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Messenger RNA (“mRNA”) is a naturally occurring molecule that carries instructions from DNA, telling cells which proteins to make.
Scientists have explored whether this process could be harnessed for medical purposes — including using mRNA as a way of instructing the body to produce certain proteins, on demand.
In theory, this offers a powerful and flexible approach to medicine. Instead of developing a different drug for each disease, mRNA technology could provide a new platform: introducing genetic “instructions” to prompt the body to produce specific proteins, for example to train the immune system to recognise a virus or to target cancer cells.
However, turning this idea into a practical treatment proved far more challenging than expected. Early versions of synthetic mRNA were fragile and delivering them into the right part of the cell was a significant technical hurdle¹. They could also trigger unwanted immune reactions, reducing their effectiveness². Over time, these challenges were addressed through a series of advances. Scientists developed ways to modify the mRNA so that it is more stable and less likely to be recognised as a threat. At the same time, new delivery systems were created to protect the mRNA and help it enter cells efficiently. Among these, tiny fat‑based particles known as lipid nanoparticles (LNPs) have proved particularly important, as they act as carriers for the fragile mRNA molecules³.
Although these developments took place over many years, mRNA technology only gained widespread recognition during the COVID‑19 pandemic. Faced with an urgent global need for vaccines, researchers were able to design mRNA vaccines simply by encoding the genetic instructions for a viral protein. Within a remarkably short time, these vaccines were tested, approved, and distributed worldwide.
This rapid success demonstrated, for the first time, that mRNA could be used at scale as a medical technology. At the same time, it brought renewed attention to the underlying science — and to the intellectual property that supports it. Technologies that had been developed gradually, often by different organisations, suddenly became central to highly valuable products.
As a result, questions about who owns the key elements of mRNA technology, and how those rights should be enforced, have come to the forefront. It is in this context that the war around RNA has emerged, with companies, research institutions, and technology developers seeking to define their positions in a complex, competitive and commercially valuable landscape. The outcomes of these battles may determine who can access foundational mRNA technologies, on what terms, and how value is shared across the next generation of RNA-based medicines.
Why mRNA litigation is happening now
The success of mRNA vaccines during the COVID‑19 pandemic brought unprecedented attention not only to the technology itself, but also to the intellectual property underpinning it. As discussed above, innovations developed over decades suddenly became central to products of enormous commercial value.
In this context, the subsequent wave of patent disputes was not an unexpected by‑product, but rather a result of a unique combination of factors. In many respects, litigation in this space was inevitable.
Traditionally, vaccine development spans many years. However, following publication of the COVID-19 viral genetic sequence in early 2020, vaccine candidates entered clinical trials within months and were approved before the end of the same year⁴.
This rapid transition — from early research to global deployment — left little time for the usual consolidation of intellectual property positions, such as cross‑licensing or portfolio alignment. In effect, the technology was commercialised before the IP landscape had fully stabilised.
At the same time, COVID‑19 vaccines generated very significant revenues, turning mRNA into one of the most valuable segments of the pharmaceutical market (valued at USD 6.01 billion in 2025⁵). Where such value is at stake, patent enforcement is almost inevitable. Notably, many claimants have not been vaccine developers themselves, but holders of underlying technologies seeking to share in that success.
Crucially, mRNA technology did not arise in isolation. As noted above, key components - including modified mRNA constructs, LNP delivery systems, and formulation strategies - build on decades of prior research and have long been the subject of patent protection⁶. This has created a complex landscape of overlapping rights and broad earlier filings, an environment in which, once commercially successful products emerged at scale, disputes were, to a large extent, unavoidable.
A further factor shaping the current disputes is the unusual context in which mRNA vaccines were first deployed. During the height of the pandemic, Moderna — one of the key players in the mRNA vaccine landscape — publicly committed not to enforce certain COVID‑19-related patents⁷. However, as the immediate crisis subsided, this position shifted. From 2022 onwards, enforcement resumed and litigation followed. This temporary suspension of enforcement during a global emergency effectively deferred disputes that might otherwise have arisen earlier, contributing to a concentrated “wave” of litigation once normal commercial conditions returned.
Taken together, these factors explain why the war around RNA was not particularly strategic or intentional, though one could take a cynical view that even during the emergency period when companies came together for the “greater good”, the eye was always on the future contentious period. The rapid rise of the technology, combined with enormous commercial stakes, crowded patent landscape, and temporary suspension of enforcement contributed to a concentrated “wave” of litigation that followed almost as a matter of course.
