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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.  Summary of 2022 Litigation Activity On February 28, lipid pioneer Arbutus and its exclusive licensee Genevant sued mRNA pioneer Moderna…
Several patent litigations have been filed involving mRNA pioneers such as Moderna, Inc. and BioNTech, Inc. (with Pfizer) over the past year relating to sales of the Moderna and BioNTech/Pfizer COVID-19 vaccine products (Spikevax® and Comirnaty®, respectively).  This post provides an overview of those cases, other cases involving other mRNA pioneers, and the overall mRNA patent litigation landscape as of August 24, 2022.[1] Arbutus and Genevant v. Moderna On February 28, 2022, Arbutus and…
On August 16, 2022, Merck (NYSE: MRK) and Orna Therapeutics each announced that they entered into a collaboration agreement relating to the discovery, development and commercialization of therapeutics and vaccines in the oncology and infectious disease spaces. The deal centers around Orna’s “oRNA” technology which is reportedly directed to the creation of circular RNAs (oRNAs) from linear RNAs through “self-circularization.” The companies indicate that “oRNA molecules have been shown to have greater stability in vivo…
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. 8,058,0698,492,3598,822,6689,364,4359,504,651, and 11,141,378 directed to lipid nanoparticle (“LNP”) delivery technology through, inter alia, sales…
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 we provide a 2021 year in review update on mRNA pioneers and key players and offer additional conclusions and outlook for 2022 and beyond. Key mRNA Pioneers and Market Players Moderna Figure 1: Overview of certain attributes of Moderna as of December 13, 2021. Since April, Moderna’s pipeline has increased from…
Following the successful development (and financial success) of its mRNA vaccine, biotech company Moderna is now looking to expand into the gene editing field. During a second-quarter earnings call on August 5, 2021, Moderna executives expressed that the company is ready to “expand our horizons” with external technologies or products. It is well known that Moderna has the funds to back it up—the company has a soaring $157B market cap and its mRNA-based COVID-19 vaccine…
mRNA pioneer BioNTech announced recently that it is developing an mRNA-based vaccine to attempt to eradicate malaria.  Its efforts are geographically focused on Africa, and the company said it is furthering those efforts to build manufacturing capacity on the African continent. This all comes on the heels of being the first to ever put an mRNA-based product on the market, its COVID-19 vaccine developed with Pfizer, demonstrated to be 95% effective. “The response to the…
In Part I of this series providing a summary of the mRNA IP and competitive landscape through one year of the COVID-19 pandemic, we focused on market players BioNTech, Moderna and CureVac; in Part II, we discussed Translate BIO, Arcturus, and eTheRNA (and other startups) and provided background on activity relating to certain Arbutus lipid nanoparticle (LNP) delivery technology. Here, in our final post, we provide an analysis of the current landscape and offer conclusions.…