Updated: Aug 27, 2022
ModernaTX Inc. and Moderna US; collectively the plaintiffs, have filed a complaint against Pfizer Inc., BioNTech SE, BioNTech Manufacturing Gmbh, and BioNTech US Inc., in the US District Court in Massachusetts. In its complaint Moderna asserts that Pfizer and BioNTech implemented vaccine designs that employed M
oderna’s patented technologies. Moderna claims that the intellectual property at issue includes 3 patents, U.S. Patent Nos. 10,898,574 (the “’574 patent”), 10,702,600 (the “’600 patent”), and 10,933,127 (the “’127 patent”). According to the Moderna complaint, while the final '574 patent titled “Delivery and formulation of engineered nucleic acids.” , was issued on the 26th of January 2021, the company already claimed priority to a provisional patent application filed on March 31st, 2011, in addition to a non-provisional patent application filed on April 2nd 2012. In its complaint .
Moderna states that its '600 and '127 patent describe the design, development and results of its corona virus vaccine, which used "mRNA encoding for the full-length spike protein for SARS-CoV-2 in a lipid nanoparticle formulation". The company states that Pfizer and BioNTech's sole COVID-19 vaccine candidate “BNT162b2”, which advancd to Phase II/III clinical trials, used the exact 1-methylpseudouridine chemical modification in a lipid nanoparticle formulation, as its patented COVID-19 vaccine. The '600 provisional patent applications were first filed in October 2015, along with a PCT application filed October 21, 2016. The final patent was issued on July 7th 2020. The final '127 patent was issued March 2nd 2021, though the provisional patent application and the PCT application were filed in October 2015 and October 2016 respectively.
These infringement claims around COVID-19 vaccine technology, are the latest, and part of multiple, overlapping infringement claims, which have been filed over the last 2 years. In July 2022, patents which claimed inventions related to lipid vesicles and nucleic acid-lipid particles, have also been the subject of a patent infringement claim brought against Moderna by Genevant and Arbutus Biopharma. In this latest complaint, Arbutus and Genevant claim infringement for a number of patents which encompass aspects of the lipid nanoparticle technology discussed above. The patents at issue in the July 2022 claim are U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378. In a much earlier appeal case decided in December 2021, ModernaTX Inc., FKA Moderna Therapeutics Inc. v Arbutus Biopharma Corporation, FKA Protiva Biotherapeutics, Inc. concerned Arbutus' '435 patent description of methods for making the lipid particles, and methods of delivering and/or administering the lipid particles. Here the Federal Circuit dismissed Moderna’s appeal for lack of standing. Further, claims 7–8, 10–11, 13, and 16–20 of U.S. Patent No. 9,364,435 were found not unpatentable, as obvious.