Neutral Citation Number: [2009] EWHC 6 (Pat)
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`IN THE HIGH COURT OF JUSTICE
`CHANCERY DIVISION
`PATENTS COURT
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`Case No: HC 07 C01243
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`Royal Courts of Justice
`Strand, London, WC2A 2LL
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`Date: 9 January 2009
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`Before :
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`MR PETER PRESCOTT QC
`(sitting as a Deputy Judge of the High Court)
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`- - - - - - - - - - - - - - - - - - - - -
`Between :
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`COREVALVE INC
`- and -
`(1) EDWARDS LIFESCIENCES AG
`(2) EDWARDS LIFESCIENCES PVT, INC
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`Claimants
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`Defendants
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`- - - - - - - - - - - - - - - - - - - - -
`- - - - - - - - - - - - - - - - - - - - -
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`Mr Antony Watson QC and Mr Thomas Mitcheson (instructed by Simmons and Simmons)
`for the Claimants
`Mr Roger Wyand QC and Mr Piers Acland (instructed by Bird & Bird ) for the Defendants
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`Hearing dates : 25th -27th and 30th June and 2nd July 2008
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`JUDGMENT
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 1 of 32
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`Mr Peter Prescott QC:
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`CoreValve Inc v. Edwards Lifesciences
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`1.
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`2.
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`Irvine, California is home both to Edwards Lifesciences – the largest artificial
`heart valve company in the world – and its competitor, CoreValve Inc. I shall
`call them “Edwards” and “CoreValve”.
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`Edwards owns European Patent No 0592410. CoreValve says this patent is
`invalid for anticipation, obviousness and insufficiency, and applies for its
`revocation. Edwards says that, on the contrary, the patent is valid and
`CoreValve has been infringing it by supplying its ReValving system; Edwards
`counterclaims accordingly. CoreValve denies that its product is covered by the
`claims of this patent, even if it is valid. As an extra line of defence, CoreValve
`says that it has been supplying the product for experimental purposes relating to
`the subject-matter of the invention (section 60(5)(b) of the Patents Act 1977).
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`3. As I assimilated the evidence and arguments in this case I gradually and
`increasingly formed the impression that the patent is valid, but that CoreValve’s
`product does not infringe it. And that is what I hold in this judgment. I must
`confess, however, that after the conclusion of the argument I had second
`thoughts: I was side-tracked by a consideration which caused me much trouble,
`which took up a lot of time in the preparation of this judgment, but which I now
`believe to be without substance. I shall return to that later. I greatly regret the
`resulting delay.
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`4.
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`5.
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`The priority date claimed for the patent, and not disputed in this case, is 18 May
`1990. Therefore I shall need to consider the state of the art at that date,
`including what was common general knowledge.
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`The patent is about artificial valves for implantation in the human body. Such a
`valve might be used to replace a natural valve. For certain medical conditions it
`might even be implanted where no natural valve exists e.g. in the oesophagus.
`But the main focus of the patent is about valves for replacing defective heart
`valves.
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`6. A little introductory terminology may be helpful. Before the date of the patent
`it was known to assist the patency, or openness, of a blood vessel e.g. a
`coronary artery by implanting a supporting scaffold called a stent, which may be
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 2 of 32
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`7.
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`CoreValve Inc v. Edwards Lifesciences
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`thought of as a slender wire cage. The stent could be delivered remotely from a
`blood vessel in the patient’s leg by a technique called catheterisation. In
`essence, a tube was passed up into the coronary artery and the stent was
`delivered over an internal guide wire. A small balloon was inflated inside the
`stent to cause it to expand and the catheter apparatus was withdrawn, leaving
`the stent in place.
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`The general idea of the patent is to implant a replacement valve remotely by
`catheterisation e.g. through a vein, without major interventional surgery, and to
`leave it in place, so that the patient may lead a normal life. This is to be
`achieved by mounting the valve on a stent; both the valve and the stent are
`elastic and can collapse i.e. they can squash inwards in order to be narrow
`enough to navigate through small passages e.g. arteries. On arriving at the
`correct site the valve and stent can be re-expanded and left in place.
