Mölnlycke Health Care AB v Brightwake Ltd (Trading as Advancis Medical)

JurisdictionEngland & Wales
JudgeJUDGE BIRSS,The patent
Judgment Date25 February 2011
Neutral Citation[2011] EWHC 376 (Pat)
Docket NumberCase No: HC 09 C 03308
CourtChancery Division (Patents Court)
Date25 February 2011

[2011] EWHC 376 (Pat)

IN THE HIGH COURT OF JUSTICE

CHANCERY DIVISION

PATENTS COURT

St. Dunstan's House

133-137 Fetter Lane

London EC4A 1HD

Before:

His Honour Judge Birss Qc

(Sitting as a judge of the Patents Court)

Case No: HC 09 C 03308

Between:
Mölnlycke Health Care AB
Claimant
and
Brightwake Limited (Trading as Advancis Medical)
Defendant

MR. IAIN PURVIS QC and MISS ANNA EDWARDS STUART (instructed by Mayer Brown International LLP) for the Claimant

DR. JUSTIN TURNER QC and MR. MILES COPELAND (instructed by Wragge & Co. LLP) for the Defendant

Hearing dates: 26th, 27th, 28th and 31st January, 3rd and 4th February 2011

JUDGE BIRSS

JUDGE BIRSS :

Contents:

Topic

Para

Introduction

1

The witnesses

4

Technical background

22

The patent

28

The claims

52

The person skilled in the art

57

Common general knowledge

65

Construction—the law

83

Construction of the claims in this case

95

—perforated carrier material [feature (ii)]

96

—silicone gel [feature (iii) and (v)]

109

— the carrier material is impervious to air and fluid, or only slightly permeable to air and fluid [feature (iv)]

122

— the carrier material is coated with silicone gel on only one side thereof [feature (v)]

137

—claims 7 and 10

150

Infringement

—the Brightwake products

155

—do the Brightwake products infringe?

162

—alternative approach (b)—carrier material is MBPU alone

178

—alternative approach (c)—carrier material is MBPU + acrylic

190

—dependent claims on the alternative bases

198

—another matter

200

Novelty

205

Brassington

207

What does Brassington disclose?

224

Enablement

242

—Enablement—the law

243

—Evidence on enablement

248

—Mr Fabo

251

—the Dillingham Experiments

256

—the repeats at Imperial

265

—the opinions of the experts

272

—conclusion

282

Inventive Step

284

Brassington

290

—claims 7 and 10

312

—coating silicone on one side only

315

Fabo

324

Conclusion

326

Introduction

1

In this action the claimant, Mölnlycke Health Care AB ("Mölnlycke"), claims that the defendant, Brightwake Limited ("Brightwake"), has infringed Mölnlycke's patent number EP 0 633 757 entitled "A method and an arrangement for manufacturing wound dressings, and a wound dressing manufactured in accordance with the method." The priority date is 30 th March 1992. The inventor is Tomas Fabo. The products alleged to infringe are Brightwake's EPISIL and EPISIL ABSORBENT wound dressings. Brightwake denies infringement and contends that the patent is invalid. Brightwake contends that the relevant claims lack novelty and are obvious in the light of two prior documents, European Patent Application EP 0 251 810 A2 ("Brassington") and United States patent 4,921,704 ("Fabo").

2

Brightwake contends claims 6 to 10 are invalid and does not attack the validity of claims 1 to 5. The claims Mölnlycke contends are independently valid and infringed are claims 6, 7 and 10. The invalidity case pressed in closing was that Brassington anticipates claims 6 and 7 and renders all three claims obvious. The case over Fabo was obviousness only, certainly against claim 6 and as I understood it against claims 7 and 10 too.

3

Mr Iain Purvis QC and Miss Anna Edwards-Stuart appeared for Mölnlycke instructed by Mayer Brown International LLP. Dr Justin Turner QC and Mr Miles Copeland appeared for Brightwake instructed by Wragge & Co. LLP.

The witnesses

4

Mölnlycke's first expert witness was Tomas Fabo. Mr Fabo is currently the Manager for Concept Development for the Wound Care Division of Mölnlycke. He obtained a Masters of Science degree in Chemical Technology from Chalmers University in Göteborg. In 1983 Mr Fabo joined Mölnlycke Hospital Products as a product developer/designer in the company's wound care team. Since then he has worked full time for Mölnlycke. Mr Fabo is the inventor of the patent in suit and of one of the cited items of prior art.

