News & Analysis as of

Patent Infringement Patents Inter Partes Review (IPR) Proceeding

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

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

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

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

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

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

Jones Day on

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

BCLP

Federal Circuit Clarifies Limits of Prosecution Disclaimer in Patent Families

BCLP on

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

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

Jones Day on

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

Jones Day

Acting Director Releases First Decisions Under New Bifurcated Process

Jones Day on

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

Jones Day

Director Review: PTAB Instructed to Allow Narrowly Tailored Discovery Regarding Time Bar

Jones Day on

USPTO Acting Director Coke Morgan Stewart recently vacated and remanded three Final Written Decisions from the PTAB.  Semiconductor Components Indus. v. Greenthread, LLC, IPR2023-01242, IPR2023-01243, IPR2023-01244, Paper 94...more

Jones Day

Estoppel Trumps Substance: ITC Bars Respondent’s Invalidity Grounds Raised in IPR

Jones Day on

Recently, an ITC Administrative Law Judge applied IPR statutory estoppel under 35 U.S.C. § 315(e)(2) in denying a Respondent’s motion for summary determination of invalidity in Certain Audio Players and Components Thereof,...more

Troutman Pepper Locke

The Top Five Challenges of Pursuing Litigation at the ITC

Troutman Pepper Locke on

Patent litigation at the International Trade Commission (ITC) is characterized by its rapid pace, with proceedings for investigations under 19 U.S.C. § 1337 typically concluding within 15 to 18 months after the filing of the...more

Jones Day

Trial Date Drives PTAB’s Denial of IPR Institution

Jones Day on

On April 16, 2025, the Patent Trial and Appeal Board (PTAB) denied institution of inter partes review (IPR) for several claims of U.S. Patent No. 7,187,307, owned by Universal Connectivity Technologies, Inc. HP Inc., Dell...more

Jones Day

Federal Circuit: Petitioner Estoppel Does Not Apply to Product Prior At Grounds

Jones Day on

In IOENGINE, LLC v. Ingenico Inc. (Fed. Cir. 2025), the Federal Circuit narrowed the scope of IPR estoppel under 35 U.S.C. § 315(e)(2), which precludes an IPR petitioner from asserting in court that a patent claim “is invalid...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: Enbrel® (etanercept) / Erelzi® (etanercept-szzs) / Eticovo® (etanercept-ykro) - May 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

A&O Shearman

The CAFC Holds That IPR Estoppel Does Not Shield Patentees From System Prior Art

A&O Shearman on

On May 7, 2025, the U.S. Court of Appeals for the Federal Circuit (“CAFC”) affirmed a decision by the U.S. District Court for the District of Delaware (“district court”) that found claims of two IOENGINE, LLC (“IOENGINE”)...more

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