EPO revokes Moderna patent in vaccine dispute with BioNTech

Moderna had sued its Mainz-based competitor BioNTech in several countries, including Germany, the UK, the Netherlands, Belgium and Ireland. The dispute revolves around Moderna’s two patents EP 3 590 949 B1 and EP 3 718 565 B1, which protect “ribonucleic acids containing n1-methyl-pseudouracils and uses thereof” and “respiratory virus vaccines” respectively.

However, while both patents are concerned with mRNA vaccines, they have different applications. EP 949 is concerned with claims concerning modified mRNA. EP 565 covers the “betacoronavirus mRNA-LNP vaccine”, an improved substance for the prevention of contracting COVID and other respiratory diseases.

A host of opponents

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 infringement 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.

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

BioNTech battles on two fronts

BioNTech and others filed an opposition against EP 565 at the EPO in September 2022. In addition to the Mainz-based biotech company and its partner Pfizer, Sanofi is also among the opponents of EP 565. The list of opponents of EP 949 also includes other well-known pharmaceutical companies such as Glaxo Smith Kline and a number of strawman opponents. Further oppositions relating to mRNA technology are pending against Moderna’s EP 2 791 160 B1, EP 3 682 905 B1 and EP 3 134 131 B1.

The EPO’s Opposition Division has now revoked EP 565 due to added matter. Moderna confirmed to JUVE Patent that it will appeal the EPO’s decision.

The Regional Court Düsseldorf will hear the case concerning EP 565 as well as EP 949 on 12 December.

Moderna changes representatives

Moderna relied on a team from Hoffmann Eitle. The firm had taken over from Mathys & Squire. London-based patent attorney David Miller had originally filed the EP 565 and represented the biotech firm at the beginning of the opposition proceedings. When he moved to Hoffmann Eitle as partner in January 2023, he continued to represent Moderna at his new firm.

David Miller

The patent attorneys of the mixed German firm Hoffmann Eitle represent the pharmaceutical company in oppositions against its other mRNA patents. They also provide technical support in the parallel infringement proceedings in Germany.

For the legal advice in the infringement proceedings spanning several European countries, Moderna instructed a pan-European team from Freshfields Bruckhaus Deringer.

Newcomer to ZSP

A team from the Munich patent attorney firm Zwicker Schnappauf was responsible for the first opposition against EP 565 on behalf of BioNTech in September 2022. Further opponents followed suit. Sebastian Höpfner, who joined ZSP from Bird & Bird in spring 2022, is conducting the current proceedings for BioNTech. In the parallel infringement proceedings, the patent attorneys are cooperating with the patent litigators at Hoyng ROKH Monegier.

ZSP is known for its expertise in pharma and biotechnology patents and has been expanding its team for several years. In January, Jens Schiener joined the firm as a partner. Peer Gaentzsch joined the patent attorneys in early November from Berlin law firm ETL IP. Gaentzsch previously worked at ZSP as a trainee patent attorney from 2009 to 2011 and as a patent attorney from April 2013 to early 2022. He specialises in biology, biochemistry and neuroscience and has experience in patent litigation.

Strong in life sciences

Pfizer followed the example of its cooperation partner BioNTech and also filed an opposition against the patent in January of this year. Munich patent attorney firm df-mp represents the company. The team around the renowned name partner Ulrich Dörries is known for its expertise in pharma proceedings. In addition to the opposition proceedings, df-mp is also advising the US pharmaceutical company on technical issues in the parallel infringement proceedings. A pan-European team from Taylor Wessing‘s offices in Munich, London, Amsterdam and Brussels is acting for Pfizer in all four jurisdictions.

In this and other oppositions involving mRNA technology, Sanofi relies on the patent attorneys of Carpmaels & Ransford. The mixed UK law firm enjoys a strong reputation for prosecution and litigation in life sciences. The team had a long-standing client relationship with Translate Bio, which was acquired by Sanofi in September 2021. Since the acquisition, Carpmaels & Ransford has regularly acted for the pharmaceutical company.

The British patent attorney firm Withers & Rogers had initially filed an opposition as a strawman, but transferred its representation to the German patent attorney firm Graf von Stosch in early October.

For Moderna
Hoffmann Eitle (London): David Miller (partner, patent attorney)

Sebastian Höpfner

For BioNTech
Zwicker Schnappauf & Partner (Munich): Sebastian Höpfner, Georg Schnappauf, Thomas Wilk (all partners, all patent attorney)

For Sanofi
Carpmaels & Ransford (London): David Holland (patent attorney)

Withers & Rogers
Graf von Stosch (Munich): Andreas Graf von Stosch (patent attorney)

For Pfizer
df-mp (Munich): Michael Eder, Ulrich Dörries (both partners); associate: Elfrun Ratzke (all patent attorneys)

22.11.23: JUVE Patent has corrected and amended this article to include information regarding when the infringement hearing will take place at the Regional Court Düsseldorf and that Moderna plans to appeal to the EPO.