Northwestern University sues Moderna over Spikevax vaccine

Image source: Northwest Complaint.

Northwestern University sued vaccine maker Moderna, Inc. on Wednesday, Oct. 16, in the U.S. District Court for the District of Delaware, alleging infringement of three patents that the school says cover key delivery method technology of Moderna’s revolutionary messenger RNA (mRNA). Covid-19 vaccine.

The complaint alleges that Northwestern inventors, at the school’s International Institute of Nanotechnology (IIN), pioneered the technology of a “vehicle for introducing genetic code into a cell by exploiting the attributes of natural structures, called lipoproteins” thanks to research launched at the end of the 2000s. This technology is covered by US patents Nos. 9,216,155, 10,328,026 and 8,323,686 and concerns synthetic lipid nanoparticles (LNPs) which facilitate entry into human cells.

According to the complaint, “years later, this breakthrough would be the key to delivering Moderna’s mRNA vaccine into targeted cells, which would trigger an immune response in the body.” » The complaint also alleges that Moderna’s respiratory syncytial virus (RSV) vaccine, mRESVIA, is infringing.

Moderna was informed of the infringement in October 2023, the complaint states, but continued to infringe and publicly stated its intention to develop additional potentially infringing products.

Moderna points to U.S. Patent Nos. 10,064,959, 10,266,485, and 10,442,756 as covering Spikevax. But according to Northwestern, “(each) of these patents refers to a family member with the same disclosures as those in the asserted patents.”

The complaint also claims that Moderna could not have completed the first clinical trials of its COVID-19 vaccine as quickly as it did – more than a month before the World Health Organization declared COVID-19 as a pandemic in March 2020 – “without appropriating technologies”. breakthroughs from previous researchers, including those at Northwestern University.

Moderna has 45% market share for COVID-19 vaccines and received $5.4 billion in U.S. revenue in 2021 from its vaccine sales and $4.4 billion in 2022. According to Reuters , the company generated $6.7 billion in revenue from Spikevax in 2023.

Moderna has said in the past that it is “not aware of any significant intellectual property hurdles for products we intend to commercialize, including mRNA-1273 (the first generation of Spikevax ). »

Northwestern seeks damages but is not seeking injunctive relief. It also said it may amend its complaint “as discovery reveals whether and how many other Moderna mRNA products are infringing.”