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23 November 2023Big PharmaLiz Hockley

EPO revokes Moderna's COVID-19 vaccine patent

The European Patent Office hands a win to BioNTech and Pfizer in coronavirus vaccine dispute | US biotech plans to appeal decision affecting mRNA patent.

Moderna suffered a setback this week in its ongoing dispute with rival coronavirus vaccine makers  BioNTech and  Pfizer, after the European Patent Office (EPO) declared an mRNA patent held by the firm to be invalid.

The decision was announced on Tuesday, November 21, and Moderna has said it plans to appeal. Moderna’s contested patent, EP3718565, covers “a betacoronavirus vaccine comprising at least one ribonucleic acid (RNA) polynucleotide having an open reading frame encoding at least one BetaCoV antigenic polypeptide”.

The US biotech’s mNRA technology is the subject of several patent lawsuits the firm has filed, including in the US, Germany and the UK. Moderna claims that German rival BioNTech infringed its ‘565 patent and another (EP3590949), through mRNA technology used to develop its Comirnaty coronavirus vaccine in partnership with Pfizer.

Messenger RNA, or mRNA, is a type of molecule that contains the instructions for cells to make a certain protein. The immune system then recognises this protein as foreign and produces antibodies, the process behind mRNA vaccination.

‘Unimaginably broad claims’

BioNTech and Pfizer filed countersuits against Moderna’s initial lawsuit. In an inter partes review petition to the US Patent Trial and Appeal Board (PTAB) in August this year, the duo claimed that Moderna obtained the patent at issue “during the pandemic, with unimaginably broad claims directed to a basic idea that was known long before the asserted priority date of 2015”.

Moderna says it patented the mRNA technology, used to develop its own coronavirus vaccine Spikevax, long before the COVID-19 pandemic that began in 2019.

BioNTech welcomed the EPO’s decision, hailing it as “an important one, as we believe that this and others of Moderna’s patents do not meet the requirements for grant and should never have been granted”,  Reuters reported.

A number of other oppositions are pending relating to patents covering Moderna’s mRNA technology, with  Sanofi and  Glaxo Smith Kline among the opponents.

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