Alnylam sues Pfizer, Moderna over COVID-19 vaccines

mRNA therapeutics came of age

Alnylam claims it is owed a slice of the massive revenues booked by Pfizer and Moderna for their mRNA-based COVID-19 vaccines, because they are both infringing patents its holds on a delivery technology.

The US biotech has filed a pair of lawsuits in Delaware alleging infringement of US Patent No 11,246,933, which covers lipid nanoparticles (LNPs) made from cationic and PEG lipids that can be used to deliver active agents "such as a nucleic acid".

In an SEC filing, Alnylam said it is seeking a judgment that Pfizer and Moderna have infringed the patent, along with compensation at last equal to  "a reasonable royalty for the unlicensed uses made of Alnylam's patented lipids by Pfizer and Moderna, together with interest and costs as may be awarded by the court".

Both Pfizer's BioNTech-partnered Comirnaty and Moderna's SpikeVax vaccines use LNPs to carry mRNA coding for the SARS-CoV-2 spike protein.

After dosing, the LNPs deliver the mRNA sequence into cells, which is then used by cellular machinery to manufacture the viral protein and stimulate an immune response.

The Alnylam litigation is the second filed against Moderna. Arbutus Biopharma and Genevant Sciences also filed a complaint claiming infringement of various patents, which cover "nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use".

All the plaintiffs say they have no intention of interfering with the supply and sale of the COVID-10 vaccines but are seeking "fair compensation" for the use of their technologies.

That could amount to a sizeable sum if they prevail in the courts. Pfizer made $36 billion in sales from Comirnaty last year and is expecting to shift another $32 billion-worth in 2022. Moderna meanwhile booked around $18 billion from SpikeVax in 2021 and is forecasting around the same again this year.

Going forward, much will depend on how COVID-19 develops in the coming months, and if there is a demand for additional booster shots to keep the pandemic under control.

It remains to be seen if the disputed patents could impact future products from Moderna and Pfizer/BioNTech.