The legal battle over mRNA vaccine technology has intensified as Moderna pursues patent infringement claims against Pfizer and BioNTech in multiple jurisdictions, with both sides experiencing victories and setbacks in what has become one of the pharmaceutical industry's most significant intellectual property disputes.
Moderna initiated the conflict in August 2022, filing complaints in the United States and Germany alleging that Pfizer and BioNTech's Comirnaty vaccine infringes on multiple patents covering Moderna's Spikevax technology. The lawsuit specifically claims that Comirnaty uses a chemical modification to prevent unwanted immune responses—a technology Moderna says its scientists discovered—and employs a lipid nanoparticle formulation that infringes on Moderna's intellectual property.
"We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," said Moderna's chief executive Stéphane Bancel.
Pfizer and BioNTech responded with surprise, stating that Comirnaty "was based on BioNTech's proprietary mRNA technology and developed by both BioNTech and Pfizer." They pledged to "vigorously defend against the allegations of the lawsuit."
Global Legal Battleground Expands
The dispute has since expanded internationally, with Moderna filing additional cases in the UK, Ireland, the Netherlands, and Belgium. In a significant development in March 2025, the Düsseldorf Regional Court in Germany ruled in favor of Moderna, finding that Pfizer and BioNTech had indeed infringed on one of Moderna's European patents and "should pay appropriate compensation."
However, Moderna faced a setback that same month when the U.S. Patent Trial and Appeal Board (PTAB) found all claims of one of Moderna's challenged patents unpatentable. Given the financial stakes, this ruling will likely be appealed.
Broader Patent Ecosystem
The Moderna-Pfizer/BioNTech dispute is just one facet of a complex web of litigation surrounding mRNA vaccine technology. Several other companies have staked claims to various aspects of the technology:
Arbutus Biopharma and Genevant Sciences filed complaints against Moderna in February 2022, alleging that Spikevax infringes on their lipid nanoparticle delivery system patents. This case has progressed steadily, with trial set for September 2025. Arbutus later expanded its litigation to include Pfizer and BioNTech in April 2023.
Alnylam Pharmaceuticals has sued both Moderna and Pfizer/BioNTech, claiming infringement of patents related to cationic lipids used in their respective vaccines. While some claims against Moderna were dismissed on non-infringement grounds (a decision currently under appeal), the case against Pfizer and BioNTech continues with trial scheduled for July 2025.
CureVac, another mRNA pioneer, sued BioNTech in Germany in June 2022, prompting BioNTech and Pfizer to file for declaratory judgment of non-infringement in the U.S. and England. CureVac has faced setbacks, with courts in Germany and the UK invalidating some of its patents, but its U.S. case remains active with trial set for September 2025.
More recently, GSK entered the fray in 2024, filing patent infringement suits against both Moderna and Pfizer/BioNTech in the District of Delaware.
Financial Implications
The financial stakes in these disputes are enormous. Pfizer reported $32 billion in Comirnaty sales for 2022, while Moderna forecast $22 billion for Spikevax in the same period. With combined vaccine sales potentially exceeding $100 billion, damages calculations based on reasonable royalties could result in substantial awards.
Several significant settlements have already occurred. Moderna agreed to pay the National Institutes of Health (NIH) $400 million, while BioNTech settled with NIH for $791.5 million. Both agreements reportedly include ongoing low single-digit royalties on future vaccine sales. Additionally, BioNTech settled a breach of contract case with the University of Pennsylvania for $467 million in December 2024.
Moderna's Evolving Patent Enforcement Strategy
Notably, Moderna had initially pledged not to enforce its COVID-19-related patents during the height of the pandemic. However, the company changed its policy in March 2022, stating that "the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world."
While maintaining its commitment never to enforce patents on COVID-19 vaccines in lower-income countries, Moderna now expects companies like Pfizer and BioNTech "to respect its intellectual property rights and consider a commercially reasonable license" in more developed markets.
Looking Forward
As these cases progress through various court systems worldwide, the outcomes will likely shape the future of mRNA technology development and commercialization. Key rulings expected in 2025 could establish precedents for intellectual property rights in this revolutionary technology platform.
The litigation also highlights the complex innovation ecosystem that enabled the rapid development of mRNA vaccines. While companies like Moderna and BioNTech were at the forefront of bringing these products to market, their work built upon decades of research by numerous entities, many of which are now seeking recognition and compensation for their contributions.
For the pharmaceutical industry, these cases represent more than just a battle over COVID-19 vaccine profits. The precedents established will influence how mRNA technology can be used for future vaccines and therapeutics, potentially affecting treatments for cancer, autoimmune disorders, and other conditions where this platform shows promise.
