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Patent Litigation Noninfringement Pharmaceutical Industry

Goodwin

Final Judgment of Non-Infringement Entered in Alnylam v. Pfizer Vaccine Patent Dispute

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​​​​​​​On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s...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

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

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - December 2024

Mirror Worlds Technologies, LLC v. Meta Platforms, Inc., Appeal Nos. 2022-1600, -1709 (Fed. Cir. Dec. 4, 2024) In this appeal from the United States District Court for the Southern District of New York, the Federal...more

Goodwin

PTAB Institutes Eight More IPRs Filed by Merck on Johns Hopkins Pembrolizumab Patents

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​​​​​​​In the last few weeks, the PTAB has granted institution of eight IPRs filed by Merck on Johns Hopkins patents directed to methods of treatment using pembrolizumab. The eight patents are generally directed to methods...more

WilmerHale

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

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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

Acuitas Seeks Declaratory Judgment of Non-Infringement and Invalidity Against Arbutus and Genevant in New Jersey Court Challenging...

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Last week, Canada-based Acuitas Therapeutics, Inc. (Acuitas) filed a complaint in the District of New Jersey for declaratory judgment of non-infringement and invalidity against Arbutus Biopharma Corp. and Genevant Sciences...more

Goodwin

Alvotech’s E.D. Va. Declaratory Judgment Action Against AbbVie Transferred to N.D. Ill.

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On Friday, October 22, 2021, Judge Raymond A. Jackson of the Eastern District of Virginia (E.D. Va.) transferred Alvotech USA and Alvotech hf.’s (jointly, “Alvotech”) declaratory judgment suit against AbbVie Inc. and AbbVie...more

WilmerHale

CAFC Patent Cases - May 2021 #2

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Precedential Federal Circuit Opinions - CAP EXPORT, LLC v. ZINUS, INC. [OPINION]  (2020-2087, 5/5/21) (Dyk, Bryson, Hughes) - Dyk, J. Affirming decision to set aside judgment and injunction pursuant to Federal Rule of...more

Wilson Sonsini Goodrich & Rosati

Federal Circuit Holds That Claims of a Patent Asserted During a Patent Term Extension Are Not Infringed by the Carboxylic Acid...

Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more

Goodwin

Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation

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On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s motion to dismiss...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

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On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Wilson Sonsini Goodrich & Rosati

District Court Case Highlights Nuances Associated with Determining If a Generic or Biosimilar Applicant Is Entitled to Protection...

A recent case at the U.S. District Court for the District of Delaware demonstrates how nuanced safe harbor protection under 35 U.S.C. § 271(e)(1) "non-infringement" can be for a pharmaceutical company developing a biosimilar...more

Goodwin

Sandoz Files Responsive Brief in Amgen v. Sandoz Appeal

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As we previously reported, the district court granted Sandoz’s motion for summary judgment of non-infringement in the ongoing Amgen v. Sandoz litigation, which relates to Sandoz’s filgrastim and pegfilgrastim biosimilars....more

Goodwin

Trial Begins in Insulin Glargine Follow-On Biologics Litigation

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On May 29, 2018, a week-long bench trial began before Judge Andrews in Sanofi-Aventis U.S. LLC v. Merck Sharpe & Dohme Corp. in the District of Delaware. As we reported here, Sanofi had sued Merck for patent infringement...more

Goodwin

New BPCIA Litigations Regarding Celltrion’s Trastuzumab and Rituximab Biosimilars

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On January 11, 2018, Celltrion and Teva filed two lawsuits against Genentech in the District Court for the Northern District of California. Case No. 3:18-cv-00274 relates to Celltrion’s Herzuma®, its trastuzumab biosimilar. ...more

Goodwin

Breaking News: Summary Judgment of Non-Infringement for Sandoz in Filgrastim/Pegfilgrastim Case

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As we previously reported, in Amgen v. Sandoz, which relates to both Sandoz’s filgrastim biosimilar (Zarxio) and its pegfilgrastim biosimilar, Sandoz had filed motions for summary judgment regarding non-infringement of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - October 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Mylan Pharma Acquisition Ltd. et al. v Fresenius Kabi USA, LLC 1:15-cv-06700; filed July 30, 2015 in the Northern District...more

Morris James LLP

Magistrate Recommends Judgment In Favor Of Defendants Based On Collateral Estoppel

Morris James LLP on

Burke, M. J. Report and recommendation regarding summary judgment that the defendants’ noninfringement motion be granted in part and denied as moot in part; defendants’ invalidity motion be granted; and plaintiffs’ validity...more

McDonnell Boehnen Hulbert & Berghoff LLP

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

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