Northwestern University Sues Moderna Over Spikevax Vaccine

Image source: Northwestern complaint.

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

The complaint alleges that Northwestern inventors at the school’s International Institute for Nanotechnology (IIN) pioneered the technology for a “vehicle for delivering genetic code into a cell by harnessing attributes of naturally-occurring structures, called lipoproteins” through research beginning in the late 2000s. This technology is covered by U.S. Patent Nos. 9,216,155, 10,328,026 and 8,323,686 and relates to synthetic lipid nanoparticles (LNPs) that facilitate entry into human cells.

According to the complaint, “[y]ears later, this breakthrough would be the key to delivering Moderna’s mRNA vaccine into the targeted cells that would trigger an immune response in the body.” The complaint also alleges that Moderna’s vaccine for respiratory syncytial virus (RSV), mRESVIA, infringes.

Moderna had notice of the infringement as of October 2023, says the complaint, but has continued to infringe, and has publicly stated its plans to develop additional products that are likely to infringe.

Moderna points to U.S. Patent Nos. 10,064,959, 10,266,485, and 10,442,756 as covering Spikevax. But according to Northwestern, “[e]ach of these patents cite to a family member with the same disclosures as those of the Asserted Patents.”

The complaint also charges 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 a pandemic in March 2020—“without appropriating the technological breakthroughs of prior researchers, including those at Northwestern University.”

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

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

Northwestern is seeking damages but is not requesting injunctive relief. It also said it may amend its complaint “as discovery discloses whether and how many of Moderna’s other mRNA products infringe.”

Earlier this week, GlaxoSmithKline (GSK) also sued Moderna for infringement of five of its patents via the Spikevax and mRESVIA vaccines. GSK asked the Delaware court for damages related to the “manufacture, use, sale, marketing, offer for sale, and/or importation” of the two vaccines. The British firm has recently filed similar lawsuits against Pfizer and BioNTech.