Without exaggeration, messenger ribonucleic acid (mRNA) vaccines can be considered a breakthrough development which during the COVID-19 pandemic turned Moderna's, Pfizers's, and BioNTech's vaccines into household names. The benefits and the future potential of mRNA vaccine technology are undisputed and go far beyond the COVID-19 vaccines. Not surprisingly, vaccine developers attempt to obtain maximum protection for the intellectual property associated with their research efforts. While this may be in the interest of the owner of the intellectual property, it may impede related efforts by other players.
On March 5, 2025, the Patent Trial and Appeal Board (PTAB) issued a decision invalidating most claims of two of Moderna's patents (U.S. Patent Nos. 10,702,600 ("the '600 patent") and 10,933,127 ("the '127 patent")) related to SARS CoV vaccines using mRNA technology.
The BioNTech & Pfizer v. Moderna Dispute
The '127 patent and the '600 patent were both filed on May 21, 2020 – notably several months into the COVID-19 pandemic. The provisional applications to which both the '127 and '600 patents claim priority were originally filed in 2015.
Claim 1 of the '600 patent reads: "A composition, comprising: a messenger ribonucleic acid (mRNA) comprising an open reading frame encoding a betacoronavirus (Beta(CoV)) S protein or S protein subunit formulated in a lipid nanoparticle." Claim 1 of the '127 patent is a related method claim.
In August of 2022, Moderna sued Pfizer and BioNTech for allegedly infringing the '127 patent, the '600 patent, and also U.S. Patent No. 10,898,574 ("the '574 patent"), e.g., by making and selling COVID-19 mRNA vaccines.1 Moderna alleges that at the time their company was founded in 2010, mRNA medicines were new and unproven technology on which they have singularly focused their efforts. For example, to advance the so-called fundamental challenge with mRNA medicines – that the body's immune system recognizes mRNA as a foreign substance and attacks it – Moderna developed a specific chemical modification of mRNAs having superior efficacy to those previously trialed.
The outbreak of Middle East Respiratory Syndrome (MERS) in 2014 led Moderna to develop mRNA vaccines for infectious disease, including a vaccine for the MERS virus. Because of this feat, Moderna asserted that they were "uniquely prepared to respond to the COVID-19 pandemic" based on existing mRNA technology. In fact, when the world predicted that a vaccine for COVID-19 could take years to develop, Moderna's existing focus on mRNA vaccine technology instead allowed the company to develop a COVID-19 vaccine that was ready for clinical trials in only a matter of weeks and was approved for use with 94% effectiveness less than a year after the COVID-19 virus had first been identified.
Moderna alleged that "Pfizer and BioNTech followed the trail Moderna blazed for mRNA vaccines and copied Moderna's innovations without ever requesting a license." Specifically, according to Moderna, Pfizer and BioNTech lacked Moderna's level of experience with developing mRNA vaccines for coronaviruses when the COVID-19 virus first emerged. In fact, the opposing companies clinically trialed four different types of COVID-19 vaccines but ultimately allegedly copied Moderna's patented technology by using the same chemical modification to their mRNA and encoded for the exact same type of coronavirus protein (namely the full-length spike protein). During the height of the COVID-19 pandemic, Moderna vowed to refrain from enforcing their COVID-19 related patents, but the vaccine manufacturer expected companies to seek licenses to use their IP once the endemic phase of the pandemic was reached. Accordingly, in the lawsuit, Moderna sought damages for revenue that Pfizer and BioNTech acquired from sale of vaccines allegedly using Moderna's patented mRNA technology.
In response, both Pfizer and BioNTech challenged validity of the '127 and '600 patents' claims in inter partes reexamination (IPR) proceedings filed on August 28, 2023. The trial court suspended the infringement litigation pending the outcome of the IPR proceedings.
IPR OUTCOMES – PTAB FINDS MODERNA'S CHALLENGED CLAIMS OBVIOUS
In both of the IPRs for the '127 and '600 patents, Petitioners Pfizer and BioNTech asserted that the challenged claims lack novelty and further that those claims would have been obvious over cited prior art. Ultimately, the PTAB concluded, based on the totality of the submitted arguments and evidence of record, that claim 1 of both the '127 and the '600 patents would have been obvious over US 2013/0266640 A1 ("Schrum") and WO 2012/006369 ("Geall").2
The Board explained in both IPRs that Pfizer and BioNTech "made a very strong showing that Schrum and Geall teach or suggest the subject matter of claim 1, and that the skilled artisan would have been motivated to combine their teachings as proposed with a reasonable expectation of success." Schrum teaches the mRNA-lipid nanoparticle (LNP) vaccine platform, and further that the same can be used to deliver an encoded immunogen and induce an immune response in a subject. Schrum even expressly points the skilled artisan to Geall's teachings, which identify a betacoronavirus spike protein—a well-known and prevalent target for vaccine development in the art that was repeatedly shown to be highly immunogenic across a variety of vaccine platforms.
On the other hand, the PTAB found that the "Patent Owner has presented strong (and, in some cases, substantively unrebutted) evidence on objective indicia of nonobviousness ...." However, Board ultimately decided that the broad claims, closeness of the prior art to the claimed subject matter, compelling reasons the skilled artisan had for selecting the S protein as the target antigen/immunogen, and the consistent (if not universal) recognition that delivering the S protein provoked an immune response in the vaccine recipient outweighed the so-called "secondary considerations" emphasized by Moderna.
The PTAB further invalidated all challenged claims as obvious over Schrum and other non-patent literature for essentially the same reasons.
CONCLUSION
Pfizer and BioNTech earned more than $5.3 billion in revenue from global sales of their vaccine COMIRNATY in 20243, while Moderna earned $3.1 billion from its vaccine SPIKEVAX4 according to company reports. While the sales of both vaccines declined significantly over time, these numbers demonstrate the sales potential of mRNA vaccine technology. Accordingly, the invalidation of Moderna's patent claims may be welcome news for Moderna's competitors. However, Moderna's lawsuit also alleged infringement of Moderna's '574 patent in addition to the '127 and '600 patents, and no validity-challenging IPR was filed for that patent, so the COVID-19 vaccine patent infringement litigation continues. More generally, and not specifically referring to the BioNTech & Pfizer v. Moderna dispute, transformational technologies such as the mRNA vaccine technology benefit from a balanced approach to patenting inventions where overly broad claims are either avoided or ultimately invalidated.
Footnotes
1 ModernaTX, Inc. and Moderna US, Inc., v. Pfizer Inc., BioNTech SE, BioNTech Mfg. GmbH, and BioNTech US Inc., No. 1_22cv11378 (D. Mass.).
2 BioNTech SE and Pfizer Inc. v. ModernaTX, Inc., IPR2023-01358, Judgment and Final Written Decision, Paper 86 (Pat. Tr. App. Bd. Mar. 5, 2025); BioNTech SE and Pfizer Inc. v. ModernaTX, Inc., IPR2023-01359, Judgment and Final Written Decision, Paper 86 (Pat. Tr. App. Bd. Mar. 5, 2025).
3 https://annualreview.pfizer.com/?linkId=359477841
4 https://investors.modernatx.com/news/news-details/2025/Moderna-Reports-Fourth-Quarter-and-Fiscal-Year-2024-Financial-Results-and-Provides-Business-Updates/default.aspx
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
