The European Patent Office has invalidated one of Moderna’s patents for its mRNA-based COVID-19 vaccine, handing a win to the vaccine giant’s German competitor, BioNTech.
BioNTech on Tuesday confirmed the news, saying it “understands and welcomes” the European authority’s decision to declare the patent invalid.
“The European Patent Office’s decision is an important one as we believe that this and others of Moderna’s patents do not meet the requirements for grant and should never have been granted,” it added.
Moderna, meanwhile, “disagrees” with the revocation. “We continue to believe in the strength and validity of the ‘565 Patent and will appeal this decision,” the Cambridge, Massachusetts-based company said in a statement.
In their race to carve up the post-pandemic commercial COVID vaccine market, Moderna and BioNTech are engaging in a series of court battles over patents of the mRNA technologies they have been using to develop the jabs.
Last year, Moderna filed patent infringement lawsuits in both Germany and the United States, claiming that the mRNA technology used to make Pfizer and BioNTech’s Comirnaty vaccine infringes three patents that cover its own Spikevax shot.
Specifically, Moderna claimed in its August 2022 complaint that Comirnaty has the “same exact mRNA chemical modification” as Spikevax. This particular chemical modification was allegedly created by Moderna scientists in 2010 to prevent the vaccine from causing an unwanted immune response when mRNA is introduced into the patient’s body.
On top of that, Moderna accused Pfizer and BioNTech of “copying” Moderna’s approach to encase full-length spike protein producing mRNA within lipid nanoparticles (LNP) for delivery into cells.
Other Pharma Companies Fight for Credit
In response to the accusations, Pfizer and BioNTech argued that those three pieces of technology—the chemical modifications to mRNA, the LNP, and the encoding of full-length spike protein—either existed before Moderna’s patent application or involved the contributions of too many non-Moderna scientists for Moderna to take full credit.“We are surprised by the litigation given the COVID-19 vaccine was based on BioNTech’s proprietary mRNA technology and developed by both BioNTech and Pfizer,” a Pfizer spokesperson said at that time, adding that the company would defend against the allegations “vigorously.”
Pfizer and BioNTech are also facing lawsuits from other companies claiming that Comirnaty vaccine infringes on their intellectual properties.
Germany’s CureVac, for instance, sued BioNTech in Germany in July 2022. It alleged that Comirnaty infringes four patents “accumulated over more than two decades of pioneering work” in the mRNA field, including those related to the engineering of mRNA molecules, such as sequence modifications to increase stability and enhance protein expression.
Meanwhile, Alnylam Pharmaceuticals, a company also based in Cambridge, Massachusetts, has filed suit against both Moderna and the Pfizer-BioNTech partnership in the United States, alleging that both their COVID vaccines infringe patents it holds on technologies related to LNP.
Two other companies, Arbutus Biopharma of Canada and Genevant Sciences of Massachusetts, have also sued Moderna over patents that cover “nucleic acid-lipid particles and lipid vesicles, as well as compositions and methods for their use.”
There is much at stake in a market that’s transitioning from a government purchase-driven model to a traditional private commercial model. In 2022, Pfizer BioNTech jointly sold $56 billion worth of their Comirnaty vaccine, topping the list of the best-selling drugs of the year. Moderna’s Spikevax was also successful, generating $18.4 billion in revenue last year.
