Pfizer Ltd v Glaxosmithkline Biologicals S.A (a company incorporated under the laws of Belgium)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Mellor |
| Judgment Date | 07 October 2024 |
| Neutral Citation | [2024] EWHC 2523 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No. HP-2022-000016 |
Mr Justice Mellor
Case No. HP-2022-000016
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST (ChD)
PATENTS COURT
Rolls Building
Fetter Lane
London, EC4A 1NL
Mr. Tom Moody-Stuart KC and Ms. Katherine Moggridge (instructed by Marks & Clerk Law LLP) appeared for the Claimant
Dr. Justin Turner KC and Mr. Thomas Lunt (instructed by Gowling WLG) appeared for the Defendant.
Hearing dates: 7–9, 12–14, 16, 29–30 June 2023
APPROVED JUDGMENT
This judgment was handed down remotely by circulation to the parties' representatives by email. It will also be released for publication on the National Archives and other websites. The date and time for hand-down is deemed to be Monday 7 October 2024 at 10.30am.
THE HON Mr Justice Mellor
Table of Contents
| INTRODUCTION | 5 |
| THE ISSUES FOR DECISION | 5 |
| WITNESSES OF FACT | 7 |
| Professor Jardetzky | 7 |
| Mr Michael Gilbert | 8 |
| THE EXPERT WITNESSES | 8 |
| Dr Johnson | 8 |
| Professor Weissenhorn | 9 |
| Dr Taylor | 9 |
| Professor Wilkinson | 9 |
| GSK's response to Pfizer's case on obviousness | 10 |
| Primary evidence | 10 |
| Secondary evidence | 12 |
| THE SKILLED TEAM | 12 |
| Legal principles | 13 |
| Application to the facts | 13 |
| TECHNICAL BACKGROUND | 17 |
| Sources of CGK | 19 |
| Basic Concepts in Immunology | 22 |
| Adaptive Immunity: Antigens, Epitopes and Antibodies | 23 |
| Basic Concepts in Virology and Vaccinology | 25 |
| Vaccines | 26 |
| RSV Virion and Proteins | 30 |
| Treatment of RSV | 36 |
| Prevention of RSV | 36 |
| RSV Vaccines | 36 |
| Additional considerations in developing an RSV vaccine | 42 |
| Characterisation techniques | 47 |
| Structural biology of viral envelope glycoproteins | 49 |
| Stabilization Strategies | 57 |
| Structural biology and vaccines | 60 |
| How the issues developed | 62 |
| Issues with Dr Taylor's evidence | 66 |
| CGK POINTS IN DISPUTE – part one | 78 |
| Interim Conclusion | 83 |
| Other CGK disputes | 83 |
| THE PATENTS | 87 |
| Examples | 94 |
| The Claims of EP258 | 98 |
| The Claims of EP710 | 98 |
| CONSTRUCTION | 99 |
| “ Stabilizes” | 99 |
| “ Polypeptide” | 100 |
| INFRINGEMENT | 105 |
| Legal principles | 105 |
| Application to the facts | 107 |
| Normal infringement | 108 |
| Equivalents | 108 |
| EP710 — Equivalents | 112 |
| PRIORITY | 115 |
| Factual background | 115 |
| Legal Principles | 115 |
| The expert witnesses on Belgian Law | 117 |
| Assessment – priority | 117 |
| VALIDITY | 122 |
| Novelty | 122 |
| WO456 | 123 |
| Disclosure | 123 |
| Application To The Facts | 128 |
| OBVIOUSNESS | 128 |
| Legal principles | 128 |
| The Disclosure of each piece of Prior Art | 129 |
| THE JARDETZKY ABSTRACT | 129 |
| Disclosure | 129 |
| THE JARDETZKY SLIDES | 130 |
| Disclosure | 130 |
| THE ORAL DISCLOSURE OF THE JARDETZKY PRESENTATION | 131 |
| Disclosure | 131 |
| YIN (2006) | 132 |
| Disclosure | 132 |
| THE ASV ABSTRACT | 135 |
| Disclosure | 135 |
| The allegations of obviousness | 135 |
| GSK's overarching arguments | 136 |
| Obviousness in the light of the Jardetzky Abstract and Slides – EP258 | 137 |
| Obviousness in the light of the Jardetzky Abstract and Slides – EP710 | 138 |
| Obviousness in the light of the Jardetzky Oral Disclosure (and Slides) | 138 |
| Obviousness in the light of Yin | 139 |
| Obviousness in the light of the ASV abstract | 140 |
| GSK'S CASE ON SECONDARY EVIDENCE | 141 |
| The Legal Principles | 141 |
| Secondary evidence – the evidence in this case | 143 |
| Pre-priority | 144 |
| Post-priority | 145 |
| FINAL CONCLUSIONS ON OBVIOUSNESS | 160 |
| OBSERVATIONS ON HOW A CASE OF SECONDARY EVIDENCE SHOULD BE RAISED | 162 |
| INSUFFICIENCY | 163 |
| The Legal Principles | 163 |
| Application to the facts | 164 |
| AGREVO OBVIOUSNESS/INSUFFICIENCY SQUEEZE | 165 |
| Relevant legal principles | 165 |
| Application To The Facts | 166 |
| PLAUSIBILITY | 166 |
| Relevant legal principles | 166 |
| Application To The Facts | 167 |
| ARROW | 168 |
| Relevant legal principles | 168 |
| Assessment in the present case | 169 |
| Whether the features are obvious | 170 |
| Whether the declaration would serve a useful purpose | 170 |
| CONCLUSIONS | 171 |
INTRODUCTION
This case concerns two patents which relate to a vaccine for respiratory syncytial virus (RSV). RSV is a common worldwide cause of lower respiratory tract infections in infants and young children, causing bronchiolitis and pneumonia. RSV is also an important cause of lower respiratory tract disease in the elderly and in people who are immunocompromised.
