Intense Legal Battle Over Moderna COVID-19 Vaccine Heats Up

Patent Infringement Case

The pharmaceutical company Moderna finds itself in an intense a legal battle regarding its popular Covid vaccine. Plaintiffs Arbutus Biopharma and Genevant Sciences are attempting to hold Moderna accountable for patent infringement. The plaintiffs claim that Moderna’s vaccine employs their messenger ribonucleic acid (mRNA) technology. This technology is designed to use synthetic mRNA to enter the body’s cells to instruct them to make proteins that the cells would generally not make on their own. Thus prompting the body’s immune system to produce antibodies that will recognize the protein in the future and destroy it.

In response to plaintiff’s complaint Moderna attempted to invalidate two of the key Arbutus patents for the mRNA technology¹. If these patents were to be successfully invalidated, Moderna would also succeed in defeating the patent infringement case. In December of 2021, U.S. Court of Appeals for the Federal Circuit largely rejected Moderna’s bid to invalidate Arbutus patents. However, the Court did partially agree with Modera by invalidating portions of one of Arbutus patents.

Moderna’s Next Moves

After an unsuccessful invalidation attempt, Moderna is now asking the Court to dismiss the Plaintiff’s lawsuit. Moderna claims that it is shielded from the lawsuit because of its agreement to supply the vaccine to the federal government. In their motion to dismiss Moderna cited a federal law that was previously used to keep patent claims from interfering with the supply of war materials during World War I.

“In that contract, the Government expressly invoked its sovereign authority to ‘authorize and consent to all use and manufacture … of any invention described in and covered by a United States patent,’” Moderna argued². Moderna then goes on to assert, in a filing at the U.S. District Court for Delaware, that the immediate problem is that the plaintiffs should have sued the U.S. government instead.

A Pending Response

The plaintiffs have not filed a response to Moderna’s motion to dismiss yet. A response should be prepared in the next coming months. However, Matthew Gline, CEO at Roivant asserts that the Plaintiffs are not seeking an injunction, which would stop the creation and distribution of the Covid 19 vaccine; stating,, “[w]e do not wish to impede in any way Moderna’s COVID-19 vaccine from reaching as many people as possible.” Instead and as stated in the original lawsuit filing, the companies are pursuing damages “sufficient to compensate Arbutus and Genevant for Moderna’s infringement … in no event less than a reasonable royalty on all infringing sales.”

Regarding sales, Moderna’s vaccine generated roughly $17.7 billion in sales last year. For 2022, the biotech expects revenues to increase to approximately $21 billion.

1. Arbutus Biopharma Corp v. Moderna Inc, U.S. District Court for the District of Delaware, No. 1:22-cv-0025

2. Patent Nos. 8,058,069 and 9,364,435