Moderna has secured a partial win in a closely watched High Court battle with Pfizer and BioNTech over the validity of two of the patents underpinning mRNA Covid-19 vaccines.

The High Court has ruled that one of the Moderna patents at the centre of the dispute is valid – European patent (EP) 949 – and has therefore been infringed by Pfizer and its German partner BioNTech’s Covid-19 vaccine, Comirnaty, that they developed together. 

The 153-page judgment handed down by Justice Meade did not go all Moderna’s way, however, as the other patent – EP565 – was found to be invalid. 

Despite this, Pinsent Masons life sciences partner Christopher Sharp described the outcome as a “commercial victory” for Moderna, which was advised by Freshfields Bruckhaus Deringer, given the need for BioNTech/Pfizer to pay damages, subject to any appeals.

The tussle kicked off in 2022 when Moderna sued Pfizer and its German partner BioNTech for patent infringement of the two disputed patents.  

In retaliation, Pfizer and BioNTech launched multijurisdictional proceedings, including this UK litigation, in an attempt to revoke the patents that cover mRNA technology and were used to create the blockbuster vaccines deployed during the Covid-19 pandemic.

Pfizer and BioNTech, advised by Taylor Wessing and Powell Gilbert respectively, relied heavily on two pieces of prior art to try and revoke EP949: an article from a peer reviewed journal, Karikó 2008, and a patent filing referred to as “UPenn” in the judgment. 

Meade didn’t find Pfizer’s attempts to prove that UPenn and Karikó “anticipated” EP949 convincing. In his view Moderna had much the better of these arguments and “there is no anticipation” by routes detailed by Pfizer and BioNTech in the court filings.

Regarding the other patent – EP565 – Meade said that the question of obviousness was the “critical aspect” and provided “a clear basis” for finding EP565 invalid.

The judge noted that proceedings were brought against the background of the Covid-19 pandemic, which has meant that the “amounts at stake are very large”.

There are parallel proceedings in a number of jurisdictions, including the US, where last year Pfizer and BioNTech petitioned the US Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB), the Netherlands, Germany, Belgium, Ireland and the European Patent Office (EPO). While various proceedings have been stayed pending the cases before the EPO and the PTAB, there have been first instance decisions in the Netherlands and by the EPO.

During the UK trial, oral proceedings took place in the EPO’s opposition division, which upheld EP949 in amended form.

Meade said in his judgment: “I am glad that I have reached a consistent conclusion and think it is likely that my reasoning coincides fairly closely” with the opposition division “although I am confident I would have arrived at the same result in any event”.

In finding the patent valid and infringed, however, the judge contradicted the findings of the district court of the Hague, which found EP949 to be invalid for lack of novelty over UPenn.

Meade commented that it is possible that the real and underlying difference between the Hague’s decision and “mine is in relation to obviousness, and explicable by different evidence”.

Moderna is not seeking injunctive relief but financial remedy.

As well as the technical trial heard by Meade, there was a separate trial heard by Justice Jonathan Richards that deals with a defence that Pfizer/BioNTech advance in the event that the patents are valid and infringed.

It concerned a pledge that Moderna had instigated at the start of the pandemic that it would not enforce its intellectual property rights relating to the vaccine. Pfizer/BioNTech argued that even if they infringed the patents, the pledge provided a defence to any allegation of infringement between the start of the pledge in October 2020 and 5 May 2023.

But the pledge was “at most a temporary forbearance”, said the judgment. Even if the pledge was an express waiver of rights, it was validly retracted by 7 March 2022.

Following the rulings, all three parties said they would appeal.

In a statement, Pfizer and BioNTech said they were “disappointed in the court’s decision to uphold the validity” of the other.

They added: “We continue to believe that this second patent is invalid and will seek to appeal this decision.”

Responding to the judgment, Moderna said it was “pleased that the UK High Court recognised the innovation of Moderna scientists by confirming the validity and infringement of the EP’949 patent and that defendants were not entitled to use Moderna’s patented technology for any infringing activity after March 7 2022”.

It added that: “We disagree with some other aspects of the decisions and will consider addressing those issues on appeal.”

Pinsent Masons’ Sharp said: “The decision can certainly be seen as a commercial win for Moderna. It aligns with the latest outcome in parallel proceedings at the European Patent Office, but goes against an earlier decision on similar issues from the Dutch courts in The Hague.

“Subject to any appeals, BioNTech/Pfizer will need to pay damages to Moderna under the valid and infringed patent for UK sales of Comirnaty from 8 March 2022. The relevant patent expires in 2031, and given the broader mRNA platform technology subject matter of the patent it may cover future BioNTech/Pfizer products (for example Covid-19 combination vaccines).”

He continued that it will be interesting to see how other European courts react, in particular in Ireland and Belgium where BioNTech/Pfizer have manufacturing facilities and damages could attach to broader manufacturing activities, rather than just local territory sales. “Given the principles of comity and the similarity of the laws between the UK and Ireland, we might expect a similar outcome in at least the Irish case,” he added.

Pfizer was represented by Three New Square’s Tom Mitcheson KC and Alice Hart (instructed by Taylor Wessing) while 8 New Square’s Michael Tappin KC and Michael Conway (instructed by Powell Gilbert) represented BioNTech.

Moderna was represented by Three New Square’s Andrew Waugh KC and 11 South Square’s Piers Acland KC and Three New Square’s Stuart Baran, Katherine Moggridge and Richard Darby (instructed by Freshfields Bruckhaus Deringer).