Moderna has landed an important victory at the European Patent Office. The Opposition Division granted a key mRNA patent in the face of an objection from nine opponents. This has implications for Moderna's infringement proceedings against BioNTech and Pfizer.
24 May 2024 by Mathieu Klos
After an inauspicious period for Moderna, the US pharmaceutical company’s litigation against Pfizer and BioNTech concerning mRNA vaccines is now picking up speed again. Following a ruling in Moderna’s favour from the EPO Opposition Division, infringement proceedings that had been suspended by Düsseldorf Regional Court can now resume.
In August 2022 Moderna filed infringment suits against Pfizer and BioNTech at the Regional Court Düsseldorf concerning two patents EP 3 590 949 and EP 3 718 565. The patents protect “ribonucleic acids containing n1-methyl-pseudouracils and uses thereof” and “respiratory virus vaccines” respectively.
But in late autumn 2023 the EPO revoked EP 565 and a Dutch court also revoked EP 949. Furthermore, nine opponents filed an objection to the granting of EP 949 at the EPO Opposition Division. In addition to Pfizer and BioNTech, these were GlaxoSmithKline, Sanofi, the Dutch company etherna Immunotherapies and four straw men. Düsseldorf Regional Court therefore suspended the infringement proceedings concerning both patents.
However, 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. Experts believe this is likely, at least in the case of Pfizer and BioNTech.
Nevertheless, the German infringement proceedings concerning EP 949 can now take place. Presiding judge Daniel Voß of Düsseldorf Regional Court’s Chamber 4b had already set a date for the oral hearing on the 21 January 2025.
Düsseldorf Regional Court had planned to hear the second case concerning EP 565 in December last year, but this is still on hold after the EPO Opposition Division did not grant the patent. Moderna has since lodged an appeal against the EPO’s decision with the Boards of Appeal. The court has not yet set a date for the oral hearing.
Notwithstanding the proceedings at the EPO, the UK High Court recently held a 20-day hearing between Moderna and defendants Pfizer and BioNTech. The court heard two cases beginning on 22 April: while judge Richard Meade held the technical trial for EP 565 and EP 949, the trial before judge Jonathan Richards considered the legal effect of Moderna’s 2020 pledge concerning the use of its vaccine technology while the pandemic was ongoing (case ID: HP-2022-000022 and HP-2022-000027).
In addition to Germany and the UK, Moderna had also sued its Mainz-based competitor BioNTech in the Netherlands, Belgium and Ireland. The disputes all revolve around the same two patents.
Nine opponents challenged Moderna’s EP 949 at the EPO. BioNTech is fighting with the support of regular counsel ZSP Patentanwälte. Thomas Wilk and Georg Schnappauf had the lead in the EPO proceedings. Hoyng ROKH Monegier partner Christine Kanz is responsible for the German infringement proceedings. Her firm is also involved in the Dutch and Belgian proceedings for BioNTech.
Pfizer and Sanofi also filed their attacks with the support of Munich-based firm df-mp Dörries Frank-Molnia & Pohlman and UK firm Carpmaels & Ransford respectively. Df-mp founder Ulrich Dörries and Carpmaels partner David Holland had the lead in each case. GlaxoSmithKline was represented by its own in-house attorneys. Dutch company etherna Immunotherapies relied on a team from Dutch mixed firm Arnold & Siedsma.
The UK patent attorney firms Patent Boutique, Kilburn & Strode, Withers & Rodgers and the German law firm Maiwald filed straw man actions. Withers & Rodgers acted as opponent, but was represented by the Munich law firm Graf von Stosch.
From the beginning of the dispute Moderna has relied on a team of lawyers from Freshfields Bruckhaus Deringer and of patent attorneys from Hoffmann Eitle. Partner James Ogle of the latter firm had the lead in the EPO proceedings regarding EP 949. Shortly before the oral hearing in early May, Moderna also took on board Carla Roth and Lars Hemsath from the Düsseldorf patent attorney firm König Szynka Tilmann von Renesse. Both patent attorney practices are among the leading outfits for pharmaceutical and biotech patents in Germany.
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. 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.