5

Brightwake drew attention to his employment for Mölnlycke and his status as inventor of the patent and the prior art and to his involvement in United States interference proceedings in relation to the other item of prior art—Brassington. Mr Fabo did not know whether his involvement with lawyers in the interference proceedings had coloured his view of Brassington. Brightwake submitted Mr Fabo was poorly placed to assist the court as a result of this. They submitted he was too close to matters to express an opinion in some respects—such as obviousness over his own prior art patent. Mr Fabo's personal relationship with the various documents and products in this case and his employment status are factors I must take into account in assessing his evidence. They do not disqualify him from being able to assist the court on the technical matters arising in this trial and in my judgment Mr Fabo did so.

6

Brightwake submitted Mr Fabo was notably evasive and uncomfortable when being cross-examined in relation to the arrangements for taking the electron micrographs in the case. In my judgment Mr Fabo was not at all evasive but he was uncomfortable. He had difficulty remembering what micrographs he had seen and when he saw them and he had difficulty remembering when he met Dr Eklund, the person who took the images. In my judgment his discomfort arose from his inability to remember precisely the details surrounding the electron micrographs when the events took place a matter of a few months ago. He was slightly embarrassed at not being able to remember these details, probably because they did not seem important to him at the time.

7

Some of Mr Fabo's evidence on other issues in the case relates to development work he carried out nearly 20 years ago. Essentially no documents now remain from that work and Mr Fabo's memory is the primary source of the evidence. I will deal with that in its proper context.

8

In summary Mr Fabo was a good witness. He gave his evidence entirely fairly.

9

Prof Clarson was called by Mölnlycke to address silicone. With a BA and D. Phil in chemistry from York, Prof Clarson is currently Professor of Chemical and Materials Engineering at the University of Cincinnati. He has five books on silicon/siloxane chemistry to his name as well as a number of patents. In 2000 Prof Clarson was elected a Fellow of the Royal Society of Chemistry. He has acted as an expert witness on silicon/siloxane chemistry in "dozens" of cases both in the USA and UK. He was a good witness.

10

Dr Dillingham is President and Chief Scientist of Brighton Technologies Group Inc., a materials research, development and testing laboratory in Cincinnati. He has a BS degree in biology, and an MSc and PhD in materials science. He gave brief evidence by video link relating to the experiments he carried out. He gave his evidence entirely fairly.

11

Prof Richard White was called by Brightwake. He is Professor of Tissue Viability at the Institute of Health and Society at the University of Worcester. He has over 35 years experience in dermatology and wound care and has published widely in those fields. He has a PhD in dermatological studies from Liverpool University. Following his PhD and post-doctoral work in the 1980s carried out in association with the Royal Liverpool Hospital, Prof White joined Squibb Pharmaceuticals as a section leader with responsibility for skin and wound healing. Then in the later 1980s he moved to ConvaTec and worked there in the development of wound dressings. Prof White left ConvaTec in 1999 and set up a consultancy. In 2004 he was a Senior Research Fellow in the Department of Tissue Viability at Aberdeen Royal Infirmary and in 2007 he took up his post at the University of Worcester. In the past 8 years Prof White has conducted consultancy work for Mölnlycke, Brightwake and Smith & Nephew.

12

Mölnlycke submitted that Prof White was clearly trying to help the court in his answers and was very knowledgeable about the clinical aspects of wound care however Mölnlycke submitted that care was needed with his direct evidence on infringement and validity. In relation to Brassington Mölnlycke submitted he had not read it with real care, particularly in relation to the way the word "coating" was used in the document. Prof. White distinguished between "coating" a substrate in which the silicone does not penetrate the surface and "encapsulation" when it does. He frankly admitted to an omission in that his definition could not apply to the examples and he agreed that the distinction needed revision. In my judgment the Professor was without doubt seeking to help the court and gave his evidence entirely fairly. However I have borne in mind that the elements of his written report which derive from the distinction he drew between "coating" and "encapsulation" required revision and cannot stand as they are.

13

Prof White's report exhibited a fairly extensive collection of wound dressings and materials which was extremely useful. The cross-examination showed that part of his report relating to the materials used to make Brightwake's product must have been prepared before he had been provided with a sample of one of Brightwake's starting materials (MBPU with acrylic backing and release liner). However this did not undermine Prof White about the materials he was referring to in the report.

14

Prof White had not reconsidered his opinion on infringement in relation to the older Brightwake products after he had seen Mr Fabo's evidence. He clearly understood that Brightwake's other expert Dr Meirowitz was going to address that issue (which did not in fact happen). Mölnlycke criticised Prof White for that. In my judgment although it was unfortunate, it did not undermine the Professor's evidence. It simply meant he had not addressed something.

15

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