CategoryThe UK Court of Appeal has upheld a ruling that Moderna’s EP’949 patent, covering modified mRNA technology used in its COVID-19 vaccine, is valid and infringed by Pfizer and BioNTech’s Comirnaty vaccine.
This outcome follows an initial decision in July 2024 by the UK High Court, which found that while Moderna’s EP’565 patent was invalid, the EP’949 patent was both valid and had been infringed. EP’949 relates to a specific modification made to mRNA, where uracil bases are replaced with N1-methyl-pseudouridine, a version of the base designed to stabilize the molecule and enhance immune response.
The dispute dates back to August 2022, when Moderna filed patent infringement lawsuits against Pfizer and BioNTech in multiple jurisdictions, including the United States, Germany, the Netherlands, Belgium, Ireland, and the UK. The company claimed entitlement to damages for sales starting from March 2022. In September 2022, Pfizer responded in UK courts, seeking revocation of the EP’949 patent and alleging that its own patents had been infringed.
In March 2022, Moderna revised an earlier pledge from October 2020, in which it had said it would not enforce its COVID-19–related patents. The revised statement indicated that Moderna would begin enforcing its patents globally, excluding 92 low- and middle-income countries.
Following the July 2024 ruling, Pfizer and BioNTech were granted permission to appeal the decision upholding the EP’949 patent. In their appeal, filed earlier this month, the companies argued that Moderna’s developments were obvious extensions of prior work, and that the patent should be invalidated. The appeal was rejected by Judge Richard Arnold.
During Moderna’s second-quarter earnings call, the company confirmed the court’s decision. Stéphane Bancel, Moderna’s CEO, stated, “The court has decided to affirm the High Court finding that Moderna’s EP’949 patent is valid and infringed by Pfizer and BioNTech. Moderna will continue to pursue and enforce its patent rights globally to protect its competitive mRNA technology.”
Pfizer and BioNTech released a joint statement in response to the ruling, asserting that it “does not change our unwavering stance that this patent is invalid,” and indicating plans to seek a further appeal. They added that the decision has no immediate impact on the companies or on the Comirnaty vaccine.
This ruling is one part of a broader set of legal proceedings between the companies in multiple countries. In March 2025, the Düsseldorf Regional Court ruled in Moderna’s favor and awarded damages. In contrast, the United States Patent Trial and Appeal Board ruled that three other Moderna patents related to mRNA technology were invalid on the basis that they attempted to patent what were described as “obvious” developments.
Moderna initially disclosed the UK appellate ruling in a press release issued on Friday morning and reiterated the outcome during its quarterly earnings call held a few hours later. The company has not issued additional comments since then.
This comes at a time when companies like Moderna are reassessing international expansion, as seen in their recent decision to halt mRNA plant development in Japan due to changing market dynamics. (Source)
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The EP’949 patent is owned by Moderna. BioSpace+1
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It claims modified mRNA in which all (100%) of the uracil nucleotides are replaced with N1-methyl-pseudouridine (m¹Ψ). Legal Blogs+1
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This modification is intended to stabilise the mRNA molecule and reduce its immunogenicity (i.e. reduce unwanted immune responses
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The EP’949 patent is owned by Moderna. BioSpace+1
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It claims modified mRNA in which all (100%) of the uracil nucleotides are replaced with N1-methyl-pseudouridine (m¹Ψ). Legal Blogs+1
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This modification is intended to stabilise the mRNA molecule and reduce its immunogenicity (i.e. reduce unwanted immune responses). BioSpace+1
What the Courts Decided
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In July 2024, the High Court of England had ruled that EP’949 was valid and that Pfizer/BioNTech’s Comirnaty infringed this patent. Reuters+3BioSpace+3Reuters+3
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Pfizer/BioNTech appealed that decision. They argued, among other things, that the patent was obvious in view of prior art and that EP’949 was anticipated by earlier publications. juve-patent.com+3Legal Blogs+3Reuters+3
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The Court of Appeal has now dismissed those appeals, confirming the High Court’s decision. That means EP’949 remains valid, and Comirnaty is judged to infringe it. Legal Blogs+2Reuters+2
Legal and Practical Implications
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Because the infringement is confirmed, Moderna is entitled to damages in relation to sales of Comirnaty in the UK from March 2022 onward. BioSpace+2Reuters+2
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However, this doesn’t immediately stop the sale or use of Comirnaty; it means Pfizer/BioNTech may owe payments. Reuters+1
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Pfizer and BioNTech have stated that the decision doesn’t change their operations or vaccine supplies. They continue to contest the patent’s validity in broader contexts.
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