On July 30, 2025, Moderna announced that the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted that the benefits of Moderna’s investigational mRNA influenza vaccine, mRNA-1010 (proposed brand name mFlusiva), outweigh its risks for adults ages 50 to 64 and adults ages 65 and older. mRNA-1010 is…
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 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…
Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement. GSK’s Lawsuits On October 15, 2024, GSK filed two complaints against Moderna in the District Court for the District of Delaware, asserting that Moderna willfully infringes GSK’s mRNA patent portfolio. In Civil…
On August 22, Moderna announced that FDA approved its supplemental Biologics License Application (“sBLA”) for a new formula of their COVID-19 vaccine, SPIKEVAX®, for individuals 12 years old and above. Emergency Use Authorization (“EUA”) was also granted for the updated vaccine for individuals aged 6 months to 11 years old….
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”),…
On May 31, 2024, Moderna announced that the FDA has approved its respiratory syncytial virus vaccine (“RSV”), mRESVIA (mRNA-1345). The vaccine was designed to protect adults from lower respiratory tract disease caused by an RSV infection. This is the second mRNA vaccine Moderna has developed to gain FDA approval, following…
We previously reported on the litigation brought by ModernaTX, Inc. and Moderna US, Inc. (collectively, “Moderna”) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech US Inc. (collectively, “BioNTech”), and Pfizer Inc. (“Pfizer”) related to Moderna’s mRNA technology and the subsequent inter partes review (IPR) petitions filed by BioNTech and Pfizer. Those…
We previously reported on patent infringement litigations between Alnylam and Moderna. Below we provide updates on two proceedings involving the mRNA vaccine producer Moderna. First, in a patent action brought by Alnylam Pharmaceuticals, Inc. (“Alnylam”) against Moderna, Inc., ModernaTX, Inc., and Moderna US, Inc. (collectively, “Moderna”), the parties entered a…
Last Friday, Alnylam Pharmaceuticals, Inc. (“Alnylam”) filed new complaints for patent infringement in the District of Delaware against Pfizer and Moderna. This is the third time Alnylam has sued Pfizer and Moderna in Delaware alleging their COVID-19 vaccine lipid nanoparticle technology infringes Alnylam’s patent rights. The patents-in-suit are U.S. Patent…