Moderna wins Covid vaccine patent case in ongoing Pfizer, BioNTech battle

MODERNA has won the latest round of its long-running legal battle with Pfizer and its German partner BioNTech over its Covid vaccine.

The European Patent Office (EPO) has upheld the validity of one of Moderna’s patents for its Spikevax vaccine, which the firm says Pfizer and BioNTech copied to develop its Comirnaty vaccine.

Patent EP949 involves technological advances in messenger RNA (mRNA) technology which Moderna says it pioneered and patented between 2010 and 2016.

Moderna began the dispute by filing two infringement lawsuits in US and German courts in 2022, and has launched similar complaints in Dutch, Belgian, and Irish courts.

Pfizer and BioNTech have in turn challenged Moderna’s patents at the US Patent Office’s Patent Trial and Appeal Board, calling them “unimaginably broad” and covering a basic idea that was known before Moderna’s development of mRNA technology.

The US Patent Office has since paused Moderna’s lawsuit to further review the patents, reports Reuters.

Moderna's mRNA claim

mRNA is a molecule that contains the genetic blueprint for cells to generate proteins from amino acids. It has had a long history of development dating back to the 1960s and it is only in the past decade that it has been developed for human medicines.

In vaccine technology, mRNA, wrapped in protective lipid nanoparticles, deliver messages to cells and instructs them to build proteins called antigens that replicate a virus. The immune system will identify these antigens as foreign and release antibodies to fight them. Remembering the fake virus antigens, the immune system is better prepared to deal with the real virus.

Moderna was founded in 2010 and has been developing mRNA technology to treat various viruses including influenza and HIV, producing an mRNA flu vaccine in 2015.

The firm says Pfizer and BioNTech used the exact same mRNA chemical modification in Spikevax for Comirnaty, which it has been developing since 2010. Moderna also claims their rivals copied the physical make-up of the mRNA developed for types of coronaviruses, which it says it created to develop a vaccine for Middle East Respiratory Syndrome (MERS).

However, Pfizer and BioNTech have both been researching mRNA technology for medicines, with BioNTech using mRNA for melanoma immunotherapy since 2012.

Covid cash grab

Moderna says it is not seeking Comirnaty to be taken off the market but does want Pfizer and BioNTech to compensate it for the continued use of the technology.

Moderna’s total revenue dropped from $19.3bn in 2022 to $6.8bn in 2023, a reduction they attribute to a decline in sales of Spikevax. Pfizer also experienced a downturn in revenue, from $100bn in 2022 to $58bn in 2023, the result of a decline in sales of Comirnaty.

Though Covid sales have dropped, the market for mRNA vaccines is expected to grow to around $40bn by 2033, according to data published by Precedence Research.

The EPO verdict on Moderna’s patent win was handed down orally and first reported by the Financial Times, with a written decision due in the coming months.

Pfizer and BioNTech have two months to lodge an appeal, which Pfizer is considering.