Novartis AG and Others v Focus Pharmaceuticals Ltd and Others
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 27 April 2015 |
| Neutral Citation | [2015] EWHC 1068 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 27 April 2015 |
| Docket Number | Case Nos: HP-2013-000011, HP-2013-000012 |
[2015] EWHC 1068 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NLL
The Hon Mr Justice Arnold
Case Nos: HP-2013-000011, HP-2013-000012
Justin Turner QC and Thomas Hinchliffe (instructed by Bristows LLP) for Novartis
Daniel Alexander QC and Henry Ward (instructed by Olswang LLP) for Focus
Daniel Alexander QC and Tom Moody-Stuart (instructed by Pinsent Masons LLP) for Actavis
Daniel Alexander QC and Mark Chacksfield (instructed by Bird & Bird LLP) for Teva
Hearing dates: 18–20, 24 March 2015
| Topic | Paragraphs |
| Introduction | 1–3 |
| Witnesses | 4–10 |
| Novartis' experts | 5–7 |
| The Defendants' experts | 8–10 |
| Technical background | 11–33 |
| Alzheimer's disease (AD) | 11–12 |
| Acetylcholine (ACh) | 13–15 |
| Treatment of AD with AChE inhibitors | 16–19 |
| Rivastigmine | 20–21 |
| The Exelon SmPC | 22 |
| Pharmacokinetic parameters | 23–24 |
| Transdermal therapeutic systems (TTS) | 25–30 |
| Development of a patch formulation | 31–33 |
| The Application | 34–61 |
| The Patent | 62–68 |
| The claim | 69 |
| The skilled team | 70–71 |
| Common general knowledge | 72–93 |
| Construction | 94–102 |
| Added matter | 103–114 |
| Obviousness | 115–134 |
| US031 | 116–122 |
| The difference | 123 |
| Was it obvious? | 124–134 |
| Insufficiency | 135–142 |
| Infringement | 143–149 |
| Summary of conclusions | 150 |
Introduction
The Claimants ("Novartis") claim that the Defendants in these two actions ("Focus", "Actavis" and "Teva") have infringed European Patent (UK) No. 2 292 219 entitled "Transdermal therapeutic system for the administration of rivastigmine" ("the Patent"). The Patent is directed to rivastigmine for use in a method of treatment of Alzheimer's disease ("AD") wherein the rivastigmine is administered by a transdermal therapeutic system, and in particular a transdermal patch. The Defendants deny infringement and counterclaim for revocation of the Patent on the grounds of added matter, obviousness and insufficiency. Although the Defendants challenged the claimed priority date of 1 December 2005 in order to contend that the Patent was anticipated by the application from which it derived, I do not consider that this challenge requires separate consideration from the added matter attack.
The Patent is one of a chain of divisionals deriving from International Patent Application No. WO 2007/064407 ("the Application"). The Patent has been opposed by no less than 13 opponents. On 19 February 2015 the Opposition Division of the European Patent Office issued a summons to oral proceedings in which it expressed the provisional opinion that the Patent was invalid on the grounds of added matter and insufficiency. The oral proceedings are due to be heard on 15 to 17 December 2015.
Other designations of the Patent, and equivalent national rights, have been extensively litigated in proceedings in other jurisdictions, namely Austria, Belgium, Denmark, Germany (Düsseldorf, Mannheim and Munich), Italy, the Netherlands, Poland, Portugal, Romania, Slovenia and Spain. Most of these proceedings have been applications for interim injunctions, although there have been final decisions on infringement in Mannheim and Portugal. There has been a striking diversity of outcomes, with some courts and tribunals finding infringement and others not on the same facts. Until now there has been no final decision on validity, although the Court of Appeal of the Hague and the Mannheim Regional Court have expressed the opinion that the Patent is probably invalid for added matter and the Düsseldorf Regional Court has expressed the same opinion about an equivalent utility model.
Witnesses
Each side called two expert witnesses, a clinician or neuroscientist and a transdermal formulator. There was a large measurement of agreement between the respective pairs of witnesses. In addition, Novartis adduced unchallenged factual evidence from Dr Nico Reum concerning the composition of Novartis' Exelon patch.
