This recent escalation in the patent fight is over the messenger RNA (mRNA) technology used by Pfizer and Moderna in developing their respective COVID-19 vaccines. Alnylam originally filed separate lawsuits against each of them back in March.
On July 12, Alnylam submitted additional documents to reinforce its case against both Big Pharma companies in the U.S. District Court for the District of Delaware. These new documents claim that Pfizer and Moderna's mRNA delivery systems violate Alnylam's patent on lipid nanoparticle technology for delivering genetic material into human cells and how these lipid nanoparticles are manufactured. (Related: BOMBSHELL: Fauci owns patent on SARS-CoV-2 gp120 HIV insertion, which destroys the body's cancer-killing T cells.)
Patent No. 11,246,933 covers "a breakthrough class of cationic biodegradable lipids used to form lipid nanoparticles that carry and deliver" mRNA-based vaccines.
The U.S. Patent and Trademark Office granted the patent to Alnylam on the same day the pharmaceutical company filed its additional complaints in federal court. Alnylam claimed in all of its lawsuits that its technology is "essential" to the COVID-19 vaccines.
The company is seeking royalties from the sale of the COVID-19 vaccines. Alnylam is not seeking to pull Pfizer and Moderna's COVID-19 vaccines from the market.
Alnylam is just the latest biotechnology company to file a patent lawsuit this year over the lipid nanoparticle technology in Pfizer and Moderna's COVID-19 vaccines. CureVac, a German pharmaceutical company that specializes in mRNA-based treatments, earlier sued BioNTech, Pfizer's German partner in developing the COVID-19 vaccine, claiming that four of its patents were infringed.
In response to the recent lawsuit, Moderna responded by referring to a statement posted on its website back in May when it moved to dismiss Alnylam's claim, contending that the suit was not appropriate for a district court.
"Under federal law, claims against U.S. government-contracted suppliers must proceed against the government in the U.S. Court of Federal Claims," wrote Moderna. The law the company is referencing provides protections for authorized government contractors like Moderna.
"Moderna's lipids do not resemble Alnylam's work," the company added. "Any assertion that the Alnylam patent covers Moderna's COVID-19 vaccine is specious and, as a result, Alnylam's claims will fail even if Alnylam complies with the statutory requirements and refiles in the Court of Federal Claims against the U.S. government."
As of press time, Pfizer has not responded to Alnylam's recent lawsuit. But Pfizer commented on Alnylam's original claim by saying that the company's patent played no role in the success of its COVID-19 vaccine, and that its vaccine "falls outside the scope of what Alnylam actually invented." Pfizer also called Alnylam's attempt to take it to court over alleged patent rights a clear-cut case of seeking improper economic benefits.
Both Pfizer and Moderna have made tens of billions of dollars each in sales from their COVID-19 vaccines. Pfizer anticipates earning $32 billion in vaccine sales this year, and Moderna predicts $21 billion in vaccine sales. Any successful infringement claims, either from Alnylam or any other pharmaceutical company whose patent rights were allegedly violated, could end up being very lucrative.
Learn more about Big Pharma companies at BigPharmaNews.com.
Watch this clip of Moderna CEO Stephane Bancel confessing to having patented the COVID-19 spike protein more than three years before the pandemic.