Actavis Group Ptc EHF and Another v Sanofi Sanofi Pharma Bristol-Myers Squibb SNC (Claimant by Counterclaim)
| Jurisdiction | England & Wales |
| Judge | Mr Justice Arnold |
| Judgment Date | 20 September 2012 |
| Neutral Citation | [2012] EWHC 2545 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC12C02525 |
| Date | 20 September 2012 |
[2012] EWHC 2545 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Rolls Building
Fetter Lane, London, EC4A 1NL
The Hon Mr Justice Arnold
Case No: HC12C02525
and
Richard Meade QC instructed by, and Tim Powell of, Powell Gilbert for Actavis
Daniel Alexander QC and Andrew Lykiardopoulos instructed by Herbert Smith LLP for Sanofi
Hearing date: 13 September 2012
Further written submissions: 14 September 2012
Contents
| Topic | Paras |
| Introduction | 1–5 |
| The witnesses | 6–10 |
| Technical background | 11–37 |
| Hypertension | 12 |
| Other conditions mentioned in the Patent | 13–18 |
| Heart failure | 14 |
| Venous insufficiency | 15 |
| Glaucoma | 16 |
| Diabetic retinopathy | 17 |
| Disorders of the central nervous system | 18 |
| The Renin-Angiotensin System | 19–20 |
| Diuretics | 21–27 |
| Thiazide diuretics | 22 |
| Thiazide-like or thiazide-related diuretics | 23 |
| Potassium-sparing diuretics | 24 |
| Loop diuretics | 25 |
| Osmotic diuretics | 26 |
| Carbonic anhydrase inhibitors | 27 |
| Other antihypertensive drugs available in 1990 | 28–34 |
| Beta-blockers | 29 |
| Calcium channel blockers | 30 |
| Alpha-blockers | 31 |
| ACE inhibitors | 32 |
| Combination therapies | 33–34 |
| Angiotensin II receptor blockers | 35 |
| Other kinds of drug mentioned in the Patent | 36–37 |
| Non-steroidal anti-inflammatory drugs | 36 |
| Tranquilizers | 37 |
| The Patent | 38–43 |
| The claims of the Patent | 44–47 |
| Construction of claim 20 | 48–49 |
| What is the inventive advance (or technical contribution) of the Patent? | 50 |
| Sanofi's marketing authorisations for Aprovel and CoAprovel | 51–54 |
| The Regulation | 55–57 |
| Interpretation of the Regulation | 58 |
| Issue 1: Article 3(a) of the Regulation | 59–77 |
| Issue 2: Article 3(c) and (d) of the Regulation | 78–96 |
| Conclusion | 97 |
Introduction
Sanofi was the proprietor of European Patent (UK) No 0 454 511 entitled "N-substituted heterocycle derivatives, their preparation, compositions containing them" ("the Patent"). The Patent had an earliest priority date of 20 March 1990, an application date of 20 March 1991, was granted on 17 June 1998 and expired on 20 March 2011. As described in more detail below, the Patent covered an antihypertensive drug whose international non-proprietary name is irbesartan.
Sanofi obtained Supplementary Protection Certificate GB98/037 for "[irbesartan] optionally in the form of one of its salts" ("the Irbesartan SPC") based on the Patent and European marketing authorisations EU/1/97/046/001–009 for irbesartan (marketed by Sanofi under the trade mark Aprovel) granted on 27 August 1997. The Irbesartan SPC was applied for on 1 October 1998, granted on 8 February 1999 and expired on 14 August 2012.
Sanofi also obtained Supplementary Protection Certificate GB99/008 for "[irbesartan] optionally in the form of one of its salts and hydrochlorothiazide" ("the Combination SPC") based on the Patent and European marketing authorisations EU/1/98/086/001–006 for a fixed dose combination of irbesartan and hydrochlorothiazide (marketed by Sanofi under the trade mark CoAprovel) granted on 15 October 1998. The Combination SPC was applied for on 12 March 1999, granted on 21 December 1999 and will expire on 14 October 2013. Sanofi Pharma Bristol-Myers Squibb SNC is the exclusive licensee under the Combination SPC. For present purposes it is not necessary to distinguish between this company and Sanofi, and in the remainder of this judgment I will refer to them collectively as "Sanofi".
Now that the Patent and the Irbesartan SPC have both expired, the Claimants (collectively "Actavis") intend to market generic versions of both Aprovel and CoAprovel. It is common ground that the latter will infringe the Combination SPC if the Combination SPC is valid. Actavis contend that it is invalid on the two grounds discussed below. As is so often the case, these contentions raise difficult issues of interpretation of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) ("the Regulation").
