
In what can be described as a legal showdown between two biotechnology heavyweights, Moderna Inc. has triumphed over Alnylam Pharmaceuticals in a fiercely contested patent dispute centered around the groundbreaking Spikevax COVID-19 vaccine.
The case, which originated in 2020, saw Alnylam claim that elements of Moderna’s lipid nanoparticle (LNP) delivery system infringed upon its intellectual property. LNPs are crucial in mRNA vaccines, acting as vehicles that protect and deliver the fragile mRNA into human cells. Given the centrality of this technology to Spikevax, the stakes of the litigation were enormous — not just for Moderna and Alnylam, but for the future landscape of mRNA-based therapeutics.
However, on June 4, 2025, the U.S. Court of Appeals for the Federal Circuit handed down a ruling in Moderna’s favor. The court determined that Alnylam’s claims — specifically its definition of the term “branched alkyl” — were too narrow to encompass the formulation used in Moderna’s LNPs. This definitional oversight ultimately cost Alnylam the case.
🧬 Scientific Innovation vs. Legal Language
The dispute perfectly exemplifies the complex relationship between scientific innovation and legal articulation. Moderna’s vaccine was clearly developed independently, but Alnylam’s attempt to stake a claim through existing patents could have succeeded — if not for a subtle but significant limitation in how their claims were framed.
Key Lessons:
- Patent Definitions Are Not Mere Formalities: Every word in a claim, especially technical terms, must be defined with foresight. Overly narrow definitions can box you in; overly broad ones can be invalidated.
- Timing Matters: The rush to secure IP during a global pandemic likely led to rapid filings, but such haste may have compromised the strategic strength of Alnylam’s portfolio.
- Defense Is as Strategic as Innovation: Moderna’s counter-arguments were not just scientific, but also deeply legal. Their team effectively used Alnylam’s own language to defend themselves — a masterclass in patent litigation.
This case will likely be cited in legal and academic circles for years to come. For any company operating in life sciences, biotechnology, or pharmaceuticals, the message is clear: Patents are not just shields or swords — they’re blueprints of your future. Draft them wisely.
Copyright © 2014-2025 Citius Minds Consulting LLP. All Rights Reserved.