On July 30, 2025, Moderna announced that the European Commission (EC) granted marketing authorization for the updated formulation of Moderna’s COVID-19 vaccine Spikevax®. The updated vaccine targets the LP.8.1 variant of SARS-CoV-2 to help prevent COVID-19 in individuals 6 months of age and older. According to the announcement, the granted…
On July 24, 2025, Acting Director of the USPTO, Coke Morgan Stewart, denied institution of inter partes review in IPR2025-00601 and IPR2025-00602, but referred the petition in IPR2025-00603 to the Board in Amgen Inc. v. Bristol-Myers Squibb Co. The Bristol-Myers Squibb (“BMS”) patents, challenged by Petitioner Amgen, relate to methods of…
On August 14, 2025, Genentech, Inc. and Hoffman-La Roche Inc. (together, “Genentech”) filed a BPCIA complaint in the U.S. District Court for the District of New Jersey against Shanghai Henlius Biotech, Inc. and Shanghai Henlius Biologics Co., Ltd. (together, “Henlius”) and Organon LLC and Organon & Co. (together, “Organon”) seeking approval…
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 EP’949 is both valid and infringed by Pfizer/BioNTech’s COVID-19 vaccine, Comirnaty®. EP’949…
On July 30, 2025, the U.S. District Court for the District of Delaware entered a Final Judgment in the dispute between Alnylam Pharmaceuticals, Inc. (“Alnylam”) and Pfizer, Inc. (“Pfizer”)—concluding that Pfizer’s COVID-19 vaccine did not infringe any of Alnylam’s patents covering nanoparticle technology. Final Judgment in this case follows behind…
On June 26, 2025, Formycon AG (“Formycon”) announced a distribution agreement with Teva Group subsidiary Ratiopharm GmbH (“Ratiopharm”) for the semi-exclusive commercialization of its Stelara biosimilar FYB202/Fymskina (ustekinumab) in Germany. Under the terms of the distribution agreement, Formycon will be responsible for the manufacture and supply of FYB202/Fymskina and will…
On July 14, 2025 Fresenius filed two IPR petitions challenging Regeneron’s patents related to aflibercept. Regeneron has not asserted that Fresenius infringes either of these patents in district court litigation; however, there are a number of district court actions against other parties related to the patents challenged in Fresenius’s IPRs….
On July 15, 2025, Biocon Biologics, a fully integrated global biosimilars company and a subsidiary of Biocon Ltd., announced that the FDA has approved KIRSTY (insulin aspart-xjhz injection), 100 units/mL, as the first and only interchangeable biosimilar to Novo Nordisk’s NOVOLOG (insulin aspart injection) in the United States. KIRSTY is…
On July 17, 2025, Harrow, Inc. (“Harrow”), announced an agreement with Samsung Bioepis Co. Ltd. (“Samsung Bioepis”) to acquire the U.S. commercial rights to two of Samsung Bioepis’s biosimilars, BYOOVIZ® (ranibizumab-nuna) and OPUVIZ™ (aflibercept-yszy). Harrow is a North American pharmaceutical company that specializes in ophthalmologic products including topical antibiotic/corticosteroid combinations,…
On July 16, 2025, Bio-Thera Solutions, Ltd. (“Bio-Thera”) announced that the U.S. Food and Drug Administration (“FDA”) had accepted its Biologics License Application (“BLA”) for its golimumab biosimilar, BAT2506, referencing Johnson & Johnson’s (“J&J”) SIMPONI®. Golimumab is a human IgG1 monoclonal antibody that blocks the inflammatory effects of tumor necrosis…