RNA therapy pioneer Alnyam Pharmaceuticals is suing the two modern and Pfizerclaiming that their messenger RNA Covid-19 vaccine violates a key patented technology for these products to be delivered and broken down in the body without causing toxic effects.
Both lawsuits were filed in federal court in Delaware on Thursday.In its announcement In the lawsuit, Alnylam said it did not want to hinder the sale, production or distribution of the Covid-19 vaccine. However, the Cambridge, Massachusetts-based company is seeking compensation for technology it claims it invented more than a decade ago.
One of the challenges facing developers of RNA-based therapies is molecular fragility. Once inside the body, enzymes quickly break down RNA before it reaches its destination. Biotech companies protect RNA with lipid nanoparticles (LNPs), tiny fatty particles that encapsulate genetic material and transport it to its cellular destination.
The types of lipids required to protect RNA do not exist in nature, so they must be synthesized. Due to the high doses required, early attempts to use such LNPs in therapy have raised toxicity concerns, Alnyam said. Alnylam licensed the LNP technology for its first product, Onpattro. In 2018, FDA Approved The drug is used to treat the rare disease hereditary transthyretin amyloidosis, making it the first approved therapy to work through a mechanism called RNA interference. These therapies deliver a type of RNA called small interfering RNA to stop genes from making disease-causing proteins.
Although the licensed technology works on Onpattro, Alnylam said in the complaint that the LNP still needs improvement and the company continues to develop its own LNP technology. According to Alnylam, LNPs developed using technology it developed in-house protect RNA until it is delivered into cells. Afterwards, these particles are metabolized and eliminated by the body. Therefore, LNP did not cause any dose-limiting toxicity. This proprietary technology has been used in products developed by Alnylam since Onpattro’s approval.
In the complaint, Alnylam said utility patent applications for its novel lipids were published in 2012 and 2013. Alnyam added that it now holds 22 patents covering its LNP invention.The lawsuit against Moderna and Pfizer focuses on infringement of a patent for “biodegradable lipids for delivery of active agents” release a month ago.
Alnylam claims Moderna has known about its LNP technology since at least early 2014, when the two companies held several meetings about potential commercial deals. The deal never happened, but Alnylam alleges that the biodegradable LNP technology used in the company’s Covid vaccine Spikevax infringed patents on biodegradable lipids. Alnylam has not held a similar meeting with Pfizer or BioNTech, but the company claims the LNP used in their Covid vaccine Comirnaty infringes the same patent.
“Alnylam’s pioneering work in creating these novel biodegradable LNPs has been used in potential RNA therapeutics in development and now in mRNA-based vaccines,” the company said in Moderna’s complaint.
Pfizer did not respond to a message seeking comment. In an emailed statement, Moderna described Alnylam’s lawsuit as “blatantly opportunistic.” Moderna added that its vaccine is the product of years of mRNA research, including the creation of proprietary LNPs.
“Moderna’s LNPs are different from Alnylam’s work, and any claim that Alnylam’s patent covers Moderna’s COVID-19 vaccine is specious,” the company said. “Alnylam’s lipids were originally tailored for intravenous delivery of different types of RNA. custom-made, whereas Moderna discovered many years ago that this lipid is not sufficient to deliver mRNA directly into the arm. Beginning in 2014, Moderna designed new lipids to overcome this mRNA delivery challenge, and it was these new lipids that appeared in our in the LNP.”
In both complaints, Alnylam said it was seeking damages or other monetary relief. Amount not specified.
Photo: Mikola VerichkoGetty Images