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`The Heart, Its Valves and Its Main Blood Vessels
`8.
`The heart is a remarkable organ. It took centuries for the world’s best
`anatomists and physiologists to figure out its mode of operation and I
`understand that they have not finished even now.
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`9.
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`The heart is a pumping device. All vertebrate hearts work on the principle that
`a muscular chamber, called a ventricle, contracts to drive out blood (during
`systole) and expands to admit it (during diastole). A pump engineer would say:
`why not have an antechamber, where returning blood can be collected so that it
`can be discharged into the ventricle at the right time during the pumping cycle?
`But nearly all vertebrate animals have evolved one of those, and it is called an
`atrium.
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`10. We mammals (and also birds) have also evolved an ingenious arrangement to
`overcome the problem that a substantial pressure drop occurs as the blood
`passes through the lungs. The solution is to have parallel circulation systems or,
`in other words, a left heart and a right heart. The left heart drives the main or
`systemic circulation of the body. The right heart drives the pulmonary
`circulation. This arrangement was evolved in rudimentary form by our
`amphibian ancestors but in our heart the septum provides a complete division
`between left and right ventricle.
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 3 of 32
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`11. Consider blood returning to the heart from the main tissues of the body through
`the veins. It enters the right atrium through the vena cava. From there it passes
`to the right ventricle through the tricuspid valve. Our pump engineer would
`rightly say that since the heart is a positive displacement pump it should have
`valves to prevent the blood flowing the wrong way during the compression
`stroke. That is indeed what the healthy valves of the heart do; and we can start
`with the function of the tricuspid valve. During systole the rising blood pressure
`in the right ventricle causes this valve to slam shut, and so it prevents the blood
`running back into the right atrium. Instead the rising blood pressure causes
`another valve to open – the pulmonary valve – so that the blood is driven
`through the pulmonary artery and thence to the lungs. The function of the
`pulmonary valve is to stop back pressure causing blood to flow backwards into
`the right ventricle during diastole.
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`12. Having dropped waste gases in the lungs and picked up oxygen, the blood now
`proceeds – to the left heart, this time – through the pulmonary veins and thence
`to the left atrium. Blood proceeding in this direction opens the mitral valve and
`hence passes to the left ventricle. This chamber of the heart does more work
`than the others and so the heart muscle (myocardium) that surrounds it is
`correspondingly thicker. During left ventricular systole the rising blood
`pressure causes the mitral valve to slam shut and so the only way out is through
`the aortic valve, thence to the aorta, which is an enormous artery that feeds the
`other arteries of the systemic circulation.
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 4 of 32
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`13. Each of the four valves of the heart is formed from three leaflets, except for the
`mitral valve, which has two (and so it also known as the bicuspid valve).
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`CoreValve Inc v. Edwards Lifesciences
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`14. Heart valve disease may be congenital or it may be acquired. If acquired, it is
`often the mitral or aortic valve that will be affected. For present purposes the
`most common afflictions are stenosis (where the valve fails to open fully, a
`common cause being degenerative calcification) and regurgitation (where the
`valve does not close tightly, thus allowing some of the blood to leak
`backwards). Regurgitation is also called insufficiency.
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`15. Blood is supplied to heart muscle itself by the coronary arteries. They are
`connected to the aorta, the biggest artery in the body – maybe 25 mm diameter
`at its root. Here is a simplified diagram. It can be seen that the ascending aorta
`leads to its arch, in the region of which there are various branches that deliver
`arterial blood to the upper body. The descending aorta delivers arterial blood to
`the lower body through various branches, not shown. Two of these are the iliac
`arteries (10 mm diameter) which supply the pelvis and lower limbs (where they
`become the femoral arteries, diameter 6-8 mm).
