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”), 11,590,229 (“the ʼ229 patent”), 11,612,657 (“the ʼ657 patent”), 11,633,479 (“the ʼ479 patent”), 11,633,480 (“the ʼ480 patent”), and 11,679,158 (“the ʼ158 patent”) (collectively, the “Alnylam Patent Family”). The patents are generally directed to lipid particles used to delivery RNA-based vaccines. Acuitas’s complaint states that “Plaintiffs seek to correct inventorship for the Patents-in-Suit by adding Dr. Hope, Dr. Ansell, and Dr. Du [], as co-inventors to each of the [Alnylam Patent Family].” They allege that “[t]o the extent there is any work that Alnylam contributed to the current mRNA vaccines, it is work that Alnylam did in collaboration with and under the tutelage of the Acuitas Scientists. Acuitas and its scientists cannot simply sit idly by while Alnylam takes credit for work in which, if it was a participant at all, it was a participant hand-in-hand with Acuitas.”
Acuitas seeks a judgment declaring that the inventorship of each of the patents in the Alnylam Patent Family be amended to add Drs. Michael Hope, Steven Ansell, and Xinyao Du as inventors; an order under 35 USC §256 requiring the Director of the PTO to issue a certificate correcting inventorship; a declaration of exceptional case awarding attorneys’ fees; and costs and expenses.
The Alnylam Patent Family is also the subject of a consolidated patent dispute between Alnylam and Pfizer in the District Court for the District of Delaware. In March 2022, Alnylam filed a complaint (C.A. 1-22-cv-00336) against Pfizer and Pharmacia & Upjohn Co., LLC alleging infringement of the ʼ933 patent. In July 2022, Alnylam filed a complaint (C.A. 1-22-cv-00924). against Pfizer and Pharmacia & Upjohn Co., LLC, BioNTech SE and BioNTech Manufacturing GmbH, alleging infringement of the ʼ979 patent. And in May 2023, Alnylam filed a complaint (C.A. 1-23-cv-00578) against Pfizer and Pharmacia & Upjohn Co., LLC, alleging infringement of the ʼ479 patent, the ʼ480 patent, the ʼ657 patent, and the ʼ229 patent. On October 2, 2023, these three cases were consolidated and the originally filed case, C.A. 1:22-cv-00336, was designated as the lead case. The consolidated case remains pending, and a jury trial is set to begin on July 7, 2025.
Alnylam has also filed complaints against Moderna in the District Court for the District of Delaware, alleging infringement of patents in the Alnylam Patent Family. In March 2022, Alnylam filed a complaint (C.A. 1-22-cv-00335), alleging infringement of the ʼ933 patent. In July 2022, Alnylam filed a complaint (C.A. 1-22-cv-00925), alleging infringement of the ʼ979 patent. The two cases were consolidated and on August 30, 2023, the Court issued a final judgment of non-infringement of both asserted patents and closed the case, in view of the parties’ stipulation for entry of final judgment of non-infringement as a result of the Court’s claim construction. The cases are currently on appeal to the Federal Circuit, Case No. 23-2357.
In March 2024, Alnylam filed a complaint (C.A. 1-22-cv-00335) against Moderna, alleging infringement of the ʼ229 patent, the ʼ479 patent, and the ʼ480 patent. On November 13, 2023, the Court dismissed Alnylam’s allegations of infringement of the ʼ229 and ʼ480 patents, in view of the parties’ joint stipulation. The case remains pending, and a jury trial is set to begin on December 15, 2025.
Stay tuned to Big Molecule Watch for further updates on these litigations.
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