USA – Alnylam Pharmaceuticals Inc has filed lawsuits in Delaware federal court against Pfizer Inc and Moderna Inc, claiming that their multibillion-dollar mRNA COVID-19 vaccines infringe on one of its patents.
Alnylam stated that it was suing for damages related to the use of lipid nanoparticle (LNP) technology in the Pfizer/BioNTech and Moderna vaccines to transport and deliver genetic material into the body.
The fragility of the molecule is one of the challenges that developers of RNA-based therapies face. Enzymes quickly break down RNA once it enters the body before it can get to where it needs to go.
Lipid nanoparticles (LNPs), tiny fat particles that encapsulate genetic cargo and deliver it to its cellular destination, are used by biotech companies to protect RNA.
Because the lipids required to protect RNA do not exist in nature, they must be synthesized.
Early attempts to use such LNPs in therapeutics, according to Alnylam, resulted in toxicity issues due to the high doses required.
Alnylam licensed LNP technology for its first product, Onpattro. The FDA approved that drug in 2018 to treat the rare disease hereditary transthyretin amyloidosis.
It is the first FDA-approved therapy that works through a mechanism known as RNA interference. These treatments use a type of RNA known as small interfering RNA to prevent a gene from producing a disease-causing protein.
Moderna, according to Alnylam, has been aware of its LNP technology since at least 2014, when the two companies held several confidential meetings about a potential business deal.
Although the deal never materialized, Alnylam claims that the company’s FDA-approved Covid vaccine, Spikevax, employs biodegradable LNP technology that infringes on the biodegradable lipids patent.
Although Alnylam did not meet with Pfizer or BioNTech, the company claims that their FDA-approved Covid vaccine, Comirnaty, contains LNPs that infringe the same patent.
Separately, Arbutus Biopharma Corp sued Moderna in federal court in Delaware last month, claiming that Moderna’s COVID-19 vaccine infringes on its patents, which also relate to RNA-delivery technology.
The National Institutes of Health in the United States has also hinted that it may sue Moderna over a vaccine-related patent application in which the NIH claims its scientists should have been listed as co-inventors.
Alnylam asked the court for an undisclosed amount of money damages from Pfizer and Moderna.
It stated in a statement that it has no intention of interfering with the production, sale, or distribution of the vaccines.
Moderna claims that its vaccine generated US$17.7 billion in revenue in 2021. Pfizer estimated last month that its vaccine would generate US$32 billion in revenue this year.