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`16. Going back to the ascending aorta, an important thing to notice is the two
`coronary arteries. They are the sole source of supply of the blood that is
`required by the muscle tissue of the heart itself (myocardium). It follows that
`blockage of the coronary arteries, were it to occur, would be disastrous.
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`Operational vs. constructional problems
`17.
`It will be convenient at this point to highlight the operational difficulties that
`would attend the implementation of the invention in suit in clinical practice and
`to contrast those with mere constructional difficulties i.e. how you build the
`device that is to be implanted. The patent does not purport to monopolise the
`operational procedure – in Europe that is not allowed anyway – but only certain
`apparatus that is to be implanted by that procedure. The operational difficulties
`loomed large in the evidence in this case.
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`18.
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`It will be apparent that the remote implantation into the heart of an artificial
`valve-on-a-stent by catheterisation could be a cardiological procedure attended
`by much difficulty and risk. For instance, suppose it was desired to implant the
`device in the native or usual position at the end of the aorta. Unless the
`cardiologist had great skill and considerable experience there would be a grave
`danger of occluding the coronary arteries with fatal results, and especially so if
`the device failed to remain in place. For one thing, it would be difficult to
`visualise the movement of the device with the X-ray apparatus commonly
`available in 1990. Or suppose it was the mitral valve that was defective: how
`would the catheter safely and reliably be navigated to that site from a blood
`vessel in the patient’s leg?
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 6 of 32
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`CoreValve Inc v. Edwards Lifesciences
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`19. Professor Rothman (who gave expert evidence for CoreValve) described a
`particularly heroic procedure that few cardiologists would care to try – nor their
`patients, either. This involves the antegrade approach, which was pioneered by
`Cribier. In essence, access to the heart is achieved by means of an ‘antegrade’
`approach – with, not against – the direction of blood flow. The catheter is
`introduced into a peripheral vein and then advanced along the vena cava to the
`right side of the heart. If access to the left side of the heart is required then the
`catheter must be fed through the septum (which is punctured for the purpose)
`from the right atrium to the left atrium. To illustrate this Professor Rothman,
`who enjoyed making our flesh creep, produced an enormous needle – it looked
`about five foot long – and vividly described how it would be used in the
`procedure just described.
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`20.
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`I will say at once that, if it is the law that the patent in suit had to teach the
`ordinary cardiologist in 1990 not only how to construct a device as claimed
`therein but how to implant it successfully and safely in a patient, the patent
`would fail. However, I hold that this was not a requirement of the law and that
`it would be enough that persons skilled in the art could actually construct such a
`device. I shall revert to this under the heading of Insufficiency.
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`Replacing Defective Heart Valves By Surgery
`21.
`In 1990 it was possible to replace a defective heart valve but it required major
`chest surgery. The patient’s chest was opened, the defective valve was excised,
`and an artificial valve was sewn in its place. The operation was complex and is
`described in detail in the expert report of Professor Pepper, an eminent cardiac
`surgeon who gave uncontroversial evidence in this case. Amongst other things,
`it required a general anaesthetic and the use of a heart-lung machine. The
`operation took 3 or 4 hours. The operation was traumatic and hence could not
`be used for a patient who was too frail, for it might kill him. That patient had to
`tolerate an inferior quality of life, assisted by such palliative medicine as was
`available. The procedure is still used today.
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`Interventional Cardiology
`22. The above-described operation was performed by a cardiac surgeon. This
`professional should not be confused with an interventional cardiologist, who is a
`not a surgeon but is a physician who specialises in treating diseases of the heart
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`23.
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`24.
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`without major surgery. I was told that in 1990 there was a certain amount of
`rivalry between these two professions, the former tending to regard the latter as
`trespassing on their patch. Relations were sometimes terse. Nowadays there
`are many procedures that are performed by cardiologists where, formerly,
`cardiac surgery would have been required.
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`In 1990 interventional cardiology was not as specialised a profession as it is
`now. I shall describe some of the things that had been done.
