News & Analysis as of

Patent Invalidity Patent Infringement Life Sciences

Robins Kaplan LLP

Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC

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INOMax® (nitric oxide) - Case Name: Mallinckrodt Pharms. Ireland Ltd. v. Airgas Therapeutics LLC, Civ. No. 22-1648-RGA, 2025 WL 472557 (D. Del. Feb. 12, 2025) (Andrews, J.)  Drug Product and Patent(s)-in-Suit: INOMax® (nitric...more

Polsinelli

Judge Connolly (D. Del.) Overturns $96 Million Molecular Diagnostics Jury Verdict, Finds Patents Invalid Under § 112

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Synopsis: In a case with implications for the litigious molecular diagnostics space and written description law, Chief Judge Connolly of the District of Delaware reversed a $96 million jury verdict in favor of Natera,...more

A&O Shearman

Poster Presentation Tied To Business Objectives Serves As Evidence Of Infringement Of Patented Methods

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On February 12, 2025, the United States District Court for the District of Delaware denied defendant Parse Biosciences’s (“Parse”) motions for summary judgment that: (i) Parse had never actually conducted any direct or...more

A&O Shearman

UPC Court of Appeal confirms strict approach to correcting patent errors by interpretation

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Alexion Pharmaceuticals v Amgen (UPC_Coa-405/2024) and Alexion Pharmaceuticals v Samsung Bioepis NL BV (UPC_CoA-402/2024); December 20, 2024. The UPC Court of Appeal has confirmed a strict approach to correcting erroneous...more

Robins Kaplan LLP

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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Minocin® (minocycline) - Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., Civ. No. 21-2636, 2024 WL 4799896 (N.D. Ill. Nov. 15, 2024) (Kness, J.)  Drug Product and Patent(s)-in-Suit: Minocin® (minocycline);...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Reverses Decision Finding Lack of Written Description for Patent Claiming a Pharmaceutical Composition Comprising...

The Federal Circuit recently reversed a District of Delaware decision that invalidated claims of Novartis’s Orange Book listed patent, U.S. Patent No. 8,101,659 (the “’659 patent”), for its blockbuster drug Entresto®, a...more

Womble Bond Dickinson

2024 Hatch-Waxman Year in Review

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In 2024, the Hatch-Waxman Act continued to play a critical role in the U.S. pharmaceutical landscape, driving the dynamics between brand-name drugmakers and generics. This landmark legislation, enacted to encourage innovation...more

Goodwin

Acuitas Sues GSK Seeking Declaratory Judgment of Invalidity and Non-Infringement of mRNA Vaccine Patents

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​​​​​​​As we previously reported, in April of last year, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC brought a lawsuit against Pfizer and BioNTech in the District Court for the District of Delaware, alleging that...more

Smart & Biggar

Dexlansoprazole formulation patent invalid and not infringed by Apotex

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On February 7, 2024, the Federal Court dismissed Takeda’s action under subsection 6(1) of the Patented Medicines (Notice of Compliance) Regulations in relation to dexlansoprazole (Takeda’s DEXILANT). Justice Furlanetto...more

Irwin IP LLP

CAFC Holds Priority Favors True Trailblazers, Not Maze-Like Paths Through a Forest of Prior Applications: Regents of the...

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The Court of Appeals for the Federal Circuit (“CAFC”) recently upheld a decision of the Patent Trial and Appeal Board (“PTAB”) that found some claims of U.S. Patent 8,815,830 (“the ’830 patent”) unpatentable as anticipated....more

A&O Shearman

PTAB Decision Invalidating Claims Finding Lack of Written Description and Later Priority Date Upheld by Federal Circuit

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Procedural History - Regents of the University of Minnesota v. Gilead Sciences, Inc., Case No. 2021-2168 (Fed. Cir. Mar. 6, 2023) is an appeal by the Regents of the University of Minnesota (“Minnesota”) from a final...more

Smart & Biggar

2022 Highlights in Canadian Life Sciences IP and Regulatory Law

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Below are highlights from the Rx IP’s team’s 2022 updates (see also our Top 10 Rx IP Update Reads of 2022): Contents: 1. Patent decisions on the merits 2. PMNOC Regulations: Fifth-year anniversary of major amendments,...more

