According to the government’s submission, the US Military will face a COVID-19 vaccine lawsuit after asking to relieve Moderna of any liability for patent infringement resulting in the performance of the “1100” contract.
The U.S. government claims that a lawsuit alleging that Moderna violated a patent with its COVID-19 vaccine should be brought against it and not Moderna.
The government argued that the court ought to permit it to “relieve Moderna of any liability for patent infringement resulting in the performance of the ‘-0100 contract and to transfer to the United States any liability for the manufacture or use of the inventions claimed in the patents-in-suit resulting from the authorized and consented acts,” according to the government’s submission (pdf below).
According to the submission, liability does not mean admitting that a patent had been violated but rather “having legal responsibility for any acts that may constitute the alleged infringement.”
In 2022, Moderna was sued by Arbutus Biopharma and Genevant Sciences in federal court in Delaware on the grounds that Moderna had exploited “breakthrough technology” in its vaccine that Arbutus had already developed and patented.
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Later, Moderna submitted a motion for dismissal, contending that under federal law, any infringement claims relating to innovations employed “by or for the government” and with “the authorization and consent of the government” must be heard in the Court of Federal Claims.
The ‘-0100 contract between Moderna and the U.S. Army, which included language stating that the agreement was “for the United States government… and the U.S. population,” satisfied the first prong, according to Moderna. The government “authorizes and consents to all use and manufacture, in performing this contract or any subcontract at any tier, of any invention described in and covered by a United States patent,” according to a regulation that was inserted, the company claimed, satisfying the second requirement.
U.S. District Judge Mitchell Goldberg rejected Moderna’s request to have the case dismissed, saying the claims against the company showed the creation and distribution of the vaccinations were primarily for the benefit of the vaccine’s recipients. He said that the U.S. government was merely an incidental beneficiary. Legal precedent dictates that inventions having incidental benefits are not protected by law 1498.
Goldberg, a George W. Bush appointment, stated that “while discovery may reveal that all, some, or none of the alleged infringing activity was ‘for the Government.” The government had not submitted any documents in support of Moderna, thus the judge declined to determine that Moderna met the requirement of having the government’s approval and permission.
Government lawyers made it plain in the new statement of interest that they support Moderna.
They urged the judge to allow them to defend against the patent claim in the court of Federal Claims and made many of the same reasons that Moderna did in their motion.
James Love, director of Knowledge Ecology International, said, “I think the U.S. government statement is quite important … because it really sets out that the free distribution of vaccines to the public is covered by 1498.” The public has been given free access to COVID-19 vaccines because the government purchased them using tax dollars.
Love thought the government’s case was well-made and is certain that it would persuade Goldberg to rule in the government’s and Moderna’s favor in the end.
Before the government filed its filing, the parties were getting ready to move into discovery. A hearing on the statement was held on February 16 instead of the intended date for discussing the discovery schedule.
David Berl, a lawyer for the plaintiffs, told the court that the government’s filing does not establish that Moderna created the vaccine for the advantage of the government.
“Is it for the government or is it, rather, for the benefit of the United States population? The government has nothing to say on this question,” Berl said. “It’s not the question for the government to decide, it’s a question for the court to decide. That is a fiercely disputed factual issue.”
According to Berl, the discovery would turn up communications that would demonstrate whether Moderna operated independently or with the consent of the government.
He added that the regulatory provisions Moderna referenced to back up the authorization and consent prong are absent from a second contract Moderna and the Army signed in 2022. The government stated in its submission that the contract specifically specifies that “the terms of the contract do not constitute express or implied Government authorization or consent under section 1498.”
This could indicate that although the initial contract part of the case moves to the Court of Federal Claims, the portion dealing with the latter contract and any non-government usage by private businesses continues in the Delaware-based U.S. court.
Last year the CDC released a draught agenda that says that they will soon vote on granting Pfizer and Moderna permanent legal immunity through the child COVID shot schedule.
According to a government attorney, the government would be the defendant in the latter court. He refused to clarify whether the administration will dispute the claims of infringement.
The judge was requested to reevaluate the decision on the motion to dismiss by Moderna’s attorneys in light of the government’s recently entered argument.
In order to better understand that request, Goldberg requested submissions from the parties.
Read the filing given below: