The legal battle between Moderna and its rivals Pfizer and BioNTech over the patents related to mRNA vaccine production is heating up. Pfizer and BioNTech have filed petitions with the US Patent and Trademark Office (PTO) to invalidate two of Moderna’s patents that they claim are too broad and unjustified.
The petitions, filed on Monday, seek inter partes reviews, which are administrative trials conducted by the PTO’s Patent Trial and Appeals Board to review the validity of claims in a patent. The process is faster and cheaper than going through the federal court system.
Pfizer and BioNTech argue that Moderna obtained the patents during the pandemic and secured “unreasonably wide claims” that cover the entire field of mRNA technology. One patent, known as the ‘127 patent, deals with the methods of administering an mRNA vaccine. The other patent, known as the ‘600 patent, concerns the composition of the vaccine.
A spokesperson for Moderna did not respond immediately to a request for comment on the new inter partes review filings.
The inter partes review bid is the latest development in a complex web of litigation that started last August, when Moderna sued Pfizer and BioNTech in the US and Germany. Moderna has also filed lawsuits in the Netherlands, the UK, Ireland and Belgium.
Moderna has stated that it is not seeking to remove Pfizer-BioNTech’s vaccine from the market, nor is it targeting their sales in low- and middle-income countries. However, Moderna is seeking compensation and damages for alleged infringement of patents related to lipid nanoparticle delivery, spike protein encoding and more.
Pfizer and BioNTech have not remained passive. In December, they countersued Moderna in the US, demanding a jury trial and attempting to refute their competitor’s infringement claims.
Pfizer and BioNTech have accused Moderna of stretching its “already overbroad” and “invalid” patents in an attempt to “take credit for others’ work.”
Meanwhile, drugmakers in general have criticized the US PTO’s inter partes review system, calling it unconstitutional.
But in 2018, the Supreme Court disagreed. In a 7-2 vote that year, the US high court held that the system is constitutional.