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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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