Modernatx, Inc. v Pfizer Ltd & or [2024] EWHC 1695 (Pat)
This trial concerned two patents owned by Moderna, EP949 and EP565. Both patents were asserted against Pfizer/BioNTech’s SARS-CoV-2 vaccines. This trial focused on the issue of revocation of the two patents – infringement was not disputed.
EP949 claims mRNA in which one of the usual nucleosides (uridine) is replaced with N1-methyl-pseudouridine (“m1Ψ”). The prior art concerned a patent application and an academic article. EP565 relates to a betacoronavirus mRNA vaccine formulated in a lipid nanoparticle, and the use of such an mRNA vaccine in a method of preventing and/or treating betacoronavirus disease. The Judgment focused on the “functional features” of claims 1 and 10 of EP565, which required that the formulated mRNA is a “vaccine”, meaning that it is able to generate an antigen-specific immune response.
The trial was heard by Meade J. The Judge upheld the validity of EP949 and revoked EP565 on the basis that it is obvious over the prior art and invalid for added matter.
The Judgment contains a useful consideration of various legal principles on the topics of the skilled team, added matter, novelty and obviousness and the test for individualised disclosure and selection from lists. The following findings are of particular interest:
- The Judge expressed his obiter view that the EPO’s alternative test of “serious contemplation” for added matter should in principle render the same results as the “golden standard” test, but is best avoided.
- The Court confirmed that it is not legitimate to say that there is a relevant pointer to one disclosure on a list merely because the CGK says that particular choice is desirable.
- Whilst the Judge accepted the proposition in T1581/12 that a full length sequence implicitly discloses all fragments, this does not mean that disclosure of use of a modified nucleotide necessarily involves disclosure of all percentage requirements of the nucleotide.
- There is no precise numerical limit to prior art lists – each case turns on its facts. Meade J found that the presence of m1Ψ in the middle of a 96-item list without any (sufficiently strong) pointers to individualise it did not amount to sufficient disclosure.
- The Court emphasised the need for the skilled team to have had a practical interest in the application of the invention, and warned against assessing the mindset at the priority date in 2015 in relation to SARS-Cov with hindsight following the 2020 pandemic.
- The Judge rejected points that only amounted to criticism of EP565 for not meeting the highest standards of experimental science, which is not required of a patent specification.
- Paragraphs [677]-[682] list several errors that can affect an added matter analysis.
The Judgment also contains useful practical indications on:
- how best to conduct a hearing on two separate patents in the same trial, placing particular emphasis on the cooperation between the parties’ legal teams and the Court; and
- the benefits of allowing multiple experts who represent the notional skilled team to interact with each other or, at the very least, to read each other’s reports.
Lastly, the Judgment contains an interesting assessment of the different evidence and arguments which led to different outcomes having been reached in the Patents Court and in the Court of Hague.
Piers Acland KC appeared for Moderna on EP949, instructed by Freshfields Bruckhaus Deringer LLP.