New Delhi: The U.S. government should face a patent lawsuit over COVID-19 vaccines, not vaccine maker Moderna Inc, the Department of Justice told a Delaware federal court on Tuesday.
The Justice Department’s court filing said the United States should be liable for any infringement of Arbutus Biopharma Corp and Genevant Sciences GmbH’s patents that took place under Moderna’s contract to provide shots for the government’s nationwide vaccination effort.
Moderna made the same argument last year in an unsuccessful bid to win an early dismissal of the lawsuit.
Genevant declined to comment on the filing. Representatives for Moderna, the U.S. Food and Drug Administration and the U.S. Department of Health and Human Services did not immediately respond to requests for comment Wednesday.
Warminster Township, Pennsylvania-based Arbutus and Genevant – a joint venture between Arbutus and Roivant Sciences Ltd – sued Cambridge, Massachusetts-based Moderna last year for royalties on its multi-billion-dollar COVID vaccines.
Both Moderna and Pfizer Inc have been the target of multiple patent lawsuits over their COVID vaccines, including a lawsuit brought by Moderna against Pfizer in August.
Moderna asked the Delaware court to dismiss Arbutus and Genevant’s case in May, arguing it could only be brought against the government in the U.S. Court of Federal Claims. It cited a law that was previously used to keep patent disputes from interfering with the supply of war materials during World War One.
But U.S. District Judge Mitchell Goldberg said in November that Moderna had not yet shown that the vaccines were made for the government or with its authorization and consent under the law, and that it may have instead been an “incidental beneficiary” of the shots.
The Department of Justice responded Tuesday that Moderna should not be liable based on its contract to provide the vaccines to the government as part of Operation Warp Speed.
It said the government’s liability is limited to Moderna’s alleged infringing activity that took place under its U.S. contract. The case is Arbutus Biopharma Corp v. Moderna Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-00252.
