News & Analysis as of

Patent Litigation Obviousness Pharmaceutical Industry

A&O Shearman

Federal Circuit clarifies presumption of obviousness for overlapping ranges

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After the Federal Circuit vacated and remanded the district court’s non-obviousness determination, the district court again found that Teva failed to show, by clear and convincing evidence, that the claims of Janssen’s patent...more

Robins Kaplan LLP

United Therapeutics Corp. v. Liquidia Techs., Inc.

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Nature of the Case and Issue(s) Presented: UTC’s ’782 patent claims a method for treating pulmonary hypertension (“PH”). PH manifests in different varieties, including pulmonary arterial hypertension (“PAH”) and pulmonary...more

Venable LLP

Jury Finds Botox® Patent Claims Nonobvious and Awards Damages from Daxxify® Sales

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On July 18, 2025, after a five-day trial, the jury in Allergan v. Revance Case No. 1:21-cv-01411 (D. Del.) entered a verdict finding claim 8 of Allergan’s U.S. Patent No. 7,354,740 (“the ’740 patent”), claim 6 of U.S. Patent...more

Alston & Bird

Patent Case Summaries | Week Ending July 11, 2025

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Egenera, Inc. v. Cisco Systems, Inc., No. 2023-1428 (Fed. Cir. (D. Mass.) July 7, 2025). Opinion by Stark, joined by Prost and Taranto. Egenera owns a patent related to improved systems and methods for deploying and...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

Knobbe Martens

An Eye Toward Prosecution History

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EYE THERAPIES, LLC v. SLAYBACK PHARMA LLC - Before Taranto, Stoll and Scarsi (sitting by designation). The patent’s prosecution history required a restrictive interpretation of the term “consisting essentially of.”...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

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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

Venable LLP

Sarepta Files Two IPRs Against Genzyme’s Patents Gene Therapy Elevidys® Allegedly Infringes

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On June 26, 2025, Sarepta Therapeutics filed IPR2025-01194, challenging as obvious claims 3-6 of Genzyme’s U.S. Patent No. 9,051,542 (“the ’542 patent), and IPR2025-01195 challenging claims 1-4, 6-7 and 11 of U.S. Patent No....more

McDonnell Boehnen Hulbert & Berghoff LLP

MSN Laboratories Private Ltd. v. Bausch Health Ireland Ltd. (Fed. Cir. 2025)

As has been noted recently (Agilent Technologies, Inc. v. Synthego Corp.), fact-based decisions from the U.S. Patent and Trademark Office (typically from the Patent Trial and Appeal Board) are reviewed under the substantial...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

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

DLA Piper

The Federal Circuit Upholds Drug Dosing Regimen as Valid and Nonobvious

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In Janssen Pharmaceuticals, Inc. v. Mylan Laboratories., the United States Court of Appeals for the Federal Circuit affirmed a district court ruling that a pharmaceutical dosing claim limitation was nonobvious despite prior...more

McDonnell Boehnen Hulbert & Berghoff LLP

Treprostinil Saga Continues

United Therapeutics Corp. (UTC) and Liquidia Technologies Inc. have been battling for close to a decade over their respective inhaled formulations of treprostinil (UTC's Tyvaso®, Liquidia's Yutrepia™) for treatment of...more

Venable LLP

Federal Circuit Affirms PTAB’s Unpatentability Findings in Gene Therapy Hemgenix® IPRs

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On May 22, 2025, the CAFC affirmed the PTAB’s (Board) Final Written Decisions in Pfizer’s IPR2021-00925 and IPR2021-00926 finding all challenged claims of uniQure’s U.S. Patent No. 9,982,248 (“the ’248 patent”) unpatentable...more

Venable LLP

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

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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

Fish & Richardson

Can Clinical Trials Negate Patentability for Pharma Inventions?

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The answer to this inquiry is “yes” — but maybe “no.” Will confidentiality agreements shield any prior art concerns? Once again, maybe “yes” — but maybe “no.” Indeed, do clinical trials constitute an experimental use that...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

A&O Shearman

Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For...

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On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

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Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

DLA Piper

Federal Circuit Refines Obviousness Framework for Drug and Biologic Dosing Regimens

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The United States Court of Appeals for the Federal Circuit recently affirmed a district court ruling that a pharmaceutical dosing claim limitation was unpatentable due to obviousness-type double patenting. The court found...more

Knobbe Martens

An Obvious Solution to an Unknown Problem?

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IMMUNOGEN, INC. v. STEWART - Before Lourie, Dyk, and Prost. Appeal from the United States District Court for the Eastern District of Virginia. A solution to a problem can be obvious even when the problem itself was unknown in...more

McDermott Will & Schulte

Inventor’s Motivation to Combine Does Not Control Obviousness

The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2025)

Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more

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