Moderna, Pfizer and BioNTech Head to The Hague for First mRNA Patent Dispute

One of Europe’s first big vaccine technology hearing is underway, as the parties convene at 9.30am at the District Court of The Hague to deliberate Moderna’s claims that Pfizer and BioNTech have infringed two of its patents for mRNA (case ID: C/09/643000). The defendants are counterclaiming for invalidity. However, Moderna has emphasised that it is seeking damages, rather than an injunction, against the defendants’ Comirnaty branded vaccine.

As well as being the first case over mRNA vaccines to be heard in the Netherlands, and the first in Europe concerning the three specific parties, observers expect that the hearing will give rise to interesting legal issues such as the so-called ‘patent pledge’. EPO opposition proceedings are also pending against the asserted patents.

Moderna asserts mRNA patents

Moderna has asserted the two patents EP 3 590 949 B1 and EP 3 718 565 B1, which pertain to “Ribonucleic acids containing n1-methyl-pseudouracils and uses thereof” and “Respiratory virus vaccines” respectively, against its competitors. However, while both patents are concerned with mRNA vaccines, they have different applications. EP 949 is concerned with claims concerning modified mRNA, while EP 565 covers the ‘Betacoronavirus mRNA-LNP vaccine’, an improved substance for the prevention of contracting COVID and other respiratory diseases.

mRNA is a new biotechnological approach which includes the administration of a nucleoside-modified messenger RNA sequence. This causes a cell to make a protein, which can then directly treat a disease or can function as an mRNA vaccine – for example, to combat COVID-19. Moderna has developed a patent portfolio encompassing this technology and is in the process of enforcing it across 13 countries globally.

Covid vaccine at issue

In 2020, Moderna developed its ‘Spikevax’ vaccine. In the same year, Pfizer and BioNTech also sold their COVID-19 vaccine under the Comirnaty brand. The claimant, which issued proceedings against the defendants at the end of 2022, is requesting damages for all sales made by its competitors after 8 March 2022.

According to a press release, which Moderna published in 2022 upon commencement of proceedings, the company 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.”

No injunction requested

Furthermore, early on in proceedings, 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).

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.

Thus, the proceedings in the Netherlands do not concern an injunction, but rather the recouping of damages.

Currently, proceedings are ongoing in Ireland, Belgium, the UK, the US and Germany. In most proceedings, it is expected that the court will split the lawsuit in two as regards to the two patents at issue.

In separate proceedings, the German company CureVac also accuses BioNTech of infringing one of its European patents, and three German utility models, with Comirnaty.

Dutch teams for mRNA dispute

Three prominent patent practices are representing the parties in the Dutch proceedings. After Moderna first announced its intention to pursue litigation against Pfizer and BioNTech, Freshfields Bruckhaus Deringer took over the case, led by partner Rutger Kleemans.

He is assisted in co-ordinating Moderna’s European strategy, which also encompasses Germany, Belgium, Ireland and the UK, by senior associate Ruben Laddé.

Both partners have worked closely with partners Laura Whiting, of the London office, and Nina Bayerl who works across Munich and Düsseldorf. Indeed, the only jurisdiction in which Freshfields is not representing Moderna is the US, where WilmerHale has taken over the instruction. In the Netherlands, the firm is working alongside patent attorney firm V.O.

Pfizer has retained go-to counsel Taylor Wessing, with partners Charlotte Garnitsch and Eelco Bergsma leading proceedings. However, 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. This is led by partner, Patricia Cappuyns, who often works very closely with the firm’s Dutch offering as part of its Benelux strategy,

Source: juve-patent.com-Amy Sandys

Editor: IPR Daily-Horace