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Inter Partes Review (IPR) Proceeding Pharmaceutical Industry Claim Construction

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

McDermott Will & Schulte

Prosecution history primacy: “Consisting essentially of” means what applicant said it meant

In a decision that underscores the primacy of prosecution history to determine claim scope, the US Court of Appeals for the Federal Circuit reversed the Patent Trial & Appeal Board’s interpretation of the transitional phrase...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: Eye Therapies, LLC v. Slayback Pharma, LLC

Eye Therapies, LLC v. Slayback Pharma, LLC, Appeal No. 2023-2173 (Fed. Cir. June 30, 2025) In its only precedential patent opinion last week, the Federal Circuit reviewed construction of the transitional claim phrase...more

Venable LLP

Pembrolizumab Patent IPR Final Written Decision Issued and Director Review Requested

Venable LLP on

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

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: 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) - 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

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

Venable LLP

Court Finds bluebird bio’s Gene Therapy Zynteglo® (betibeglogene autotemcel) Does Not Infringe San Rocco Therapeutics’ Patents

Venable LLP on

On May 16, 2025, the Court in Case No. 1:21-cv-01478 (D. Del.) granted bluebird bio’s motion for summary judgment, finding that its gene therapy Zynteglo® (betibeglogene autotemcel) does not infringe San Rocco Therapeutics‘...more

DLA Piper

What is a “Clear and Unmistakable” Prosecution History Disclaimer?

DLA Piper on

The Federal Circuit’s March 21, 2025 decision in Maquet Cardiovascular LLC v. Abiomed Inc. et al. (No. 2023-2045) and the recent Patent Trial and Appeal Board (PTAB) Delegated Rehearing Panel decision in SynAffix B.V. v....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

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: Rituxan® (rituximab) / Truxima® (rituximab-abbs) / Ruxience® (rituximab-pvvr) / Riabni™ (rituximab-arrx) - April...

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

WilmerHale

Federal Circuit Patent Watch: A comparative statement in a patent specification can be “definitional” for purposes of claim...

WilmerHale on

Precedential and Key Federal Circuit Opinions - 1.  PARKERVISION, INC. v. VIDAL [OPINION] (2022-1548, 12/15/2023) (Prost, Wallach, and Chen)* - Chen, J. The Court affirmed the PTAB’s determination that the patent...more

WilmerHale

Federal Circuit Patent Watch: Federal Circuit rejects invitation to create a bright-line rule regarding whether numerical ranges...

WilmerHale on

Precedential and Key Federal Circuit Opinions - MALVERN PANALYTICAL INC. v. TA INSTRUMENTS-WATERS LLC [OPINION] (2022-1439, 11/1/2023) (Prost, Hughes, and Cunningham) - Prost, J. The Court vacated the district court’s...more

Goodwin

PTAB Grants Petitioner Celltrion’s Motion To Submit Supplemental Information in Tocilizumab IPR

Goodwin on

​​​​​​​The U.S. Patent Trials & Appeals Board (Board) recently issued an Order granting Celltrion’s motion to submit supplemental information in its IPR (2022-00578) against U.S. Pat. No. 8,580,264, owned by Chugai Seiyaku...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - January 2020

PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more

Morgan Lewis

Pharma Review - Issue 3

Morgan Lewis on

Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...more

Foley & Lardner LLP

Federal Circuit Agrees “Pharmaceutical Composition” May Be Toxic

Foley & Lardner LLP on

The claim construction determinations in Mayne Pharma International Pty. Ltd. V. Merck Sharp & Dohme Corp. may leave stakeholders in the pharmaceutical space scratching their heads, and highlights that it’s rarely possible to...more

Morrison & Foerster LLP

What Are the Top Hatch-Waxman and BPCIA Developments for October 2018?

This month we highlight a new law requiring notification to the Federal Trade Commission and Department of Justice of biosimilar litigation settlements and perhaps the end of a long-running Mylan venue dispute in Delaware....more

Goodwin

Biosimilar-Related Appeals Pending before the Federal Circuit

Goodwin on

There are presently seven biosimilar-related appeals pending before the Federal Circuit. Two of those appeals, Amgen v. Sandoz (Case No. 18-1551) and Amgen v. Coherus (Case No. 18-1993), are from district court judgments in...more

Troutman Pepper Locke

CAFC Affirms PTAB’s Decision That Printed Matter Doctrine Can Be Used In Claim Construction

Troutman Pepper Locke on

In an inter partes review proceeding, a challenger cannot raise patent-eligibility as a ground of invalidity. Rather, the invalidity grounds are limited to lack of novelty and obviousness. ...more

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