Angiotech Pharmaceuticals Inc. v Conor Medsystems Inc.
| Jurisdiction | England & Wales |
| Judge | Lord Justice Jacob,Lord Justice Tuckey,Lord Justice Mummery |
| Judgment Date | 16 January 2007 |
| Neutral Citation | [2007] EWCA Civ 5 |
| Docket Number | Case No: A3/2006/0657 |
| Court | Court of Appeal (Civil Division) |
| Date | 16 January 2007 |
[2007] EWCA Civ 5
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM CHANCERY DIVISION PATENTS COURT
MR JUSTICE PUMFREY
HC05C00376
Royal Courts of Justice
Strand, London, WC2A 2LL
Lord Justice Mummery
Lord Justice Tuckey and
Lord Justice Jacob
Case No: A3/2006/0657
Andrew WAUGH Q.C. and Colin BIRSS (instructed by Messrs Taylor Wessing) for the Appellants
Simon THORLEY Q.C. and Thomas HINCHLIFFE (instructed by Messrs Simmons & Simmons) for the Respondents
Hearing dates: 12 th, 13 th, 14 th December 2006
The patentees, Angiotech and the University of British Columbia, appeal the decision of Pumfrey J [2006] EWHC 260 (Pat) that their EP (UK) 706376 is invalid for obviousness. They do so with the Judge's permission. Mr Andrew Waugh QC and Mr Colin Birss argued the case for Angiotech, Mr Simon Thorley QC and Mr Thomas Hinchliffe that for the Respondents, Conor.
Appeals on obviousness face the particular hurdle that it must be shown the Judge was wrong which in turn involves showing that he made some error of principle – see Biogen [1997] RPC 1 at 45 which I do not set out here.
Pumfrey J provided a useful introduction by way of background to the technology, all of which is uncontroversial and there is no point in my doing other than borrowing wholesale and with gratitude:
“[4] Coronary heart disease is caused by a narrowing or blockage of the coronary arteries, whose task is to supply the heart muscle with blood. Arterial walls have three layers: a thin inner layer called the intima; a middle layer called the media, which consists of muscle; and an outer layer called the adventitia, which is a loose layer of connective tissue. The normal cause of arterial narrowing is atherosclerosis, in which a gradual build-up of fatty material in the inner layer of the artery wall takes place. This build-up of fatty material is followed by a deposit of fibrous tissue which produces a plaque protruding into the channel of the artery. The narrowing caused by the plaque is called a stenosis. The channel of the artery is referred to as the lumen, and as the lumen becomes progressively narrowed, the heart muscle becomes deprived of blood when demands are made of it, for example during exercise. The patient may then complain of angina, which is typically a crushing or constricting sensation in the chest and which may spread elsewhere, for example in the left arm or neck. If the protective fibrous cap on the surface over the fat-laden core of the plaque (the so-called atheroma) breaks, the platelets in the bloodstream adhere to the roughened exposed surface and a blood-clot forms. Any angina may worsen and, if the lumen of the artery is suddenly closed off, blood-flow ceases and the heart muscle dies, resulting in a heart attack.
[5] By the mid 1980s, there were three ways of treating coronary heart disease: drugs, coronary bypass surgery and angioplasty. Drugs may be used to relieve the symptoms of angina by relaxing the muscle of the artery wall, which improves the supply of blood to the heart muscle. They may also be used to make the heart beat less forcefully, so reducing its workload. Clot-dissolving drugs may be used, as may anti-platelet drugs, which reduce the tendency of the platelets to adhere to the plaques. (Platelets are specialised cells responsible for clotting.) If drugs alone are insufficient, and there is narrowing and blockage in several arteries, the patient may undergo coronary artery bypass surgery, in which vessels from elsewhere in the patient's body are used to bypass the problem by connecting them round the blockage. This surgery can relieve angina and may be successful for many years if the grafts remain open. Angioplasty is a technique originally developed in the early 1960s, but whose application to the coronary arteries became possible after the development of a balloon which, when inflated, was strong enough to dilate an arterial stenosis in a coronary artery. One Andreas Grüntzig developed a catheter with a relatively non-elastic sausage-shaped balloon near its tip. The catheter had two channels: one for introducing a guide-wire along which the balloon catheter could be passed and the other carrying fluid at a high pressure (between 6 and 12 bar) to inflate the balloon. The catheter is inserted in one of the main arteries, normally in the groin or in the arm, and manoeuvred to the site of the stenosis by the operator, who observes its progress using radiological techniques.
