Modernatx, Inc v Pfizer Limited & Ors

For novelty, a prior disclosure must clearly and unambiguously disclose subject-matter which, if performed, would necessarily fall within the claim. A list and a class are not subject to rigidly different rules. The question is whether the claimed subject-matter has an individualised description, assessed by the document as a whole. Selection from multiple lists is not mechanically novel, but an obvious choice is not thereby disclosed.

Obviousness under the Patents Act 1977 is a fact-sensitive, multi-factorial assessment. Motivation, alternative research paths, effort, routine research, expectation of success and hindsight must be assessed in context. The appeal was dismissed because the claim was neither anticipated nor obvious.

Modernatx owned EP949, a patent concerning modified mRNA. After a 19-day trial, Meade J held that EP949 was valid and infringed, while a separate patent, EP565, was invalid: [2024] EWHC 1695 (Pat). The Pfizer and BioNTech defendants appealed the finding that EP949 was valid.

On appeal, the only claim relied upon was claim 3, concerning mRNA in which 100% of uracil-containing nucleotides are replaced with N1-methyl-pseudouridine. The central questions were whether the claim lacked novelty over UPenn or was obvious in light of it, and whether the judge had erred in identifying the skilled person, evaluating the expert evidence, interpreting UPenn and assessing motivation and expectation of success.

1. Appeal dismissed. The Court of Appeal held that Meade J had made no error of law or principle in finding claim 3 valid. Appellate intervention in a multi-factorial obviousness assessment is limited to error of law or principle: Actavis v ICOS, Lifestyle Equities and Iconix.
2. Novelty. Prior disclosure requires a clear and unambiguous disclosure, or clear and unmistakable directions, to subject-matter which would necessarily infringe. It is not enough that the skilled person would obviously modify the prior art. The individualised-description test applies equally to a list and a class. Selection from multiple lists is assessed by asking whether the claimed combination would be clearly and unambiguously derived from the document as a whole, having regard to the independence of the lists and any pointer to the combination.
3. UPenn did not anticipate claim 3. Route 3 involved selections of N1-methyl-pseudouridine and 100% replacement from separate disclosures, with no pointer to their combination. Route 1 was an open-ended, prophetic proposal to test many nucleosides. It contained no individualised technical teaching of the claimed nucleoside, replacement level or combination.
4. Skilled person and experts. The skilled person is identified by the problem addressed and the established field in which it arises. A patent is addressed to persons with a real and practical interest in making or using the invention. The judge was entitled to reject a purely basic-research characterisation and to regard Professor Rosenecker as more useful in assessing the skilled person’s reasoning. Expert evidence may address obviousness, but the expert must be properly qualified to speak to the relevant common general knowledge, and the reasons for an opinion matter more than its bare conclusion.
5. Obviousness. The structured Pozzoli approach is useful but not mandatory. The court must assess all relevant circumstances, including motivation, alternative research routes, effort, routine character, obviousness to try and expectation of success, without hindsight. The proposed work involved blind trial and error, no concrete expectation of success, no special pointer in UPenn and no immediate practical incentive. It was not a routine experiment for the notional skilled person. Claim 3 was therefore not obvious.

• Court of Appeal (Civil Division): The appeals by Pfizer and BioNTech were dismissed insofar as they challenged the validity of EP949.
• High Court of Justice, Patents Court: Meade J held EP949 valid and infringed after trial, while EP565 was invalid: [2024] EWHC 1695 (Pat). Permission to appeal concerning EP565 was refused.