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On August 1, 2025, a UK Court of Appeal upheld the validity of Moderna’s European Patent No. 3,590,949 (“EP’949”) in a dispute with Pfizer and BioNTech. The decision affirmed a July 2024 UK High Court ruling finding that...more
EYE THERAPIES, LLC v. SLAYBACK PHARMA LLC - Before Taranto, Stoll and Scarsi (sitting by designation). The patent’s prosecution history required a restrictive interpretation of the term “consisting essentially of.”...more
In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...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
This case involves an appeal from Regeneron Pharmaceuticals, Inc.’s (Regeneron) efforts to prevent defendants from marketing biosimilar versions of EYLEA®, a drug used to treat eye diseases, by asserting patent infringement....more
Ingenico Inc., et al. v. IOENGINE, LLC, No. 2023-1367 (Fed. Cir. (D. Del.) May 7, 2025). Opinion by Hughes, joined by Dyk and Prost. Ingenico filed a declaratory judgment action against IOENGINE relating to two patents owned...more
Just under two weeks ago, we reported the Court of Appeal had awarded AstraZeneca (AZ) a preliminary injunction in the UK against Glenmark’s generic dapagliflozin (dapa) product for type II diabetes, until the hearing...more
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
Azurity Pharmaceuticals, Inc. v. Alkem Laboratories Ltd., No. 2023-1977 (Fed. Cir. (D. Del.) Apr. 8, 2025). Opinion by Murphy (sitting by designation), joined by Moore and Chen. Azurity owns a patent directed to non-sterile...more
In a reversal of fortune, yesterday (9 April) the UK Court of Appeal awarded AstraZeneca (AZ) an interim injunction keeping Glenmark’s dapagliflozin (dapa) off the UK market until the form of order hearing in the parallel...more
September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more
RUSSIA RESPONDS TO WESTERN SANCTIONS WITH PATENT RETALIATION - On March 6, 2022, the Russian government retaliated against the West’s imposition of sanctions by issuing a decree permitting patented innovations to be used...more
September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more
On June 9, 2021, the Federal Court of Appeal (FCA), following grant of leave to hear Sunovion’s appeal, dismissed Sunovion’s appeal from a Federal Court (FC) decision of Furlanetto J. (2021 FC 37) granting Taro leave to amend...more
An interesting procedural question under the amended Patented Medicines (Notice of Compliance) Regulations (PMNOC Regulations) is the extent to which separate actions against multiple generic manufacturers can proceed...more
Federal Circuit Summary - Before Lourie, Chen, and Stoll. Appeal from the Patent Trial and Appeal Board. Summary: A generic pharmaceutical company had standing to appeal the Board’s decision in an IPR that claims of a...more
Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more
Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more