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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
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
Precedential and Key Federal Circuit Opinions - STEUBEN FOODS, INC. v. SHIBUYA HOPPMANN CORPORATION [OPINION] (2023-1790, 1/24/2025) (Moore, Hughes, Cunningham) - Moore, Chief J. The Court reversed the district...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
Bayer's ‘053 patent on its drug Xarelto® expires in November 2024, and Bayer granted Mylan a covenant not to sue. Bayer has a second patent that is subject to a pediatric exclusivity that expires later - February 2025 - and...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
We are excited to announce Venable’s inaugural Life Sciences Webinar Series. This month-long series will explore the intricacies and latest developments that shape the life sciences industry. Join us as we hear from our...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
Welcome to the third issue of the Morgan Lewis Pharma Review, which summarizes key recent cases from the Federal Circuit and district courts that impact the pharma space, including Federal Circuit and district court decisions...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
As we have previously reported on Sandoz’s Biologics License Application (“BLA”) for its proposed biosimilar to Neulasta® (pegfilgrastim), Sandoz received a complete response letter from FDA, and had resubmitted its...more
On February 21, 2019, Sandoz initiated a lawsuit against Amgen in the Northern District of California seeking a declaration that its biosimilar filgrastim and pegfilgrastim products do not infringe the Amgen’s ’997 patent. ...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
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
Apotex’s Infringement of AstraZeneca’s Omeprazole Formulation Patent Upheld - As previously reported, the Federal Court of Appeal, in a unanimous decision released on January 12, 2017 (2017 FCA 9), has affirmed the...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Tris Pharma Inc. v. Actavis Elizabeth LLC et al. 1:16-cv-00603l; filed July 12, 2016 in the District Court of Delaware ...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Ventana Medical Systems, Inc. v. Hologic, Inc. 3:16-cv-02703; filed May 18, 2016 in the Northern District of California. ...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