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Now that the vaccine race is over and shots are widely available, Moderna has filed suit against Pfizer and BioNTech for claiming to have infringed Moderna’s 2010-2016 mRNA patents.
Moderna, a Massachusetts-based company, has filed suit against New York-based Pfizer and BioNTech in Düsseldorf, Germany, in connection with the company’s joint Comirnaty vaccine and Moderna’s agreements with Spikevax. Moderna claims in the lawsuit that it does not want to stop vaccine production. The lawsuit also does not seek damages for sales before March 8, 2022, sales in AMC 92 low- or middle-income countries, or sales where “the U.S. government would be responsible for any damages.”
In a statement announcing the lawsuit, Moderna said it expected Pfizer and BioNTech to “respect their intellectual property rights” and “consider a commercially reasonable license” to sell vaccines outside of the terms accepted, but the firms have failed to do so. .
“Our mission to create a new generation of transformative medicines for patients by delivering on the promise of mRNA science cannot be accomplished without a patent system that rewards and protects innovation,” said Shannon Thyme Klinger, Chief Legal Officer of Moderna , in the statement. Moderna did not specify its claim for damages in the lawsuit. A Pfizer spokesperson told The New York Times that the company was “surprised by the lawsuit.”
Moderna claims it started its “mRNA technology platform” in 2010 and patented it in 2015 and 2016. This work enabled record-breaking vaccine production, Moderna’s CEO Stéphane Bancel said in the statement.
Vaccines based on mRNA use a shell of fatty nanoparticles to deliver a piece of genetic code – “messenger RNA – from viruses. In the case of SARS-CoV-2, the virus spike protein blueprint is transferred. With that bit of code, the body can train the immune system to target the spike protein, creating powerful antibodies to fight infection.
Moderna’s patent claims are linked to chemical modifications made to the mRNA in the vaccine from Pfizer and BioNTech, and to the lipid (fat) coating.
mRNA-based vaccines have proven effective against COVID-19 and could be the next leap forward for flu and other vaccinations. Moderna demanding a license for all non-AMC-92, post-March-2022 mRNA vaccines could hinder that. The company has previously been criticized for dragging its feet on sharing its vaccine formula for global distribution, even winning a “2020 Shkreli Award” for skyrocketing the price of its vaccine after receiving $1 billion in government funding.
But pharmaceutical giants suing each other over life-saving innovations is not uncommon. Such lawsuits also do not come after public funding. Although Moderna, as The New York Times points out, accepted $2.5 billion in taxpayer dollars to develop its vaccine, that’s unrelated to the patents underlying the delivery mechanisms, which Moderna claims go back further.
Medical journalist Matthew Herper says in STAT (paywall) that pharmaceutical patent litigation is “moving at an icy pace” and that mRNA development is inherently fraught. Moderna, Pfizer and BioNTech are all being sued by a company across town from Moderna, Alnylam, over greasy nanoparticle work. And the origins of mRNA delivery can go back even further.
Derek Lowe notes in Science that there is “hardly ever an example of a breakthrough biopharmaceutical technology not leading to a flood of patent lawsuits.” Moderna had to license an RNA modification after initially claiming it invented its own RNA modification. Lowe also notes that Moderna is currently being sued by two other companies alleging their own patents on lipid nanoparticles have been infringed.
While it may be business as usual for major pharmaceutical companies, it could be damaging to vaccination efforts and public perception of healthcare. And while the public investment in the vaccine race may not be directly related to this lawsuit, it doesn’t look great to be reminded of the divide between public health and the private companies that often benefit from it.
(Update 1:12 PM: Added link and context from Derek Lowe’s Science post, and quote from Pfizer spokesperson to The New York Times.)
