On August 12, 2024, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Samsung Bioepis and Samsung Biologics related to Samsung Bioepis’s proposed biosimilar of Amgen’s PROLIA and...more
Late last week, GlaxoSmithKline Biologicals SA and GlaxoSmithKline LLC filed suit in the District of Delaware alleging that Pfizer, Pharmacia & Upjohn, BioNtech SE, BioNtech Manufacturing GMBH, and BioNTech US, Inc....more
As we previously reported, REGENXBIO Inc. and the Trustees of the University of Pennsylvania filed suit in Delaware in June 2023 against Sarepta Therapeutics, Inc., Sarepta Therapeutics Three, LLC, and Catalent, Inc.,...more
Yesterday, Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (“Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts. In its...more
Our readers may recall that nine HUMIRA biosimilars have been licensed to launch in July 2023, with Amgen’s AMJEVITA the only one to launch to date....more
Last week, Arbutus Biopharma Corp. and Genevant Sciences GmbH (collectively, Arbutus) filed a complaint for patent infringement in the District of New Jersey against Pfizer, Inc. and BioNTech SE....more
As we ring in the new year, we look back at the top legal developments of 2022 that could influence the market for biologics and biosimilars. There were many interesting decisions and other developments in district court, at...more
1/9/2023
/ Antitrust Litigation ,
Antitrust Provisions ,
Biologics ,
Biosimilars ,
Enablement Inquiries ,
Inter Partes Review (IPR) Proceeding ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art
The U.S. Supreme Court, in Limelight v. Akamai, recently reversed a Federal Circuit decision holding Limelight Networks liable for inducing patent infringement. The Supreme Court ruled that a party cannot be held liable for...more
The U.S. Supreme Court, in Nautilus v. Biosig, recently reversed a Federal Circuit ruling that a patent is valid as long as the description of what it claims is not “insolubly ambiguous.” The Supreme Court’s decision, which...more