Pharmaceutical Industry Information Portal

Alnylam Pharmaceuticals files patent infringement suits against Moderna, Pfizer

Alnylam Pharmaceuticals, Inc. announced that it has separately filed suit in United States District Court for the District of Delaware against Pfizer, Inc. and Moderna, Inc., seeking damages for infringement of U.S. Patent No. 11,246,933 in the parties’ manufacture and sale of their mRNA COVID-19 vaccines, as the company’s website says.

The patent relates to Alnylam’s biodegradable cationic lipids that are foundational to the success of the mRNA COVID-19 vaccines. The complaints can be accessed on Alnylam’s website Pfizer and Moderna.

While Cambridge, Massachusetts-based Alnylam is not attempting to halt production of the vaccines, it is seeking damages for the “defendants’ wrongful acts in an amount to be determined at trial” and royalties.

While Pfizer raked in sales of $36.7 billion for its vaccine last year and expects an additional $32 billion this year, Moderna made $17.7 billion on its shot and expects to make an additional $22 billion this year.

Moderna commented:

Our vaccine is a product of the many years we have spent pioneering our mRNA platform, including the creation of our own proprietary lipid nanoparticles (LNPs) that have been pivotal to combatting the COVID-19 pandemic. Moderna’s LNPs do not resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s COVID-19 vaccine is specious. Alnylam’s lipids were originally tailored for intravenous delivery of a different type of RNA, and Moderna discovered many years ago that such lipids were insufficient for delivering mRNA directly into the arm. Starting in 2014, Moderna designed new lipids that overcame this mRNA delivery challenge, and it is those novel lipids which are found in our LNPs.

Alnylam, which was established in 2002, says it used the lipid nanoparticle delivery technology in creating its RNAi drug Onpattro, which was approved in 2018 for polyneuropathy in people with a rare condition—hereditary transthyretin-mediated amyloidosis.


Expert Articles