Covid-19 vaccine battle between Moderna, Pfizer and BioNTech heats up in Germany and US

Freshfields leads Moderna to win in German court but pharma company is not so successful in the US

Covid-19 mRNA vaccine patent battle continues pepmiba

The Düsseldorf Regional Court has ordered Pfizer and its German partner BioNTech to pay damages for the use of Moderna’s European Patent 949 (EP 949), in the latest ruling in the global litigation over mRNA patents underpinning blockbuster Covid-19 vaccines.

Moderna alleges that Pfizer and BioNTech’s Covid vaccine Comirnaty infringes the patent. The website Juve Patent has reported that Pfizer and BioNTech, represented by Taylor Wessing and patent attorney firm df-mp, must provide information on the extent of the use of EP 949, and on the prices and profits achieved. 

Furthermore, the judgment stated that the defendants had to pay the plaintiff reasonable compensation and damages. The amount of damages has not been calculated.

Pfizer and BioNTech had argued that a pledge Moderna had instigated at the start of the Covid-19 pandemic that it would not enforce its intellectual property rights relating to the vaccine provided a defence.

Pfizer and BioNTech maintained that even if they had infringed the patent, the pledge provided a defence to any allegation of infringement between the start of the pledge in October 2020 and 5 May 2023.

However, Moderna, represented by Freshfields, convinced the court led by presiding judge Daniel Voss, that permission had been rescinded as per a separate press release dated March 2022.

This is another favourable ruling for Moderna: in July the UK High Court ruled that the same patent, EP 949 was valid and therefore had been infringed by Comirnaty. The other Moderna patent in contention – EP 565  – was found to be invalid. An appeal against that decision is now also pending.

In May, the European Patent Office (EPO) Opposition Division upheld the EP 949 patent in amended form, a decision Pfizer is appealing at the EPO Technical Board of Appeal.

In a statement following the latest German ruling, Pfizer said it was disappointed with the Dusseldorf court’s decision not to stay the infringement case in relation to EP 949 pending the appeal to the EPO Technical Board of Appeal. 

Pfizer added that it believed in the “value and strength of our innovative science and our own intellectual property, and we will appeal the decision”.

US proceedings

There are parallel proceedings between the trio in a number of jurisdictions, including the US. 

On the same day of the Düsseldorf judgment last week (5 March), the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) ruled that two Moderna patents were invalid, with the docket sheet stating that “all challenged claims were held unpatentable”.

The patents in contention covered the composition and administration of an mRNA vaccine “encoding any spike protein or spike protein subunit of any betacoronavirus (whether in existence or arising at any later point in time), formulated in a lipid delivery system”.

In petitions to PTAB, Pfizer and BioNTech had argued that Moderna obtained the patents 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”.

Pfizer said in statement that it was “pleased with the decision”, adding: “This decision by the Patent Trial and Appeal Board confirms Pfizer’s and BioNTech’s position that the two Moderna patents are invalid.”

For the fourth quarter of 2024, Pfizer reported that its Comirnaty vaccine, once a nearly $38bn a year product, brought in global revenues of $3.38bn, down 37% compared to the previous quarter in 2023 where revenues totalled $5.36bn.
 

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