Moderna aims to offset COVID vaccine lawsuit to US govt
Moderna has rejected claims that its COVID-19 vaccine violates the patent rights of two biopharma companies, arguing that its contract with the US federal government has conferred immunity.
The biotech filed its countersuit at the US District Court for the District of Delaware on May 6, holding that the plaintiffs, Arbutus BioPharma and Genevant Sciences, should instead pursue the US government.
Back in February, the companies jointly sued Moderna over royalties from the sales of its COVID-19 vaccine, which allegedly uses their tech for a drug-delivery system without authorisation.
According to the complaint, Moderna’s breakthrough vaccine would not have been possible without the use of the technology Arbutus had already created and patented—a revolutionary lipid nanoparticle (LNP) delivery platform.
World War II statute
But Moderna insisted that it is shielded by a statute that was first enacted during World War II. According to Section 1498, when an allegedly infringing product is used or manufactured by or for the US, the only remedy for the alleged infringement is an action against the US in the US Court of Federal Claims.
The statute was amended over a century ago specifically “to prevent patent infringement suits from interfering with the supply of war materials during World War I,” as “Congressional concern was that if contractors feared an infringement suit, they might decide not to manufacture desperately-needed products for the United States’ war effort.”
Moderna argued that the government and companies had been presented with a similar scenario during the height of the pandemic. “Short of war, it is difficult to conceive of a situation more within the heart of Section 1498 than the COVID-19 crisis, ‘one of the greatest public health challenges in modern history’.”
Moderna pointed out that the complaint against it contains no indication that the plaintiffs ever approached the government to seek compensation.
It further argued that the plaintiffs’ complaint completely ignores the terms of Moderna’s contract with the US government. “This was not by mistake—in prior disputes with Plaintiffs, Moderna informed plaintiffs that sales to the US government are subject to Section 1498,” Moderna contended.
