USPTO Finds Claims of Two of Moderna’s mRNA Patents Unpatentable: What’s Next in the Vaccine Wars?

On Wednesday, March 5, 2025, the United States Patent Trial and Appeal Board (“PTAB”) handed down the latest decision in the COVID vaccine proceedings between Pfizer Inc. (“Pfizer”) and BioNTech SE (“BioNTech”) and ModernaTX, Inc. (“Moderna”). The PTAB found all challenged claims unpatentable in two patents held by Moderna related to Moderna’s COVID-19 vaccine technology: U.S. Patent Nos. 10,702,600 (the “’600 patent”) and 10,933,127 (the “’127 patent”), both entitled “Betacoronavirus mRNA Vaccine.”

Back in October 2020, Moderna stated that it would not enforce its COVID-19-related patents during the pandemic. Later, in early 2022, as the global response to COVID-19 evolved and vaccine supply was no longer a significant barrier in many regions, Moderna revised its stance to specify that, although it would not enforce its COVID-19-related patents in the low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC), competitors should respect its intellectual property rights outside of these countries.

On August 26, 2022, Moderna sued Pfizer and BioNTech in the District of Massachusetts, alleging infringement of certain claims of the ’600 and ’127 patents and also a third patent, U.S. Patent No. 10,898,574 (the “’574 patent”), entitled “Delivery and Formulation of Engineered Nucleic Acids.”

In response, on August 28, 2023, Pfizer and BioNTech petitioned for inter partes review (“IPR”) at the PTAB, challenging the claims in the ’600 and ’127 patents that were asserted against them in the district court case. BioNTech SE & Pfizer Inc. v. ModernaTX, Inc., IPR2023-01358, Paper 3 (P.T.A.B. Aug. 28, 2023); BioNTech SE & Pfizer Inc. v. ModernaTX, Inc., IPR2023-01359, Paper 1 (P.T.A.B. Aug. 28, 2023). The district court case was stayed pending the results of the IPR proceedings.

On Wednesday, March 5, 2025, the PTAB ruled in favor of Pfizer and BioNTech, finding all challenged claims in the ’600 and ’127 patents unpatentable as obvious. BioNTech v. Moderna, IPR2023-01358, Paper 86 (P.T.A.B. Mar. 5, 2025); BioNTech v. Moderna, IPR2023-01359, Paper 86 (P.T.A.B. Mar. 5, 2025).

The PTAB's analysis primarily focused on the petitioners’ Ground 2, where Pfizer and BioNTech asserted that all challenged claims would have been unpatentable as obvious over the combination of US 2013/026640 (“Schrum”) (Moderna’s own patent publication) and WO 2012/006369 (“Geall”). Shrum incorporates Geall by reference in its entirety. Pfizer and BioNTech argued that Schrum teaches methods involving the delivery of nucleic acids encoding a protein by “contacting the ‘mammalian cell or tissue with a formulation comprising a modified mRNA encoding a polypeptide of interest.’” Geall was used for its teaching that the encoded immunogen could be “a betacoronavirus (BetaCoV) S protein.” In response, Moderna argued, among other things, that a person of ordinary skill in the art (“POSA”) would not have been motivated to combine Schrum and Geall.

The PTAB determined that all challenged claims were obvious in light of the combination of Schrum and Geall. The PTAB rejected Moderna’s arguments that a POSA would not be motivated to combine the teachings of the Schrum and Geall, noting that Schrum “identifies and incorporates” the teachings of Geall in their entirety and “encourages use of mRNA-based vaccines to induce an immune response, and relays no skepticism.”

The PTAB also found Moderna’s own FDA submissions weakened Moderna’s “arguments about the state of the art and the extent to which skilled artisans would have considered prior art, preclinical studies about [different nucleic acid vaccine platforms] relevant and reasonably predictive of safety and efficacy across platforms.” For example, the PTAB indicated that Moderna provided a 2016 Investigator Brochure to FDA that explicitly referenced several preclinical studies conducted before 2015 to support the “Proof-of-Concept with mRNA-Based Vaccines” in “various animal models.” The PTAB reasoned that, just as Moderna’s own Schrum reference guided a POSA to Geall’s teachings on saRNA vaccines, Moderna’s FDA submissions did as well. The PTAB further explained that “FDA submissions specific to the development of its COVID-19 mRNA vaccine also cite prior art successes with DNA vaccines in support.” The PTAB found that these submissions, together with testimony of the parties’ respective FDA experts, “support[] a finding that skilled artisans would not have limited their consideration to only data and results about the particular nucleic acid vaccine platform (mRNA, DNA, saRNA) under development when forecasting a reasonable likelihood of success.”

Although the PTAB indicated that it gave “substantial weight” to Moderna’s objective indicia of non-obviousness—including the long-felt and unmet need for a vaccine that would be safe and effective against betacoronaviruses, failure of others to develop such a vaccine, significant industry praise for Moderna’s and Pfizer’s COVID-19 vaccines, and commercial success for Moderna’s and Pfizer’s COVID-19 vaccines—the PTAB found that these objective indicia were “outweighed by the very strong evidence of obviousness.”

Although the PTAB’s ruling is a victory for Pfizer and BioNTech, the vaccine wars are far from over. Moderna may still appeal the PTAB’s decision to the Federal Circuit, and at least Moderna’s claims for infringement of the ’574 patent (which was not challenged at the PTAB) remain in the District of Massachusetts. The district court may also grapple with the question of whether Moderna provided an implied license to its patents through its public statement that it would not enforce its IP during the pandemic. Further, in a separate front, a German court ruled that Pfizer and BioNTech infringed one of Moderna’s European patents on COVID-19 vaccine technology and owe Moderna damages that are to be determined.

Stay tuned for updates on further rulings and appeals as we continue to monitor the situation.

Key Takeaway

Incorporations by reference in a patent specification and statements made to the FDA demonstrating safety and efficacy may undermine a Patent Owner’s arguments of non-obviousness.