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The U.S. government — and not COVID-19 vaccine maker Moderna — should face a patent infringement lawsuit currently pending against the company, U.S. Department of Justice (DOJ) lawyers told the U.S. District Court for the District of Delaware in documents submitted to the court Tuesday, Reuters reported.
These arguments came as part of ongoing litigation in Arbutus v. Moderna, concerning a lawsuit filed against Moderna by two pharmaceutical companies — Arbutus Biopharma and Genevant, a joint venture between Arbutus and Roivant Sciences Ltd. — alleging patent infringement.
The filing claims that the U.S. government is liable because Moderna’s COVID-19 vaccine was developed under the auspices of “Operation Warp Speed” in 2020, reports Becker’s Hospital Review.
According to a Feb. 28, 2022, Reuters story, “Arbutus said it developed the so-called lipid nanoparticles (LNP) that enclose genetic materials known as messenger RNA or mRNA, the patents related to which were licensed to Genevant Sciences.”
In its filing, quoted in part by Becker’s Hospital Review, the DOJ used World War II-era patent legislation to support its filing:
“The history of U.S. patent laws and precedents is nearly as old as the nation itself, but during World War II, a law amended one patent statute so that ‘the use or manufacture of an invention described in or covered by a patent of the United States by a contractor, a subcontractor or any person, firm, or corporation for the government and with the authorization or consent of the government, shall be construed as use or manufacture for the United States.’”
As a result, reports Becker’s Hospital Review, DOJ lawyers argued that companies such as Arbutus and Genevant are “limited to pursuing a claim against the United States” in relation to the $8.2 billion federal contract awarded to Moderna for the development of its COVID-19 vaccine, under the Warp Speed program.
According to Reuters, the DOJ further stated that the U.S. government’s liability is restricted to the alleged infringing activity committed by Moderna under its federal contract.
Notably, Moderna had used the same argument in May 2022, in an attempt to dismiss the Arbutus and Genevant lawsuit. At the time, according to Reuters, Moderna argued such a lawsuit “could only be brought against the government in the U.S. Court of Federal Claims.”
Moderna’s effort was unsuccessful, as in November 2022, U.S. District Judge Mitchell Goldberg said that there was no “clear language” that the company produced its COVID-19 vaccine for the government or with the government’s authorization and consent under the law.
As reported by Reuters in November 2022, Genevant issued a statement saying it was pleased the court “rejected Moderna’s attempt to shift liability for its actions to U.S. taxpayers.”
Moderna, in turn, stated following this ruling in November 2022 that it looks forward to “proving not only that Arbutus and Genevant sued the wrong party in the wrong court, but also, at the appropriate time, that there was no patent infringement here.”
The same argument was also made by Moderna in another patent infringement lawsuit against it, this one filed by Alnylam Pharmaceuticals. Alnylam, which also claims that Moderna violated its patents on lipid nanoparticle technology, yesterday sought to expand its lawsuit, which is still pending.
Moderna is embroiled in a number of other similar legal disputes. As reported by The Defender in August 2022, Moderna sued Pfizer and BioNTech, alleging those companies infringed upon patents Moderna held for an mRNA structure it developed and for the coding of the spike protein on the outside of the COVID-19 virus.
The company is also involved in a separate and ongoing legal dispute with the National Institutes of Health, also involving rights to mRNA technology.
Separately, Moderna yesterday released its interim Phase 3 safety and immunogenicity results for mRNA-1010, its leading flu vaccine candidate.
Couched in dense language, the report admits that its candidate vaccine did not achieve “non-inferiority” during clinical trials on two key influenza strains that are particularly common among young people, and caused a higher rate of side effects.
Remarking on this development, investigative journalist Alex Berenson wrote on his blog:
“The lack of efficacy was notable because flu vaccines have almost no real-world efficacy, as Dr. Anthony Fauci himself conceded in a paper last month.
“With demand for mRNA Covid shots cratering nearly to zero worldwide, the company is desperately trying to find new illnesses its mRNA shots can treat.”
“Yesterday’s failure makes clear the difficulties mRNA shots will face winning approval in a more normal regulatory environment — especially if they must be compared to other treatments, rather than placebos,” Berenson added.
Moderna’s stock fell by almost 5% today. According to Investor’s Business Daily, this drop was the result of the “mixed results” demonstrated by its candidate flu vaccine.
As previously reported by The Defender, Moderna is attempting to develop mRNA vaccines and therapeutics for a wide range of ailments, including heart failure.