News & Analysis as of

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

Robins Kaplan LLP

Janssen Prods., L.P. v. EVER Valinject GmbH

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Yondelis® (trabectedin) - Case Name: Janssen Prods., L.P. v. EVER Valinject GmbH, Civ. No. 24-7319, 2025 WL 639380 (N.D. Ill. Feb. 27, 2025) (Harjani, J.)  Drug Product and Patent(s)-in-Suit:  Yondelis® (trabectedin); U.S....more

Fenwick & West LLP

Familiar Tactics, New Targets: Non-Practicing Entities Move Into Life Sciences and Consumer Tech

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High-volume patent monetization entities have long focused on targets in the information technology and software sectors. But that trend is shifting....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

Venable LLP

Spotlight On: Herceptin® (trastuzumab) / Ogivri® (trastuzumab-dkst) / Herzuma® (trastuzumab-pkrb) / Ontruzant® (trastuzumab-dttb)...

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

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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

Proskauer - The Patent Playbook

Litigating Patents in the ITC: When and Why Companies Take the Section 337 Route

Formerly a niche venue for trade-related matters, the International Trade Commission (“ITC”) has emerged as a battleground for many high stakes intellectual property disputes, particularly in the technology, life sciences,...more

Goodwin

GSK and Pfizer Stipulate to Dismissal of RSV Vaccines Lawsuit

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On April 3, 2025, GlaxoSmithKline (GSK) and Pfizer filed a stipulation to dismiss with prejudice GSK’s litigation in the United States District Court for the District of Delaware....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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases: In re: Xencor, Inc.

In re: Xencor, Inc., Appeal No. 2024-1870 (Fed. Cir. Mar. 13, 2025) Our case of the week is an appeal from a decision of the Appeals Review Panel of the Patent Trial and Appeal Board, concerning Xencor’s patent application...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

McDonnell Boehnen Hulbert & Berghoff LLP

DNA Genotek Inc. v. Spectrum Solutions LLC (Fed. Cir. 2025)

Sometimes important contributions to innovation can come from the mundane rather than the extraordinary. One (perhaps apocryphal) example comes from the story of the early development of television by Philo Farnsworth (the...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

Venable LLP

Spotlight On: Biosimilar Litigations - March 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

Venable LLP

Spotlight On: Prolia® / Xgeva® (denosumab) / Jubbonti® / Wyost (denosumab-bbdz) / Ospomyv™ / Xbryk™ (denosumab-dssb) - March 2025

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Denosumab Challenged Claim Types in Litigation: Claims are counted in each litigation, so claims from the same patent challenged in multiple litigations are counted more than once. Within each litigation a claim is counted...more

Venable LLP

Stipulated Dismissal of Gene Therapy Elevidys® Manufacturing Litigation

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On February 19, 2025, Wilson Wolf Manufacturing and Sarepta’s stipulated dismissal with prejudice of Case No. 1:19-cv-02316 (D. Del.) related to the manufacturing of Elevidys® (delandistrogene moxeparvovec-rokl) was granted....more

Polsinelli

Personal Jurisdiction Considerations for International Biosimilars Companies

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The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more

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

2024 Federal Circuit IP Appeals – Amarin Pharma, Inc. v. Hikma Pharm. USA Inc., 104 F.4th 1370 (Fed. Cir. 2024) (Moore, Lourie,...

Amarin sells the drug icosapent ethyl under the brand name Vascepa. Vascepa is approved by the FDA for two indications: (i) to treat severe hypertriglyceridemia, a condition characterized by blood triglyceride levels greater...more

Venable LLP

Spotlight On: Neulasta® (pegfilgrastim) / Fulphila® (pegfilgrastim-jmdb) / Udenyca® (pegfilgrastim-cbqv) / Ziextenzo®...

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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 - February 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

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

IP Hot Topic: Federal Circuit Affirms Small U.S. Investments Can Satisfy Domestic Industry Requirement

A domestic industry may never be too small so long as the commercial product is 100% American-made according to the latest Federal Circuit opinion. In Wuhan Healthgen Biotech v. ITC, the Federal Circuit affirmed the...more

Robins Kaplan LLP

ANDA Litigation Settlements - Winter 2024

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This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed pursuant to the Hatch-Waxman Act....more

McDermott Will & Emery

Eye-Catching: Biosimilars Injunction Prevails

Addressing a preliminary injunction in patent litigation related to the Biologics Price Competition and Innovation Act (BPCIA), the US Court of Appeals for the Federal Circuit upheld the district court’s grant of a...more

Robins Kaplan LLP

Silvergate Pharms., Inc. v. Bionpharma Inc.

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Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.)  Drug Product and Patent(s)-in-Suit: Epaned®...more

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