Knobbe Martens

Medical Device Patentee Petitions Supreme Court Regarding On-Sale Bar and Price Quotes

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A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more

Knobbe Martens

Silence Is No Support for Negative Claim Limitation

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NOVARTIS PHARMACEUTICALS CORP. V. HEC PHARM CO., LTD. Before Moore, Hughes, and Linn (dissenting). Appeal from the United States District Court for the District of Delaware. Summary:  Silence regarding the presence or...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

American Conference Institute (ACI)

[Complimentary Conference] Pharma & Biotech Patent Litigation - February 23rd - 24th, 9:00 am - 5:00 pm CET

15 Years of Pharma & Biotech Patent Litigation in Europe - C5’s Pharma & Biotech Patent Litigation in Europe will take place 23–24 February, 2022 in Amsterdam, the Netherlands. This is the only industry-shaping event that...more

Knobbe Martens

Federal Circuit Reverses PTAB’s Invalidation of Patent Claims for an Artificial Heart Valve (Snyders vs St. Jude)

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On October 5, 2021, the U.S. Federal Circuit reversed a finding of invalidity by the Patent Trial and Appeal Board (PTAB) for patent claims related to an “artificial valve for repairing a damaged heart valve.”  ...more

Kramer Levin Naftalis & Frankel LLP

Federal Circuit Invalidates Early CAR-T Patent

On Aug. 26, 2021, the Federal Circuit held the asserted claims of Sloan Kettering’s CAR-T patent invalid for lack of written description, reversing the final judgment of a California district court awarding Sloan Kettering...more

McDonnell Boehnen Hulbert & Berghoff LLP

Juno Therapeutics, Inc. v. Kite Pharma, Inc. (Fed. Cir. 2021)

Dominating the entering gallery of the Impressionists exhibit at the Art Institute of Chicago is Georges Seurat's A Sunday on La Grande Jatte (see below). Painted in the pointillist style, the work comprises millions of...more

Goodwin

Alvotech Files Suit Against AbbVie to Invalidate Humira Patent Portfolio

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On May 11, 2021, Alvotech USA and Alvotech hf (jointly, Alvotech) filed a complaint seeking declaratory judgement against AbbVie Inc. and AbbVie Biotechnology Ltd (jointly, AbbVie) in the Eastern District of Virginia. As...more

Knobbe Martens

Broad Claim Language and Unpredictability in the Art Lead to Non-Enablement

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ENZO LIFE SCIENCES, INC. v. ROCHE MOLECULAR SYSTEMS, INC. Before Prost, Reyna, and Wallach. Appeal from the United States District Court for the District of Delaware. Summary: Broad patent claims were invalid as not...more

Smart & Biggar

Year-end Round-up: Notable Canadian Patent Cases of 2018

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Earlier this month we published an exhaustive review of the life sciences and regulatory cases in the Canadian courts, and decisions on the merits for the year are summarized in our in our Rx IP Update 2018 Highlights in...more

Neal, Gerber & Eisenberg LLP

NGE IP Focus: Life Sciences

Neal Gerber Eisenberg and Wolters Kluwer have teamed up to bring you NGE IP Focus, a quarterly newsletter dedicated to intellectual property-related legal decisions. ...more

Dechert LLP

Recent Federal Circuit Decisions on Obviousness-Type Double Patenting May Shape Life Science Patent Portfolio Management

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The Federal Circuit recently decided two appeals, Novartis AG v. Ezra Ventures LLC (“Ezra”) and Novartis Pharms. Corp. v. Breckenridge Pharm. Inc. (“Breckenridge”) that both relate to the effect of obviousness-type double...more

McDonnell Boehnen Hulbert & Berghoff LLP

LifeNet Health v. LifeCell Corp. (Fed. Cir. 2016)

The complexities that can be attendant on defending against an infringement allegation, and the possibility that a straightforward path to non-infringement can be complicated by claim construction even for terms construed...more

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