Sanofi has filed a patent infringement lawsuit against Moderna in the U.S. District Court for the District of New Jersey, alleging that Moderna's mRNA vaccine technologies infringe a portfolio of patents originally developed by Translate Bio, a biotechnology company acquired by Sanofi in 2021. The complaint names Translate Bio, Translate Bio MA, Sanofi Vaccines US, and VaxServe as plaintiffs, while Moderna, ModernaTX, and Moderna US are listed as defendants.
According to the complaint, the lawsuit concerns 10 U.S. patents covering key technologies used in messenger RNA (mRNA) medicines, including lipid nanoparticle (LNP) delivery systems, ionizable cationic lipids, and methods for producing highly purified mRNA suitable for human use. Sanofi claims these inventions were developed over many years of research and now form part of its extensive intellectual property portfolio.
Sanofi alleges that Moderna's commercially available vaccines, SPIKEVAX® for COVID-19, MNEXSPIKE®, and the RSV vaccine MRESVIA®, utilize technologies protected by these patents. The complaint states that the vaccines contain purified mRNA encapsulated within lipid nanoparticles containing the ionizable lipid SM-102, along with PEG-modified lipids and other components that allegedly fall within the scope of Sanofi's patented inventions.
The filing explains that Translate Bio and its predecessor companies spent nearly two decades researching RNA therapeutics and developing technologies to overcome major challenges associated with mRNA medicines. These innovations include improving the purity of laboratory-produced mRNA, enhancing the stability of mRNA inside lipid nanoparticles, and designing delivery systems capable of efficiently transporting mRNA into human cells.
Sanofi also outlines its history with Translate Bio, noting that the companies entered into an mRNA vaccine collaboration in 2018, expanded the partnership in 2020, and completed Sanofi's acquisition of Translate Bio in 2021. According to the complaint, the acquisition strengthened Sanofi's capabilities in mRNA vaccine research and development.
The lawsuit further alleges that Moderna's prescribing information instructs healthcare professionals to administer the vaccines using methods that practice Sanofi's patented technologies. In addition to the delivery methods, the complaint claims that Moderna's lipid nanoparticle formulations, ionizable lipid composition, and mRNA purification processes infringe multiple patent claims.
Sanofi is seeking monetary compensation for the alleged patent infringement, including damages of no less than a reasonable royalty, together with prejudgment and post-judgment interest and other relief deemed appropriate by the court. The complaint does not seek an injunction to prevent Moderna from manufacturing or selling its vaccines while the litigation is pending.
The case adds to the growing number of intellectual property disputes involving mRNA technologies, reflecting the increasing commercial importance of innovations related to mRNA design, purification, lipid nanoparticle delivery systems, and vaccine manufacturing. The lawsuit remains at an early stage, and the allegations contained in the complaint have not yet been tested or decided by the court.
