Moderna has sued Pfizer and BioNTech in Massachusetts and Germany (where the defendants are based), claiming that the companies violated three of its patents related to mRNA technology used to develop COVID-19 vaccines.
As we discussed back in 2020,
With billions of dollars – and millions of lives – at stake, companies are hurrying to file patents to protect their COVID-related inventions.
However, given the rush to file, and the multiple simultaneous vaccine development tracks, it may be some time before it’s clear who owns what rights.
The patents at issue in this latest dispute pre-date the pandemic and were filed between 2011 and 2016.
mRNA technology directs the immune system to recognize and fight a virus based on its genetic code. As Nature notes, although mRNA-based vaccines for COVID-19 were quickly developed and approved in response to the pandemic, mRNA vaccine technology is more than 20 years old.
According to the New York Times,
Moderna’s suits claim that Pfizer and BioNTech copied crucial features of its patented technology, including making the same chemical modification to their mRNA and targeting the same type of protein, known as a spike protein, that Moderna scientists had pioneered years earlier.
As the Times notes,
Experts said Moderna’s litigation, regardless of its outcome, was unlikely to impede access to Covid vaccines or chill the development of mRNA products. But the outcome could dictate whether Pfizer or Moderna controls and profits more from a powerful and lucrative medical technology.
At issue is who has the right to license the technology and thus collect royalties from those who want to use it.
As the Times noted,
Moderna is seeking damages, which could include royalties and lost profits, incurred since March, when the company said it would begin enforcing its Covid-related patents in wealthier countries after previously pledging not to do so during the pandemic emergency. Moderna’s lawsuits said the company would not seek damages from Pfizer’s sales of its shot to the world’s poorest countries. They also said the company would not pursue any damages that would be the responsibility of the U.S. government, which has bought hundreds of millions of doses of the Pfizer-BioNTech vaccine.
The US government gave Moderna more than $10 billion to develop and test its COVID vaccine and manufacture doses.
Moderna has also been engaged in a dispute with the National Institutes of Health over which co-inventors should be named on the “principal patent application” for the vaccine.
According to Jacob S. Sherkow, an expert on biotechnology patent law at the University of Illinois College of Law, Pfizer might be forced to pay tens of millions of dollars in damages if found liable for patent infringement. However, this is only a small fraction of the overall sales for Pfizer’s Covid vaccine, which were $36.8 billion in 2021.
A number of other COVID-related patent battles are raging across the globe.
Alnylam Pharmaceuticals Inc. sued Pfizer and Moderna for allegedly infringing its patent for lipid nanoparticle (LNP) technology for delivering genetic material into human cells. The suit was filed the same day the US Patent and Trademark Office (USPTO) issued the patent.
Recently, CureVac filed what seems to be the first COVID-19 vaccine-related patent infringement complaint outside the US. The complaint was filed in the Dusseldorf Regional Court and accused BioNTech of infringing four of CureVac’s patents.
According to the Times,
Analysts at the investment bank SVB Securities wrote in a note to investors on Friday that the history of disputes over intellectual property between similar companies “suggests the most likely outcome would be modest royalties paid by both companies, with little net favorable financial impact for anyone but the law firms involved.”
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