Novartis' experts
Professor Clive Ballard is Professor of Age Related Diseases and Co-Director of the Wolfson Centre for Age Related Diseases at King's College London, Director of the Biomedical Research Unit for Dementia and Honorary Consultant at the South London and Maudsley NHS Foundation Trust. He obtained a BMBS degree from the University of Leicester in 1987, a Masters in Psychiatry from the University of Birmingham in 1992 and an MD from Leicester in 1995. During this period he also completed his medical training at various hospitals in the Midlands and was a Lecturer in Psychiatry at Birmingham. Between 1995 to 2003 he was successively Senior Lecturer, Reader and Professor of Old Age Psychiatry at the University of Newcastle and Consultant in Old Age Psychiatry at Newcastle General Hospital. In 2003 he took up his current positions. He has held numerous other positions, including Director of Research for the Alzheimer's Society UK from 2003 to 2013. He has published more than 500 publications, including four books in the area of dementia and AD. He has also acted as a consultant to a number of pharmaceutical companies, including Novartis in relation to its Exelon patch.
Counsel for the Defendants submitted that Prof Ballard had adopted an overly cautious approach to the development of a new formulation of rivastigmine and had been inconsistent in his approach to the Patent and the prior art. I am sure that Prof Ballard was doing his best to assist the court, but I think there is force in both these points, and I shall take them into account in assessing the evidence.
Professor Marc Brown is Chair of Pharmaceutics at the School of Pharmacy at the University of Hertfordshire. He obtained a BSc in Medicinal and Pharmaceutical Chemistry from Loughborough University of Technology in 1990 and a PhD from the same institution in 1993. From 1993 to 1995 he was a Post-Doctoral Research Fellow, and from 1996 to 2006 he was a Lecturer and then a Senior Lecturer, at the Department of Pharmacy at King's College London. He took up his current position in 2006. In addition to his academic work, in 1999 Prof Brown co-founded MedPharm Ltd, a contract research organisation specialising in the formulation of topical and transdermal medicines, which he continues to be Chief Scientific Officer and Chief Operating Officer of. No criticism was made of his evidence.
The Defendants' experts
Professor Paul Francis is Professor of Neurochemistry at the Wolfson Centre for Age Related Diseases at King's College London. He obtained a BSc in Physiology and Biochemistry from the University of Reading in 1979 and a PhD in Neuroscience from the same institution in 1984. From 1982 to 1990 he was a Post-Doctoral Research Fellow, and from 1990 to 1995 he was an Honorary Lecturer, at the Institute of Neurology, Queen Square. In 1995 he became Senior Lecturer in Biochemistry and Molecular Biology at the United Medical and Dental Schools of Guy's and St Thomas' Hospitals, which merged with King's College in 2000. He was appointed Reader in 2004 and Professor in 2008. Since 2008 he has also been Director of Brains for Dementia Research, a partnership between Alzheimer's Research UK and the Alzheimer's Society. He has published 138 peer-reviewed articles and about 60 book chapters and reviews in this field. He has spoken at meetings and symposia for, and received research funding from, various pharmaceutical companies, including from Novartis in relation to rivastigmine.
Counsel for Novartis submitted that Prof Francis' field of expertise was less appropriate to this case than that of Prof Ballard, since Prof Francis had no clinical experience, nor had he carried out any pharmacokinetic studies. Furthermore, as at 2005, he had not done any research on the efficacy or side effects of AChE inhibitors in man. On the other hand, he was more knowledgeable about the biochemical mechanisms of action of such inhibitors than the relevant member of the skilled team. I agree that Prof Ballard had more directly relevant expertise than Prof Francis, but nevertheless I consider that Prof Francis was in a position to assist the court.
Professor Adrian Williams is Professor of Pharmaceutics and Head of the School of Chemistry, Food and Pharmacy at the University of Reading. He obtained a BSc in Combined Sciences, Biology and Chemistry in 1987 and a PhD in Pharmaceutical Technology from the University of Bradford in 1990. From 1990 to 2004 he was successively Lecturer, Senior Lecturer and Reader in Pharmaceutical Technology and Professor of Biophysical Pharmaceutics at the same institution. Since 2004 he has been a Professor at Reading. He has published 89 peer-reviewed articles and many reviews and book chapters, including a chapter entitled "Topical and transdermal drug delivery" in the well-known textbook Aulton's Pharmaceutics: The Design and Manufacture of Medicines (M.E. Aulton and K.M.H. Taylor eds, 4 th ed, 2013). He sits on the Scientific Advisory Board of MedPharm and has acted as consultant to pharmaceutical companies. No criticism was made of his evidence.
Technical background
Alzheimer's disease (AD)
AD is a progressive neurodegenerative disease that is the most common cause of dementia. There are approximately 750,000 dementia sufferers in the UK, of whom more than 520,000 have AD. Symptoms of AD include short-term memory loss, impairments of attention and concentration,...
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