Moderna takes first win in UK trials with Pfizer and BioNTech

In the global dispute between Moderna on one side and Pfizer and BioNTech on the other, all opponents saw a measure of success in the UK High Court yesterday. In a combined judgment, High Court judge Richard Meade ruled that Moderna’s EP 3 718 565 is not valid (case IDs: HP-2022-000022 and HP-2022-000027). The EPO had already revoked the patent in late autumn 2023 but Moderna appealed the decision at the EPO Boards of Appeal.

Nevertheless, one hit is enough to win and Moderna still emerged victorious as Richard Meade considered Moderna’s EP 3 590 949 valid and infringed by the two competitors. If the judgment is upheld, both companies will have to pay damages to Moderna.

Attack on multiple fronts

Back in 2022, Moderna began suing its Mainz-based competitor BioNTech and Pfizer in several countries, including Germany, the Netherlands, Belgium, Ireland and the UK. The dispute revolves around Moderna’s two patents EP 949 and EP 565, which protect “ribonucleic acids containing n1-methyl-pseudouracils and uses thereof” and “respiratory virus vaccines” respectively.

While in 2020 Moderna developed its ‘Spikevax’ vaccine, Pfizer and BioNTech simultaneously began selling their COVID-19 vaccine under the Comirnaty brand. In filing the first infringement suits in 2022, Moderna emphasised that it was not looking to remove Comirnaty from the market. Instead, it was seeking damages for all sales made by its competitors after 8 March 2022.

The pledge trial

In the parallel proceedings over Moderna’s so-called “patent pledge”, the central issue concerned when the obligation to pay damages begins. Moderna issued its pledge in October 2020 stating that, while the pandemic continues, Moderna would not enforce its COVID-19-related patents against those making vaccines intended to combat the pandemic. In March 2022, Moderna updated the pledge and withdrew from the commitment not to enforce patents against the manufacturers of COVID-19 vaccines unless parties manufactured those vaccines exclusively for use in 92 low- and middle-income countries.

The pledge trial therefore dealt with the question of whether Moderna’s pledge ended in March 2022 or on 5 May 2023, as argued by Pfizer and BioNTech. However, BioNTech and Pfizer were not successful here. In his judgment, High Court judge Jonathan Richards concluded that “Pfizer/BioNTech had non-contractual consent to perform acts that would otherwise infringe the patents between 8 October 2020 and 7 March 2022.” This means that BioNTech and Pfizer owe Moderna damages from 8 March.

UK Appeal likely

The UK High Court judgments may not be the end of the dispute. The parties can appeal to the Court of Appeal. Moderna is likely to be particularly upset that the UK High Court has overturned EP 565. A Moderna spokesman told JUVE Patent, “We are 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 7 March 2022. We disagree with some other aspects of the decisions and will consider addressing those issues on appeal.”

However, spokespersons of BioNTech and Pfizer were more specific when asked by JUVE Patent. In a coordinated statement they said, “We believe in the value and strength of our innovative science and our own intellectual property. While we are pleased that EP 565 has been found invalid, we disagree with the court’s decision to uphold the validity of EP 949. Our stance is that neither of these patents is valid, and we and our partner Pfizer will seek to appeal the decision for EP 949.”

But before the UK Court of Appeal can review the decision, the three companies will first meet again for a Form of Order Hearing at the UK High Court. The court could then order an inquiry as to damages, in which the court determines how much money BioNtech and Pfizer owe Moderna for the use of EP 949.

However, to avoid lengthy and expensive damages proceedings, parties often agree on a settlement beforehand.

Düsseldorf to hear case over EP 949

However, if the parties fail to reach an agreement, the next stage would be the hearing of Moderna’s infringement claim over EP 949 in Düsseldorf. It is considered to be a main patent in Moderna’s portfolio. The Düsseldorf Regional Court had stayed the proceedings pending a decision from the EPO on the patent’s validity.

On 17 May the EPO Opposition Division upheld EP 949. The EPO made slight changes to the originally filed version but these do not affect the claims on which Moderna bases its lawsuits in Germany and other suits in the UK.

The opponents can still appeal the decision to the EPO Boards of Appeal, but the infringement proceedings can now continue. Presiding judge Daniel Voß of Düsseldorf Regional Court’s Chamber 4b had already scheduled the oral hearing for 21 January 2025.

Additionally, the EPO revoked Moderna’s EP 565 in late autumn 2023. Düsseldorf Regional Court had planned to hear the second case concerning EP 565 in December last year, but this is still on hold.

Meanwhile, a Dutch court has also revoked EP 949.

Continuity of counsel

For the legal advice in the infringement proceedings spanning several European countries, Moderna instructed a pan-European team from Freshfields Bruckhaus Deringer. The team is led by Amsterdam partner Rutger Kleemans. In the UK technical trial, Moderna relied on a barrister team around Piers Acland from 11 South Square as well as Andrew Waugh, Katherine Moggridge, Stuart Baran and Richard Darby from Three New Square, instructed by Freshfields partners Laura Whiting and Chris Stothers. Anneliese Day and Gillian Hughes from Fountain Court were the barristers responsible for the pledge trial.

On behalf of Pfizer, Simon Cohen and Nigel Stoate of Taylor Wessing instructed another barrister team from Three New Square around Tom Mitcheson and Alice Hart. Pfizer’s barristers in the pledge trial are Michael Bloch, Will Bordell and Sean Butler from Blackstone. Law firm Taylor Wessing is also active for Pfizer in Germany, Belgium and the Netherlands.

BioNTech has retained Penny Gilbert and Tess Waldron from London IP firm Powell Gilbert. BioNTech’s counsel for the pledge trial was James Segan from Blackstone. For the technical trial BioNTech relied on Michael Tappin and Mike Conway from 8 New Square. In other important jurisdictions such as Germany, Belgium and the Netherlands, BioNTech relies on the international IP boutique Hoyng ROKH Monegier.

The EPO procceedings feature numerous patent attorney firms active on behalf of Moderna and its opponents. Read more about the important EPO ruling and the advisors involved here.