Moderna has filed a patent infringement suit against Pfizer and BioNTech at the Regional Court Düsseldorf and in the US over mRNA vaccines. In Germany, the company has asserted two patents, hoping to claim damages from its competitor and its various subsidiaries.
29 August 2022 by Mathieu Klos
Moderna has filed an infringement claim at the Düsseldorf Regional Court (case ID: 4b O 62/22). As the company announced last Friday, it also filed suits in the United States District Court for the District of Massachusetts.
In Düsseldorf, Moderna has asserted EP 35 90 949 and EP 37 18 565. However, the suit is only for damages, not injunctive relief. It is likely that Moderna chose this route to ensure the supply of vaccines to the population. During the height of the covid pandemic, mRNA patent owners hesitated to file lawsuits against competitors. Primarily, this was to avoid causing political and social uproar.
In May, CureVac became the first mRNA patent owner to file a lawsuit against BioNTech at the Düsseldorf Regional Court.
The US lawsuit is already public, while the German ones are not. However, Moderna’s press release gives an indication of Moderna’s motives.
Moderna believes Pfizer and BioNTech copied two key features of Moderna’s patented technologies. These are critical to the success of mRNA vaccines. Moderna believes that neither Pfizer nor BioNTech were at the same level of mRNA vaccine development as Moderna prior to the Corona pandemic. The company says, “They knowingly followed our lead in developing their own vaccine.”
The press release continues, “First, Pfizer and BioNTech took four different vaccine candidates into clinical testing, which included options that would have steered clear of Moderna’s innovative path. Pfizer and BioNTech, however, ultimately decided to proceed with a vaccine that has the same exact mRNA chemical modification to its vaccine as Spikevax®. Moderna scientists began developing this chemical modification in 2010 and were the first to validate it in human trials in 2015.”
It adds, “Second, and again despite having many different options, Pfizer and BioNTech copied Moderna’s approach to encode for the full-length spike protein in a lipid nanoparticle formulation for a coronavirus. Moderna scientists developed this approach when they created a vaccine for the coronavirus that causes Middle East Respiratory Syndrome (MERS) years before COVID-19 first emerged.”
However, observers knew early on that Moderna had long believed that BioNTech and Pfizer infringed its patents through its own Covid-19 vaccines. Experts had therefore expected lawsuits against the two competitors for some time.
Moderna justified the move last Friday, saying, “Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax.”
Pfizer and BioNTech sell their Covid-19 vaccine under the Comirnaty brand.
Moderna’s chief legal officer, Shannon Thyme Klinger, says, “We believe that Pfizer and BioNTech unlawfully copied Moderna’s inventions, and they have continued to use them without permission. Outside of AMC 92 countries, where vaccine supply is no longer a barrier to access, Moderna expects Pfizer and BioNTech to compensate Moderna for Comirnaty’s ongoing use of Moderna’s patented technologies.”
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. Moderna is not seeking damages related to Pfizer’s sales to AMC 92 countries.
Moderna also emphasised, in regard to the still-strained situation with COVID infections, that it is not seeking to remove Comirnaty from the market. But, 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.
The US company is also not seeking damages for Pfizer’s sales where the US government would be responsible for any damages.
Moderna chief executive officer Stéphane Bancel says, “We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered and patented during the decade preceding the COVID-19 pandemic. This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016.”
Bancel adds, “Moderna is using our mRNA technology platform to develop medicines that could treat and prevent infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer.”
Experts have long suspected that lawsuits, such as the current case are not so much aimed at competitors’ Covid-19 vaccine. Rather, it is hoped they will provide clarity for the development of future mRNA-based drugs.
The lawsuit at Düsseldorf Regional Court is still new. In all likelihood, the court will split the lawsuit according to the two patents. According to JUVE Patent information, the two lawsuits are directed against various companies belonging to Pfizer and BioNTech.
