Bayer's Monsanto sues mRNA COVID-19 vaccine makers

Bayer's agrochemicals unit Monsanto has filed lawsuits in the US against the manufacturers of mRNA-based COVID-19 vaccines, claiming that they used its patent-protected technology in their products.

One lawsuit – filed in a federal court in Delaware – asserts that Pfizer/BioNTech's Comirnaty and Moderna's Spikevax vaccines, which generated tens of billions of dollars in revenues during the pandemic, used technology developed by Monsanto in the 1980s designed to eliminate 'problem' coding sequences in the building blocks of cells "to improve mRNA stability and the amount or quality of protein produced" in crops.

The technology was awarded a US patent in 2010 (No. 7,741,118) and is not due to expire until June 2027. According to the suit, Pfizer/BioNTech and Moderna used it to stabilise their mRNA vaccines.

"To develop effective mRNA medicines, defendants needed to stabilise the mRNA molecule and optimise its protein expression," it claims, adding that they "optimised and manufactured their infringing mRNA vaccine products starting with a DNA template" and using Monsanto's patented process.

Meanwhile, Reuters has also reported that Bayer independently filed a similar lawsuit against Johnson & Johnson in a New Jersey federal court, contending that a DNA-based process the company used in manufacturing its adenovirus vector-based COVID-19 vaccine also infringes the patent.

The shot – known as the Janssen vaccine – won emergency authorisations in the US and other markets and made blockbuster sales in the pandemic before its use diminished due to concerns about rare clotting side effects. It was withdrawn from sale in the US in 2023.

While sales are well down on their peak, Comirnaty brought in worldwide revenues of more than $3.3 billion for Pfizer and BioNTech last year, with Moderna earning $3.2 billion from Spikevax.

Bayer has said it does not intend to do anything that would restrict the commercial use of the COVID-19 vaccines – although, that is already being achieved due to changing immunisation policies in the US under the Trump administration – but is seeking damages "in an amount adequate to compensate" for the infringement of its intellectual property and royalties on sales.

Pfizer, BioNTech, and Moderna have all said they are confident in the IP for their own vaccines and intend to defend the lawsuits "vigorously." J&J had not yet commented on its position at the time of writing.

The lawsuits are just the latest in a series of disputes over IP related to mRNA-based COVID-19 vaccines, with almost all of the companies that worked on the shots involved in suits and countersuits over the technology.

Photo by Wesley Tingey on Unsplash