Moderna Seeks to Dismiss Covid-19 Vaccine Patent Lawsuit

It is the latest move in the high-stakes legal battles that are breaking out among companies and the government over patents surrounding Covid-19 vaccines.

Arbutus and Genevant claimed in their lawsuit that Moderna’s vaccine has components covered by their patents, and they are seeking royalties from the multibillion-dollar sales of Moderna’s vaccine. The patents cover tiny substances called lipid nanoparticles, which encase the genetic material messenger RNA in the vaccine and help get into human cells once injected.

Moderna, of Cambridge, Mass., says its vaccine doesn’t infringe the patents and that it uses its own proprietary lipid nanoparticle technology.

Moderna said in the new court filing that even if it had infringed the patents, federal patent law protects government contractors from certain patent-infringement lawsuits. A section of the law requires that a patent holder must file a claim against the U.S. in the U.S. Court of Federal Claims if the patent holder believes that a product manufactured for the government by a contractor infringes the patent.

The provision usually applies to defense contractors and not pharmaceutical companies, since the U.S. government isn’t typically the sole, direct purchaser of drugs and vaccines.

But during the Covid-19 pandemic, the federal government has been the only U.S. purchaser of doses of Moderna’s Covid-19 vaccine for use in the U.S., and has distributed them at no cost to vaccine recipients since late 2020. In 2021, Moderna delivered 332 million vaccine doses to the government for distribution and recorded $5.4 billion in U.S. revenue.

Moderna wants a judge to dismiss the lawsuit’s claims seeking royalties on the sale of its Covid-19 vaccine doses to the U.S. government. Moderna said Arbutus and Genevant should instead file a patent-infringement lawsuit against the federal government in the U.S. Court of Federal Claims.

“This law provides an important statutory protection for authorized government suppliers and played a critical role in encouraging companies, including Moderna, to step up and help the Government fight the Covid-19 pandemic,” Moderna said in a statement.

The company added that even if Arbutus and Genevant were to pursue claims against the U.S. government, they would fail because Moderna’s vaccine doesn’t infringe the patents.

Genevant said it would oppose Moderna’s motion to dismiss the patent claims. “Rather than respond to the substance of our claims, Moderna is trying to shift responsibility for its patent infringement to the U.S. taxpayer,” Genevant said in a statement.

Moderna’s move to shift potential liability to the government may draw criticism because it has received substantial federal funding for its vaccine.

In addition to the vaccine supply contracts, Moderna has received at least $1.7 billion from the federal Biomedical Advanced Research Development Authority to fund the development of the vaccine, according to a securities filing.

Moderna also collaborated closely with National Institutes of Health scientists in the design and testing of its Covid-19 vaccine.

The company drew criticism last year when it declined to name NIH scientists as inventors on a company application for a U.S. patent for its vaccine. Moderna subsequently dropped that patent application, saying it valued its cooperation with the NIH.

In March, Moderna said it would never use its own vaccine-related patents to stop others from manufacturing the shots in more than 90 low- and middle-income countries, but signaled it was prepared to begin enforcing its patents in wealthier countries.

Write to Peter Loftus at [email protected]