Pfizer Limited v GlaxoSmithKline Biological SA & Anor
| Judge | Mr Justice Mellor |
| Neutral Citation | [2024] EWHC 2523 (Pat) |
| Year | 2024 |
| Court | Chancery Division (Patents Court) |
| Counsel | Stuart Kc,Ms. Katherine Moggridge,Dr. Justin Turner Kc,Mr. Thomas Lunt,Mr . Tom Moody-stuart Kc |
| Date | 07 October 2024 |
Neutral Citation Number: [2024] EWHC 2523 (Pat)
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
7 October 2024
Before :
MR JUSTICE MELLOR
- - - - - - - - - - - - - - - - - - - - -
Between :
PFIZER LIMITED
- and –
(1) GLAXOSMITHKLINE BIOLOGICALS S.A
(a company incorporated under the laws of
Belgium)
(2) ID BIOMEDICAL CORPORATION OF
QUEBEC
(a company incorporated under the laws of
Quebec, Canada)
Claimant
Defendants
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
High Court Approved JudgmentPfizer v GlaxoSmithKline
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
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High Court Approved JudgmentPfizer v GlaxoSmithKline
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
Page 3
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