Teva Uk Ltd and Another (Claimants in 4779) (3) Accord Healthcare Ltd and Another (Claimants in 553) (5) Hexal Ag (Claimants in 1095) (6) Sandoz Ltd v Astrazeneca Ab
| Jurisdiction | England & Wales |
| Judge | MR JUSTICE ARNOLD |
| Judgment Date | 22 March 2012 |
| Neutral Citation | [2012] EWHC 655 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 22 March 2012 |
| Docket Number | Case Nos: HC10C04779, HC11C00553, HC1101095 |
[2012] EWHC 655 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case Nos: HC10C04779, HC11C00553, HC1101095
Daniel Alexander QC and Tom Mitcheson (instructed by Pinsent Masons LLP) for the Claimants in 4779
Daniel Alexander QC and Adrian Speck (instructed by Taylor Wessing LLP) for the Claimants in 553 and 1095
Piers Acland QC and Mark Chacksfield (instructed by Bristows) for the Defendant
Hearing dates: 20–23, 27 February 2012
Further written submissions 15 March 2012
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.
Contents
| Topic | Paragraphs |
| Introduction | 1 |
| The skilled team | 2–6 |
| The witnesses | 7–11 |
| Common general knowledge | 12–71 |
| Clinical common general knowledge | 14–32 |
| Schizophrenia | 14–15 |
| Causes of schizophrenia | 16 |
| The "typical" antipsychotics | 17–19 |
| The "atypical" antipsychotics | 20–24 |
| Theories as to the mechanism of action of antipsychotic drugs | 25–30 |
| Metabolism of antipsychotics | 31 |
| Quetiapine | 32 |
| Formulation common general knowledge | 33–46 |
| Routes of administration | 33 |
| Basics of drug absorption and action | 34–36 |
| Immediate release formulations | 37–39 |
| Sustained release formulations | 40–45 |
| Excipients | 46 |
| Compliance and convenience | 47–64 |
| Compliance from the clinician's perspective | 48–55 |
| Compliance from the formulator's perspective | 56–59 |
| Prescribing practice | 60–61 |
| Convenience | 62 |
| The Patent | 63 |
| Conclusion | 64 |
| High first pass metabolism | 65–70 |
| pH modifiers | 71 |
| The Patent | 72–81 |
| The claims | 82–83 |
| Gefvert | 84–85 |
| What would the skilled team find out about quetiapine? | 86–93 |
| Obviousness | 94–110 |
| The law | 94–98 |
| The skilled team and the common general knowledge | 99 |
| The inventive concept of claim 1 | 100 |
| The difference between Gefvert and claim 1 | 101 |
| Would it have been obvious? | 102–109 |
| Claim 15 | 110 |
| The Dutch judgment | 111–119 |
| Conclusion | 120 |
Introduction
The Claimants in these three claims all seek revocation of European Patent (UK) No. 0 907 364 ("the Patent") in the name of the Defendant ("AstraZeneca"). The Patent is for a sustained release formulation of an anti-psychotic drug known as quetiapine (marketed by AstraZeneca under the trade mark Seroquel). Supplementary protection certificates for quetiapine based on European Patent No. 0 240 228 ("228") will expire on 23 March 2012, hence the timing of the present claims. The Claimants contend that the Patent is invalid on the ground of obviousness over an item of prior art referred to as Gefvert, other objections not having been pursued at trial. There is no challenge to the claimed priority date of 31 May 1996.. AstraZeneca applied to make two alternative sets of amendments to the claims of the Patent, but did not pursue those applications. If claim 1 is invalid, the only claim which AstraZeneca asserted to be independently valid is claim 15.
The skilled team
A patent specification is addressed to those likely to have a practical interest in the subject matter of the invention, and such persons are those with practical knowledge and experience of the kind of work in which the invention is intended to be used. The addressee comes to a reading of the specification with the common general knowledge of persons skilled in the relevant art, and he or she reads it knowing that its purpose is to describe and demarcate an invention. He (or she) is unimaginative and has no inventive capacity. In some cases the patent is addressed to a team of persons with different skills.
In the present case there was little dispute by the end of the trial as to the identity of the skilled team to whom the Patent is addressed. It is common ground that the Patent is addressed to a team comprising a clinician, a pharmacologist, a formulation scientist and a pharmacokineticist.
