Moderna and Freshfields triumph in Düsseldorf against BioNTech and Pfizer

Today, Düsseldorf Regional Court handed down its judgment in favour of Moderna in its battle against BioNTech and Pfizer for infringement of the former’s mRNA patents (case ID: 4b O 62/22).

In August 2022 Moderna filed infringement suits against Pfizer and BioNTech at the court concerning two patents, EP 3 590 949 and EP 3 718 565. Both protect “ribonucleic acids containing n1-methyl-pseudouracils and uses thereof” and “respiratory virus vaccines” respectively. Moderna accuses Pfizer and BioNTech of infringing both patents with their mRNA vaccine Comirnaty.

Early on Moderna emphasised that it is not seeking to remove Comirnaty from the various markets or seeking an injunction to prevent future sales. Instead, Moderna is requesting damages for all sales made by its competitors after 8 March 2022.

Judges find Moderna revoked use

The judges have now ordered the defendants to 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. This is according to a press release from the court seen by JUVE Patent.

BioNTech and Pfizer did not dispute having infringed the patent. However, both companies argued a press release distributed by Moderna in October 2020 authorised the use of the patent during the COVID-19 pandemic. BioNTech and Pfizer claimed this authorisation was valid until 5 May 2023 when the World Health Organisation declared the COVID-19 pandemic to be over, thus rendering the permission null and void.

The judges around presiding judge Daniel Voß did not follow this argument, stating that the Moderna had revoked the permission to use the patent by means of a further press release on 7 March 2022.

The high-calibre panel of Civil Chamber 4b included not only Daniel Voß but also Sabine Klepsch and judge Schröder. Like Daniel Voß, Klepsch is also a UPC judge and heads the parallel chamber 4c at Düsseldorf Regional Court. She helped out in the dispute by representing the sister chamber.

The parties may appeal to the Higher Regional Court Düsseldorf.

A spokesperson for BioNTech commented, “Today’s decision by the Düsseldorf District Court not to stay the infringement case related to EP 949 and its finding that EP 949 has been infringed by Pfizer and BioNTech do not change our unwavering and unequivocal stance that this patent is invalid. It is important to note that an appeal to the European Patent Office’s Technical Board of Appeal regarding the ongoing opposition to this patent is pending. Today’s decision has no immediate impact on Pfizer, BioNTech, or Comirnaty. We continue to believe that EP949 is invalid, and therefore not infringed, and will appeal the Düsseldorf District Court’s decision on this patent.”

The court has not yet determined how much money Moderna is owed. This will be determined in a separate proceeding.

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.

Back to life in 2024

However, 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.

After the EPO Opposition Division upheld EP 949 in May 2024 the related infringement case in Düsseldorf resumed. The EPO made slight changes to the originally filed version of EP 949 but these do not affect the claims on which Moderna bases its lawsuits in Germany and in the UK.

As a result of the EPO ruling the Düsseldorf Court proceeded with Moderna’s claims regarding EP 949. The panel around Daniel Voß heard the case on the 21 January 2025. In their current decision, the judges found the patent sufficiently valid in view of the Opposition Division’s decision which rejected the defendant’s opposition.

The fact that the dispute over the grant of the two Moderna patents continues at the EPO has not had an impact here. Appeals against both decisions are now pending before both Boards of Appeal but the boards have not yet scheduled any oral hearings.

First win for Moderna in UK

In early July 2024, Moderna celebrated a big win in the UK. The High Court found Pfizer and BioNTech are infringing Moderna’s EP 949 with their COVID-19 vaccine Comirnaty and owe the US company damages. However, High Court judge Richard Meade also declared EP 565 invalid. An appeal against the decision is now also pending. The UK Court of Appeal will probably hear it next summer.

Additionally, the Court of Appeal in the Netherlands will probably review a first-instance decision in the summer. In late 2023, Moderna suffered a defeat at the District Court The Hague when the court declared the Dutch part of EP 949 invalid due to lack of novelty.

Pan-European teams

Moderna instructed a pan-European team from Freshfields for the infringement proceedings spanning several European countries. Amsterdam partner Rutger Kleemans leads and coordinates the team.

In the German proceedings Freshfields partners Nina Bayerl and Frank-Erich Hufnagel have the lead. Elena Hennecke, Vanessa Werlin, Anton Porsche, and Denise Gruber complete the full-service law firm’s team.

Right from the start, Moderna has also relied on a team of patent attorneys from Hoffmann Eitle. Partner James Ogle had the lead in the EPO proceedings regarding EP 949. Joachim Renken and David Miller also belong to the team.

Shortly before the oral hearing at the EPO, Moderna also took on board Düsseldorf-based patent attorneys Carla Roth and Lars Hemsath. At that time both worked at IP firm König Szynka Tilmann von Renesse. In February large parts of the firm merged into Hoffmann Eitle, bulding one of the strongest outfits for pharmaceutical and biotech patents in Germany.

Continuity on defendant side

BioNTech’s go-to firm for various disputes over mRNA vaccines is Hoyng ROKH Monegier. Düsseldorf-based partner Christine Kanz is responsible for the German infringement proceedings. Her team includes Andreas Staudigel, Max von Leitner, Moritz Lohr and patent attorney Carolin Wollschlaeger. Hoyng ROKH is also involved in the Dutch and Belgian proceedings for BioNTech.

Kanz and her team are also representing BioNTech in a newly filled claim at the Unified Patent Court. Earlier this year, US biotech company Promosome claimed BioNTech and Pfizer have infringed one of its patents. On the patent attorney side BioNTech retained Munich-based firm Zwicker Schnappauf & Partner. Partners Georg Schnappauf and Thomas Wilk are not only involved in the EPO and UPC proceedings but also in the German infringement cases. In the UK, BioNTech’s firm of choice is Powell Gilbert.

Pfizer has also relied on law firm Taylor Wessing since the beginning of the dispute in most European countries. The full service firm is active for Pfizer in Germany, Belgium, the UK and the Netherlands. The German team is lead by Munich-based partners Anja Lunze and Gisbert Hohagen and also includes salary partners Nora Wessendorf, Verena Bertram, and Julius Zacharias as well as associate Aurel-Damian Roscher.

On the patent attorney side, Pfizer relies on Munich IP-firm df-mp with a team comprising Ulrich Dörries, Michael Eder, and Nicolas Raeder. Dörries also represents Pfizer in the EPO opposition proceedings.