Vaccine technology

Moderna targets Ireland and Belgium in next round against Pfizer and BioNTech

In the next stage of COVID-19 vaccine patent suits, US pharmaceutical company Moderna has filed patent infringement suits at the High Court in Dublin against Pfizer and BioNTech. The company has also filed a suit at the Brussels Commercial Court in Belgium. Now all three companies are going head-to-head in four European countries, as well as in two parallel cases in the US and the UK.

11 July 2023 by Amy Sandys

In July 2023, US biotechnology company Moderna sued Pfizer and BioNTech for patent infringement in Ireland. It has also filed a corresponding suit in Belgium. ©Ustun/ADOBE STOCK

Ireland and Belgium are the next two targets for Moderna’s campaign for damages over alleged infringement, by Pfizer and BioNTech, over mRNA vaccine technology. According to JUVE Patent information, the court heard Moderna’s motion to seek entry to the High Court’s Commercial IP & Technology list on 3 July 2023, over two patents it alleges are infringed by the defendants.

The judge admitted the matter to the commercial list on consent, making an order in respect of the directions which the parties had agreed. In Ireland, the court will hear the case in 2024. However, less is known about the current Belgian state of play.

Moderna seeks compensation

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 suits in 2022, Moderna emphasised that it was not looking to remove Comirnaty from the market. However, while Moderna is not looking for an injunction to prevent future sales, it is requesting damages for all sales made by its competitors after 8 March 2022.

According to a press release, which the company published in 2022 upon commencement of proceedings, Moderna believes Pfizer and BioNTech copied two key features of Moderna’s patented technologies critical to the success of mRNA vaccines. It states that neither Pfizer nor BioNTech were at the same level of mRNA vaccine development as Moderna prior to the COVID-19 pandemic, stating, “They knowingly followed our lead in developing their own vaccine.”

BioNTech responded at the time, saying “BioNTech’s work is original, and we will vigorously defend against all allegations of patent infringement.”

Damages, not injunction

Early on, Moderna asserted that it would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the so-called Gavi COVAX Advance Market Commitment (AMC 92). This remains the case for the newly-filed lawsuits in Ireland and Belgium. Moderna is not seeking damages related to Pfizer’s sales to AMC 92 countries, nor any damages for Pfizer’s sales where the US government would be responsible for any damages.

As well as the latest suits in Ireland and Belgium, most recently Moderna also filed a lawsuit at Düsseldorf Regional Court, which the court is likely to split according to the two patents EP 3 590 949 and EP 3 718 565.

According to JUVE Patent information, the two lawsuits are directed against various companies belonging to Pfizer and BioNTech. Proceedings over the same mRNA technology are also pending in the UK, the US and the Netherlands.

Pharma expertise for Moderna

In Ireland, several law firms are involved in proceedings. Leading Irish commercial law firm William Fry represents Moderna, with Laura Scott the partner in charge. She has specific experience in pharmaceutical cases, including previously acting for Eli Lilly in infringement and revocation proceedings against a Novartis patent, and for ViiV Healthcare against Gilead over an anti-retroviral HIV treatment. She also acts for Clonmel Healthcare in the CJEU referral, heard by the Supreme Court in Ireland, over cholesterol-lowering drug, Inegy.

Elsewhere, Amsterdam-based Freshfields Bruckhaus Deringer partner Rutger Kleemans coordinates the European litigation for the US pharmaceutical company. He works closely with the Freshfields teams in London and Düsseldorf, which also act for Moderna in the proceedings. In Belgium, according to JUVE Patent information, law firm Altius led by partners Christophe Ronse and Kirian Claeyé acts for the US company. WilmerHale is coordinating proceedings in the US.

IP boutique up again

According to JUVE Patent information, like in the German proceedings, the Belgium office of Hoyng ROKH Monegier is acting for co-defendant BioNTech. In Ireland, the Dublin office of DLA Piper represents the German biotechnology company, led by partner Aoife Murphy. She recently moved to the international firm from full-service firm Whitney Moore, where she had been a partner for 18 years. While at her previous firm, Murphy represented Merck Sharp & Dohme at the Supreme Court over the CJEU referral regarding Inegy.

In both US proceedings against CureVac and Moderna, BioNTech relies on global law firm, Paul Hastings. IP boutique Powell Gilbert, which also recently opened an office in Ireland, is acting for BioNTech in the UK.

Taylor Wessing coordinates in Eurpoe

Fiona O’Beirne, who has been a partner at McCann FitzGerald for over 32 years, is the lead partner for Pfizer in Ireland. She has previously acted for Bristol-Myers Squibb in Commercial Court patent litigation against Merck Sharp & Dohme in relation to a patent protecting the use of antibodies for cancer treatment.

A pan-European team from Taylor Wessing’s offices in Munich, London and Amsterdam acts for Pfizer in all three jurisdictions, with the Belgian team taking on the case in Brussels. Patricia Cappuyns is the partner leading for Pfizer. She joined the team just over a year ago from Fox IP.

For Moderna (Irish proceedings)
William Fry (Dublin): Laura Scott (partner); associates: John Sugrue, Aisling Casey

For Moderna (Belgian proceedings)
Altius (Brussels): Christophe Ronse (partner); associate: Kirian Claeyé (counsel)

For BioNTech (Irish proceedings)
DLA Piper (Dublin): Aoife Murphy, Gavin Woods (both partners)

For BioNTech (Belgian proceedings)
Hoyng ROKH Monegier (Brussels): No information

For Pfizer (Irish proceedings)
McCann FitzGerald (Dublin): Fiona O’Beirne

For Pfizer (Belgian proceedings)
Taylor Wessing (Brussels): Patricia Cappuyns (partner); associates: Narmeen Al Ganim, Alexandre Domken

High Court of Ireland, Commercial Court, Dublin
Denis McDonald (presiding judge)