KCI Licensing Inc. and iothers v Smith & Nephew Plc and Others

JurisdictionEngland & Wales
JudgeMR JUSTICE ARNOLD
Judgment Date23 June 2010
Neutral Citation[2009] EWHC 2143 (Pat),[2010] EWHC 1487 (Pat)
Docket NumberCase No: HC09C02624
CourtChancery Division (Patents Court)
Date23 June 2010
Between
(1) Kci Licensing Inc
(2) Kci Medical Resources
(3) Kci Medical Limited
Claimants
and
(1) Smith & Nephew Plc
(2) Smith & Nephew Inc
(3) Smith & Nephew Medical Limited
(4) Smith & Nephew Healthcare Limited
Defendants

[2010] EWHC 1487 (Pat)

Before: The Honourable Mr Justice Arnold

Case No: HC09C02624

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

Michael Tappin QC and Henry Ward (instructed by Olswang LLP) for the Claimants

Simon Thorley QC and Andrew Lykiardopoulos (instructed by Bristows) for the Defendants

Hearing dates: 20–21, 24–27 May 2010

Approved Judgment

I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.

THE HON MR JUSTICE ARNOLD

MR JUSTICE ARNOLD

MR JUSTICE ARNOLD:

Contents

TopicParagraphs

Introduction 1

Background 2–6

Argenta 7–14

‘504 15–28

Claims of ‘504 in issue 29–32

‘950 33–35

Claims of ‘950 in issue 36–39

The witnesses 40–48

Priority 49–100

The right to priority 50–54

The applications 55–56

The issues 57

Did KC Inc have the right to claim priority by virtue of the

Confidentiality Agreement? 58–72

Did KC Inc have the right to claim priority by virtue of a specific

assignment? 73–78

Was Mediscus an applicant for the purposes of the claim to priority? 79–90

Would it adversely affect the claim to priority if Mediscus was an

applicant? 91–99

Conclusion 100

The skilled team 101–103

Common general knowledge 104–138

The law 105–112

The common general knowledge of the clinician 113–120

The treatment of wounds 114–117

Dressings 118–119

Prep sponges 120

The common general knowledge of the design engineer 121–138

Reticulated foam 123–128

Gel-forming substances 129–138

Obviousness 139–169

The skilled team and their common general knowledge 141

Would the skilled team implement Argenta? 142–145

Obviousness of claim 5 of ‘504 and claim 8 of ‘950 over Argenta 146–154

Obviousness of claim 7 of ‘950 over Argenta 155–160

Obviousness of claim 7 of ‘950 over Karakelle 161–169

Construction and infringement 170–192

The allegedly infringing products 172

Construction and infringement of ‘504 173–187

Integer [8] 174–181 Integer [10] 182–187

Construction and infringement of ‘950 188–192

Integer [3] 189–192

The infringing acts alleged 193–213

Infringing acts in relation to claim 5 of ‘504 and claim 8 of ‘950 194–205

Infringing acts in relation to claims 7 and 8 of ‘950 206–213

Conclusions 214

Introduction

1

The Claimants (who I shall refer to collectively as “KCI”) claim that the Defendants (who I shall refer to collectively as “S & N”) have infringed European Patents (UK) Nos. 0 777 504 B1 entitled “Wound drainage equipment” (“'504”) and 0 853 950 B1 entitled “Wound drainage canister” (“'950”) (which I shall refer to collectively as “the Patents”). ‘950 is a divisional of ‘504, and both have a claimed priority date of 22 August 1994. S & N deny infringement of either Patent and counterclaim for revocation of both Patents. At trial KCI did not defend the validity of the broader claims of the Patents, and therefore the issues are confined to the validity and infringement of claim 5 of ‘504 and claims 7 and 8 of ‘950.

Background to the dispute

2

The Patents concern apparatus for use in Negative Pressure Wound Therapy (“NPWT”). NPWT involves packing the wound with a dressing which is then covered by a film to create a seal. A partial vacuum is then applied to the area under the seal. NPWT has been found to reduce bacterial infection and to promote tissue growth, and thus to help heal wounds which were difficult to treat by previous methods. The development and use of NPWT has been pioneered by Dr Louis Argenta and Dr Michael Morykwas of Wake Forest University (“WFU”), although it turns out that they were not the first to devise such a technique.

3

NPWT was the subject of an International Patent Application by WFU, No. WO 93/09727 (“Argenta”), which is the principal item of prior art relied on by S & N in these proceedings. Argenta led to the grant of a family of patents, including European Patent No. 0 620 720 B2 (“'720”). KCI is the exclusive licensee under those patents.

