Dan Shores

As we previously discussed, beginning in 2022, a series of patent infringement lawsuits were filed against Moderna and collaborators Pfizer+BioNTech seeking damages based on their respective sales of the Spikevax® and Comirnaty® COVID-19 vaccines. Key suits were filed by third party mRNA and lipid pioneers that, while not having any mRNA-based products on the market themselves, leveraged their patent portfolios claiming a share of the billions of dollars in sales the vaccines have generated. Direct competitors Moderna and Pfizer+BioNTech also clashed in patent litigation beginning in 2022, with cases initiated in the United States and later expanding abroad.

Substantial patent litigation activity occurred in the mRNA space in 2022, involving nearly all of the major mRNA and lipid nanoparticle (LNP) pioneers. Since this is the most significant happening in this space with respect to IP in 2022, this post will provide an overview of that activity as well as a summary exposure analysis.

In the first major patent infringement lawsuit in the mRNA space, on February 28, 2022, Arbutus Biopharma Corporation (“Arbutus”) and Genevant Sciences GmbH (“Genevant”) sued Moderna, Inc. and ModernaTX, Inc. (collectively “Moderna”) in the United States District Court for the District of Delaware. The plaintiffs have alleged that Moderna infringed U.S. Patent Nos. 8,058,069, 8,492,359, 8,822,668, 9,364,435, 9,504,651, and 11,141,378 directed to lipid nanoparticle (“LNP”) delivery technology through, inter alia, sales of its COVID-19 vaccine and booster products.

This article, originally published on 12/27/2021, was updated on 1/12/2022 and republished on 1/13/2022 to include information that was omitted in error, beginning after “Conclusions and Outlook”.

In Part I of this post, we provided an update on three lead pioneers in the mRNA IP space, Moderna, BioNTech and CureVac. In this post we profile Sanofi, Arcturus, eTheRNA and other mRNA companies and offer conclusions. Sanofi (NASDAQ: SNY), headquartered in Paris, FR, acquired mRNA pioneer Translate Bio in September 2021 for approximately $3.2 billion and mRNA startup Tidal Therapeutics in April 2021 for approximately $470 million. With its acquisition of Translate alone, Sanofi obtained an mRNA pipeline of nine candidates (two in the clinic), hundreds of patents, and undoubtedly valuable mRNA-based technical and regulatory know-how.

In April of this year, we provided a three-part series relating to the IP and Competitive Landscape for the mRNA market. In this post (Part I), we provide a 2021 year in review update on mRNA pioneers Moderna, BioNTech and CureVac, and in Part II, we profile Sanofi and other companies in the mRNA space and offer additional conclusions and outlook for 2022 and beyond.