A key COVID-19 vaccine case is moving to the discovery phase after a U.S. judge rejected a bid by Moderna to dismiss some of the patent infringement claims against it.
Moderna and the U.S. government, which backed the company, failed to prove that claims involving the company’s COVID-19 vaccine contract with the government should be dismissed, U.S. District Judge Mitchell Goldberg ruled on March 10.
Goldberg in late 2022 rejected a similar effort but Moderna revived its bid after the government filed a statement asserting it, not the company, should face the claims relating to the contract.
The parties, though, have failed to prove that the government’s interpretation “trumps a court’s analysis of this issue,” Goldberg said.
Moderna and the government had argued that under 28 U.S.C. 1498, the claims should be dismissed and moved to the Court of Federal Claims. That would mean the government was inserted as the defendant, replacing Moderna, and leave the government responsible for paying any damages awarded.
The law in question states that any infringement claims relating to inventions being used “by or for the government” and with “the authorization and consent of the government” must be handled in the Court of Federal Claims.
The 2020 vaccine contract between Moderna and the U.S. Army stated that it was “for the United States government … and the U.S. population.”
While Moderna and the government said that evidence supported the contract being “by or for the government,” Arbutus Biopharma and Genevant Sciences said the dispute “can only be resolved on a fully developed record” and urged the court to allow discovery.
Goldberg, a George W. Bush appointee, agreed.
“I will consider the [Section] 1498(a) issue after both parties have engaged in discovery, which will provide Plaintiff an opportunity to review the entire unredacted version of the ’-0100 Contract and discover facts regarding that Contract,” he said.
New Developments Highlight Need for Discovery
New developments in the case highlight the need for discovery, the judge said.
The original contract, or the ’-0100 Contract, was for the government, both Moderna and U.S. officials say. But the parties have also acknowledged that a second contract, reached in 2022 and known as the ’-0017 contract, doesn’t fall under the law because it lacks certain language.
The position on the second contract wasn’t known when the judge ruled in 2022 on the motion to dismiss.
“Had I granted the relief Moderna sought in its original motion to dismiss, this fact would not have come to light and the relief ordered could have been incorrect,” the judge said.
“Discovery is necessary to ensure that any application of [Section] 1498(a) is based upon developed facts and not solely on the Government’s say-so.”
Even if the judge had ruled in favor of Moderna, proceedings related to the second contract would likely have moved forward in U.S. District Court in Delaware, where the judge is based and where the lawsuit was filed.
The government helped develop Moderna’s vaccine and has started receiving royalty payments.
Arbutus and Genevant sued Moderna in March 2022, asserting the company used technology Arbutus had already patented.
That included a lipid nanoparticle system used by the COVID-19 vaccine to deliver spike protein into the body.
Moderna was aware of the patents and even tried to license them for other products, according to the lawsuit. Moderna didn’t try to license the technology for its COVID-19 vaccine, instead attempting to invalidate the patents and, when those efforts failed, using the patented technology anyway.
Moderna has denied the claims, describing its vaccine as “a product of Moderna’s many years of pioneering mRNA platform research and development, including creation of our own proprietary lipid nanoparticle delivery technology.”
The Moderna and Pfizer COVID-19 vaccines utilize messenger RNA, or mRNA, platforms.
Several other patent infringement claims have been lodged over the vaccines, which have yielded billions of dollars for Moderna and Pfizer.
In one case, Moderna sued Pfizer, alleging Pfizer used technology it had developed.
That case, overseen by U.S. District Judge Richard Stearns, has also moved to the discovery phase. Discovery will be completed by Dec. 13, according to a scheduling order entered by Stearns, a Clinton appointee.
CureVac, a German company, in 2022 sued Pfizer partner BioNTech, asserting it had developed proprietary technology utilized by the companies’ vaccines.
“CureVac’s intellectual property rights need to be acknowledged and respected in the form of a fair compensation to reinvest into the further advancement of mRNA technology and the ongoing development of new classes of life saving medicines,” the company said at the time.
Pfizer and BioNTech then sued CureVac in the United States, alleging the latter was trying to profit from their successful vaccine.
CureVac announced in 2021 it was abandoning its experimental COVID-19 vaccine, which was also based on mRNA technology, shifting its focus to a collaboration with GlaxoSmithKline on second-generation vaccine candidates. The firms have since said the vaccine performed well in early trials, but it’s still in development.