones Day

Applying Fintiv to a Parallel ITC Investigation

Jones Day on

The Patent Trial and Appeals Board (“PTAB”) recently denied institution of an inter partes review (“IPR”), exercising its discretion under 35 U.S.C. § 314(a)and Apple Inc. v. Fintiv Inc., IPR2020-00019 (PTAB Mar. 20, 2020)...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Alnylam Pharmaceuticals, Inc. v. Moderna, Inc.

Alnylam Pharmaceuticals, Inc. v. Moderna, Inc., Appeal No. 2023-2357 (Fed. Cir. June 4, 2025) In this week’s Case of the Week, the Federal Circuit affirmed a final judgment that Moderna’s mRNA-based COVID-19 vaccine did...more

Jones Day

April 2025 Institution Rate Slips Below 45 Percent

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The PTAB has published its monthly statistics wrap up for April 2025. As expected, those statistics show a significant decline in the institution rate compared to the first six months of the fiscal year. In those first six...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

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The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

Jones Day

Acting Director Releases First Decisions Under New Bifurcated Process

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On May 16, 2025, USPTO Acting Director Coke Morgan Stewart released the first four discretionary denial decisions under the PTAB’s new process. Under the new process, the parties separately brief discretionary denial issues...more

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