Bayer Sues Pfizer, Moderna, BioNTech and J&J Over Alleged COVID-19 Vaccine Patent Infringement

Bayer has launched a new round of high-stakes patent litigation against the makers of several leading COVID-19 vaccines, alleging that they improperly used intellectual property originally developed by Monsanto decades ago. 

In separate lawsuits filed in U.S. federal courts, the German life sciences giant accuses Moderna, Pfizer and its partner BioNTech, and Johnson & Johnson of infringing patented technology related to mRNA optimization. Bayer filed complaints against Moderna and against Pfizer and BioNTech in federal district court in Delaware, while its case against Johnson & Johnson was filed in U.S. district court in New Jersey. 

At the center of the dispute is a technology designed to modify or remove so-called “problem” coding sequences in genetic material. According to Bayer, this process, often referred to as codon optimization, improves the stability of messenger RNA and enhances the amount or quality of protein produced by cells. Bayer argues that this technology was critical to the development and commercial success of COVID-19 vaccines. 

The intellectual property in question traces back to Monsanto, the agricultural biotechnology company Bayer acquired for $66 billion in 2016. Monsanto first sought patent protection for the technology in 1989, and the U.S. Patent and Trademark Office ultimately granted the patent in 2010, according to the lawsuits. Monsanto originally applied the technology in agriculture, using it to boost the expression of insect-resistant proteins in genetically modified crops. That innovation reduced reliance on pesticide sprays and increased crop yields. 

Bayer now contends that vaccine makers relied on the same foundational approach to overcome one of the biggest technical hurdles in mRNA vaccine development: instability that can lead to poor protein expression. In its complaint against Pfizer and BioNTech, Bayer argues that solving this problem was essential to improving the vaccines’ ability to confer immunity to the virus. The company also points to public statements in which BioNTech has acknowledged using codon optimization in its mRNA products. 

Although Johnson & Johnson’s COVID-19 vaccine was based on a more traditional viral vector platform and is no longer on the market, Bayer claims the technology was still used to increase mRNA stability and protein expression during development. 

Pfizer and Johnson & Johnson declined to comment on the lawsuits. Moderna and BioNTech confirmed they are aware of the litigation but did not provide further details. 

Bayer is seeking jury trials in all cases and is asking for monetary damages, including a share of proceeds from past vaccine sales as well as royalties on any future sales. In its filing against Pfizer and BioNTech, Bayer noted that the companies reported more than $93 billion in revenue from their COVID-19 vaccine, Comirnaty. 

The lawsuits add to an already crowded and contentious legal landscape surrounding mRNA technology. Pfizer, BioNTech and Moderna have faced multiple infringement claims from other pharmaceutical and biotech companies. Just five months ago, GSK reached a $320 million settlement with Pfizer and BioNTech in a dispute that also involved German mRNA specialist CureVac. GSK has separately sued Moderna over similar allegations, while Moderna has filed its own lawsuit against Pfizer and BioNTech. Several smaller biotech firms have also asserted patent claims related to mRNA platforms. 

Taken together, the cases highlight how decades-old biotechnology patents, many developed for agriculture or basic research, are now being tested in court as companies seek to define ownership and value in the rapidly evolving mRNA vaccine market.