Last week, GlaxoSmithKline and Northwestern University filed separate lawsuits against Moderna, accusing its mRNA-based vaccines of patent infringement.
GSK’s Lawsuits
On October 15, 2024, GSK filed two complaints against Moderna in the District Court for the District of Delaware, asserting that Moderna willfully infringes GSK’s mRNA patent portfolio.
In Civil Action No. 1:24-cv-01135, GSK accuses Moderna’s Spikevax(R) SARS-CoV-2 S protein mRNA vaccine products of infringing U.S. Patent Nos. 11,291,682, 11,324,770, 11,596,645, 11,690,862, 11,707,482, 11,666,534, and 11,786,467. GSK seeks, among other relief, money damages for the alleged infringement and a compulsory ongoing licensing fee.
In Civil Action No. 1:24-cv-01136, GSK accuses Moderna’s mRESVIA(R) RSV F mRNA vaccine product of infringing U.S. Patent Nos. 11,324,770, 11,690,861, 11,690,864, 11,717,529, 11,786,467, and 11,883,534. GSK seeks money damages and a permanent injunction against the manufacture, use, offer to sell, sale, and importation of mRESVIA(R).
According to GSK, the asserted patents are directed to “compositions and formulations comprising lipids and messenger ribonucleic acid (‘mRNA’) molecules encoding a protein immunogen, methods for obtaining the same, and methods of administering the same to elicit an immune response against the immunogen.”
We previously reported on GSK’s lawsuit filed in April of this year against Pfizer, Pharmacia & Upjohn, and BioNTech, alleging infringement of five mRNA patents, including three patents now being asserted against Moderna.
Northwestern’s Lawsuit
On October 16, 2024, Northwestern sued Moderna in the District Court for the District of Delaware, alleging willful infringement of U.S. Patent Nos. 9,216,155, 10,328,026, and 8,323,686, which are directed to lipid nanoparticle (LNP) technology.
Northwestern alleges in its complaint that Moderna would not have been able to rapidly develop its Spikevax(R) vaccine products “without appropriating the technological breakthroughs of prior researchers, including those at Northwestern University.” Northwestern alleges that Moderna’s COVID-19 vaccine and RSV vaccine (mRESVIA(R)), as well as other products Moderna has under development, all use Northwestern’s LNP technology.
Northwestern claims that the LNP technology covered by the asserted patents solved the decades-long problem of delivering mRNA to human cells such that proteins can be generated within the body. It claims that researchers at the university solved this problem by causing the LNPs to adopt “certain characteristics of lipoproteins so the body would recognize these synthetic particles as naturally-occurring materials.” The complaint indicates that the technology covered by the patents bloomed out of Northwestern’s International Institute for Nanotechnology, which it claims “has conducted more than $1 billion in nanoscience research” and has led to “over 2,000 new commercial products and over 40 new startup companies.”
Northwestern seeks only damages and not injunctive relief. No judge has been assigned to the case (1-24-cv-01151) yet.
Stay tuned to Big Molecule Watch for further updates on these litigations.