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`In balloon angioplasty a diseased blood vessel was expanded mechanically by
`inflating a balloon that was delivered to the affected site on a catheter. The
`technique was first demonstrated in 1977 by Andreas Gruentzig of Zurich, and
`by 1990 it was common to use it for treating a defective coronary artery. The
`procedure could be carried out while the patient was awake.
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`25. A flexible plastic tube called a guide catheter was introduced into a remote
`blood vessel, typically a femoral artery in the patient’s groin. It could be
`introduced through a needle (rather like injection) or by making a small incision
`called a cut-down. (This is called percutaneous access.) A fluid opaque to X-
`rays was introduced and so the cardiologist could visualise his apparatus and
`steer it up the artery to the correct site. A fine guidewire was inserted through
`the guide catheter and into the coronary artery. A special balloon was mounted
`on the guidewire and conveyed to the affected site. The balloon was then
`inflated so as to dilate the coronary artery, thus curing the problem. That was
`the hope, anyway, for the technique did have its problems.
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`26. When this technique was introduced into hospitals it was necessary for the
`cardiac surgeon to stand by in case emergency heart surgery became necessary.
`For example, the coronary artery might suddenly close again (restenosis).
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`27. One technique for preventing restenosis was to use a stent. As indicated, a stent
`is a supporting scaffold, typically a tube, made of wire, perforated metal sheet
`or other suitable material. The stent could be mounted on the balloon and
`expanded to hold the blood vessel open.
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`28. A variety of stents were introduced and some were self-expanding. Early stents
`were made of bare metal but nowadays they can be impregnated with drugs: the
`idea is to prevent the formation of blood clots.
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`29. Sometimes a technique called valvuloplasty was tried. In this, a balloon was
`delivered to the interior of an aortic valve that had become stiff through
`calcification and expanded in the hope of improving its patency (openness).
`The idea was to make the patient’s natural heart valve behave better.
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`30. Stents were also employed by cardiac surgeons in order to hold artificial heart
`valves in place. Of course in this case their use required open chest surgery. A
`variety of such stents were designed and used.
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`31. By 1990 stents were well known to cardiologists, but their use was limited.
`Perhaps the best known was due to Palmaz. Schools of thought differed: some
`thought stents were the way of the future, others that little would come of them,
`still others that their use was for emergency surgery only.
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`Dr Andersen
`32.
`It appears that the invention of the patent in suit was largely the work of Dr
`Henning Andersen, a Danish doctor. In practical terms Dr Andersen took the
`work no further forward than certain experiments in pigs. These were not
`particularly successful but the work was published in professional refereed
`journals. In passing, the reaction of the referees was that the idea was bold and
`interesting but somewhat too ambitious. It also appears that Dr Andersen did
`not succeed in persuading clinicians to take up his idea and he eventually sold
`his patent; in the end it was acquired by Edwards. In my judgment those facts,
`in themselves, are neutral to what I have to decide. They are consistent with
`what is a common situation in patent practice: a one-man band failing because
`large resources were necessary in order to achieve clinical validation in what
`was a very risky branch of medicine.
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`The Patent
`33. The patent in suit claims priority from a Danish application and it has suffered
`slightly in translation. There are few practical instructions and those that are
`there are concerned with a prototype device used in experiments with pigs.
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`34. As illustrated in Figure 2, the patent describes a stent made of two folded
`surgical stainless steel wires 2, 3 to form two superposed rings secured together
`by sutures and having three tall loops 4. To this stent a natural pig heart valve
`6, suitably cleaned, is secured by suturing. (I understand that Dr Andersen
`obtained his pig valves from a butcher.) The commissural points 5 of this heart
`valve are secured to the tallest loops, thus providing a sort of “three-cornered
`hat” structure. “Commissural points” is something of a patent agent’s
`expression but it caused no difficulty to the experts in this case. Essentially, the
`commissural lines of a heart valve are where the edges of the valve leaflets
`meet, and so a commissural point is where the corners do. The patent indicates
`that a suitably adapted valve would be used in the case of humans and it says
`that instead of a biological valve it would be possible to have a valve made from
`synthetic materials.