The clinician would be a trained psychiatrist, specialising in the diagnosis and treatment of patients with psychotic illnesses, and in particular schizophrenia. The pharmacologist would have specialist knowledge concerning the effects of psychiatric drugs on the body, in particular their interaction with receptors in the brain. It is clear from the evidence that there would be an overlap between the common general knowledge of the clinician and pharmacologist members of the skilled team. For present purposes, it is not necessary to distinguish between them, and I shall refer to the clinician and the pharmacologist simply as "the clinician".
The formulation scientist would have experience in developing pharmaceutical formulations. Pharmacokinetics is concerned with what happens to drugs in the body, particularly with reference to their absorption, distribution, metabolism and excretion. In the context of a drug development programme, a pharmacokineticist develops protocols for and analysis of data from animal and patient studies. The formulator will need to have sufficient knowledge of the basic principles of pharmacokinetics to understand the likely effects of any formulation on the pharmacokinetics of the drug in question. Accordingly, for present purposes it is again not necessary to distinguish between them, and I shall refer to them simply as "the formulator".
The only dispute between the parties was as to which member of the team should be regarded as the leader. The Claimants contend that the Patent is a primarily directed to the formulator. AstraZeneca contends that the development of a new formulation of quetiapine would be primarily driven by clinical considerations and to that extent would be led by the clinician. The formulator would then use his knowledge and experience to try to prepare an appropriate formulation and method of manufacture for that formulation in accordance with the clinician's instructions as to what was required. In my judgment these contentions are not inconsistent with each other: AstraZeneca is looking at the position prior to the Patent, whereas the Claimants are looking at the position after the Patent. I therefore accept both contentions. Either way, as both sides accept, there would be a notional conversation between the members of the team, in which the advantages and disadvantages of potential formulations would be considered.
The witnesses
Each side called two experts, a clinician and a formulator. The Claimants' clinician was Professor Paul Harrison, who is presently a Professor of Psychiatry at Oxford University, an Honorary Consultant in General Adult Psychiatry at Oxford Health Foundation NHS Trust and a Governing Body Fellow of Wolfson College, Oxford. He graduated with a BA (First Class) in Physiological Sciences from Oxford in 1982 and qualified in medicine in 1985. From 1985–1988 he trained in psychiatry. From 1988 to 1991 he continued part-time clinical training whilst a research fellow in London. He became a Member of the Royal College of Psychiatrists in 1989, Clinical Lecturer in Psychiatry in 1991, a Wellcome Trust Senior Fellow in 1995, was appointed to his present post in 1998 and became a Fellow of the Royal College of Psychiatrists in 2002. His work combines research, clinical practice and teaching.
The Claimants' formulator was Dr Peter Rue. He graduated with a BSc degree in Pharmacy in 1973 from the University of Aston in Birmingham, and was awarded his PhD in 1978. From 1977 to 1999 he worked in various positions in industry, including Head of the Pharmaceutical Development Department at Glaxo Group Research from 1990 to 1996. Since 2001, he has been a Visiting Lecturer at the Department of Pharmacy at Aston, and he currently holds a Visiting Chair there. In addition, he has acted as a consultant. It is relevant to note that Dr Rue had previously acted as an expert witness in a patent case concerning a sustained release formulation of fluvastatin, Actavis UK Ltd v Novartis AG [2009] EHWC 41 (Ch), on appeal [2010] EWCA Civ 82, [2010] FSR 18.
AstraZeneca's clinician was Professor Stuart Montgomery, who has been Emeritus Professor of Psychiatry at the Imperial College of Science, Technology and Medicine, London since 1996. He received a Bachelor of Science degree from the University of London in 1960, a Bachelor of Medicine and Bachelor of Surgery from University College Hospital in 1963, a Diploma in Psychological Medicine from the Royal College of Physicians and Surgeons in 1973 and a Doctor of Medicine degree from the Karolinska Institute in 1978. Having held posts at various institutions from 1973 to 1979, he has been successively senior lecturer, reader and professor at St Mary's Hospital School since 1979. He was a Member of the Council of the Royal College of Psychiatrists from 1980 to 1982, President of the British Association of Psychopharmacology from 1990 – 1992, and the President of the European College of Neuropsychopharmacology from 1992 to 1995. He was a Member of the Committee on the Safety of Medicines from 1987 to 1993. Over the last 30 years his work has combined clinical practice, research and teaching. He also has experience in consulting, and providing licensing approval...
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