Posts Tagged: "Moderna"

Pfizer, Inc. and BioNTech SE on Monday hit back at competitor COVID-19 vaccine maker Moderna with inter partes review (IPR) petitions against two Moderna patents on mRNA vaccine technology at the Patent Trial and Appeal Board (PTAB). Pfizer/ BioNTech told the PTAB that Moderna’s patents include “unimaginably broad claims directed to a basic idea” and asked the Board to cancel all of the challenged claims of both patents.  

The Council for Innovation Promotion (C4IP) on Monday held a webinar featuring some big names in the IP world to clear up what the organization characterizes as misguided views on the use of Title 28 of the U.S. Code, Section 1498(a). The event was prompted in part by a recent U.S. government statement of interest filed in a patent infringement suit against Moderna, Inc.’s COVID-19 vaccine. That statement argued that Moderna should be released from infringement liability under the terms of a government contract that “authorize[d] and consent[ed] to all use and manufacture” of any U.S. patented invention.

On March 22, the U.S. Chamber of Commerce’s Global Innovation Policy Center (GIPC) sent a letter addressed to Senators Bernie Sanders (I-VT) and Bill Cassidy (R-LA), respectively the Chair and Ranking Member of the U.S. Senate Committee on Health, Education, Labor, and Pensions, regarding a Health Committee hearing held that same day on the pricing of Moderna’s COVID-19 vaccine. The GIPC’s letter sought to push back on false narratives regarding the role of public funding in private pharmaceutical research & development (R&D,) and also doubled down on the Center’s criticisms of drug pricing controls in the recently enacted Inflation Reduction Act.

For well over a year, Senator Elizabeth Warren (D-MA) and some members of Congress have engaged in a campaign to urge the Health and Human Services Secretary Xavier Becerra to break patents on pharmaceuticals to lower drug prices by invoking a century-old statute, Title 28 of the U.S. Code 1498. This is their “game plan”: HHS should contract with generic drug companies willfully to infringe pharmaceutical patents, thereby requiring any damages to be paid from public funds. This strategy took a new tack in early March 2023, when the Biden Administration’s Justice Department filed a surprise “Statement of Interest” in a private lawsuit on behalf  “the Government and its Department of Health and Human Services and the Department of Defense.” The case, filed in Delaware federal court, was initiated by Arbutus Biopharma and Genevant Sciences, which allege that that patents they own were infringed by Moderna in producing its version of the COVID-19 vaccine.

On March 2, U.S. District Judge Mitchell S. Goldberg of the District of Delaware received several filings related to the impact of the U.S. government’s recent statement of interest filed in a patent infringement suit against Moderna’s COVID-19 vaccine. That statement argued that Moderna should be released from infringement liability under the terms of a government contract that “authorize[d] and consent[ed] to all use and manufacture” of any U.S. patented invention. The federal government’s statement of interest, filed on February 14, contended that the use of such authorization and consent clauses should eliminate Moderna’s alleged liability under 28 U.S.C. § 1498, the statute governing remedies for patent infringements by government use. While there’s nothing surprising about the positions taken by defendant Moderna or plaintiffs Arbutus Biopharma and Genevant Sciences, the relevance of Section 1498(a) to arguments surrounding government control of drug pricing could make Judge Goldberg’s next ruling an important moment in the drug pricing debate.

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”).

The National Institutes of Health (NIH) is at legal odds with Moderna, claiming that Moderna neglected to add three NIH scientists to Moderna’s patent application on a principal COVID-19 vaccine. If a court ends up siding with NIH, it would co-own any issued patents on the technology, which could prove to be quite valuable; in 2021, Moderna’s vaccine sales were forecasted to be in the range of $15 billion and $18 billion. With an equal undivided interest in the patent, NIH could do whatever it wishes with it, such as licensing it to others and collecting royalties.

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.

In the wake of the development of COVID-19 vaccines, the Biden-Harris Administration has suggested major shifts in U.S. policy concerning patent protection. In May of this year, Ambassador Katherine Tai, the U.S. Trade Representative (USTR) announced the Administration’s support for waiving intellectual property protections for COVID-19 vaccines. Most recently, the National Institutes of Health (NIH) Director Dr. Francis Collins accused Moderna of excluding three NIH scientists as co-inventors of a key patent for the COVID-19 vaccine. This article explores an alternative possibility of the Administration exercising certain rights in the COVID-19 vaccine invention under the 1980 Bayh-Dole Act—one day after the bill’s co-sponsor, Senator Bob Dole, passed away—and whether such an exercise of rights is in line with past precedent or would be a violent disruption to the status quo.  

Moderna and the National Institutes of Health (NIH) are poised for a legal battle over inventorship of a vaccine for COVID-19. While a court may resolve the dispute over inventorship for the patent application, court review of current inventorship rules could be a slippery slope to chaos. Moderna and NIH collaborated on developing a functional vaccine for COVID-19, which is not in dispute. As a result of the collaboration, a vaccine labeled “mRNA-1273” was created and a U.S. patent application was filed by Moderna, with no NIH scientists listed as inventors. Moderna has commented that, after an internal review, no NIH scientists designed the actual vaccine claimed in the U.S. patent application. NIH has commented that it believes three scientists should be included in the U.S. patent application as co-inventors with the Moderna scientists.

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.

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.