Dive Brief:

• Alnylam is accusing Pfizer and Moderna of violating a patent it holds for technology that Alnylam claims the two companies use in their respective COVID-19 vaccines.
• The Cambridge, Massachusetts-based drugmaker laid out its allegations in separate lawsuits filed Wednesday in the U.S. District Court for the District of Delaware that seek monetary compensation from Pfizer and Moderna, both of which are earning tens of billions of dollars from sales for their vaccines.
• Alnylam’s lawsuits are the latest battle over who owns rights to the inventions and research advances that allowed Pfizer and Moderna to develop their COVID-19 vaccines. Moderna has sparred with the U.S. government and is also facing a patent infringement lawsuit from Arbutus Biopharma and Genevant Sciences over its shot.

Dive Insight:

The world knows Pfizer’s and Moderna’s COVID-19 shots as “messenger RNA,” or mRNA, vaccines, so called for the genetic code they use to train the body against the coronavirus.

But just as critical to their existence and effectiveness is the lipid nanoparticle shell that encapsulates the mRNA, which otherwise would be quickly eroded after injection into the body. Giuseppe Ciaramella, who led Moderna’s infectious disease research from 2014 to 2018, even described lipid nanoparticles as the “unsung hero” of mRNA vaccines in a 2021 interview with Chemical and Engineering News — a fact Alnylam cited in its lawsuit against Moderna.

Alnylam has a significant interest in lipid nanoparticles as it spent a decade working on them in its quest to develop medicines that use another type of RNA. The company’s research was rewarded with nearly two dozen patents on positively charged, biodegradable lipids, including one granted just last month that covers use of that technology for delivery of RNA-based “active agents.”

It’s this new patent, numbered 11,246,933 or ‘933, that Alnylam claims Pfizer and Moderna are infringing with the sale of their COVID-19 vaccines. In the two lawsuits, Alnylam claims the lipids Pfizer and Moderna use in their vaccines are covered under the ‘933 patent.

Alnylam isn’t seeking to halt sales, but rather aims to win an infringement judgment and monetary damages, which could be significant given the high sales of both Moderna’s and Pfizer’s shots.

In at least Moderna’s case, Alnylam also cites discussions the two companies had about Moderna licensing Alnylam’s lipid nanoparticle technology, which concluded in 2014 without an agreement being reached.

Lipid nanoparticles also are the subject of Arbutus and Genevant’s suit against Moderna.

In an emailed statement, Moderna described Alnylam’s suit as “blatant opportunism,” and said its lipid nanoparticles “do not resemble Alnylam’s LNPs, and any assertion that the Alnylam patent covers.” The nanoparticles it uses in its COVID-19 vaccine, Moderna said, are built around lipids it designed starting in 2014.

While it’s unclear how Alnylam’s suits might proceed, court cases can take years to unfold. That may increase the pressure on at least Moderna, according to Dennis Ding, an analyst at Jefferies.

“[Moderna] now needs to prepare and engage on multiple fronts defending its LNP technology in trials that could take multiple years and millions of dollars to fund, and it simply could be more efficient to settle in the near term,” he wrote in a March 17 note to clients.

Moderna shares fell about 3% Thursday morning, while a broader biotech industry index rose by about 1%.