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
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
Last week, the PTAB instituted inter partes review of two Chugai patents directed to methods of treating rheumatoid arthritis with a combination of tocilizumab and methotrexate. Fresenius filed petitions for inter partes...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
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
Janssen’s suit against Celltrion in the District of Massachusetts (C.A. No. 1:15-cv-10698) is one of the few currently pending litigations related to biosimilars and the BPCIA. To date, the litigation has focused on three...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
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
The Biologics Price Competition and Innovation Act (BPCIA) provides for a series of disclosures between a biosimilar applicant and the innovator company, commonly referred to as the “patent dance.” 42 U.S.C. §262(l). While...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