Mölnycke Healthcare AB v Wake Forest University and Another
| Jurisdiction | England & Wales |
| Judge | Mr Justice Warren,Lord Justice Ward,Mr Roger Wyand QC,Lord Justice Jacob |
| Judgment Date | 31 July 2009 |
| Neutral Citation | [2009] EWCA Civ 848 |
| Date | 31 July 2009 |
| Docket Number | Case No: A3/2009/0931 & A3 2009/1227 |
| Court | Court of Appeal (Civil Division) |
[2009] EWCA Civ 848
IN THE SUPREME COURT OF JUDICATURE
COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Roger Wyand QC
Before: Lord Justice Ward
Lord Justice Jacob and
Mr Justice Warren
Case No: A3/2009/0931 & A3 2009/1227
[2009] EWCH 908
James Mellor QC and Andrew Lykiardopolos (instructed by Messrs Bristows) for the Appellants
Daniel Alexander QC and James Abrahams (instructed by Messrs Olswang) for the Respondents
Hearing dates: 9th July 2009 and 14th July 2009
Mr Justice Warren (giving the first Judgment at the invitation of Lord Justice Ward)
Introduction
The appeal and cross-appeal in this case relate to Patent EP 0 620 720 (“ the Patent”). The Patent concerns a medical device shortly described as “Apparatus for treating tissue damage”. The invention (see paragraph [0001]) relates
“generally to wound healing, and more specifically is directed to apparatus for treating wounds that are unlikely to heal completely under conventional methods.”
The proprietor of the Patent is the first Claimant/Appellant (“ Wake Forest”). The second and third Claimants/Appellants (together “ KCI”) are between them exclusive licensees and carry out the commercial exploitation of the invention.
The Judge, Mr Roger Wyand QC sitting as a Deputy Judge in the Patents Court held that certain claims, including the main claim, Claim 1, were anticipated. He rejected the contention of the Defendants/Respondents (together “ S&N”) that other claims, in particular Claims 4, 16 and 19, were obvious.
S&N appeal against those findings concerning obviousness. Wake Forest and KCI cross-appeal against the findings of invalidity in relation to Claim 1 and various other claims. It is only the cross-appeal in relation to Claim 1 on the grounds of anticipation which has been pursued in this Court.
Background
The prior art relied on by S&N is a paper written in Russian by a Russian doctor, NA Bagautdinov (“Bagautdinov”) which I shall consider in detail later. It dates from 1986. It refers to a number of earlier papers, including one dating from 1984, by SV Lohvitskii and AA Bilkevich: the title of that earlier paper is “External vacuum aspiration in the treatment of purulent disorders of the soft tissues”. This paper is not part of the cited prior art but it provides some interesting history. After a very brief description of external vacuum aspiration, we find this:
“The external vacuum aspiration method consists in the placement of a vacuum instrument outside the wound cavity. It was first proven and used by N.I. Pirogov. [see http://en.wikipedia.org/wiki/Nikolay_Ivanovich_Pirogov for further information]. In his “Report on the Journey to the Caucasus” (1849), he wrote that to create the efflux and removal of foreign bodies from gunshot wounds, “….in many cases, I replaced incisions to advantage by the attachment of a cupping glass at the entry and exit holes.” It was not until the end of the 19 th century that A. Bier and R. Klapp used the already long forgotten glass as one of the options for creating congestive hyperemia in an inflammatory focus for the purpose of activating the body's defensive powers to fight infection. The method of Bier and Klapp was widely used until 1920's – 1930's, and many surgeons have remarked that it implements the classic principal of purulent surgery, the removal of pus from a wound. Yet, during the period in which antibiotic therapy blossomed, the method was forgotten and, in the opinion of S. T. Pavlov (1957), began to represent only historical interest.”
