Modernatx Inc v Pfizer Ltd & Ors

Factual and Procedural Background

This appeal concerns an order made by Mr Justice Meade on 25 September 2024 following a 19-day trial in the High Court of Justice, Business and Property Courts of England and Wales, Intellectual Property List (ChD), Patents Court. The trial involved two European Patents (UK) Nos. 3 590 949 ("EP949") and 3 718 565 ("EP565"), both owned by the Claimant ("Moderna"). The judge found EP949 valid and infringed by the Defendants ("Pfizer/BioNTech" or "PBNT"), whereas EP565 was held invalid. The appeal challenges the judge's conclusion that EP949 is valid. The Defendants do not dispute the priority date of 1 October 2010 but contend that EP949 lacks novelty or is obvious in light of International Patent Application No. WO 2007/024708 filed by the Trustees of the University of Pennsylvania ("UPenn"). Other validity challenges raised at trial are no longer pursued, and the Claimant now relies only on claim 3 of EP949. The alleged infringement relates to PBNT’s mRNA-based SARS-CoV-2 vaccine marketed under the trade mark Comirnaty.

Legal Issues Presented

1. Whether claim 3 of EP949 is novel over the prior art disclosure in UPenn.
2. Whether claim 3 of EP949 involves an inventive step or is obvious in light of UPenn and the common general knowledge.
3. The proper identification of the person skilled in the art for the purposes of assessing obviousness and novelty.
4. Whether the expert evidence of the Defendants was tainted by hindsight affecting the assessment of obviousness.
5. The interpretation of paragraph [0056] of UPenn and its significance for novelty and obviousness.

Arguments of the Parties

Defendants' Arguments

• EP949 lacks novelty over UPenn because UPenn discloses mRNA comprising pseudouridine modifications, including m1-methyl-pseudouridine (m1Ψ), and 100% replacement of uracil, either individually or in combination.
• The skilled person would have been motivated to explore other pseudouridine modifications, including m1Ψ, based on UPenn’s teachings and the RNA Modification Database ("RNAMD").
• The skilled person is a basic scientist interested in fundamental research, with a willingness to undertake empirical testing without a concrete expectation of success.
• The expert evidence of the Claimant’s witness was incorrectly preferred over that of the Defendants’ expert, whose evidence was unfairly sidelined.
• Paragraph [0056] of UPenn should be interpreted as a technical teaching identifying a list of pseudouridine-like nucleosides of particular interest.

Claimant's Arguments

• EP949 is novel because UPenn’s disclosure does not provide an individualised, clear, and unambiguous teaching combining m1Ψ with 100% uracil replacement in mRNA.
• The skilled person is someone with a practical interest in improving mRNA translation and immunogenicity across a range of applications, not a basic scientist focused solely on fundamental research.
• The Defendants’ expert evidence was affected by hindsight, particularly in focusing on m1Ψ and paragraph [0056] of UPenn.
• The choice of m1Ψ and 100% replacement involves selection from multiple independent lists without a clear pointer to their combination, thus maintaining novelty.
• Obviousness is denied because the skilled person would have no positive expectation of success, and the testing regime proposed by Defendants is a blind trial without practical motivation.

Table of Precedents Cited

Court's Reasoning and Analysis

The Court carefully analysed the novelty and obviousness of claim 3 of EP949 in light of UPenn and the common general knowledge. On novelty, the Court emphasised the strict test requiring clear and unambiguous prior disclosure of the claimed invention. It rejected the Defendants’ argument that UPenn’s lists of pseudouridine modifications and percentage replacements individually or collectively disclosed the claimed m1Ψ-mRNA with 100% uracil replacement, noting the absence of any pointer to combine these features. The Court distinguished between a mere definition or list and a technical teaching, finding paragraph [0056] of UPenn to be a definition without technical teaching or preference for m1Ψ or 100% replacement. The Court also found that the prophetic example 31 in UPenn was a vague proposal without specific results or technical teaching, further supporting novelty.

Regarding obviousness, the Court identified the skilled person as someone with knowledge of RNA biology and a practical interest in improving mRNA translation and immunogenicity across various fields, rejecting the Defendants’ narrower definition of a basic scientist focused on fundamental research. The Court found that the Defendants’ expert evidence was affected by hindsight, particularly in focusing on m1Ψ and paragraph [0056].

The Court applied the established principles from Actavis v ICOS and other authorities, considering factors such as motivation to try, expectation of success, and the nature of the research. It found no positive expectation of success in modifying pseudouridine as proposed by the Defendants, characterising their approach as blind trial and error without practical motivation. The Court also considered the RNA Modification Database and relevant literature, concluding that the skilled person would not be clearly directed to m1Ψ modification with 100% replacement. Overall, the Court upheld the trial judge’s findings that claim 3 of EP949 was novel and non-obvious over UPenn.

Holding and Implications

The Court DISMISSED THE APPEAL, thereby affirming the validity of claim 3 of European Patent (UK) No. 3 590 949 as held by the trial judge.

The direct effect of this decision is that the Claimant’s patent claim remains valid and infringed by the Defendants’ mRNA vaccine product. No new legal precedent was established beyond the application of established principles on novelty, obviousness, and assessment of expert evidence in patent cases. The judgment underscores the importance of clear and unambiguous disclosure in prior art for novelty and the careful evaluation of hindsight in obviousness assessments.