The Biden administration has inserted itself into a private patent infringement lawsuit against Moderna, a COVID-19 vaccine maker, by filing a “statement of interest” in the case. The filing was made by U.S. Attorney David Weiss on behalf of the Department of Defense and the Department of Health and Human Services, arguing that the federal government should assume any liability for patent infringement Moderna may have committed in the development of its vaccine. The government has used a rarely-used early 1900s law to support its position, which could set a dangerous precedent, according to experts.

Moderna received approximately $10 billion in taxpayer money to produce its COVID-19 vaccine and has since earned billions more in profits selling it. Genevant Sciences and Arbutus Biopharma Corp. sued Moderna for using technology they have patented in its vaccine, and have asked a federal court in Delaware to award them damages for the infringement. Weiss’ filing came a year after Moderna argued that any damages should be paid by the federal government since it contracted the vaccine from the company amid a global health emergency. The Department of Justice has cited a government use patent statute, 28 U.S.C. § 1498, to argue that the government should take on patent infringement liability. The statute has generally been used in cases related to the government’s purchase of military equipment, and experts believe this could be a misuse of the law.

Moderna has also accused Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® of infringing patents it filed between 2010 and 2016 covering its foundational mRNA technology, which was critical to the development of its own mRNA COVID-19 vaccine, Spikevax®. According to Moderna, Pfizer and BioNTech copied its technology without permission to make Comirnaty®.

The legal battle between the biotech companies has significant implications for the pharmaceutical industry. If the government assumes liability for patent infringement, it could discourage private investment in drug development and reduce the incentive to innovate. Additionally, if Moderna is found to have infringed on Genevant and Arbutus’ patents, it could face significant damages and could set a precedent for future patent infringement cases. Conversely, if the government assumes liability, it could limit the damages awarded to the plaintiffs and reduce the risk for Moderna, potentially benefiting the company’s shareholders.

In conclusion, the Biden administration’s involvement in the patent infringement lawsuit against Moderna has significant implications for the pharmaceutical industry and could set a dangerous precedent. The government’s use of a rarely-used law to argue that it should assume liability for patent infringement has raised concerns among experts. The outcome of the legal battle between the biotech companies could have significant implications for drug development and innovation, and the pharmaceutical industry as a whole.