Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology

Alnylam Files Lawsuits Against Pfizer and Moderna Over Patent Infringement of RNA Delivery Technology

Alnylam is claiming that both Pfizer and Moderna infringed on patents for its RNA lipid nanoparticle delivery system, using it without permission or attribution in their mRNA COVID-19 vaccines.

Credited as a pioneering RNA interference (RNAi) therapeutics company, Alnylam Pharmaceuticals is taking Pfizer and Moderna to court, claiming that the companies’ use of the lipid nanoparticle (LNP)-based RNA delivery technology in their mRNA COVID-19 vaccines infringes on a patented technology.

Alnylam filed lawsuits against each company in a Delaware federal court on Thursday.

Alnylam claims it invented the RNA delivery technology used in the vaccines more than a decade ago.

In the lawsuit filed against Pfizer, the Cambridge, Massachusetts-based biotech says its Patent No. 11,246,933 covers “a breakthrough class of cationic biodegradable lipids used to form LNPs that carry and safely deliver” mRNA-based vaccines and therapeutics.

Alnylam was founded in 2002 and specializes in RNAi technologies. Their work has led to the development of the world’s first approved RNAi therapeutics, which include Onpattro (patisiran) in 2018, Givlaari (givosiran) in 2019 and Oxlumo (lumasiran) in 2020.

The company says it isn’t trying to block Pfizer and Moderna from making the vaccines, it is simply looking to claim damages for the “defendants’ wrongful acts in an amount to be determined at trial” and royalties.

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In a press release, Alnylam said it is “seeking fair compensation for use of its technology based on patent claims to a broad class of biodegradable lipids invented over a decade ago resulting from extensive research and investment. The Company is proud that this work has supported rapid development of the life-saving vaccines. Alnylam does not intend to seek an injunction or take action that impedes production, sale or distribution of the vaccines.”

Moderna hit back at Alnylam, saying that the company is engaging in “blatant opportunism.” In a statement, Moderna said the RNAi specialist is “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.”

Alnylam says it used the LNP-based RNA delivery technology to create Onpattro for polyneuropathy in people with the rare condition hereditary transthyretin-mediated amyloidosis.

Moderna maintains that its vaccine “is a product of the many years we have spent pioneering our mRNA platform, including the creation of our own proprietary LNPs that have been pivotal to combatting the COVID-19 pandemic.”

The company explained that its LNPs “do not resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s COVID-19 vaccine is specious.”

Moderna explained that Alnylam’s lipids could not efficiently deliver mRNA directly into the arm, as they were made for a different type of RNA. Given this, beginning in 2014, Moderna says it “designed new lipids that overcame this mRNA delivery challenge, and it is those novel lipids which are found in our LNPs.”

Alnylam isn’t the only one suing Moderna over patent infringements of RNA delivery technologies. Vancouver-based Arbutus Biopharma and jointly owned biopharmaceutical company Genevant Sciences filed a lawsuit in the same Delaware court claiming Moderna infringed on its LNP delivery technology. Moderna had tried to invalidate Arbutus-owned patents two months ago, which prompted the company to file the suit.

To date, Pfizer has garnered $36.7 billion in sales of its vaccine in 2021 and expects $32 billion this year. Moderna earned $17.7 billion on its COVID-19 vaccine last year, the company’s first commercial product, and anticipates bringing in another $22 billion this year.