RNA therapies pioneer Alnylam Prescription drugs is suing each Moderna and Pfizer, claiming that their messenger RNA Covid-19 vaccines infringe on a patented know-how key to the best way these merchandise are delivered within the physique and break down with out inflicting poisonous results.
The 2 lawsuits had been filed Thursday in federal courtroom in Delaware. In its announcement of the litigation, Alnylam mentioned it doesn’t wish to impede the sale, manufacturing, or distribution of Covid-19 vaccines. Nevertheless, the Cambridge, Massachusetts-based firm is looking for compensation for know-how that it claims it invented greater than decade in the past.
One of many challenges dealing with builders of RNA-based therapies is the fragility of the molecule. As soon as contained in the physique, enzymes shortly break down RNA earlier than it will get the place it must go. Biotech firms defend RNA with lipid nanoparticles (LNPs), tiny particles of fats that encapsulate the genetic cargo and ship it to its mobile vacation spot.
The kind of lipids wanted to guard RNA don’t exist in nature, so that they have to be synthesized. Alnylam mentioned that early makes an attempt to make use of such LNPs in therapeutics posed toxicity issues due to the excessive doses required. Alnylam in-licensed LNP know-how for its first product, Onpattro. In 2018, the FDA authorized that drug for treating the uncommon illness hereditary transthyretin amyloidosis. It’s the primary authorized remedy that works by a mechanism referred to as RNA interference. These therapies ship a sort of RNA referred to as small interfering RNA to cease a gene from producing a disease-causing protein.
Although the in-licensed know-how labored for Onpattro, Alnylam mentioned within the complaints that LNP nonetheless wanted enchancment and the corporate went on to develop its personal LNP know-how. In keeping with Alnylam, LNPs developed with this internally developed know-how defend RNA till supply right into a cell. After that, these particles are metabolized and eradicated by the physique. Consequently, these “biodegradable” LNPs don’t trigger any dose-limiting toxicity. This proprietary know-how is utilized in merchandise that Alnylam has developed since Onpattro’s approval.
Within the complaints, Alnylam mentioned that utility patent purposes for its novel lipids had been revealed in 2012 and 2013. Alnylam added that it now has 22 patents overlaying its LNP innovations. The fits in opposition to Moderna and Pfizer give attention to the infringement of 1: a “Biodegradable Lipids for the Supply of Lively Brokers” patent that was issued one month in the past.
Alnylam alleges that Moderna has been conscious of its LNP know-how since no less than 2014, when the 2 firms had a number of confidential conferences a few potential enterprise deal. That deal by no means occurred, however Alnylam alleges that the corporate’s FDA-approved Covid vaccine, Spikevax, makes use of biodegradable LNP know-how that infringes on the biodegradable lipids patent. Alnylam didn’t have comparable conferences with Pfizer or BioNTech, however the firm claims that their FDA-approved Covid vaccine, Comirnaty, makes use of LNPs that infringe the identical patent.
“Alnylam’s seminal work to create these novel biodegradable LNPs has been employed in potential RNA therapeutics in growth and now mRNA-based vaccines,” the corporate mentioned in each complaints.
Pfizer didn’t return a message looking for remark. In an emailed assertion, Moderna characterised Alnylam’s lawsuit as “blatant opportunism.” Moderna added that its vaccine is the product of years of mRNA analysis that embrace the creation of proprietary LNPs.
“Moderna’s LNPs don’t resemble Alnylam’s work, and any assertion that the Alnylam patent covers Moderna’s Covid-19 vaccine is specious,” the corporate mentioned. “Alnylam’s lipids had been initially tailor-made for intravenous supply of a special kind of RNA, and Moderna found a few years in the past that such lipids had been inadequate for delivering mRNA instantly into the arm. Beginning in 2014, Moderna designed new lipids that overcame this mRNA supply problem, and it’s these novel lipids that are present in our LNPs.”
In each complaints, Alnylam mentioned it’s looking for damages or different financial aid. No quantities had been specified, however the firm requested for “at least an affordable royalty.”
Picture: Mykola Velychko, Getty Photographs