In a highly anticipated and developing case concerning the Moderna COVID-19 vaccine, a U.S. Judge rejected a bid to dismiss some of the “patent infringement claims against it,” according to a report in The Epoch Times.
The judge’s decision allows the case to move to the discovery phase.
On March 10, U.S. District Judge Mitchell Goldberg ruled that Moderna, which the U.S. government backs, unsuccessfully argued their case to dismiss. The ruling follows a 2022 rejection of a government filing asserting claims against Moderna were not valid.
Goldberg wrote: “The parties … have failed to prove that the government’s interpretation trumps a court’s analysis of this issue.”
The Epoch Times noted that Moderna and the government argued that under 28 U.S.C. 1498, claims against the pharmaceutical should be “dismissed and moved to the Court of Federal Claims.”
It appears the government’s argument was an attempt to shield Moderna from litigation. If the judge accepted the argument, the government, rather than Moderna, would become the defendant.
U.S. statute 28 U.S.C. 1498 notes that 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.
Moderna argued it was shielded from liability because the 2020 vaccine contract with the U.S. Army stated that it was “for the United States government … and the U.S. population.”
Those bringing the suit against Moderna and the U.S. government, including Arbutus Biopharma and Genevant Sciences, argued that the dispute “can only be resolved on a fully developed record.” Goldberg agreed and ruled the case would move forward to the discovery phase.
Qualifying the ruling, Goldberg said: “I will consider the § 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.”
In his ruling, Goldberg noted that new developments in the case justified the need for discovery. Specifically, the disclosure of a 2022 contract between Moderna and the U.S. government lacks the language to shield it from protections associated with U.S. statute 28 U.S.C. 1498.
Goldberg referenced the recently disclosed second contract, saying:
“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.”
Goldberg added: “Discovery is necessary to ensure that any application of § 1498(a) is based upon developed facts and not solely on the Government’s say-so.”
In March 2022, Arbutus and Genevant filed a patent infringement suit against Moderna, alleging the pharmaceutical utilized a patented “lipid nanoparticle system used by the COVID-19 vaccine to deliver spike protein into the body.”
Arbutus and Genevant argued that Moderna was aware of the patents and attempted to relicense them. The suit alleges: “Moderna did not 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, arguing that its COVID-19 vaccine is “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 Epoch Times report noted that several other patent infringement claims are working their way through the courts. In one notable case, Moderna is suing Pfizer, alleging Pfizer used technology Moderna developed.
U.S. District Judge Richard Stearns oversees that case and recently allowed it to move forward to the discovery phase.
Similarly, the German company CureVac is suing Pfizer partner BioNTech in 2022. Their grievance notes:
“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.”
Pfizer and BioNTech responded by issuing a countersuit against CureVac in the United States.
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