Modernatx, Inc. v Pfizer Ltd

Hearing dates: 23–26 and 30 April, 1–3, 7, 9, 13–15 and 21 May 2024

APPROVED JUDGMENT

Remote hand-down: This judgment will be handed down remotely by circulation to the parties or their representatives by email and release to The National Archives. A copy of the judgment in final form as handed down should be available on The National Archives website shortly thereafter but can otherwise be obtained on request by email to the Judicial Office (press.enquiries@judiciary.uk).

INTRODUCTION

This is the trial of two actions, HP-2022-000022 and HP-2022-000027, concerning the following pair of European Patents (collectively “the Patents” or sometimes in the context of just one “the Patent”):

i) European Patent (UK) No. 3 590 949 (“EP949”); and

ii) European Patent (UK) No. 3 718 565 (“EP565”).

For convenience, and because this trial focused primarily on revocation rather than infringement, I will where appropriate use the terms ‘Claimants’ and ‘Defendant’ to refer to the designations in the revocation action (HP-2022-000027). More usually I will refer to the Claimants as “Pfizer” and “BioNTech”, and together as “Pfizer/BioNTech”.

The Patents are in the name of the Defendant (“Moderna”). Both patents are asserted against Pfizer/BioNTech's SARS-CoV-2 vaccines.

Infringement was not in issue; effectively it was admitted, with the Claimants saying that they did not dispute infringement on any interpretation of the claims advanced by either side. There was no issue of fact about the alleged infringing products.

EP949 is entitled “ Ribonucleic acids containing N1-methyl-pseudouracils and uses thereof” and concerns messenger RNA (“mRNA”). It claims mRNA in which one of the usual nucleosides (uridine) is replaced with N1-methyl-pseudouridine (“m ¹Ψ”). EP949 has a priority date of 1 October 2010 (the “EP949 Priority Date”), which was not challenged in these proceedings. The prior art primarily concerned pseudouridine (“Ψ”), although the main citation mentions m ¹Ψ. The structures of Ψ and m ¹Ψ are shown at paragraph 306 below.

EP565 is entitled “ Respiratory virus vaccines” and 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. Moderna relied on the ninth priority document, dated 28 October 2015 (the “EP565 Priority Date”), but priority was challenged by Pfizer/BioNTech and Moderna conceded it shortly after opening skeletons were exchanged. The filing date of EP565's application is 21 October 2016 (the “EP565 Filing Date”) and that is therefore the date for assessing its validity.

Moderna is a pharmaceutical company based in the US. It focuses on exploring potential uses for mRNA in medicine. Pfizer Inc. is a pharmaceutical and biotechnology company based in the US, and BioNTech SE is a biotechnology company based in Germany. In March 2020, BioNTech and Pfizer announced their partnership for the development, testing, manufacturing, distribution and regulatory approval of an mRNA-based SARS-CoV-2 vaccine. This vaccine is now known as Comirnaty.

At trial:

i) Piers Acland KC represented Moderna on EP949, leading Stuart Baran;

ii) Andrew Waugh KC dealt with EP565 for Moderna, leading Katherine Moggridge and Richard Darby;

iii) Tom Mitcheson KC conducted the oral advocacy for Pfizer/BioNTech on EP949, with the exception of closing submissions relating to secondary evidence on obviousness, which were dealt with by Ms Hart;

iv) Michael Tappin KC was the advocate at trial for Pfizer/BioNTech on EP565, leading Michael Conway;

save in relation to some legal issues on added matter and novelty which were common to both actions, as explained below, where leading Counsel crossed over somewhat.

I am grateful that regard was had by Pfizer/BioNTech for the encouragement in the Patents Court Guide (and the recent speech of the Lady Chief Justice) for parties to make greater use of junior advocates. However, it was an equally valid choice to have the same advocate deal with all relevant issues for each party on each Patent.

Pfizer and BioNTech had separate solicitors and, as I understand it, formally speaking their respective Counsel...