Rival Covid-19 jab developers face off in High Court patent trial

Rival developers of Covid-19 jabs have faced off at the High Court in London as a weeks-long trial over life-saving vaccine technology patents began.

Pharmaceutical giant Pfizer and drug manufacturer BioNTech are locked in a legal dispute with vaccine maker Moderna over the use of messenger RNA (mRNA) technology in coronavirus jabs amid parallel litigation in the US, Germany, the Netherlands and other countries.

US firm Moderna is suing American competitor Pfizer and its German-partner BioNTech for alleged patent infringement in relation to their Comirnaty vaccine, arguing it is due compensation for products manufactured after March 7 2022.

Pfizer and BioNTech have denied infringement with both firms seeking the “revocation” of two Moderna patents, claiming that they are “invalid”.

An expected three-and-a-half week trial before judge Mr Justice Meade started on Tuesday focusing on one of the patents at the heart of the legal dispute.

The second patent is expected to be considered next week, when there is also expected to be a linked hearing before a different judge for arguments over Moderna’s “patent pledge”.

Moderna said in 2020 that it would not enforce its Covid-19 related patents while the pandemic continued.

But the company said in March 2022, with vaccine supplies improving globally, that it was updating the pledge and expected its intellectual property to be respected in non-low and middle-income countries where supply was no longer a barrier to access.

Tom Mitcheson KC, representing Pfizer and BioNTech, said in written arguments that Moderna was seeking damages but not seeking a court injunction due to it “recognising the public interest in the continued availability of the Comirnaty range of vaccines”.

He said the challenge over the validity of one of the patents centred on an alleged “lack of novelty” in relation to work done by Katalin Kariko and Drew Weissman when at the University of Pennsylvania in the US.

The pair won the 2023 Nobel Prize in Medicine for discoveries that were “critical for developing effective mRNA vaccines against Covid-19 during the pandemic”, the court was told.

Mr Mitcheson said that “it is clear that even on Moderna’s case the difference between the prior art and the patent is wafer thin”.

Piers Acland KC, for Moderna, said in written submissions that the rival developers’ arguments were “not credible”, adding: “It does no disservice to Professors Kariko and Weissman’s extraordinary contributions to acknowledge Moderna’s extraordinary contribution too.”

Moderna’s Spikevax vaccine was the third jab to be approved for use in the UK in January 2021 after the Pfizer/BioNTech and Oxford/AstraZeneca vaccines were approved.

How the Moderna and Pfizer/BioNTech vaccines work is by targeting the spike protein in Covid-19 which the virus uses to enter human cells.

The Moderna and Pfizer/BioNTech vaccines use synthetic messenger RNA (mRNA), a genetic material that contains information about the spike protein.

The vaccines provide the body with instructions to produce a small amount of this protein which, once detected by the immune system, leads to a protective antibody response.

The trial continues.