RNA therapies pioneer Alnylam Pharmaceuticals is suing both Moderna and Pfizer, claiming that their messenger RNA Covid-19 vaccines infringe on a patented technology key to the way these products are delivered in the body and break down without causing toxic effects.
The two lawsuits were filed Thursday in federal court in Delaware. In its announcement of the litigation, Alnylam said it does not want to impede the sale, production, or distribution of Covid-19 vaccines. However, the Cambridge, Massachusetts-based company is seeking compensation for technology that it claims it invented more than decade ago.
One of the challenges facing developers of RNA-based therapies is the fragility of the molecule. Once inside the body, enzymes quickly break down RNA before it reaches its destination. Biotech companies protect RNA with lipid nanoparticles (LNPs), tiny particles of fat that encapsulate the genetic cargo and deliver it to its cellular destination.
The type of lipids needed to protect RNA don’t exist in nature, so they must by synthesized. Alnylam said that early attempts to use such LNPs in therapeutics posed toxicity problems because of the high doses required. Alnylam in-licensed LNP technology for its first product, Onpattro. In 2018, the FDA approved that drug for treating the rare disease hereditary transthyretin amyloidosis, making it the first approved therapy that works by a mechanism called RNA interference. These therapies deliver a type of RNA called small interfering RNA to stop a gene from producing a disease-causing protein.
Though the in-licensed technology worked for Onpattro, Alnylam said in the complaints that LNP still needed improvement and the company went on to develop its own LNP technology. According to Alnylam, LNPs developed with its internally developed technology protect RNA until delivery into a cell. After that, those particles are metabolized and eliminated by the body. As a result, the LNPs don’t cause any dose-limiting toxicity. This proprietary technology is used in products that Alnylam has developed since Onpattro’s approval.
In the complaints, Alnylam said that utility patent applications for its novel lipids were published in 2012 and 2013. Alnylam added that it now has 22 patents covering its LNP inventions. The suits against Moderna and Pfizer focus on the infringement of one: a “Biodegradable Lipids for the Delivery of Active Agents” patent that was issued one month ago.
Alnylam alleges that Moderna has been aware of its LNP technology since at least early 2014, when the two companies had several meetings about a potential business deal. That deal never happened, but Alnylam alleges that the company’s Covid vaccine, Spikevax, uses biodegradable LNP technology that infringes on the biodegradable lipids patent. Alnylam did not have similar meetings with Pfizer or BioNTech, but the company claims that their Covid vaccine, Comirnaty, uses LNPs that infringe the same patent.
“Alnylam’s seminal work to create these novel biodegradable LNPs has been employed in potential RNA therapeutics in development and now mRNA-based vaccines,” the company said in the Moderna complaint.
Pfizer did not return a message seeking comment. In an emailed statement, Moderna characterized Alnylam’s lawsuit “blatant opportunism.” Moderna added that its vaccine is the product of years of MRNA research that include the creation of proprietary LNPs.
“Moderna’s LNPs do not resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s COVID-19 vaccine is specious,” the company said. “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.”
In both complaints, Alnylam said it is seeking damages or other monetary relief. No amounts were specified.
Photo: Mykola Velychko, Getty Images
