In a legal dispute that has broken out over messenger RNA (mRNA) vaccines against COVID-19, Moderna has asserted three inventions, yet one of them was really patented by two university scientists years earlier.
Moderna claims that Pfizer and its collaborator BioNTech "co-opted Moderna's patented ideas" that cover various components of the two COVID-19 vaccines, which have already brought the two firms billions of dollars, in a complaint filed on August 26 in a U.S. district court in Massachusetts.
Both vaccines rely on mRNA that produces the SARS-CoV-2 spike protein.
In a statement, BioNTech insisted that its work on the COVID-19 vaccine was "unique" and vowed to "vigorously defend" itself from any claims of patent infringement.
The business is "confident in our intellectual property underpinning the Pfizer/BioNTech vaccine," Pfizer stated in a press release, adding that it had "not yet fully studied the case but we are startled by the litigation."
The two vaccines were the first to be approved for COVID-19 in the US and the first to demonstrate the efficacy of the mRNA platform in humans for any disease. In 2020, Moderna declared that while the pandemic was still going on, it would not enforce patent claims.
The business may have changed its position because it and Pfizer-BioNTech may soon have new markets for formulations of their vaccines that target coronavirus variations, according to a patent attorney in of the top US law firms. Regulators are anticipated to quickly approve these revised vaccines.
The majority of the doses that Moderna and Pfizer-BioNTech initially supplied to the U.S. government are now being sold on the open market globally with much higher profit margins. Now that these are goods, Moderna's filing "makes sense".
The actions that made it possible for mRNA to be used as a vaccination are at the centre of Moderna's patent infringement claim. The fundamental discovery was made in 2005 by Drew Weissman and Katalin Karikó, both of the University of Pennsylvania (Karikó currently works for BioNTech). They demonstrated that altering one of the essential components of mRNA, the nucleotide uridine, made the molecule less toxic and also improved its ability to evade immune destruction.
A specific change known as 1-methylpseudouridine is patented by Moderna, a company established to create drugs based on mRNA. The complaint claims that Moderna's scientists made the ground-breaking discovery that switching out uridine for 1-methylpseudouridine in the mRNA molecule led to surprisingly superior protein production—an increase of severalfold over chemically modified mRNAs studied previously—with a significantly diminished immune response against the mRNA itself. This work served as the mRNA platform's building block.
Weissman and Karikó pointed out that they have an active patent that was filed six years before Moderna's and that specifically mentions the 1-methylpseudouridine alteration.
According to a Lifesciences focused patent attorney, the earlier patent will probably weaken but not entirely invalidate their 1-methylpseudouridine claim.
Two other patent and intellectual property infringements are claimed in Moderna's case. The business "further discovered that encapsulation of the chemically-modified mRNA in a lipid nanoparticle formulation allowed for the efficient delivery of the mRNA to cells," according to the Moderna statement. In addition, Moderna asserts that it created the specific application of mRNA vaccines for defence against betacoronaviruses, the family of viruses that includes SARS-CoV-2. These claims have been characterised as "extremely broad" by patent attorneys who have examined the specifics of them.
Industry observers assert that Moderna is probably aiming to boost its claims in order to profit from upcoming mRNA vaccines.
The U.S. Patent Office may decide to conduct a streamlined inter partes review (IPR) of the complaint, which could result in a swift determination of the validity of the claims. It could also take years, similar to other patent disputes involving multibillion-dollar biological breakthroughs.