Modernatx Inc v Pfizer Limited & Ors

For added matter and novelty, the decisive question is whether the claimed subject matter is directly and unambiguously disclosed. A document is not a reservoir from which features may be selected and combined at will. A general disclosure, list or definition does not necessarily individualise every member or combination within it. Selection from multiple lists is not automatically impermissible, but the whole document must contain a clear teaching or pointer to the claimed combination.

Obviousness requires assessment in the circumstances of the case, including motivation, alternative research paths, burden, hindsight and expectation of success. Routine experiments with uncertain results may be obvious where the skilled person understands the system and has a reasonable expectation that at least one route will work. Blind trial and error without a practical incentive or expectation of success is not enough.

Two related actions concerned the validity and infringement of European Patent (UK) Nos 3 590 949 and 3 718 565, both owned by Moderna and asserted against Pfizer/BioNTech SARS-CoV-2 vaccines. Infringement of EP949 was effectively admitted if the patent was valid. Pfizer/BioNTech challenged EP949 for lack of novelty, obviousness and insufficiency. EP565 was challenged for lack of novelty, obviousness, added matter and insufficiency, with conditional and unconditional amendments also in issue.

The central questions were whether the prior-art disclosures directly and unambiguously disclosed the claimed subject matter, whether the skilled person would find the EP949 invention obvious, and whether the EP565 mRNA/LNP betacoronavirus vaccine would be obvious over WO674.

1. EP949. The skilled person was a person with knowledge of RNA biology and a practical interest in improving mRNA translation and immunogenicity across relevant applications. The court rejected both the narrow definition confined to transcript therapy and the broad definition of a pure basic scientist.
2. For novelty, the applicable standard was direct and unambiguous disclosure. A general document, list or definition was not a reservoir from which features could be combined at will. The 96-member list in UPenn, its open-ended wording, and the references to Examples 2 and 7 did not individualise mRNA containing m₁Ψ with 100% uridine replacement and, where required, a polyA tail. The alternative Route 3 also failed because there was no pointer to the combination of m₁Ψ and 100% replacement.
3. EP949 was not obvious over UPenn or Karikó 2008. The prior art provided strong results for Ψ but no reliable explanation for them. The proposed programme involved selecting and testing variants through blind trial and error, with no concrete expectation of success and no sufficiently immediate practical incentive. Charette & Gray would more likely point away from m₁Ψ. Routine experimental formats did not make the strategic selection of variants routine.
4. EP565. The skilled team operated in the broader established field of vaccine development and would know that SARS and MERS were important targets. WO674 expressly identified an mRNA MERS-CoV spike-protein vaccine and supplied an LNP platform with positive influenza results. The selection of MERS, the spike protein and a suitable LNP formulation were routine decisions with good prospects of success. EP565 was therefore obvious over WO674.
5. EP565 was also invalid for added matter because its claims combined features drawn from separate parts of the application without a clear teaching to combine them. The claims were not anticipated by WO674 because its disclosure did not individualise the claimed combination. The proposed amendments did not alter the conclusions.
6. The court concluded that EP949 was valid and infringed. EP565 was obvious and invalid for added matter, although not anticipated. The parties were to address the form of order.

First-instance judgment. The judgment records parallel proceedings before the EPO and the District Court of the Hague, but this court’s decision was made independently.