Amid the global fight against the COVID-19 pandemic, Moderna and BioNTech, leading pharmaceutical companies responsible for the development of mRNA vaccines, find themselves embroiled in a patent dispute. Moderna has filed lawsuits against BioNTech in multiple countries, including Germany, the UK, the Netherlands, Belgium, and Ireland, over two patents related to mRNA technology.
The primary concern of the legal battle centers around Moderna’s 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. While both patents are related to mRNA vaccines, their applications differ. EP 949 focuses on modified mRNA, while EP 565 covers the “betacoronavirus mRNA-LNP vaccine,” an improved substance for preventing COVID-19 and other respiratory diseases.
Moderna claims that Pfizer and BioNTech copied essential features of its patented technologies crucial to the success of mRNA vaccines. It asserts that both competitors were not at the same level of mRNA vaccine development as Moderna before the pandemic. However, Moderna is not seeking an injunction to remove BioNTech’s Comirnaty vaccine from the market. Instead, it is requesting damages for all sales made by its competitors after March 8, 2022.
In response, BioNTech, supported by other opponents including Sanofi, Glaxo Smith Kline, and several strawman opponents, has filed an opposition against Moderna’s EP 565 at the European Patent Office (EPO). The EPO’s Opposition Division has already revoked EP 565 due to added matter, and it remains to be seen whether Moderna will appeal this decision.
The German infringement proceedings concerning patent EP 565 are currently on hold. Both Moderna and BioNTech have sought legal representation to navigate these complex disputes. Moderna is represented by a team from Hoffmann Eitle, while BioNTech relies on a team from the Munich-based patent attorney firm Zwicker Schnappauf.
As the legal battle unfolds, the outcome of this patent dispute will not only impact the future of mRNA vaccines but also have broader implications for the pharmaceutical industry as a whole.
Frequently Asked Questions:
1. What are mRNA vaccines?
mRNA vaccines are a type of vaccine that uses messenger RNA to instruct cells in the body to produce proteins that trigger an immune response. This approach has become increasingly important in the development of COVID-19 vaccines.
2. What is the patent dispute between Moderna and BioNTech about?
The patent dispute revolves around two patents owned by Moderna: EP 3 590 949 B1 and EP 3 718 565 B1. Moderna claims that BioNTech and Pfizer copied key features of its patented technologies related to mRNA vaccines.
3. What is the current status of the dispute?
The European Patent Office (EPO) has revoked one of Moderna’s patents, EP 565, due to added matter. It is unclear whether Moderna will appeal this decision. The German infringement proceedings for patent EP 565 are currently suspended.
4. What are the potential implications of the outcome of this patent dispute?
The outcome of this patent dispute will not only impact the future of mRNA vaccines but also have broader implications for the pharmaceutical industry. It could shape the development and commercialization of mRNA-based therapies and set precedents for patent protection in the field of biotechnology.