While this article is focused on the drivers behind the war around RNA, it is worth noting that these disputes have already begun to generate a series of significant legal decisions across multiple jurisdictions. These include challenges to the validity of key patents, as well as findings of infringement in relation to foundational mRNA technologies. Our analysis of those decisions — and what they may mean for innovators, particularly in relation to claim strategy, drafting, and competitive positioning — falls outside the scope of the present article. However, given their potential to shape the future of the field, this is a topic we intend to return to in subsequent pieces.
Economic and strategic consequences of mRNA litigation
The recent wave of mRNA litigation influences how the industry allocates value, accesses technology, and directs future research. Notably, intellectual property is no longer merely a defensive tool, rather, a primary tool defining the structure of the market.
- Shifting value upstream
The disputes around mRNA vaccines concern technologies that often sit at the level of platform infrastructure. As highlighted by recent decisions (which we will comment on in more detail in a future article in this series), certain patents — particularly those directed to such core platform technologies — may ultimately underpin a wide range of products. In practice, this shifts value upstream, from developers (even where those developers are responsible for product innovation, clinical development, and commercialisation) to the companies that control foundational technologies.
- Royalty benchmarks are beginning to emerge
Where such patents are enforced, courts may determine the economic terms under which the technology can be used. Recent settlements provide early indications of how those terms may be set in practice. In a number of recent disputes, patent holders have not sought injunctive relief, instead pursuing compensation for past and ongoing use. For example, the 2025 CureVac–BioNTech/Pfizer settlement reportedly involved a royalty of around 1%of vaccine sales, alongside substantial upfront payments⁸. While this appears to be at the lower end of potential royalty outcomes, it nonetheless demonstrates how courts and settlements may establish de facto royalty benchmarks for platform technologies, particularly where products generate significant revenues.
- Licensing is becoming central to freedom to operate
In parallel, access to mRNA technologies is increasingly likely to depend on licensing rather than independent development. Several recent settlements and cross-licensing arrangements emerging from the war around RNA suggest a move towards a model in which companies procure necessary technologies through bilateral licensing agreements, partnerships and collaborations; and targeted acquisitions. In such a landscape, freedom to operate becomes less about avoiding existing rights, and more about securing access.
- R&D choices shaped by patent access
The patent landscape may also influence R&D strategy, with companies prioritising developments that address gaps in their intellectual property position or enable access to key technologies, rather than pursuing purely incremental scientific advances.
Final remarks
The mRNA disputes highlight a broader shift in how intellectual property functions in platform technologies. Patents are no longer merely defensive assets; they are resources for allocating economic participation, structuring partnerships, and, ultimately, shaping the direction of innovation itself.
What remains to be seen is whether this evolving landscape will stabilise. In the CRISPR field, prolonged conflict has largely consolidated the landscape around a smaller number of key players, each aligned with particular patent positions and operating within a still-fragmented intellectual property environment. The difficulties in navigating this landscape, particularly for startups, has led to the development of CRISPR-alternative gene editing platforms. The mRNA field may follow a similar path. Alternatively, it may remain fragmented, characterised by overlapping rights, ongoing litigation, and a reliance on negotiated settlements.
This will determine whether innovators operate in a relatively coherent licensing ecosystem, or in a complex and contested environment where access to key technologies must be negotiated case by case.
Perhaps the more open question is whether the current disputes mark the resolution of first-generation mRNA technologies — or the start of a new phase. As the field moves towards next-generation constructs and delivery systems⁹, or alternatives such as in vivo cell editing, the contours of the patent landscape are likely to shift once again. In that context, the real question may not be whether the war on RNA is coming to an end, but whether itis about to be repeated.
References
[1] mRNA-based therapeutics: looking beyond COVID-19 vaccines
[2] How Karikó and Weissman pioneered the mRNA vaccine
[3] Lipid nanoparticle-mediated delivery of mRNA therapeutics and vaccines
[4] Annex COVID-19 vaccine development timeline
[6] Biotech review of the year
[7] Statement by Moderna on intellectual property matters during the COVID-19 pandemic
[8] GSK provides update on US settlement of CureVac/BioNTech mRNA patent litigation
[9] Rise of the RNA machines – self-amplification in mRNA vaccine design
