Alnylam sues Pfizer and Moderna claiming infringement on its delivery technology for COVID shots

Less than three weeks after two companies sued Moderna, claiming the vaccine maker infringed on their patents in developing its COVID-19 shot, Alnylam has done the same, suing Moderna and Pfizer in separate lawsuits.

In Delaware federal court, Alnylam filed (PDF) claims against the two COVID-19 vaccine producers alleging that more than a decade ago it invented the delivery technology employed by both shots.

Alnylam says its Patent No. 11,246,933 covers “a breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles that carry and safely deliver” mRNA-based vaccines.

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.

"Alnylam has engaged in what can only be seen as blatant opportunism—improperly expanding the scope of a ten-year old patent in an attempt to stake a claim to unprecedented and meaningful innovations in the mRNA space," Moderna said in a statement.

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.

"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 added. "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."  

Last month Arbutus Biopharma of Vancouver and Genevant Sciences of Cambridge, Mass. filed suit in the same Delaware court claiming Moderna infringed on its lipid nanoparticle delivery technology. The suit was not a surprise considering Moderna’s attempt two months earlier to invalidate patents owned by Arbutus protecting the system.

In language mirrored in Alnylam’s claim, Arbutus and Genevant aren’t seeking an injunction to halt Moderna’s vaccine production but want damages and a “reasonable royalty.”

Genevant CEO Pete Lutwyche said on a conference call that he expects “litigation with Moderna could take at least two years.”