Mölnlycke Health Care AB and Another v BSN Medical Ltd and Another
| Jurisdiction | England & Wales |
| Judge | THE HON MR JUSTICE FLOYD,Mr Justice Floyd |
| Judgment Date | 09 November 2012 |
| Neutral Citation | [2012] EWHC 3157 (Pat) |
| Court | Chancery Division (Patents Court) |
| Date | 09 November 2012 |
| Docket Number | Case No: HC09C03755 |
[2012] EWHC 3157 (Pat)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
Royal Courts of Justice
Rolls Building London EC4A1NL
The Hon Mr Justice Floyd
Case No: HC09C03755
Iain Purvis QC and Anna Edwards-Stuart (instructed by Charles Russell LLP) for the Claimants
Richard Meade QC and Tim Powell (solicitor advocate) (instructed by Powell Gilbert LLP) for the Defendants
Hearing dates: 12, 15, 16 & 18 October 2011
Approved Judgment
Introduction
By this action, the claimants, Mölnlycke Health Care AB and Mölnlycke Health Care Limited (together "Mölnlycke") sue the defendants BSN Medical Limited and BSN Medical GmbH (together "BSN") for infringement of European patent (UK) No 0 855 921. BSN denies infringement and maintains that the patent is invalid for lack of novelty, obviousness and insufficiency.
The patent relates and has claims to wound dressings, and to a method of making them. Only the product claims are in issue here. The BSN products accused of infringement are part of a range marketed by them under the brand name Cutimed Siltec.
Mr Iain Purvis QC argued Mölnlycke's case with Ms Anna Edwards-Stuart; Mr Richard Meade QC argued the case for BSN with Mr Tim Powell.
Expert Witnesses
Mölnlycke called two main expert witnesses, Mr Larry Bogart and Professor Stephen Clarson.
Mr Bogart joined Scott Paper Company in 1969 to work in process development for non-woven materials. In 1988 he went to work for Scott Healthcare, to work on the development of new wound care products and in particular wound dressings. His evidence goes primarily to the validity of the patent.
Professor Clarson is a Professor in the Department of Chemical and Materials Engineering at the University of Cincinnati in Cincinnati, Ohio. He holds a doctorate in chemistry from the University of York, and is a fellow of the Royal Society of Chemistry and a Member of the American Chemical Society. He is an expert on silicon and silicone chemistry. His evidence goes primarily to the issue of infringement.
BSN called two expert witnesses, Dr Andrew Reed and Professor Joseph Gardella.
Dr Reed obtained a doctorate in the area of polymers for use in medicine and surgery from the University of Liverpool. Since then he has held a variety of posts in industry developing polymers for bio-medical applications. By the priority date he had worked at the Imperial Chemical Industries PLC/ University of Liverpool Joint Laboratory, for Millipore Corporation, Mitral Medical, Matrix Medica and Polymedica Industries. He is currently president and chief executive officer of a consultancy company based in Florida, USA.
Professor Gardella is the John and Francis Larkin Professor of Chemistry at the State University of New York. He is an expert on surface analytical chemistry, in particular spectroscopic and microscopic analysis related to the characterisation of polymers, membranes, coatings and films. He obtained a PhD in analytical chemistry from the University of Pittsburgh in 1981. His evidence relates to the experiments carried out by both parties aimed at establishing the structure of the alleged infringing products.
I came to the conclusion that in giving their oral evidence all these principal experts were doing their best to be frank with, and to assist, the court. Mr Purvis criticised Dr Reed for some of the statements in his written reports, but I did not understand him to say that this affected the value of his oral evidence. I am satisfied that Dr Reed was not setting out to mislead the court. In any case Mr Purvis' attack was limited to very specific aspects of Dr Reed's report, which are better dealt with in the context in which they arise.
Other witnesses
Mölnlycke served a witness statement from Dr David Haberthür concerned with the carrying out of their x-ray tomography experiments. He was not cross-examined. In addition they called Dr Barbara Fayard and Mr Peter Löwenhielm. I gave permission, which in the end was unopposed, for these witnesses to give expert evidence about the experiments which they conducted. No real criticism was levelled at Dr Fayard's evidence about her tomography experiments. The experiments which Mr Löwenhielm conducted were more or less abandoned by Mölnlycke, so discussion of the value of his report and oral evidence is unnecessary.
