The legal battle for dominance in the mRNA therapeutic space has intensified in 2025. As companies scale their platforms beyond COVID-19, patents covering mRNA constructs, delivery systems, and manufacturing methods have become critical assets, sparking legal challenges around the globe. Multiple biotechnology companies are now litigating key patents related to mRNA vaccine and delivery technologies. These proceedings span various jurisdictions and the outcomes are poised to reshape the biotechnology landscape. At the center of this landscape is the dispute between Moderna and Pfizer/BioNTech, two of the leading developers of mRNA-based COVID-19 vaccines. This case serves as the starting point in a broader narrative that continues to unfold across the biotech industry.

Technical Background

Messenger RNA (mRNA) is a single-stranded molecule that carries genetic information derived from DNA, essential for protein synthesis through a process called transcription. An mRNA vaccine utilizes this mRNA to stimulate an immune response. One effective method of delivering mRNA into biological systems involves encapsulating it within Lipid Nanoparticles (LNPs). The typical composition of an LNP delivery system includes an ionizable cationic lipid, a helper lipid, cholesterol, and a polyethylene glycol (PEG)-lipid. Upon administration, cells internalize the mRNA-LNP complex via endocytosis, a process in which LNPs bind to the cell membrane and enter the cell enclosed within an endosome. The acidic environment inside the endosome destabilizes the LNP membrane, releasing the mRNA into the cytosolic environment. Subsequently, the cellular ribosomal machinery translates the mRNA sequence into the corresponding protein, eliciting the desired immune response. Given the technical and economic importance of these delivery systems, patents protecting mRNA platforms and LNP formulations have become central to the rapidly evolving legal landscape.

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Moderna v. Pfizer/BioNTech

PTAB Ruling in the U.S.

Moderna's key mRNA vaccine patents came under challenge at the Patent Trial and Appeal Board (PTAB), with Pfizer and BioNTech seeking to invalidate them on grounds of obviousness and lack of novelty. The challenged patents primarily covered aspects of Moderna's mRNA sequence design and lipid nanoparticle delivery systems, both of which were central to its COVID-19 vaccine. In March of 2025, the PTAB ultimately ruled in favor of the challengers, holding that prior art disclosures rendered Moderna's claims unpatentable. The decision highlights the vulnerability of mRNA filings that fail to sufficiently distinguish themselves from preexisting publications in the field. Strategically, this outcome represents a setback for Moderna, limiting its ability to enforce exclusivity and potentially encouraging other developers to move forward without licensing its platform. The ruling may also influence how future mRNA patent applications are drafted, prompting companies to more clearly articulate inventive steps over known technologies.

Despite the PTAB ruling, Moderna leadership remained firm in defending its platform. In response, Moderna Chief Executive Officer Stéphane Bancel emphasized the company's commitment to defending its intellectual property. "We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic," Bancel stated. "This foundational platform, which we began building in 2010, along with our patented work on coronaviruses in 2015 and 2016, enabled us to produce a safe and highly effective COVID-19 vaccine in record time after the pandemic struck. As we continue to combat health challenges moving forward, Moderna is using our mRNA platform to develop medicines targeting infectious diseases like influenza and HIV, as well as autoimmune and cardiovascular diseases and rare forms of cancer."

Düsseldorf Regional Court Ruling

In contrast to the U.S. setback, Moderna secured a significant win in Europe. In a separate case dating back to 2022, the Regional Court of Düsseldorf in Germany ruled in March 2025 that Pfizer and BioNTech infringed one of Moderna's European patents related to mRNA vaccine technology. This marked a key victory for Moderna abroad, even as its U.S. patents came under fire. Taken together, these outcomes highlight the fragmented and jurisdiction-dependent nature of mRNA patent enforcement—where a win in one forum may be offset by challenges in another, complicating global exclusivity strategies for platform developers.

As this legal tug-of-war continues to unfold across courts and continents, the Moderna-Pfizer/BioNTech dispute serves as a cautionary tale for how rapidly evolving science meets a patchwork of international patent systems.

Footnotes

1. Park JW, Lagniton PNP, Liu Y, Xu RH. mRNA vaccines for COVID-19: what, why and how. Int J Biol Sci 2021; 17(6):1446-1460. doi:10.7150/ijbs.59233. https://www.ijbs.com/v17p1446.htm

2. Hou, X., Zaks, T., Langer, R. et al. Lipid nanoparticles for mRNA delivery. Nat Rev Mater 6, 1078-1094 (2021). https://doi.org/10.1038/s41578-021-00358-0

3. Rouf, N. Z., Biswas, S., Tarannum, N., Oishee, L. M., & Muna, M. M. (2022). Demystifying mRNA vaccines: an emerging platform at the forefront of cryptic diseases. RNA Biology, 19(1), 386-410. https://doi.org/10.1080/15476286.2022.2055923

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