In the West, development of the technique did not occur until the late 1980s. At least, there is no evidence of any research or development. Indeed, Dr Orgill, the expert for Wake Forest and KCI, has exhibited to his report an article, co-authored by himself and Dr Hemling, which was published in 1988. It was entitled “Current concepts and approaches to wound healing”; it does not mention the technique but, under the heading New Advances, mentions a number of entirely different technologies—Growth Factors, Human Growth Hormone and Skin Substitutes.
Before turning to the Patent and Bagautdinov, I note that the skilled team would include, as is common ground, a surgeon experienced in the treatment of wounds and a wounds nurse. The team, working on wound treatment, would be entirely familiar with a variety of wounds and with common techniques and equipment to be found in hospitals where treatment takes place. No dispute exists about the state of the common general knowledge, the relevant details of which I will cover later.
No dispute exists, either, about the correct approach to obviousness. Although it is not compulsory, it is usually a helpful approach – and certainly so in the present case – to apply the Windsurfing test as re-stated by Jacob LJ in Pozzoli v BDMO [2007] FSR 37. The test is, of course, now well known but it is worth setting out again:
(1)(a) Identify the notional “person skilled in the art”;
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it.
(3) Identify what, if any, differences exist between the matter cited as forming part of the state of the art and the inventive concept of the claim or the claim as construed.
Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? The application of steps (1) to (3) does no more than place the court in the correct frame to assess obviousness under step (4). It does not itself provide a test for obviousness. Nor does it provide any gloss on the single statutory question. The judge did not refer to Pozzoli. He did not address the steps set out in the test as set out there. As will be seen I think this led him into error.
The authorities are full of examples of different glosses which the courts have, in a wide variety of circumstances, placed on the statutory test namely that an invention shall be taken as involving an inventive step if it is not obvious to a person skilled in the art. The correct approach is stated by Kitchin J in Generics v Lundbeck [2007] RPC 32 at 72 (cited with approval by Lord Hoffmann in Conor Medsystems Incorporated v Angiotec Pharmaceuticals Incorporated [2008] UKHL 49, [2008] RPC 28) when he was considering how a number of different factors should be taken into account:
“The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success.”
I have well in mind that S&N are asking us to overturn the Judge's findings on obviousness. Mr Alexander reminds us of the role of the appellate court in a case of obviousness and of the decision in Biogen Inc. v Medeva Plc [1997] RPC 1, in particular the part of Lord Hoffmann's speech at 45 where he said:
“The need for appellate caution in reversing the judge's evaluation of the facts is based upon much more solid grounds than professional courtesy. It is because specific findings of fact, even by the most meticulous judge, are inherently an incomplete statement of the impression which was made upon him by the primary evidence. His expressed findings are always surrounded by a penumbra of imprecision as to emphasis, relative weight, minor qualification and nuance (as Renan said, la vérité est dans une nuance), of which time and language do not permit exact expression, but which may play an important part in the judge's overall evaluation.”
Those observations are directed not at the facts as found by a judge but to his evaluation of them in the context of the ultimate question of obviousness. If a judge has adopted the wrong approach to obviousness – for instance taking a mistaken view as what is disclosed by the prior art or what the difference between the prior art and the claim under attack is – then of course the appellate court will have to form its own evaluation on the basis of the facts as found by the judge or which appear clearly from the documents or other evidence without having been expressly mentioned in the judgment.
The Patent
The Patent has a priority date of 14 November 1991. I have set out paragraph [0001] already. The background of the invention is set out in paragraphs [0002] to [0005]. So far as material to the present appeal, they read as follows:
“[0002] The treatment of open wounds that are too large to spontaneously close has been a troublesome area for many years. Wound closure requires that epithelial and subcutaneous tissue adjacent to the wound migrate toward and eventually close the wound. Some wounds are sufficiently large or infected that they are unable to close spontaneously. In such instances, a zone of stasis, an area in which localized swelling of tissues restricts the flow of blood to these tissues, forms near the surface of the wound. Without...
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