Pfizer, Moderna set to tangle in COVID vaccine patent trial next April: reports

As parallel litigation simmers in the U.S., Germany and the Netherlands, the United Kingdom’s High Court has set the venue for one of Pfizer and Moderna’s first skirmishes in a heated battle over COVID-19 vaccine patents.

The case, comprising dueling lawsuits from the mRNA rivals, is set to go to trial in London in April 2024, multiple news outlets report.

Spikevax maker Moderna sued Pfizer and BioNTech in the U.K. last September, seeking compensation and damages for sales of the partners’ rival mRNA shot Comirnaty. Moderna claims Pfizer’s vaccine flouts patents related to lipid nanoparticle delivery, spike protein encoding and more.

Not content to play sitting duck, Pfizer and BioNTech parried with their own U.K. case challenging the validity of Moderna’s COVID-19 vaccine patents.

Pfizer did not immediately respond to Fierce Pharma’s request for comment on the latest litigation update. Moderna, for its part, said it did not have a statement at this time.

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The case is of “considerable value and importance” to the companies, Andrew Waugh, for Moderna, said in court documents quoted by The Independent. Experiments and expert testimony from biochemists, immunologists, virologists and vaccine delivery experts may be needed to resolve the dispute, the court was told at a preliminary hearing Thursday.

The mRNA kerfuffle has largely played out the same in the U.S., where Moderna first sued Pfizer in August. At the time, Moderna CEO Stéphane Bancel argued his company was trying to “protect the innovative mRNA technology that we pioneered, invested billions of dollars into creating, and patented during the decade preceding the COVID-19 pandemic.”

In a unique twist, Moderna said it wouldn’t seek to remove Pfizer and BioNTech’s shot from the playing field. Instead, in developed markets, Moderna said it expected its mRNA rivals to “respect its intellectual property rights” and “consider a commercially reasonable license.” Moderna added that it would keep away from Comirnaty sales in many low- and middle-income countries.

Pfizer and BioNTech hit back with a countersuit in December, demanding a jury trial and refuting Moderna’s infringement claims. The partners contended Moderna was stretching its “already overbroad” and arguably “invalid” patents and was trying to “claim credit for others’ work.” The companies argued that Moderna, in its original lawsuit, tried to rewrite the well-known story of the COVID-19 pandemic to put itself in the “single, starring role” by ignoring the contributions of other players.

Adding another wrinkle to the saga is Moderna’s 2020 pledge not to enforce its vaccine patents against other companies during the pandemic—and the biotech’s subsequent reversal of that promise in developed markets last March.

In a March 2022 update to its pledge, Moderna reaffirmed it would “never” enforce its IP against companies manufacturing in or for the 92 low- and middle-income countries in the Gavi Covax Advance Market Commitment (AMC). But outside those countries, Moderna said it would start getting tough, though it remains willing to license its COVID shot technology to manufacturers on “commercially reasonable terms.”

Besides the Pfizer-Moderna fracas, both companies are engaged in separate legal disputes over their mRNA vaccine technology. A year ago, Arbutus Biopharma and Genevant Sciences filed a lawsuit against Moderna in a Delaware federal court in pursuit of damages for alleged infringement of six patents. Pfizer, for its part, is playing defense in German and U.S. patent litigation with Germany’s CureVac, which filed suit in July.

In Moderna’s case, the biotech recently got some support from on high after the U.S. Department of Justice said the United States government—not Moderna—should be on the hook for any infringement of Arbutus and Genevant’s patents that took place under the government contract to crank out COVID-19 vaccines. Moderna made the same argument last year when it failed to get the lawsuit dismissed early, Reuters notes.