[6] The first percutaneous angioplasty was performed in 1977. The idea is that, once the wire is in place and the balloon passed into position along it, the balloon is then inflated so as to expand the lumen at the point of the stenosis. The procedure was and is successful, and in many cases relieves the patient of the burden of a bypass operation. It has low morbidity, rapid recovery time, and is repeatable. It is minimally invasive and does not require a general anaesthetic. It appears to have rapidly gained ground in the 1980s and by the middle of that decade had become widely accepted as an alternative to bypass surgery.
[7] By the mid 1980s it was becoming clear that there were problems associated with balloon angioplasty. Two in particular are important. The first, acute closure, took place in between 5% and 10% of patients. It occurred as the catheter was withdrawn. Without quick reaction by the operator, backed up if need be by emergency bypass surgery, acute closure would be fatal to the patient. The other problem is the gradual closure of the lumen, known as restenosis. Restenosis occurs in 33% to 50% (or possibly more) of patients. It normally takes place within six months following the angioplasty procedure, and is likely to re-occur at the same sort of rate among patients who had second and subsequent angioplasties. There is no doubt that restenosis was and remains a serious problem with the balloon angioplasty procedure.
[8] The attempt to deal with this problem has passed through a number of stages. The first was the employment of coronary stents. Stents are devices inserted into the diseased artery at the point at which the balloon expanded to open the lumen. They act as scaffolding to hold the artery open. The desirability of stenting had been obvious from the early days of balloon angioplasty, but real success only came with the use of stents that were themselves held on the balloon and expanded with it so as to be automatically placed in the right position during the procedure. A number of expandable core stents were developed from the mid 1980s onwards and were used from the late 1980s to see if they might reduce restenosis – they are obviously useful in preventing acute closure. Nonetheless, patients who had received a stent still suffered restenosis, and the reduction in restenosis rates was investigated. Two studies suggested that there was still a very significant rate of restenosis in patients receiving a balloon expandable stent in angioplasty.”
The priority date of the patent is 19 th July 1993. Identical amendments to it were allowed by the Opposition Division of the EPO and Pumfrey J. Although Angiotech formally maintained that claims 1, 6 and 12 were independently valid, the real debate has been about claim 12 and particularly that aspect of it concerned with vascular stents. There is no dispute that if claim 12 fails, the wider claims must fail too.
Pumfrey J set out the material claims at [25]:
“1. A stent for expanding the lumen of a body passageway, comprising a generally tubular structure coated with a composition comprising an anti-angiogenic factor and a polymeric carrier, the factor being anti-angiogenic by the CAM assay, and wherein said anti-angiogenic factor is taxol, or an analogue or derivative thereof.
…..
6. A stent according to any one of claims 1 to 5 wherein said stent is a vascular stent.
…..
[11. A stent according to any one of claims 1 to 5 for treating narrowing of a body passageway.]
12. A stent according to claim 11 for treating or preventing recurrent stenosis.”
Claim 12 can therefore be written out without the dependencies in this way:
“A stent
for expanding the lumen of a body passageway,
comprising a generally tubular structure coated with
a composition comprising an anti-angiogenic factor and a polymeric carrier, the factor being anti-angiogenic by the CAM assay,
and wherein said anti-angiogenic factor is taxol, or an analogue or derivative thereof,
for treating narrowing of a body passageway,
for treating or preventing recurrent stenosis.”
This is clumsy wording, arising in part from the process of amendment. What really matters, and what the dispute is about, is whether a vascular stent in accordance with this claim is obvious.
The Patent
As originally drawn the patent cast its disclosure and claimed monopoly much, much wider than vascular stents coated with taxol in a carrier. Indeed its opening words are mainly about cancer treatment:
“Technical field
The present invention relates generally to compositions and methods for treating cancer and other angiogenic-dependent diseases, and more specifically to compositions comprising anti-angiogenic factors and polymeric carriers, stents which have been coated with such compositions, as well as methods for utilizing these stents and compositions”
The Judge rightly observed that “very little of [the patent] is about restenosis and stents”. Having set out those opening words he went on to summarise the relevant parts of the disclosure as follows:
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