Sandoz AG & Ors v Biogen MA Inc
| Court | Chancery Division (Patents Court) |
| Judge | Mr Justice Mellor |
| Neutral Citation | [2024] EWHC 2567 (Pat) |
| Date | 11 October 2024 |
| Year | 2024 |
| Counsel | Michael Tappin Kc,Kathryn Pickard,Thomas Lunt,Justin Turner Kc,Tom Alkin |
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
11 October 2024
Before :
THE HON MR JUSTICE MELLOR
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Between :
(1) SANDOZ AG
(2) SANDOZ LIMITED
(3) SANDOZ GMBH
(4) POLPHARMA BIOLOGICS SA
Claimants
- and -
BIOGEN MA INC
Defendant
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- - - - - - - - - - - - - - - - - - - - -
MICHAEL TAPPIN KC, KATHRYN PICKARD and THOMAS LUNT (instructed by
Bristows LLP) for the Claimants
JUSTIN TURNER KC and TOM ALKIN (instructed by Powell Gilbert LLP) for the
Defendant
Hearing dates: 22nd, 24th, 27th-30th November, 5th & 6th December 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 Friday 11 October 2024 at 10.30am.
THE HON MR JUSTICE MELLOR
The Hon Mr Justice Mellor
Sandoz v Biogen EP792
Page 2
Mr Justice Mellor:
INTRODUCTION.................................................................................................................... 6
OUTLINE OF THE ISSUES FOR TRIAL ......................................................................................... 9
WITNESSES OF FACT ............................................................................................................. 10
EXPERT WITNESSES .............................................................................................................. 11
THE SKILLED TEAM ......................................................................................................... 13
COMMON GENERAL KNOWLEDGE ............................................................................. 13
A. The Central Nervous System .................................................................................... 13
B. Multiple Sclerosis..................................................................................................... 14
Pathology ..................................................................................................................... 14
Types of MS ................................................................................................................. 15
Diagnosis...................................................................................................................... 16
Treatment ..................................................................................................................... 16
C. Tysabri (natalizumab) .............................................................................................. 17
Mode of action ............................................................................................................. 17
Development, clinical trials and regulatory approval .................................................. 18
Withdrawal from US market, reintroduction and approval in Europe ......................... 18
D. Progressive Multifocal Leukoencephalopathy (PML) ............................................. 19
E. John Cunningham Virus (JCV) ................................................................................ 20
F. Knowledge and experience of PML ......................................................................... 21
Assessing PML Risk .................................................................................................... 21
G. Use of assays ............................................................................................................ 23
H. Immunology, antibodies and viruses........................................................................ 24
Antibodies .................................................................................................................... 24
Viruses and viral infection ........................................................................................... 25
I. Types of assay .......................................................................................................... 26
Polymerase chain reaction (PCR) ................................................................................ 26
Haemagglutination inhibition assay (HAI) .................................................................. 26
Immunoassays .............................................................................................................. 26
Indirect ELISA ............................................................................................................. 26
Competitive (inhibition) ELISA .................................................................................. 28
J. Performing an ELISA ............................................................................................... 29
Optical density (OD) measurement ............................................................................. 29
Plates and controls ....................................................................................................... 31
ELISA output ............................................................................................................... 31
K. Analysing assay performance .................................................................................. 32
THE PRIOR ART .................................................................................................................. 33
GORELIK ............................................................................................................................... 33
Patients and Methods ....................................................................................................... 34
Technical details of the assay ...................................................................................... 34
Establishing cut points of the assay ............................................................................. 35
Results .......................................................................................................................... 35
Use of the Gorelik assay to determine seropositivity rate, false negative rate and
seroconversion ............................................................................................................. 37
Discussion .................................................................................................................... 38
The disputed point on disclosure ..................................................................................... 39
WO369 ................................................................................................................................. 40
The Hon Mr Justice Mellor
Sandoz v Biogen EP792
Page 3
Additional technical information ................................................................................. 41
The dispute over the disclosure of WO369 ...................................................................... 42
THE PATENT ........................................................................................................................ 44
Background and acknowledged prior art ..................................................................... 44
Summary of the Invention ........................................................................................... 45
The Detailed Description ............................................................................................. 46
Example 1 .................................................................................................................... 48
Example 2 .................................................................................................................... 48
Example 3 .................................................................................................................... 49
The meaning of ‘titer’ in the Patent ............................................................................. 50
Example 4 and Fig 11 .................................................................................................. 51
Reference Example 5 ................................................................................................... 52
Example 6 and Figs 12 & 13........................................................................................ 52
Example 7 and Table 10 .............................................................................................. 59
CLAIM INTERPRETATION/CLAIM SCOPE ................................................................. 62
LEGAL PRINCIPLES ................................................................................................................ 62
INTERPRETATION OF CLAIM 1 ............................................................................................... 65
THE DEVELOPMENT OF THE ISSUE OF INTERPRETATION OF CLAIM 1 ...................................... 66
Sandoz’s construction .................................................................................................. 66
Biogen’s constructions ................................................................................................. 67
ANALYSIS ............................................................................................................................. 74
MY CONCLUSIONS AS TO THE CONSTRUCTION OF CLAIM 1 .................................................... 76
The numerical limit of >1.5 ......................................................................................... 77
VALIDITY.............................................................................................................................. 78
INSUFFICIENCY .................................................................................................................. 78
INTRODUCTION ..................................................................................................................... 78
LEGAL PRINCIPLES ................................................................................................................ 79
Classical Insufficiency – undue burden ....................................................................... 79
Uncertainty ................................................................................................................... 80
Breadth of claim insufficiency ..................................................................................... 81
APPLICATION TO THE FACTS .................................................................................................. 82
Classical undue burden insufficiency & uncertainty insufficiency .................................. 82
The target ..................................................................................................................... 82
Sandoz’s case in outline ............................................................................................... 83
Biogen’s case in outline. .............................................................................................. 84
Cut-off calibrator ......................................................................................................... 85
Mr Baldwin’s first route................................................................................................... 85
The ‘key features’ in Example 3 .................................................................................. 86
HPVLPs and other assay components ......................................................................... 89
The “top 50% of seropositives” – “like trying to build a house on quicksand” ............. 93
Identifying the seronegatives ....................................................................................... 94
Splitting the seropositives 50/50 .................................................................................. 95
Biogen’s attempted answers ........................................................................................ 97
MR BALDWIN’S SECOND APPROACH ..................................................................................... 98
Biogen’s case in closing............................................................................................... 99
Secondary evidence of insufficiency ......................................................................... 100
Conclusions .................................................................................................................... 101
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