The patent in suit
The patent in suit has a priority date of 14 th May 1996. The title of the specification of the patent is "Wound dressing and manufacturing method therefor".
The specification begins by describing the wound dressings disclosed in a prior European Patent Specification, and a further international patent application. It explains at [0002] that the wound dressing disclosed in the prior specifications has a layer of silicone gel on the skin-facing side, and that an advantage of such a layer is that it will adhere to dry skin, but not to the surface of a wound. Such gel layers are preferably perforated to enable excess fluid from the wound to be absorbed into an absorbent body placed on top of the gel layer. The perforation is obtained by supporting the layer on a carrier that includes a pattern of holes, such as a knitted textile material or a perforated plastic film (a gel carrier). The prior art discussed in this paragraph is said also to disclose the use of an absorbent layer in combination with such a gel layer (including its carrier).
A further international patent application, number WO-93/ 19710 is also referred to in this introductory paragraph. It is acknowledged as describing a three-component dressing having an absorbent body on top of such a gel layer (i.e. a perforated gel layer supported on a gel carrier) and a liquid-impermeable layer on top of the absorbent body.
The specification then explains at [0003] that:
"The object of the … invention is to provide a wound dressing … whose properties are as good as or better than the properties of the aforedescribed dressing which has a simpler construction which can be produced much more cheaply …"
The objects of the invention are said at [0004] to be achieved by having:
"a layer of absorbent foam material that includes a pattern of holes which open [on the skin-facing side], wherein the foam material is coated with a layer of hydrophobic gel which adheres to the skin, and wherein the walls of the holes in the foam material are coated with gel at those end parts of the walls which lie proximal to the wearer's skin when the dressing is used."
The specification explains that, because the foam material is used as the gel carrier, the dressing has a simpler construction and can be produced more easily. It continues:
"Even a thin gel layer will function as a spacer layer, because it covers an end part of the hole walls and therewith prevents contact between foam material and skin, which reduces material requirements and therewith the cost of the dressing".
There is said to be an additional advantage as well:
"because of its hydrophobicity, the spacer layer will prevent spontaneous reflux of the absorbed fluid to the skin or the wound."
I have quoted extensively from [0004] because an important issue of construction, and probably the most important issue in this case, is the meaning of the expression " the walls of the holes in [the] foam material are coated with gel at those end parts of the holes that lie proximal to the wearer's skin when the dressing is worn". These statements in [0004] explain in general terms why the gel needs to coat the end parts of the hole walls.
Two preferred embodiments are described. In the first, which is said to be intended for wounds from which fluid is exuded only slightly or in normal quantities, the holes of the hole pattern are comprised of pores in the foam material. In the second embodiment, said to be intended for wounds that exude fluid in normal to copious quantities, the holes are created in the foam material and are through-penetrating.
Still in the general part of the description at [0008], the specification gives values for the skin and adhesion force of the dressing, measured in Newtons. At [0010] it states that the thickness of the layer of gel, in the first embodiment, is 0.1 to 1.0 mm. This figure contrasts with a thickness of the total gel layer in the specific embodiment described, including the penetration into the pores of the foam material, of 0.2–2.0mm (see [0013]).
The specification then goes on to describe the specific embodiments in more detail by reference to figures. Figures 1 and 1A which contain an exploded partial view of the structure are reproduced below:
The dressing is thus comprised of an absorbent foam material (2) which has been coated with a gel layer (3) on the skin-facing side. The specification explains:
"As illustrated schematically in Figure 1A, the gel layer 3 is disposed so that even a part of the walls of the open cells or pores 4 in the foam material that open into the gel-coated side thereof are gel coated. Because the gel layer 3 does not close, but only covers, a part of the walls in an end portion of the pores of the foam material that face the wound, excess wound fluid can be drawn into the foam material 2 and absorbed thereby. The gel layer also forms a spacing layer which prevents the foam material from coming into direct contact with the wound or skin of the wearer."
Some of the pores may be blocked by the gel layer: the specification gives...
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