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`35. The patent also describes a device with a stent with a closed wall, which may be
`self-expanding once in place.
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`36. All of the devices shown in the diagrams of the patent have stents of essentially
`cylindrical conformation.
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`37. Although the patent refers to trials on pigs, it contains no results of those trials.
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`38. Claim 1 of the patent reads as follows:
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`A valve prosthesis (9), preferably a cardiac valve prosthesis, for implantation in the
`body and comprising a collapsible elastical valve (6) which is mounted on an elastical
`stent (1) wherein the commissural points (5) of the elastical collapsible valve (6) are
`mounted on the cylinder surface of the elastical stent (1), characterized in that the
`stent is made from a radially collapsible and re-expandable cylindrical support means
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`(7,8,24) for folding and expanding together with the collapsible valve for implantation
`in the body by means of technique of catheterization.
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`CoreValve Inc v. Edwards Lifesciences
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`The Witnesses
`39. The following witnesses testified for CoreValve: Professor Martin Rothman (an
`eminent cardiologist); Dr Richard Hillstead (who had experience in stent
`design); and Mr Robrecht Michiels (CoreValve’s President and CEO).
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`40. The following witnesses testified for Edwards: Dr Nigel Buller (an eminent
`cardiologist); Professor John Pepper (an eminent heart surgeon); Dr Anthony
`Lunn (who had experience in stent manufacture); and Mr Stanton Rowe
`(Edwards’ Vice President of Advanced Technology).
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`41.
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`I thought all of these men were honest witnesses. Those who were expert
`witnesses impressed me with their knowledge of their subject matter. The
`witnesses of fact were generally reliable, although of course there were
`questions of degree of emphasis.
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`42. Both sides mounted the usual attacks on the other side’s experts: they were said
`not to be impartial, and so on. Beyond the obvious and inevitable fact that
`every man in the world has his own personal eccentricities of approach, I reject
`those attacks. They were probably made because each side worried the other
`side would do the same. Counsel fear too much that courts in patent cases will
`be unduly influenced by the opinions (i.e. value judgments) of experts, as
`opposed to the cogency of their reasoning.
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`43.
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`In Alan Nuttalt Ltd v. Fri-Jado UK Ltd [2008] EWCH 1311 (Pat) I said, largely
`quoting from Jacob LJ:
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`[27] It is worth recalling what is the proper function of expert witnesses in a patent
`case. It is not to act as a latter-day Sir Bernard Spilsbury. Their true function, and what
`makes their evidence cogent or not, was explained by Jacob LJ in SmithKline Beecham
`Plc v. Apotex Europe Ltd [2004] EWCA Civ 1568.
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`“[51] Before I go further, however, it is as well to remember what the key
`function of an expert witness in a patent action is - as I said in Rockwater
`(para. 12):
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`‘Their primary function is to educate the court in the technology -
`they come as teachers, as makers of the mantle [i.e. of the person
`skilled in the art] for the court to don. For that purpose it does not
`matter whether they do or do not approximate to the skilled man.
`What matters is how good they are at explaining things.’
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`[52] To that I would add this: although it is inevitable that when an expert is
`asked what he would understand from a prior document's teaching he will
`give an answer as an individual, that answer is not as such all that helpful.
`What matters is what the notional skilled man would understand from the
`document. So it is not so much the expert's personal view but his reasons for
`that view - these the court can examine against the standard of the notional
`unimaginative skilled man. There is an analogy here with the well-known
`Bolam test for professional negligence - what matters is not what the
`individual expert witness says he personally would have done, but whether
`the conduct said to be negligent falls short of what a reasonable professional
`would have done.
