Acuitas Therapeutics Inc. (“Acuitas”) filed a complaint (1-24-cv-00816) on July 12 against Alnylam Pharmaceutical Inc. (“Alnylam”) in the U.S. District Court for the District of Delaware, alleging incorrect inventorship of seven U.S. Patents related to COVID-19 mRNA-LNP vaccines, namely U.S. Patent Nos. 11,246,933 (“the ʼ933 patent”), 11,382,979 (“the ʼ979 patent”),…
Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After…
As we previously reported, Alexion Pharmaceuticals, Inc. and Alexion Pharma International Operations Ltd. (collectively, “Alexion”) sued Samsung Bioepis Co. Ltd. (“Samsung”) in January 2024 in the U.S. District Court for the District of Delaware, alleging infringement of six patents under the BPCIA based on Samsung’s submission of its BLA for…
In a decision that issued last week, a Patent Trial and Appeal Board (“PTAB”) panel instituted inter partes review (“IPR”) of a petition filed by Merck Sharp & Dohme LLC (“Merck”) for a patent owned by The Johns Hopkins University (“Johns Hopkins”), U.S. Patent No. 11,591,393 (the ’393 patent). The…
In a sealed order that issued last week, the Court has granted a preliminary injunction against Samsung Bioepis in the aflibercept BPCIA litigation brought by Regeneron. Regeneron had limited its preliminary injunction motion to a single patent, U.S. Patent No. 11,084,865 (“’865 patent”), generally directed to an ophthalmic formulation with…
In a sealed order that issued on June 11, the Court granted a permanent injunction in favor of Regeneron against Mylan/Biocon in the pending aflibercept BPCIA litigation. The Court’s ruling on the permanent injunction follows a nine-day bench trial, held in June 2023, after which the Court held on December…
FDA approves first interchangeable biosimilars to EYLEA (aflibercept) to treat macular degeneration and other eye conditions Regeneron’s regulatory exclusivity for EYLEA expired on May 18, 2024. Two days later, on May 20, 2024, the FDA announced that it has approved Mylan Pharmaceuticals, Inc. and Biocon Biologics, Inc.’s YESAFILI (aflibercept-jbvf) and Samsung…
On May 28, Amgen filed a BPCIA complaint in the District Court for the District of New Jersey against Celltrion related to its denosumab biosimilar of Amgen’s PROLIA and XGEVA. This is the second BPCIA litigation regarding denosumab, following Amgen’s earlier litigation against Sandoz. Amgen and Sandoz stipulated to dismiss…
On May 17, 2024, an Appeals Review Panel (ARP) of the United States Patent and Trademark Office (“USPTO”) released its decision in Ex parte Chamberlain (referred to in Federal Circuit proceedings as In re Xencor; “Chamberlain”). The Chamberlain decision provides some clarity on the USPTO’s position on written description requirements for Jepson and means-plus-function claims in…
As we previously reported, in May 2023, Amgen filed a BPCIA complaint in the District of New Jersey alleging infringement based on Sandoz’s denosumab biosimilars of Amgen’s PROLIA and XGEVA (“the Sandoz Denosumab Litigation”). The FDA subsequently, in March 2024, approved Sandoz’s denosumab biosimilars, WYOST (denosumab-bbdz) and JUBBONTI (denosumab-bbdz), as…