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Moderna’s COVID vaccine lawsuit looks ahead to future markets

Moderna’s unexpected patent infringement lawsuit against Pfizer and BioNTech over COVID vaccine technology says more about the future market for mRNA shots than the current state of the pandemic.

The big picture: With the federal government’s vaccine purchases likely to drop off, experts see top manufacturers jockeying for customers and using the technology for other conditions.

  • “Moderna looks at Pfizer’s success as threat to market share,” said Jacob Sherkow, an authority on intellectual property and the life sciences University of Illinois’ College of Law and College of Medicine. “Filing suit may slow that down and be one way to ensure Moderna’s share of product is going to remain a leader in this particular space.”
  • Moderna has said it is using its mRNA platform in four areas: infectious disease, cancer, rare diseases and autoimmune disorders.
  • “They’re trying to protect the franchise,” Erik Gordon, a University of Michigan business professor, lawyer and expert on the drug industry, told Axios’ Nathan Bomey. “They do want money — but I think the bigger money is money they hope to get in the future based on this platform.”

Catch up quick: Moderna on Friday alleged Pfizer and BioNTech copied technology that Moderna first developed years before the pandemic in producing the first COVID-19 vaccine approved in the U.S.

  • Moderna isn’t seeking monetary damages for sales prior to March 8, 2022 or asking for Pfizer’s vaccine to be removed from the market. Nor is it seeking financial gains from vaccine distribution in 92 developing countries.
  • “We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” said Moderna CEO Stéphane Bancel.

Yes, but: In 2020, Moderna said in financial filings it “cannot be certain that we were the first to make the inventions claimed in our patents or pending patent applications” — including the company’s experimental coronavirus vaccine.

  • Moderna itself is facing lawsuits from biotech companies over aspects of its vaccine technology, per Fierce Pharma.

Reality check: Drugmakers have often portrayed vaccines as among their least attractive business lines.

  • But as Villanova Law’s Ana Santos Rutschman has noted, there are many profitable vaccine markets in developed nations, such as vaccines targeting human papillomavirus.
  • And the gamble to take on COVID-19 vaccines has delivered in a big way for both Moderna and Pfizer, as CNN Business noted.

What we’re watching: The Moderna case could pivot around a pledge Moderna made in October 2020 not to enforce its COVID-19 vaccine patents during the pandemic.

  • It later updated that pledge, limiting it to the 92 low- and middle-income countries in the Gavi COVAX vaccine alliance.
  • “If they are held to those promises then it’s going to be difficult to win,” said Sherkow. “If they’re not held to that pledge, then it becomes more garden variety patent litigation.”
  • Such cases can take two or three years to decide, before any appeals, he said.

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