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`[53] Thus in weighing the views of rival experts as to what is taught or what
`is obvious from what is taught, a judge should be careful to distinguish his
`views on the experts as to whether they are good witnesses or good teachers -
`good at answering the questions asked and not others, not argumentative and
`so on, from the more fundamental reasons for their opinions. Ultimately it is
`the latter which matter - are they reasons which would be perceived by the
`skilled man?
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`[28] While I am touching on the topic of expert testimony, it is worth completing the
`quotation from the Rockwater case, although strictly speaking it is mainly about
`obviousness…. In Rockwater Ltd v. Technip France SA [2004] EWCA Civ 381 Jacob
`LJ continued thus:-
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`[13] But it also is permissible for an expert witness to opine on an "ultimate
`question" which is not one of law. I so held in Routestone v Minories Finance
`[1997] BCC 180 and see s.3 of the Civil Evidence Act 1972. As regards
`obviousness of a patent Sir Donald Nicholls V-C giving the judgment of the
`Court of Appeal in Mölnlycke v Proctor & Gamble [1994] RPC 49 at p. 113
`was explicit on the point:
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`“In applying the statutory criterion [i.e. as to whether an alleged
`inventive step was obvious] and making these findings [i.e. as to
`obviousness] the court will almost invariably require the assistance of
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`expert evidence. The primary evidence will be that of properly
`qualified expert witnesses who will say whether or not in their
`opinions the relevant step would have been obvious to a skilled man
`having regard to the state of the art.”
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`[14] But just because the opinion is admissible:
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`“it by no means follows that the court must follow it. On its own
`(unless uncontested) it would be “a mere bit of empty rhetoric”
`Wigmore, Evidence (Chadbourn rev) para. 1920. What really matters
`in most cases is the reasons given for the opinion. As a practical
`matter a well-constructed expert's report containing opinion evidence
`sets out the opinion and the reasons for it. If the reasons stand up the
`opinion does, if not, not. A rule of evidence which excludes this
`opinion evidence serves no practical purpose. What happens if the
`evidence is regarded as inadmissible is that experts' reports simply
`try to creep up to the opinion without openly giving it. They insinuate
`rather than explicate” (Minories at p. 188).
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`[15] Because the expert's conclusion (e.g. obvious or not), as such, although
`admissible, is of little value it does not really matter what the actual attributes
`of the real expert witness are. What matters are the reasons for his or her
`opinion. And those reasons do not depend on how closely the expert
`approximates to the skilled man.
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`29. In weighing the evidence in this case I have made allowances for the personal
`attributes and prejudices which these witnesses - like all of us - inevitably have.
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`44. So in the present case. Thus I have allowed for the fact that, for example,
`Professor Rothman is an enthusiast by temperament, very alive to the latest
`innovations in his profession; and for the fact that Dr Buller has been (as they
`say in theatrical circles) “on the road” for a long time now, having given expert
`evidence in many patent cases. Both witnesses were excellent.
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`Construction of the Patent
`45. The first words of Claim 1 of the patent are ‘A valve prosthesis, preferably a
`cardiac valve prosthesis, for implantation in the body’. The word “preferably”
`imposes no limitation; but it does indicate that, whatever other type of valve
`prosthesis is covered by this claim, it does at least cover a cardiac valve
`prosthesis.1 The word “for” at the start of a patent claim is conventionally taken
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`to mean that the device is suitable for the stated purpose, and not that it is
`necessarily intended for that purpose, still less that it is actually used for it. For
`example, if a piece of prior art is as a practical fact capable of being used for a
`certain purpose, it may anticipate a patent claim even though it would never
`occur to anyone so to use it. If a patentee wishes to protect himself from that
`kind of attack his proper course is to limit his claim accordingly. The classic
`illustration is Adhesive Drive Mounting v. Trapp (1910) 27 RPC 341 where a
`claim to a sheet that would become tacky when heated “for” sticking
`photographs in albums was held to be anticipated by a sheet (called a “pellicle”)
`that did have those physical properties even though nobody had previously
`suggested its use for that special purpose. The inventor of the pellicle had
`anticipated the later claim as M. Jourdain had spoken prose – without knowing
`it.
