Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry of a preliminary injunction preventing Celltrion, Inc. (“Celltrion”) from...more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
On November 9, 2022, the PTAB issued final written decisions in IPR2021-00880 and IPR2021-00881, filed by Mylan on two Regeneron patents related to aflibercept—U.S. Patent Nos. 9,254,338 and 9,669,069. The PTAB ruled in...more
As we previously reported, on June 3, 2022, Genentech filed a complaint against Tanvex in the U.S. District Court for the Southern District of Florida, alleging infringement of three patents under the BPCIA based on...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
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 September 25, 2018, the 10-day bench trial came to an end in the Immunex v. Sandoz patent litigation under the BPCIA concerning Sandoz’s Erelzi™ (etanercept-szzs) biosimilar. As we previously reported, prior to the start...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
Nantkwest, Inc. v. Matal [Order rehearing en banc] (No. 2016-1794, 8/31/17) (Prost, Newman, Lourie, Dyk, Moore, O'Malley, Reyna, Wallach, Taranto, Hughes, Stoll) - Per Curiam. Sua sponte vacating panel opinion, ordering...more
Since the Biologics Price Competition and Innovation Act of 2009 (BPCIA) was signed into law in 2010, only a small handful of abbreviated Biologics Licensing Applications (“aBLAs”) have been filed and of those the FDA has...more
Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto) - July 5, 2016 12:05 PM - Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a...more
Pre-AIA and Post-AIA Issues Presented by the On-Sale Bar - The “on-sale” bar to patentability refers to a sale or offer for sale of an invention that can invalidate the patent for that invention. The...more
The District Court for the District of Massachusetts (Judge Wolf) recently decided two pending motions in Janssen v. Celltrion: - ..Plaintiffs’ motion to stay litigation on the ‘471 patent (covering infliximab) pending...more
Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more
On May 26, 2015, the Supreme Court reversed the Federal Circuit’s decision in Commil USA, LLC v. Cisco Systems, Inc. and held that a defendant’s belief regarding patent validity is not a defense to an induced infringement...more