Mölnycke Healthcare AB v Wake Forest University and Another
| Jurisdiction | England & Wales |
| Judgment Date | 28 August 2009 |
| Neutral Citation | [2009] EWHC 2204 (Pat),[2009] EWHC 908 (Pat) |
| Court | Chancery Division (Patents Court) |
| Docket Number | Case No: HC 08 C00744 |
| Date | 28 August 2009 |
[2009] EWHC 2204 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Strand, London, WC2A 2LL
The Honourable Mr Justice Kitchin
Case No: HC 08 C00744
Hearing dates: 15–17 July 2009
MR. JUSTICE KITCHIN:
Introduction
This is a patent revocation action in which the claimant (“Mölnlycke”) seeks revocation of European Patent (UK) No. 0 620 720 B2 (“the Patent”) in the name of the defendants (collectively “Wake Forest”).
The Patent has a priority date of 14 November 1991 and is entitled “Apparatus for treating tissue damage”. The invention it describes relates generally to wound healing and, more specifically, to apparatus for treating wounds that are unlikely to heal completely using conventional methods. The invention has found practical application in a commercial embodiment known as the V.A.C. System. There is no doubt that this has been enormously successful and made a significant contribution to patient care. It is used for treating serious open wounds involving substantial tissue loss, such as diabetic leg ulcers and gun shot wounds which, before the invention, were in many cases very difficult to heal. The V.A.C. System has now been used on more than three million patients.
The action has come on for trial in unusual circumstances, as I shall explain. But first I must provide a little background. Mölnlycke commenced these proceedings on 14 March 2008. It did not give details of any proposed product, so there is no counterclaim for infringement.
In December 2008, Smith & Nephew announced the launch of a new product which Wake Forest believed fell within the scope of the Patent. It therefore launched infringement proceedings on 15 December 2008 and applied for an interim injunction. The application was heard and an interim injunction was granted by Lewison J on 13 January 2009. He directed the trial of the action be expedited and a trial date was fixed for March 2009.
Smith & Nephew alleged invalidity of the Patent on one ground only, namely that the Patent was invalid for lack of novelty or obviousness in the light of an article entitled “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of Soft Tissues” published in 1986 in Current Problems in Modern Clinical Surgery by Chuvasia State University, USSR (“Bagautdinov”) and which had not at that time been cited in these proceedings by Mölnlycke. It was at least partly upon that basis that Lewison J made the directions that he did, so allowing the two actions to proceed in parallel rather than ordering the Smith & Nephew proceedings to be tried at the same time as these proceedings which had, by that time, had their trial date fixed for July 2009.
Mölnlycke did not in fact become aware of Bagautdinov until late 2008 and on 24 February 2009, it applied to amend its Grounds of Invalidity so as to plead it as an additional citation which rendered the Patent invalid for lack of novelty or obviousness.
By two applications dated 18 and 19 February 2009, Wake Forest applied first, for directions in the light of Mölnlycke's request to amend to plead Bagautdinov and second, for permission to make a conditional application to amend the Patent in the light of Bagautdinov.
All of those applications were dealt with at a joint case management conference between Wake Forest, Smith & Nephew and Mölnlycke which came before me on 26 February 2009. I recognised it was plainly desirable for the actions to be tried together but declined to make an order to that effect essentially for two reasons: first, Smith & Nephew was subject to an injunction and strongly resisted any delay in the hearing of its trial. Second, Mölnlycke had so arranged its affairs as to be ready for a trial in July 2009 and, relying as it was not just upon Bagautdinov but a number of other pieces of art, made clear it was simply not going to be ready for a trial in March 2009. I also granted Wake Forest permission to issue and serve a conditional application to amend the Patent in the light of Bagautdinov and directed that any objections by either Smith & Nephew or Mölnlycke were to be served by 12 March 2009. That amendment application was made in the Smith & Nephew action only. Mölnlycke did not file a Statement of Objections, having taken the view that if the Patent was invalid in the light of Bagautdinov then the proposed amendment could not save it.
