Specifically, the Biden Department of Justice has inserted the federal government — and with it hardworking American taxpayers — into a patent infringement dispute alleging that Moderna stole intellectual property from smaller biotech companies and used it to create and produce its COVID-19 mRNA vaccine that's since been administered more than 250 million times in the U.S. and sent the company's revenue soaring.
According to the two small biotech companies alleging patent infringement — called Arbutus and Genevant — Moderna stole their vaccine delivery method that uses lipid nanoparticles (LNPs) to protect vaccine-introduced mRNA in the bloodstream and help ensure it reaches the intended target to become effective.
Moderna's response to Arbutus and Genevant has not focused on the companies' claims, but sought to have the case dismissed entirely. Moderna says that, under a World War I-era law found in Section 1498 of U.S. Code, its vaccine development and production is shielded from patent claims because it was under contract to provide the vaccine to the federal government. Moderna maintains its COVID vaccine did not infringe on intellectual property, but said that "dispute is for later."
Rather than allowing the case to play out on its own, the Biden administration — via Delaware U.S. Attorney David Weiss — filed a statement of interest in the dispute last month "to relieve Moderna of any liability for patent infringement resulting in 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." The "-0100 Contract" mentioned by the U.S. attorney in its statement of interest is an $8.2 billion contract between Moderna and the Department of Defense coded as "pharmaceutical preparation manufacturing."
So, the Biden administration appears to be stepping in and seeking to put hardworking American taxpayers on the hook for what could be potentially billions of dollars worth of liability claims caused by Moderna's alleged theft of intellectual property to make its COVID vaccine.
Why would the Biden administration, after the federal government has already poured billions of dollars into Moderna for its COVID vaccine, now seek to bail them out for, potentially, billions more? And why did the Biden DOJ wait until February of 2023 to file a statement of interest when the case against Moderna has been in motion since early 2022?
And that's where another twist complicates the Biden DOJ's intervention and raises more questions about how the decision to intervene was made.
The U.S. attorney filed the statement of interest on behalf of the Biden DOJ on February 14 and, one day later on February 15, Moderna announced its "commitment to patient access in the United States." The company's announcement states that "Moderna remains committed to ensuring that people in the United States will have access to our COVID-19 vaccines regardless of ability to pay" and Americans who are uninsured or underinsured will still be able to get Moderna's COVID vaccines at pharmacies and doctors' offices at "no cost" to them.