4

This is the second patent action brought by KCI against S & N in respect of apparatus for NPWT in as many years. In the first action KCI and WFU sued S & N for infringement of ‘720 on 15 December 2008 and obtained an interim injunction from Lewison J on 13 January 2009: see Wake Forest Health Sciences v Smith & Nephew plc [2009] EWHC 45 (Pat), [2009] FSR 11. After a speedy trial, Roger Wyand QC held in a judgment dated 1 May 2009 [2009] EWHC 908 (Pat) that claims 1, 2 and 15 were anticipated by, and claims 8, 9, 13 and 17 were obvious in the light of, a short article written in Russian by N. A. Bagautdinov entitled (in translation) “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of Soft Tissues” published in Current Problems in Modern Clinical Surgery by Chuvasia State University of the USSR in 1986. Nevertheless, Mr Wyand concluded that claims 4, 16 and 19 were valid and had been infringed by S & N. On 14 July 2009 the Court of Appeal allowed an appeal by S & N, holding that claims 4, 16 and 19 were obvious, and dismissed a cross-appeal by KCI and WFU against the finding that claim 1 was anticipated. The Court of Appeal gave its reasons for that decision in a judgment dated 31 July 2009 [2009] EWCA Civ 448.

5

Prior to the launch of KCI and WFU's claim against S & N, Mölnlycke Health Care AB had commenced a claim for revocation of ‘720. That claim came to trial just after the Court of Appeal had announced its decision, but Kitchin J nevertheless proceeded to hear and determine it since KCI and WFU intended to apply to the Supreme Court for permission to appeal against the Court of Appeal's judgment. In the event that application was refused. In the meantime Kitchin J concluded in a judgment dated 28 August 2009 [2009] EWHC 2204 (Pat) that ‘720 was invalid not only in the light of the Bagautdinov article, but also another item of prior art called Zamierowski. He also concluded that ‘720 was invalid as a result of an amendment after grant which extended the scope of the patent.

6

KCI also sought an interim injunction in these proceedings, but that application was refused by Mann J on balance of convenience grounds on 31 July 2009 [2009] EWHC 2143 (Pat).

Argenta

7

Since the Patents are for improved apparatus for use in the procedure disclosed in Argenta, it is convenient to consider the disclosure of Argenta before turning to the disclosure of the Patents.

8

The background to the invention is set out at page 1 line 6 – page 2 line 27 as follows:

“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 sufficient blood flow, the wound is unable to successfully fight bacterial infection and accordingly is unable to close spontaneously.

The most common techniques for closure of open wounds has long been the use of sutures or staples. These mechanical closure methods provide tension on the skin tissue at the wound border that encourages epithelial tissue to migrate toward the wound and cover it. While suturing and stapling of wounds is widely practiced, it has a major drawback: the tensile force required to achieve closure with sutures or staples causes very high localized stresses at the suture insertion points, resulting in the rupture of the tissue at these points. Substantial rupture will eventually cause dehiscence [ie tearing] in some wounds, which results in additional tissue loss. Moreover, some infected wounds harden and inflame to such a degree that closure by suturing is not feasible. Wounds not reparable by suturing or stapling generally require prolonged hospitalisation, with its attendant high costs, and major surgical procedures, such as grafts of surrounding tissue. Examples of such wounds include large, deep, open wounds, pressure sores resulting from prolonged pressure, ulcers resulting from chronic osteomyelitis, and partial thickness burns that subsequently develop into full thickness burns.

To date, there has been no consistently satisfactory method for treating such wounds. What is needed is a method of closing the wound without the localized stresses that accompany suturing while at the same time treating any infection present in the wound along with a simple apparatus to carry out the method. Such a method and apparatus would reduce hospitalization and increase the probability of wound closure.”

9

The invention is summarised at page 2 line 29 —page 3 line 37. The “fifth aspect” of the invention is described at page 3 lines 24–37 as follows:

“an apparatus for facilitating the healing of wounds which comprises vacuum means for creating a negative pressure on the area of tissue surrounding the wound, sealing means operatively associated with the vacuum means to maintain the negative pressure on the, wound, and screen means for preventing overgrowth of tissue in the wound area. A preferred embodiment of the invention comprises a section of open-cell foam configured to be placed over a wound, a flexible tube inserted into the foam section for attachment to a suction pump, and a flexible polymer sheet overlying...

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