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`46. Hence the claim in the present case covers a cardiac valve prosthesis that is in
`fact practically suitable for implantation in the human body, whether one knows
`it or not. I do not understand those propositions to be disputed.
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`47. The following words and phrases in Claim 1 of the patent were in contention.
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`48.
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`‘Elastical’. This is a rather poor translation, but I make the necessary
`accommodation and read it as ‘elastic’. According to Edwards it means that the
`stent and the valve will deform when loaded and recover when the load is
`removed e.g. according to the contractions of the heart. According to
`CoreValve it imports no real limitation at all because the Claim anyway informs
`us that the stent is radially collapsible and re-expandable.
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`49. The word occurs in a context of a stent and valve that are stated to be elastic and
`radially collapsible and re-expandable during implantation by means of
`catheterisation. “Elastical” should therefore mean something more than merely
`being collapsible and re-expandable. It suggests a certain inherent springiness.
`This is confirmed by the description in the patent. It tells us that the device of
`Fig 2 is made of stainless steel wire. At column 3 lines 10-20 the patent says:
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`When the valve prosthesis is introduced and placed correctly the stent is expanded by
`self-expansion or by means of the expansion arrangement [i.e. the balloon catheter]
`until the stent is given an outer dimension which is slightly larger than the channel in
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 14 of 32
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`which it is placed. As the stent is elastic a contraction of the stent is prevented once it
`is expanded.
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`CoreValve Inc v. Edwards Lifesciences
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`50. At column 7 of the patent there is a description of implanting the valve
`prosthesis by means of a balloon catheter. At lines 40 to 45 it is stated that the
`outer diameter of the device when fitted on the balloon is 10 mm but after
`inflation of the balloon it achieves a diameter of 30 mm. Then at line 52 it says:
`“The balloon catheter 11 may subsequently be removed from the aorta 10 (Fig.
`7). Due to the stiffness of the metal the valve prosthesis will prevent a
`contraction. However, smaller contractions may occur (<10% diameter
`reduction) after the deflation of the balloon catheter 13.” This suggests that the
`device is not rigid but is elastic under hemodynamic loading and unloading, but
`not necessarily to the extent of being self-expanding on implantation i.e. without
`a balloon catheter to assist2.
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`51.
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`52.
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`In conclusion, therefore, I hold that “elastical” refers to the springiness of the
`stent and valve i.e. they have some capacity to flex and recover their original
`configuration at least when a hemodymanic load is applied and removed, but
`not necessarily so when the load is heavy i.e. during insertion. A device devoid
`of flexibility is excluded.
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` ‘Cylindrical’ and ‘cylinder surface’. Claim 1 requires that the stent is made
`from a “cylindrical support means” and that the commissural points of the valve
`are mounted on the “cylinder surface” of that stent. The meaning of those
`phrases is highly in contention. The reason for that, as we shall see, is that
`CoreValve’s device has not a uniform cross-section, but is bulbous at one end.
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`53. According to Edwards, there are four possible conditions in which to consider
`the stent:
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`(a) in its condition as manufactured i.e. before being assembled into a
`catheter;
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`(b) in its condition when ready to be introduced;
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`(c) in its condition once implanted in the body (when it will tend to conform
`to the shape of the site);
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`(d) in the case of a self-expanding stent, in its condition when “free in air”.
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`Edwards Lifesciences Corporation, et al. Exhibit 1037, p. 15 of 32
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`CoreValve Inc v. Edwards Lifesciences
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`54. Edwards rejects conditions (a), (c) and (d) and urges condition (b): more
`precisely, they contend that the device is collapsible into a cylinder so that it can
`be delivered by catheter. They say that a third party should be able to know
`whether their product infringes without having to know its conformation when
`inside the human body; and that the “free in air” approach cannot be applied
`consistently to self-expanding and balloon-expandable stents.
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`55. CoreValve say that the device must be cylindrical with a constant