In the US, Moderna sued Pfizer as well as BioNTech SE and BioNTech US Inc. It also sued the German subsidiary, BioNTech Manufacturing GmbH.
BioNTech responded to the lawsuits over the weekend. In a statement, the company says, “BioNTech’s work is original, and we will vigorously defend against all allegations of patent infringement. BioNTech also values and respects valid and enforceable intellectual property rights of others and remains confident in its intellectual property.”
The Mainz-based company did not provide details on its legal strategy. However, in the case of CureVac’s lawsuit, BioNTech quickly responded with a counterclaim in the United States.
BioNTech asked the District Court of Massachusetts for a declaratory judgment that its mRNA vaccine against COVID-19 does not infringe CureVac’s US patents. With a quick ruling from the US, BioNTech presumably wants to cement early facts for the German proceedings.
Observers consider it certain that BioNTech will not leave Moderna’s lawsuits unanswered. Likewise, Moderna could follow up with further lawsuits in other countries.
WilmerHale, as lead counsel, filed the lawsuits for Moderna in the US. However, Freshfields Bruckhaus Deringer filed the suits in Europe, with Amsterdam partner Rutger Kleemans coordinating proceedings. Kleemans has long-standing contacts with Moderna. Frank-Erich Hufnagel and Nina Bayerl filed the lawsuits in Düsseldorf. The firm appointed Bayerl as partner at the beginning of the year.
Freshfields and Wilmer Hale are acquainted through numerous global disputes for Apple over mobile technology.
Hoffmann Eitle provided technical support for the German lawsuits. The patent attorneys have a long-standing relationship with Moderna. The firm filed EP 949, for example, while Mathys & Squire filed EP 565.
Hoffmann Eitle files numerous patents for Moderna in Europe and also represents the company in EPO oppositions against mRNA patents. However, parties have never challenged EP 949 and EP 565 in oppositions.
In both US proceedings against CureVac and Moderna, BioNTech relies on global law firm, Paul Hastings. In the German proceeding, BioNTech again relies on Hoyng ROKH Monegier. Düsseldorf-based partner Christine Kanz is also defending the Mainz-based company against CureVac’s latest claim in Düsseldorf.
JUVE Patent cannot yet confirm which patent attorney firm advises the technical parts of the German proceeding. In the CureVac cases, BioNTech relies on the patent attorneys of Zwicker Schnappauf & Partner in Munich.
Name partner Georg Schnappauf not only files patents for BioNTech, but also supported the young company for a long time in setting up its own IP department.
Freshfields Bruckhaus Deringer (Düsseldorf/Munich): Rutger Kleemans (lead Europe, Amsterdam), Frank-Erich Hufnagel (lead Germany), Nina Bayerl (all partners); associates: Sabrina Biedermann, Elena Hennecke
Hoffmann Eitle (Munich): Joachim Renken, James Ogle (both partners, both patent attorneys)
Hoyng ROKH Monegier (Düsseldorf): Christine Kanz, Martin Köhler; associates: Valentin Wagner, Maximilian Schellhorn, Max von Leitner
Regional Court Düsseldorf, 4b Civil Chamber
Daniel Voß (presiding judge)
Update 20.12.2022: In autumn 2022, Moderna filed claims against BioNTech and Pfizer in UK as well as in the Netherlands. Freshfields partner Rutger Kleemans coordinates the European litigation for the US pharmaceutical company and works closely with the Freshfields teams in London and Düsseldorf.
A pan-European team from Taylor Wessing’s offices in Munich, London and Amsterdam acts for Pfizer in all three jurisdictions. While Powell Gilbert is acting for BioNTech in the UK, in the Netherlands – just like in Germany – Hoyng ROHK Monegier is advising BioNTech.
Parallel to this dispute, CureVac also sued BioNTech and Pfizer in Germany and UK.
JUVE Patent updated this article on 20.12.2022 to reflect the latest developments in the ongoing case over COVID-19 vaccines.