Mikele Bicolli
Oct 6, 2023
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Landmark Hague Trial: Europe's First mRNA Vaccine Patent Dispute Begins Moderna vs. Pfizer and BioNTech

ANDA Litigation

 

 

In a groundbreaking legal battle, the District Court of The Hague is set to hear Europe's first case involving mRNA vaccine patents. Claimant Moderna is facing off against defendants Pfizer and BioNTech over allegations of patent infringement. This high-stakes dispute is a significant moment in the biotechnology and pharmaceutical industries, with implications for the future of vaccine technology.

The Patent Dispute Unveiled

The dispute centers around two patents owned by Moderna: EP 3 590 949 B1 and EP 3 718 565 B1. These patents are related to "Ribonucleic acids containing n1-methyl-pseudouracils and uses thereof" and "Respiratory virus vaccines." While both patents deal with mRNA vaccines, they have distinct applications. EP 949 focuses on modified mRNA, while EP 565 covers the 'Betacoronavirus mRNA-LNP vaccine,' designed to combat COVID-19 and other respiratory diseases.

The Battle Over mRNA Technology

mRNA technology is at the forefront of vaccine development, allowing cells to produce proteins to treat diseases or function as vaccines. Moderna has a substantial patent portfolio in this field and is actively enforcing it across multiple countries. This dispute stems from Moderna's allegations that Pfizer and BioNTech copied key features of its patented technology related to mRNA vaccines.

Key Legal Issues and 'Patent Pledge'

The case introduces intriguing legal questions, including the concept of a 'patent pledge.' Additionally, European Patent Office (EPO) opposition proceedings are underway concerning the patents in question. Observers anticipate that the court proceedings will provide valuable insights into these issues and their impact on patent law.

No Injunction, Just Damages

It's essential to note that Moderna is not seeking an injunction but rather damages against Pfizer and BioNTech's Comirnaty branded vaccine. This distinction highlights the focus on compensation rather than halting vaccine production.

International Ramifications

This legal battle extends beyond the Netherlands, with ongoing proceedings in Ireland, Belgium, the UK, the US, and Germany. In most cases, the court is expected to separate the lawsuit concerning the two patents.

Legal Representation

Moderna, Pfizer, and BioNTech have assembled formidable legal teams for the groundbreaking mRNA vaccine patent dispute in The Hague. Moderna is represented by Freshfields Bruckhaus Deringer, with Rutger Kleemans at the helm, supported by senior associate Ruben Laddé, along with a dedicated team of associates. V.O. brings its expertise to Moderna's side, with Jetze Beeksma and Henri Van Kalkeren, both partners and patent attorneys, lending their legal prowess to the case. On the opposing side, Pfizer has enlisted the services of Taylor Wessing, led by Charlotte Garnitsch and Eelco Bergsma, partners with a dedicated team of associates, including David Mulder, Yolandi Coetzee, Karlijn van Laar, Nicky Willemsen, Iris van der Heijdt, and Pauline Springorum. Representing BioNTech is Hoyng ROKH Monegier, with Theo Blomme and Peter van Schijndel, both partners, spearheading the defense, supported by an adept team that includes Jeroen den Hartog as counsel, Akiva Friedmann, Nathalie Rodrigues, Ella van Aanhold as a patent attorney, and Alba Folguieres González as a trainee patent attorney.

The outcome of this historic case will likely have far-reaching consequences for the future of mRNA vaccine development and patent law in Europe. Stay tuned for updates on this significant legal battle shaping the biotechnology landscape.

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