Despite Pfizer and Moderna having resolved and tied off certain threads in their separate webs of mRNA patent litigation, they now face more legal hurdles, with Sanofi having opened a new front to challenge the companies’ blockbuster Covid-19 vaccines, reports Fierce Pharma.
In separate complaints filed in the New Jersey District Court last week, Sanofi lawyers took aim at the lipid nanoparticle (LNP) tech undergirding the delivery of mRNA in Pfizer’s Covid-19 shot Comirnaty, plus two versions of Moderna’s mRNA coronavirus prophylactic – Spikevax and mNexpsike – and its respiratory syncytial virus (RSV) vaccine mResvia.
Sanofi’s legal team specifically argues that Pfizer’s and Moderna’s LNP technologies have infringed related patents developed by Translate Bio – which Sanofi had acquired in 2021 for $3.2bn, signalling continued commitment to the field despite the company’s failure to muster its vaccine expertise behind an approved mRNA Covid-19 shot.
Sanofi separately partnered with Novavax in May 2024 to help co-commercialise the the biotech’s approved, protein-based Covid jab Nuvaxovid, and to develop potential combination vaccines.
In the complaints, Sanofi’s legal team contends that when healthcare professionals administer Pfizer’s or Moderna’s vaccines, they are ultimately violating a quartet of Sanofi- and Translate-held patents tied to the method for delivery of mRNA, with the drugmakers ultimately shouldering the blame as the vaccines’ developers.
Sanofi is calling for a jury trial in both cases and, alongside determinations to back up its infringement allegations, the French pharma is hoping to receive damages or other monetary relief from its vaccine rivals.
Moderna told Fierce Pharma it would defend itself against the claims, while Pfizer did not immediately respond.
Multiple biotechs and large pharmas have been waging battle over mRNA patents, with Pfizer and Moderna often at the centre, in recent years.
Earlier this year, Moderna resolved some of those disputes, putting patent battles to bed with Alnylam, plus Roivant unit Genevant and infectious disease biotech Arbutus, in that latter case agreeing to pay $950m upfront while escaping potential future royalties to the plaintiffs on vaccine sales.
Pfizer, for its part, agreed to pay GSK $320m upfront to settle a similar dispute with the British pharma and its partner CureVac last August.
But spats over mRNA IP continue to flare up. In January, Bayer filed lawsuits against Moderna and Pfizer and its mRNA partner BioNTech, and it separately sued Johnson & Johnson over its non-mRNA Covid shot.
In that instance, Bayer’s legal team argued that Pfizer and Moderna used its tech in creating their vaccines “to eliminate ‘problem’ coding sequences in the building blocks of cells to improve mRNA stability and the amount or quality of protein produced”.
That said, most of the legal disputes over the shots have come back to similar LNP delivery concerns driving the latest action by Sanofi.
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