Posts Tagged: "mRNA"

On October 2, the Nobel Assembly at Karolinska Institutet announced that Hungarian-American biochemist Katalin Karikó and American immunologist Drew Weissman were awarded the 2023 Nobel Prize in Physiology or Medicine for their discoveries related to modified messenger ribonucleic acid (mRNA) for use in vaccines. A critical part of the world’s response to the COVID-19 pandemic, mRNA vaccines were not an effective option until the pioneering work of these two scientists, one of whom faced considerable rejection while laying the foundation that answered one of the world’s greatest public health crises.

The U.S. Court of Appeals for the Federal Circuit (CAFC) today affirmed in a precedential decision the Patent Trial and Appeal Board’s (PTAB’s) finding that Moderna Therapeutics proved certain claims of Arbutus Biopharma Corporation’s mRNA delivery patent invalid as anticipated. U.S. Patent No. 9,404,127 is titled “Non-liposomal Systems for Nucleic Acid Delivery” and is directed to “an invention that provides stable nucleic acid-lipid particles (‘SNALP’) that have a non-lamellar structure and ‘comprise a nucleic acid . . . methods of making the SNALP, and methods of delivering and/or administering the SNALP.’” SNALP has a three-dimensional structure that is either a lamellar morphology or non-lamellar (pictured).

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.

Moderna has sued Pfizer and BioNTech over the mRNA vaccine patents behind the COVID-19 vaccines. Moderna is not seeking to remove Comirnaty® from the market and is not asking for an injunction to prevent future sale, nor damages related to Pfizer’s sales for any COVID-19 vaccine used in 92 low- and middle-income countries. Moderna is represented by Wilmer Cutler Pickering Hale and Dorr. The patents asserted in the complaint filed in the District of Massachusetts are: U.S. Patent Nos. 10,898,574 (the “’574 patent”), 10,702,600 (the “’600 patent”), and 10,933,127 (the “’127 patent”).

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.

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.

The U.S. Court of Appeals for the Federal Circuit ruled yesterday in two precedential decisions that Moderna’s challenges to decisions of the Patent Trial and Appeal Board (PTAB) in favor of Arbutus both failed. The CAFC dismissed one ruling for lack of standing and in the other said Moderna’s arguments that the PTAB erred in its finding that Arbutus’ patent was not unpatentable as obvious were unpersuasive.

At today’s Heritage Foundation event in Washington, D.C., titled Restoring American Leadership in Patent Law and Innovation Policy, former U.S. Patent and Trademark Office Director (USPTO) Andrei Iancu began by lamenting the failure of decision makers to make the connection between intellectual property and innovation. Increasingly, policy makers think innovation just happens, Iancu explained, with too many believing monetization happens after the fact, rather than driving innovation. “Without IP, the free market does not participate, or does not participate to scale,” Iancu told the Heritage audience. Laurie Self, Senior Vice President and Counsel, Government Affairs, Qualcomm, agreed with Iancu and added that, without a strong patent system, there is no opportunity to maintain a strong innovation leadership position. Presumably alluding to developments such as the Biden Administration’s support for waiving IP rights under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) related to COVID-19 inventions and the recent Executive Order on Competition, Self said: “We are seeing a series of policies that if implemented would undermine our system… this cognitive dissonance is a threat.”

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.

Shortly after we posted about Moderna, Inc.’s October 2020 pledge not to enforce its COVID-19-related patents during the pandemic, the United States Food & Drug Administration (FDA) granted emergency regulatory approval for two COVID-19 vaccines produced by Moderna and BioNTech (with Pfizer), making these groups the first to ever enter the commercial market with mRNA-based therapies. This little-known and never-before-approved mRNA technology has since been widely administered and represents a primary weapon being used to defeat the pandemic. While this effort carries on, market players are confident that COVID-19 is but one of many indications that the mRNA technology platform might be utilized for, and that approval of the mRNA vaccines could open the door for the approval of other mRNA-based medicines, creating a wide range of new markets. With the anticipated increase in market activity and competition, we will provide an overview of the mRNA IP and competitive landscape in a series of three posts in the context of certain key players’ patent positions, drug pipelines, strategic relationships, and other attributes. These posts are based on publicly available information, are non-exhaustive, and do not identify all market players or potential market players in this space.

As Pfizer and BioNTech announced this week that results of their COVID-19 vaccine have exceeded expectations, the technology behind the vaccine (messenger RNA, or mRNA) has taken center stage. Last month, Moderna Therapeutics, one of the global leaders in the race to produce a COVID-19 vaccine using mRNA, made the following statement regarding enforcement of its patents: “We feel a special obligation under the current circumstances to use our resources to bring this pandemic to an end as quickly as possible. Accordingly, while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic. Further, to eliminate any perceived IP barriers to vaccine development during the pandemic period, upon request we are also willing to license our intellectual property for COVID-19 vaccines to others for the post pandemic period.” This post examines why Moderna made this patent pledge by examining its mRNA technology, go-to-market status, patent landscape, and market position.