Dr Reddy's Laboratories (UK) Ltd v Eli Lilly and Company Ltd
| Jurisdiction | England & Wales |
| Judge | THE HON MR JUSTICE FLOYD,Mr Justice Floyd: |
| Judgment Date | 13 October 2008 |
| Neutral Citation | [2008] EWHC 2345 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 13 October 2008 |
| Docket Number | Case No: HC07C00963 |
[2008] EWHC 2345 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
The Hon Mr Justice Floyd
Case No: HC07C00963
Mr Henry Carr QC, Mr Andrew Lykiardopoulos and Mr James Whyte (instructed by Powell Gilbert LLP) for the Claimant
Mr Simon Thorley QC, Mr Andrew Waugh QC, Mr Colin Birss QC and Mr Miles Copeland (instructed by Howrey LLP) for the Defendant
Hearing dates: 8, 10, 11, 14–18, 22–24 July 2008
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic
Dr Reddy's Laboratories (UK) Limited (“DRL”) brings this action to seek revocation of European Patent (UK) No 0 454 436 (“the Patent”) which belongs to the Defendant Eli Lilly and Company Limited (“Lilly”).
The Patent has a priority date of 25 th April 1990. It concerns Lilly's drug olanzapine which is a widely prescribed anti-psychotic agent used for the treatment of schizophrenia. Claim 3 is a claim to olanzapine alone. The case raises issues as to the validity of patents for individual compounds selected from a prior class.
Witnesses
DRL called three expert witnesses: Professor John Geddes, Professor Peter Jenner and Professor Stanley Roberts.
Professor Geddes is a psychiatrist. He is currently a Senior Clinical Research Fellow and Professor of Epidemiological Psychiatry at the University of Oxford. He is also an Honorary Consultant Psychiatrist for the Oxfordshire & Buckinghamshire Mental Health Foundation Trust. In such positions he spends approximately 60% of his time on research and 40% of his time in clinical practice as a consultant psychiatrist. He has been involved in the treatment of patients with a wide range of psychotic illnesses and has conducted research into the efficacy and effectiveness of drug treatments.
Lilly said that Professor Geddes was not really qualified to give evidence about the detail of toxicological pre-clinical studies. Professor Geddes accepted that his expert knowledge was based on reviewing, rather than conducting such trials which was not really his area. To the extent that it matters, I have kept this in mind. Lilly had a more general criticism of Professor Geddes, based on his tendency to give long answers to questions. I do not think there is anything in this. Professor Geddes was indeed a very fluent witness, and displayed a commendable anxiety to ensure that his evidence was explained and understood. I do not think that he can be accused of becoming an advocate for DRL's case as Lilly suggested.
Professor Peter Jenner is a pharmacologist and currently Emeritus Professor of Pharmacology in the School of Health & Biomedical Sciences, King's College London. He is also Director of the Neurodegenerative Disease Research Group at King's College, Director of the National Parkinson Foundation Centre of Excellence and Director and Chief Scientific Officer of Proximagen Neurosciences plc (a drug discovery and development company) and a Director of Primagen Limited (a pharmaceutical consultancy company). Professor Jenner's particular expertise lies in the assessment of movement disorders amongst (inter alia) those suffering from psychotic illness or as a result of the treatment thereof.
Lilly submitted that Professor Jenner's expertise was somewhat circumscribed, making it difficult for him to express views on some aspects of the case. Where this was the case Professor Jenner very fairly acknowledged that this was so. I have taken this into account in reaching my conclusions.
Professor Stanley Roberts is currently an Honorary Visiting Professor in the School of Chemistry at Manchester University. He is also a Director of Oxyrane Limited, a company involved in the development of biopharmaceuticals, and a Scientific Advisor to York Pharma Limited, a speciality pharmaceutical company. From 1980 to 1986, he was Head of Chemical Research at Glaxo Group Research in Greenford where his research focused on the development of new pharmaceuticals as head of a team of around 80 employees. Since leaving Glaxo he has been Professor of Organic Chemistry at Exeter, Liverpool and now Manchester Universities.