These proceedings were commenced on 26 June 2012 and have been tried on an expedited basis. Thanks to the efficiency of both parties' counsel, the trial was completed in one day.
The witnesses
It is common ground that, as is normal in patent cases, the Patent must be interpreted in the light of the common general knowledge of the skilled person, or team of skilled persons, to whom it is addressed as at the priority date. It is also common ground that the Patent is addressed to a skilled team comprising a medicinal chemist, a pharmacologist and a clinician. Both parties called an expert witness who is a clinical pharmacologist to educate the court as to the common general knowledge which is relevant for the purposes of the present dispute. Somewhat unusually, the expert witnesses are colleagues in the same institution.
Actavis' expert was Dr Michael Schachter. Dr Schachter is a Senior Lecturer in clinical pharmacology and therapeutics at the Department of Clinical Pharmacology, Faculty of Medicine, Imperial College, London, which is an internationally recognised centre for hypertension research. He is also a fellow of the Royal College of Physicians and a hypertension specialist consultant at the Peart-Rose Clinic at the International Centre for Circulatory Health at Imperial. The ICCH is a specialist cardiovascular unit which carries out the assessment, investigation and management of patients with hypertension and associated cardiovascular risk factors and is engaged in clinical research including therapeutic trials. Dr Schachter qualified as a doctor at University College London in 1974, having undertaken an intercalated BSc in biochemistry. After his pre-registration year he worked successively at the Royal Marsden Hospital, King's College Hospital, the Department of Clinical Pharmacology in Oxford and St Mary's Hospital Medical School before moving to Imperial in 1996. He has published widely, including on hypertension.
Sanofi's expert was Prof Peter Sever. Prof Sever is Professor of Clinical Pharmacology at Imperial. He is also Honorary Consultant Physician at the Imperial Healthcare NHS Trust; Co-Director of the International Centre for Circulatory Health; Head of the Cardiovascular Disease Prevention Section at the National Heart and Lung Institute; Theme Leader for Cardiovascular Disease Prevention, Biomedical Research Centre, Imperial College Healthcare NHS Trust; and Panel Member of the National Specialty Group for Cardiovascular Medicine, UK Clinical Research Network. He was a Senior Investigator at the National Institute for Health Research in 2009–2012. He graduated from the University of Cambridge in 1965 and completed his medical training at St Mary's. After various appointments, he became Honorary Consultant Physician and Senior Lecturer at St Mary's in 1976 and Professor in 1980 (St Mary's was subsequently incorporated into Imperial). He too has published widely, including on hypertension.
Both experts were very knowledgeable and helpful. Unsurprisingly, there was very little if any difference between them.
In addition, Sanofi called Bénédicte Sergent. She is Sanofi's Regulatory Affairs Manager. She was a straightforward witness, but through no fault of her own her evidence was of relatively little value. The purpose of her evidence was to explain the procedure by which, and in particular the studies in reliance upon which, Sanofi had obtained the marketing authorisations for Aprovel and CoAprovel. She was not employed by Sanofi at that time, however. Furthermore, as she made clear, her expertise was in regulatory procedure rather than in clinical matters. Thus she was not able to add much to the relevant documents.
Technical background
The relevant technical background, all of which would have formed part of the common general knowledge of the skilled team, may be summarised as follows.
Hypertension
Hypertension is the technical name for high blood pressure. Hypertension is classified as mild, moderate, severe or very severe depending on how high the blood pressure is compared to normal. A distinction is made between primary (or essential) hypertension, which is predominantly caused by genetic and lifestyle factors, and secondary hypertension, which is due to specific underlying abnormalities. Primary hypertension accounts for about 95% of individuals with raised blood pressure.
Other conditions mentioned in the Patent
In addition to hypertension, the Patent refers to a number of other conditions.
Heart failure. Heart failure results from a divergence between cardiac output and the requirements of the body. This leads to pulmonary oedema (i.e. excess fluid in the lungs), leg or more generalised swelling, shortness of breath and fatigue. The main cause is coronary heart disease (for example, after a heart attack or due to a gradual decrease in the rate at which the heart pumps the blood around the body). Other causes include hypertension, cardiomyopathies (primary and often genetic diseases of the heart muscle) and valvular disease which results in "leaky" valves in the heart.
Venous insufficiency. Venous insufficiency is a term used to describe swelling of the legs usually caused by damage to the veins or to their valves. Venous insufficiency is usually treated with compression stockings and/or surgery.
Glaucoma. Glaucoma is a condition in which loss of vision occurs because of abnormally high pressure in the eye.
Diabetic retinopathy. Diabetic retinopathy...
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