The trial of the Smith & Nephew action took place over three days at the end of March 2009 before Mr Roger Wyand QC sitting as a deputy High Court judge. Expert evidence was adduced from a Dr Orgill for Wake Forest and a Dr Gordon for Smith & Nephew. The deputy judge gave judgment on 1 May 2009. He found that claim 1 and certain dependent claims of the Patent were anticipated by or obvious in the light of Bagautdinov; claims 4, 16 and 19 of the Patent were valid; and that Smith & Nephew's device infringed those valid claims.
After judgment, Wake Forest applied to amend claim 1 in the manner set out in the Bagautdinov amendment application. Essentially that amendment involved the addition of the words “by increasing the rate of formation of granulation tissue”. The deputy judge held that that did not amount to a material limitation of the claim and therefore did not save claim 1 from a finding of invalidity.
Smith & Nephew accepted the findings of infringement but appealed against the finding that claims 4, 16 and 19 of the Patent were valid. Wake Forest contended by its cross-appeal that all the claims were valid.
In summary, therefore, following the trial of the Smith & Nephew action, the only claims of the Patent found to be valid and infringed were original claims 4, 16 and 19. The injunction was continued and accordingly the appeal was expedited. It was heard on 9 July 2009.
On 13 July 2009, I asked the parties to appear before me and canvassed with them the possibility of inviting the Court of Appeal to consider whether, if the court had reached a concluded view on the appeal, it would be prepared to give its decision, if not its reasons, in advance of the commencement of this trial. On 14 July 2009, and no doubt in the hope it would avoid the need for this trial, the Court of Appeal notified the parties to the Smith & Nephew proceedings that it had decided to announce its decision, with written reasons to follow. That same day the Court of Appeal announced its decision that the Patent was wholly invalid over Bagautdinov and adjourned all other outstanding matters for further argument to a date to be fixed.
On 15 July 2009, at the commencement of the trial, Wake Forest applied to adjourn the trial, essentially upon the basis that the Patent having been adjudged by the Court of Appeal to be invalid, to proceed with the trial would potentially involve a substantial waste of costs and judicial time. At the same time, however, Wake Forest made clear that it anticipates inviting the Court of Appeal to stay any order for revocation pending an application to the House of Lords or the Supreme Court for permission to appeal and, if permission should be granted, pending the disposal of the appeal. Mölnlycke resisted the application. It contended that it had planned its commercial activities on the assumption that the trial would proceed and determine the validity of the Patent, not just on the basis of Bagautdinov but also on the basis of the other prior art upon which it relies, and an additional attack that the protection conferred by the Patent has been extended. It also submitted that, in the light of the position taken by Wake Forest, it would not be right to proceed on the basis that a further appeal has no prospect of success. If such an appeal were to succeed, adjournment of the trial would mean a delay in the determination of the issues which arise in these proceedings potentially until sometime in 2011. That, it contended, would be most unjust. It also pointed out that the costs of and occasioned by the trial had to a very substantial extent already been incurred. The parties and the witnesses were present before me and the trial was ready to be heard. In all the circumstances, but not without some hesitation, I decided that the trial should proceed but with effective case management to ensure that it took no longer than necessary. In the event it was heard over some two and a half days.
The issues
The relevant claims of the Patent are alleged to lack novelty in the light of:
(a) United States Patent No. 4,969,880 (“Zamierowski”);
(b) Bagautdinov.
They are also alleged to be obvious over:
(a) Zamierowski;
(b) Bagautdinov;
(c) an article entitled “An improved Technique for Skin Graft Placement Using a Suction Drain” published in Surgery, Gynaecology and Obstetrics, 1984, Vol. 159, Part 6 (“Johnson”);
(d) an article entitled “Managing draining wounds and fistulae: new and established methods” published in Chronic Wound Care, 1990 (“Jeter”); and
(e) the common general knowledge.
The Patent is said to be insufficient arising from the requirement in the claims that the device be such as to prevent overgrowth of tissue in the wound. Mölnlycke says that if this limitation adds anything to the teaching of the prior art then it is not sufficiently described for the skilled person to be able to make such a device without undue effort.
More substantively, there is also an allegation that the protection conferred by the Patent has been extended by an amendment which should not have been allowed. In related proceedings the German equivalent...
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