Mixed Verdict in Pfizer v. Moderna COVID-19 Vaccine Patent Dispute
On July 2nd, the High Court in London ruled in favor of Moderna, determining that Pfizer infringed one of Moderna's patents related to their COVID-19 vaccine. However, the court also invalidated a second Moderna patent. Both companies expressed their disagreement with the ruling and signaled intentions to appeal.
Background of the Case
The disputes began in 2022 when Moderna claimed that its patents had been infringed by Pfizer and its German partner BioNTech in several countries, including the UK. The contested patents, EP 35 90 949 B1 and EP 37 18 565 B1, pertain to "ribonucleic acids containing N1-methyl-pseudouracils and their uses" and "respiratory virus vaccines," respectively. Pfizer and BioNTech aim to invalidate these two patents held by Moderna.
Moderna claims that Pfizer and BioNTech copied key features of its mRNA technologies, which were developed and patented between 2010 and 2016. In 2022, Pfizer’s Comirnaty vaccine generated $11.2 billion in sales, while Moderna’s Spikevax brought in $6.7 billion.
A Global Legal Battle
The legal conflict is part of a global dispute with parallel proceedings in multiple jurisdictions including Germany, the Netherlands, Belgium, the U.S., Ireland, and at the European Patent Office. It marks a shift from the unusual collaboration among pharmaceutical companies during the pandemic to a return to typical industry competition and patent enforcement.
Moderna filed lawsuits in the United States and Germany, alleging that Pfizer and BioNTech's COVID-19 vaccine, Comirnaty. Seeking compensation and damages, Moderna has stressed that it does not intend to remove Comirnaty from the market but expects its intellectual property rights to be respected in developed markets. Moderna is open to offering a commercially reasonable license and will not enforce its patents against manufacturers in low- and middle-income countries.
In response, Pfizer and BioNTech challenged the validity of Moderna's patents at the U.S. Patent and Trademark Office's Patent Trial and Appeals Board in August 2023. They argue that Moderna's patents are overly broad and invalid, claiming that Moderna's lawsuit overlooks the contributions of other organizations involved in the pandemic response.
Implications to the Industry
The mixed ruling presents both challenges and opportunities for Moderna. The invalidation of its EP 3 718 565 respiratory virus vaccine patent is a significant setback, weakening its patent portfolio. However, the court's decision to uphold another key patent allows Moderna to potentially collect damages from Pfizer and BioNTech for sales of the infringing vaccine, reinforcing its intellectual property in the mRNA space.
This ongoing legal uncertainty may hinder the advancement of this promising vaccine technology. The broader legal battle over mRNA vaccine intellectual property highlights the complex trade-offs between protecting IP rights, fostering innovation, and ensuring access to life-saving vaccines.
Policymakers may need to revisit issues like patent term extensions, compulsory licensing, and the scope of patentable subject matter to ensure a sustainable innovation ecosystem for vaccines and other critical medical technologies. Balancing innovation incentives with public health needs will be crucial for shaping the future of the vaccine industry and enhancing global pandemic response efforts.