This is also a case about so-called ‘secondary evidence’ of obviousness or lack of it. In particular it raises questions of whether the point needs to be pleaded and how it can and should be supported in evidence.
The two patents in suit are EP (UK) 3 109 258 and EP (UK) 2 222 710 (the Patents, EP258 and EP710 respectively), both entitled “Recombinant RSV antigens”. EP258 is a divisional application of EP710. The Patents describe a strategy for vaccinating against RSV. The strategy includes use of the F subunit vaccine stabilised in its prefusion conformation (sometimes referred to as “Pre Fusion” or “PreF”), and how to construct a stabilised F antigen in the prefusion conformation.
The Patents are largely identical with the exception of the claims and the “Summary of the Invention”. In EP 258, the key is it is a recombinant RSV polypeptide that is stabilised through use of a trimerisation domain, and in EP 710 the additional feature is the absence of furin cleavage sites. Both Patents claim priority from the same documents: US patent application 61/016,524 (filed on 24 December 2007 (the “Priority Date”)) and US patent application 61/056, 206 (filed on 27 May 2008). Whether the Patents are entitled to the claimed priority is in issue in this action.
The Defendants (‘GSK’) are the registered proprietor of the Patents. The Claimant (‘Pfizer’) say that the Patents are invalid and they sought to clear the way ahead of a commercial launch in the UK of their own RSV vaccine (known as “RSVPreF”) for use in the prevention of RSV-associated disease.
At the time of trial it was common ground there is no vaccine for RSV in the UK, but it has been a significant target for vaccine development for some years. Also at the time of trial, both parties had vaccines on the brink of obtaining approval in the UK. The GSK vaccine is for the elderly population only. The Pfizer RSVPreF, the subject of this claim, is for both elderly and the maternal population.
GSK are not seeking an injunction in relation to the maternal indication, subject to suitable terms being agreed.
THE ISSUES FOR DECISION
The action as originally formulated was for revocation of three patents owned by GSK: EP710, EP258 and EP (UK) 3,178,490. They each concern recombinant (i.e., genetically engineered) RSV antigens. GSK has counterclaimed for infringement as a matter of ‘normal’ infringement and also under the doctrine of equivalents.
GSK has submitted to judgment in respect of EP490 such that EP490 has been revoked and GSK has discontinued its counterclaim alleging infringement of the same. Accordingly, EP490 is no longer in issue in these proceedings.
GSK now rely on claims 1, 5 and 8 (as proposed to be unconditionally amended) of EP258 and claims 1, 10, 22, 23 and 24 of EP710 as being independently valid.
Critical issues at trial involved (a) the makeup of the Skilled Team (b) communication and collaboration between the members of the Team and (c) what was their collective CGK.
Therefore the issues which I have to decide are:
i) The membership and skillsets of the Skilled Team.
ii) Their CGK.
iii) Claim interpretation. Two issues of interpretation arise on the claims: how to construe stabilizes and the meaning of the term polypeptide.
iv) Infringement. GSK alleges that Pfizer's product, RSVPreF, infringes each of EP 258 and EP 710. RSVPreF contains RSV F antigens which, the PPD accepts, are in the prefusion form. Infringement is put on the basis of normal infringement and infringement by equivalence.
v) Priority. There is a formal challenge to priority of both Patents which gives rise to issues on Belgian law. If that is successful then WO456 becomes full prior art for inventive step, otherwise it is a novelty only citation. The Belgian law issues are self-contained and it is convenient to deal with those in a separate section. I have, however, applied the result of my analysis when considering WO456.
vi) Novelty at the priority date. WO456 is intervening novelty-only art at the priority date and is said to anticipate claims 1 and 2 of EP 258.
vii) Obviousness at the priority date. The art cited against both Patents are Yin, the Jardetzky disclosures, and the ASV Abstract. In response, GSK developed, very largely in cross-examination, a case on secondary evidence of non-obviousness.
viii) Obviousness at the filing date if priority is lost. Pfizer relies on WO 456 as full art (in addition to Yin, the Jardetzky disclosures, and the ASV Abstract) against both Patents.
ix) AgrEvo obviousness. Pfizer only relies on this as a squeeze on GSK's construction of the term stabilizes.
x) Insufficiency. Pfizer's insufficiency case is limited to a single point that engages matters of undue burden and uncertainty, together with an enablement squeeze over the prior art, and as a plausibility attack in respect of the use of a product claimed without an adjuvant (this is aimed at certain claims only).
xi) Arrow relief. Pfizer also seeks Arrow relief declaring that at...
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