Part II of mRNA Patent Wars: The Growing Legal Battles Shaping the mRNA Landscape

Written by: Shirin Tehrani, McKendra Heinke, Haoju Li, PhD, and Tyler Anne Giglio

Part II of the mRNA patent wars series highlights a rapidly intensifying wave of litigation as biotech companies, academic institutions, and pharmaceutical giants assert competing claims over foundational mRNA and lipid nanoparticle (LNP) technologies. Plaintiffs in these cases are seeking to enforce patents covering everything from lipid formulations to sequence design and delivery systems. Together, these disputes signal a broader reckoning over who owns the building blocks of mRNA-based medicine and how courts will interpret overlapping, technically complex patent rights in a global race for dominance.

Arbutus & Genevant v. Moderna

As of February 2025, Arbutus Biopharma and Genevant Sciences have asserted infringement claims against Moderna based on their LNP patents. These LNP systems are critical for delivering mRNA payloads into cells, and the plaintiffs allege that Moderna’s vaccines rely on protected LNP formulations. Moderna has pushed back with invalidity and non-infringement defenses. The case centers on highly technical claim construction and expert interpretation of lipid structures, making it one of the most complex and consequential biotech patent disputes currently underway. The outcome may set a precedent for how delivery technologies are licensed and challenged across the industry, particularly in disputes involving critical but technically complex LNP formulations. [1]

Alnylam v. Moderna and Pfizer/BioNTech

Originally filed in March 2022, Alnylam Pharmaceuticals’ litigation continues in 2025. In 2022, parallel suits were filed against Moderna and Pfizer/BioNTech, claiming infringement of its patented cationic lipid technology. Alnylam contends that the accused vaccines utilize components that fall within the scope of its delivery platform patents. The defendants argue their lipid formulations are distinct and independently developed. Central to the dispute is the structural similarity between Alnylam’s claimed molecules and those used in commercial products. As claim construction progresses, courts will be tasked with interpreting the breadth of Alnylam’s patents, potentially setting a critical precedent for future lipid-based delivery disputes. The litigation spotlights the growing importance of structural lipid patents and may shape how narrowly or broadly courts interpret chemical similarity in biotechnology infringement suits. [2]

CureVac v. BioNTech

CureVac has reasserted its position in the mRNA field through coordinated litigation against BioNTech in both U.S. and European venues. In March of 2025, the European Patent Office upheld CureVac’s patent related to mRNA sequence optimization for enhanced therapeutic performance, strengthening the company’s claims that BioNTech’s Comirnaty vaccine infringes its intellectual property. With validity affirmed in Europe, CureVac is in a stronger position to pursue injunctive relief or licensing arrangements. [3]

Meanwhile, litigation in the U.S. continues, with CureVac seeking similar recognition of its early mRNA innovations. This case reflects the increasing cross-border complexity of biotech IP enforcement and the growing power of validated European portfolios in global strategy. On the global stage, CureVac continues to press its own claims of early innovation. Following a key victory in Europe, CureVac is gaining momentum in its litigation efforts. “We welcome the decision of the EPO to uphold EP 3 708 668 B1 and remain confident that the patent is infringed in its amended form. Today’s decision marks an important step on our path that we expect will lead to recognition of CureVac’s major contribution to safe and efficacious COVID-19 vaccines as the earliest pioneer in mRNA technology,” said Dr. Alexander Zehnder, Chief Executive Officer of CureVac. “This effort is a multi-step process in Europe and the U.S. We remain determined to have our contributions to the field of mRNA technology acknowledged and fairly compensated, and to continue making advances that expand the frontiers of mRNA-based medicines.” [4] This cross-border dispute reflects the rising influence of European patent portfolios in global IP strategy and may establish a model for asserting early mRNA innovations in both the EPO and U.S. courts.

GSK v. Moderna and Pfizer/BioNTech

As of April 2025, GlaxoSmithKline (GSK) filed infringement lawsuits against Moderna and Pfizer/BioNTech, asserting patents related to mRNA sequence design and delivery optimization. GSK claims that its long-standing R&D efforts in the mRNA field have been improperly commercialized by competitors in the race to develop COVID-19 vaccines. The defendants have responded with aggressive defenses, including assertions of invalidity and non-infringement. As the litigation progresses, GSK’s entry represents a notable shift, signaling that established pharmaceutical companies intend to assert long-held patent rights over foundational platform technologies. This may signal that legacy pharmaceutical players are now aggressively protecting their long-standing R&D investments, expanding the scope of conflict from delivery mechanisms to sequence-level design innovations.

Acuitas Therapeutics v. GSK

In January 2025, Acuitas Therapeutics filed a lawsuit against GSK, seeking a declaratory judgment of non-infringement and invalidity concerning five GSK patents related to mRNA vaccine technology. This legal action underscores the competitive tensions in the mRNA vaccine space, particularly regarding proprietary delivery technologies such as LNP systems, which are essential for transporting fragile mRNA strands into cells. These delivery platforms play a critical role in the effectiveness, stability, and safety of mRNA vaccines, making them a focal point in ongoing patent disputes. The case is currently pending, with both parties preparing for a complex legal battle.By filing preemptively, Acuitas aims to gain early control over jurisdiction and legal framing—a tactical use of declaratory judgment that is becoming increasingly common in high-stakes biotech IP litigation. [5]

Northwestern University v. Moderna

In October 2024, Northwestern University filed a lawsuit against Moderna in the U.S. District Court for the District of Delaware, alleging infringement of several patents related to mRNA vaccine technology. Northwestern contends that Moderna’s Spikevax COVID-19 vaccine infringes upon these patents. As of early 2025, the case remains pending, with Moderna having filed a motion to dismiss, arguing that the allegations fail to state a claim for which relief can be granted. This case highlights the role of academic institutions in asserting patent rights in the commercial biotech arena, and may influence how licensing agreements are structured for publicly funded innovations. [6]

The ongoing mRNA patent disputes illustrate the increasing complexity of intellectual property enforcement in a field built on overlapping innovations and rapidly evolving technologies. These cases may influence how courts approach claim scope, technical interpretation, and the balance between early foundational patents and later commercial implementation, ultimately shaping future collaboration, licensing, and competition strategies across the biotech sector. Stay tuned for Part III, where we explore how international enforcement strategies, cross-licensing, and acquisition trends are transforming the future of mRNA innovation.