Covid-19 vaccine maker Moderna filed a lawsuit on August 26, 2022 against Pfizer Inc. and BioNTech, alleging that its rivals “followed the trail Moderna blazed” years ago in developing the technology behind the mRNA platform at the heart of the Covid-19 vaccines the companies produced. Moderna’s suit alleges that Pfizer and BioNTech copied two key components of Moderna’s patented technology in developing their Covid-19 vaccines.
The suit, filed in Massachusetts federal court, said Pfizer and BioNTech had other options in developing their COVID-19 vaccine that could have steered clear of Moderna’s patented technology, but instead they copied two key components of Moderna’s platform. They used the same chemical modification and encoded their vaccine for the same coronavirus protein — the full-length spike protein — that Moderna said in the suit it pioneered long ago.
Moderna was founded in 2011 in Cambridge, MA. The name of the company was created by combining the words “modified” and “RNA” – a play on the mRNA technologies the founding scientists developed. Since that time, Moderna has been developing mRNA therapeutics and vaccine technologies, particularly for MERS, which encoded for the full-length spike protein of the MERS coronavirus in a lipid nanoparticle.
According to the complaint, “When the COVID-19 pandemic struck, Moderna had already conducted a decade of foundational research in the area of mRNA medicines, including specifically on coronaviruses, and was uniquely positioned to respond to the crisis.” In addition, “[N]either Pfizer nor BioNTech had Moderna’s level of experience with developing mRNA vaccines for coronaviruses. Upon information and belief, before the emergence of COVID-19, unlike Moderna, neither Pfizer nor BioNTech had ever developed an mRNA vaccine for a coronavirus,” the complaint states.
According to Moderna, Pfizer and BioNTech started with a number of different options when they considered how to design their vaccine. As alleged in the complaint, they took four different candidates into clinical testing, including options that would have steered clear of Moderna’s innovative path by using unmodified mRNA. Ultimately, however, Pfizer and BioNTech discarded those alternatives and copied Moderna’s patented technology, according to the complaint.
Moderna also filed an infringement suit against the companies in the Regional Court of Düsseldorf in Germany, where BioNTech is based.
Pfizer and BioNTech said that their vaccine is based on original and proprietary technology created by BioNTech and that they would vigorously defend against Moderna’s allegations, according to a report in The Wall Street Journal.
Given the unprecedented challenges of the COVID-19 pandemic, Moderna voluntarily pledged on October 8, 2020 that, “while the pandemic continues, Moderna will not enforce our COVID-19 related patents against those making vaccines intended to combat the pandemic.” Moderna refrained from asserting its patents earlier so as not to distract from efforts to bring the pandemic to an end as quickly as possible, according to the complaint.
By early 2022, however, the collective fight against COVID-19 had entered a new endemic phase and vaccine supply was no longer a barrier to access in many parts of the world, including the United States. In view of these developments, Moderna announced on March 7, 2022, that it expected companies such as Pfizer and BioNTech to respect Moderna’s intellectual property and would consider a commercially-reasonable license should they request one. This announcement was widely publicized, including through coverage in The Wall Street Journal.
Moderna said it waited to take legal action until it became clear that Pfizer and BioNTech plan to continue serving the global market, including by marketing booster doses of their vaccine. According to the complaint, Moderna wants “fair compensation” for use of its patented mRNA platform, which it said will allow it to reinvest in the very technology that allowed all three companies to address the global pandemic.
Moderna said in the suit that it’s not seeking an injunction, or asking for the Pfizer and BioNTech vaccine to be taken off the market. It also made clear that it’s not seeking damages for any sales Pfizer and BioNTech made to the U.S. government, which are shielded by Section 1498 of the U.S. Code. Nor are these patents related to any intellectual property developed during the company’s collaboration with the National Institutes of Health, according to the suit.
The company also said it has no intention of enforcing its patent rights for vaccines used in 92 low- and middle-income countries designated in the COVAX initiative to ensure global vaccine access, but that it does expect to be compensated for use of its patented technology outside of those countries.
“Indeed, were Pfizer and BioNTech allowed to freely copy Moderna’s patented technology for their own benefit, the next generation of biotech startups would lose their ability to rely on the patent system that is the bedrock upon which future medicines will be discovered,” Moderna argued in the suit.
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Moderna’s suit is the latest high stakes battle over new and developing pharmaceutical technologies. While the Covid-19 pandemic has entered an endemic phase and the efficacy of the vaccines and boosters has waned with each emerging variant, the underlying technology has established its potential. And therein lies the motivating bases for the players to jockey for position to protect their respective proprietary technologies.
Complaint – Moderna v. Pzizer Inc., BioNTech, et al., No. 1:22-cv-11378 2022-08-26
The patents-in-suit are U.S. Patent Nos. 10,898,574, 10,702,600, and 10,933,127.
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Richard A. Catalina, Jr. is a senior partner and Chair of the Intellectual Property and Complex Litigation Department of Jardim, Meisner and Susser, P.C. Mr. Catalina specializes in litigating patent, trademark, trade secret and related Lanham Act disputes, and inter partes proceedings before the Patent Trial and Appeal Board. Mr. Catalina has been practicing law for more than 33 years and has litigated more than one hundred matters in federal and state courts across the U.S, as well as inter and ex partes matters before the Trademark Trial and Appeal Board and the Patent Trial and Appeal Board.
Thanks for this information. Very interesting.