Lilly suggested that Professor Roberts was poorly placed to give expert evidence on the medicinal chemistry aspects of the case as his primary expertise was that of a synthetic chemist, and even then, not in the field of anti-psychotic agents. I think it is fair to say that Professor Roberts comes to this case as someone with general experience of working with drug development teams in the pharmaceutical industry, and therefore with first hand knowledge of how such teams operate. He was not properly described as a medicinal chemist when he arrived at Glaxo; but by the time he left he had gone up the steep learning curve to become one. I am satisfied that he was well able to assist me on the approach of a medicinal chemist, albeit without any specific experience of research into anti-psychotics.
Lilly also called three expert witnesses: Professor David Nichols, Professor Guy Goodwin and Dr Ronald James.
Professor David Nichols is a medicinal chemist whose research interest is studying the structure activity relationships of central nervous system drugs and drug design. The particular focus of his research has been hallucinogenic and anti-dopaminergic drugs, the latter being of particular relevance here. He holds the Robert and Charlotte Anderson Distinguished Chair in Pharmacology at Purdue University, Indiana, USA and has been the Professor of Medicinal Chemistry at Purdue since 1984 and Professor of Pharmacology since 1985. From 1990 to 1996 he taught graduate chemists a course on medicinal chemistry and structure activity relationships of drugs.
DRL criticised the evidence of Professor Nichols in a number of ways. First DRL drew attention to Professor Nichols' lack of experience in industry. It is correct that he had not been employed in industry, but he had experience of working with industry. I have taken this lack of hands-on experience into account, to the extent that it matters. Secondly DRL pointed to the fact that this was not the first time Professor Nichols had assisted Lilly on its olanzapine patents: he had given evidence, either orally or in writing, on a number of previous occasions. DRL suggested that this had led to a lack of objectivity.
Two principal matters were relied on by DRL in support of this criticism: Professor Nichols' evidence about the general knowledge on the need for electron-withdrawing substituents in effective atypical anti-psychotics, and some differences between his evidence in the United States and here. As to the first point, that is a matter to which I will have to return in its proper context. I think Professor Nichols may have stated his proposition too broadly. But, that said, I do not think that this affected the weight I should attach to other parts of his evidence As to the second point, it is true that there was, on the face of it, a stark difference between the evidence given by Professor Nichols in relation to the 1989 Chakrabarti paper in the United States and these proceedings. But this difference was explained by the fact that he had been asked different questions in the two jurisdictions. Here, rather bizarrely, his instructions had restricted him to considering progressing the identified compounds only. It is perhaps unfortunate that he did not make this aspect of his instructions clear, particularly as his instructions more or less precluded a conclusion of obviousness. But once it is accepted, as it must be, that he was answering different questions, the force of the criticism falls away. Overall, I found Professor Nichols a helpful witness.
Professor Goodwin has since 1996 been W.A. Handley Professor of Psychiatry at Oxford University, a role that incorporates his clinical practice at the Warneford Hospital in Oxford. Earlier he held positions as Honorary Consultant Psychiatrist, Honorary Senior Lecturer and Professor of Psychiatry at the University of Edinburgh. I found him to be a first rate expert witness, giving his evidence entirely fairly.
Dr James is an experienced animal toxicologist, having worked for Huntingdon Life Sciences and, in an interval from 1980–1984, the Wellcome Foundation.
DRL criticises Dr James in three respects. Firstly DRL says that Dr James was answering rather different questions from those that arise in the action, namely whether Lilly's commercial decisions were reasonable rather than whether evidence existed for the claims made in the patent as to the advantages of olanzapine. DRL are correct as to the approach that Dr James was taking, but I must evaluate the effect of his having taken that approach in its proper context: it is not a criticism of him as a witness. Secondly DRL criticise Dr James for having included a table in his second report which included a treatment of the data which he was not inclined to support in his oral evidence, except on the basis that it was a kind of tit-for-tat response to a sentence in Professor Geddes' report. This did not, in my judgment, reflect well on Dr James, who should never have embarked on this potentially misleading exercise. His justification for doing so does not hold water. Finally DRL says that Dr James admitted to severe reservations in respect of an MPI study which he had relied on (without making those reservations clear) in his reports. I think there is force in that criticism as well.
I concluded that I should exercise caution before relying too heavily on Dr James' evidence.
Lilly also called two factual...
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