Moderna prevails in patent dispute against Pfizer/BioNTech
On March 8, 2025, the Düsseldorf Regional Court ruled in a widely noted case that Pfizer and BioNTech infringed Moderna’s patent rights with their mRNA vaccine (Ref.: 4b O 62/22). The judgment marks another significant step in the complex field of industrial property protection in biotechnological research and could have considerable consequences for the biopharmaceutical product market. The decision is not yet final; appeals are possible and the further course remains to be seen.
Background of the legal dispute
The legal dispute between Moderna and Pfizer/BioNTech centers on the extent to which innovations in the development of mRNA-based vaccines are protected by patent law and whether the use of certain technologies by third parties without the consent of the rights holder is permissible. The proceedings primarily hinged on whether the patents held by Moderna, EP 3 718 565 B1 and EP 3 590 949 B1, were infringed by the use of specific technologies in the manufacture of Pfizer/BioNTech’s COVID-19 vaccine (Comirnaty).
Key issues in dispute
At its core, the case concerned technical intellectual property rights relating to the development of mRNA-based vaccines. This includes, for example, the use of chemical modifications on mRNA components to increase the stability and efficacy of the active ingredients. The court found that the inventive steps claimed by Moderna exhibited both sufficient novelty and industrial applicability in terms of patent law, thereby affording comprehensive protection for the relevant technologies.
Defendant’s arguments presented
Pfizer/BioNTech rejected the allegations of patent infringement. In the proceedings, they invoked, among other things, exemptions such as the so-called Bolar provision (clinical trial exemption), and further argued that the technology in question was not developed solely under Moderna’s patents but had been independently developed by numerous research groups. The Regional Court dismissed these arguments and affirmed the validity and scope of the relevant patents.
Outlook and significance for the industry
The judgment by the Düsseldorf Regional Court is likely to serve as a signal for the entire mRNA research sector and the associated pharmaceutical development industry in Europe and beyond. The specific structuring of patents in forward-looking technology fields such as mRNA therapy is thus gaining strategic importance, also with regard to future research collaborations, licensing, and technology transfer agreements.
Innovation versus access to medicines
Beyond the narrow question of patent infringement, the case highlights the conflicts of interest between the protection of intellectual property and general access to essential medicines in the context of a pandemic. While the judgment solely addresses matters focused on technical property rights, it simultaneously brings the importance of international patent law agreements, like the TRIPS Agreement, and the discussion surrounding compulsory licensing back into focus.
Potential consequences for pharmaceutical manufacturers
In view of the decision, players in the life sciences sector must pay even closer attention to sufficiently considering any possible existing third-party intellectual property rights when developing and distributing medicines and vaccines, in order to avoid high-risk disputes. Pending or announced appeals may provide further clarification in this regard.
Procedural status and further developments
At the time of publication, the ruling is not final. It remains to be seen to what extent higher courts will confirm or modify the decision. In particular, the interpretation of complex patent law provisions and the balancing of innovation protection versus public interest will continue to be subject to judicial review and public debate. Readers are advised that the presumption of innocence remains in effect and the case can only be definitively assessed once it is legally concluded (Source: Düsseldorf Regional Court ruling, 4b O 62/22; urteile.news dated 10.03.2025).
The decision underscores the growing importance of intellectual property rights in the field of innovative medicines. Companies, investors, and research-intensive players operating in related technology sectors often face similar challenges. In complex matters of patent law, licensing agreements, or technical know-how protection, the lawyers at MTR Legal are ready to provide you with expert advice.
