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You are here: BAILII >> Databases >> England and Wales Court of Appeal (Civil Division) Decisions >> Molylycke Health Care v Brightwake [2012] EWCA Civ 602 (24 April 2012) URL: http://www.bailii.org/ew/cases/EWCA/Civ/2012/602.html Cite as: [2012] EWCA Civ 602 |
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ON APPEAL FROM CHANCERY DIVISION
HIS HONOUR JUDGE BIRSS QC
Strand, London, WC2A 2LL |
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B e f o r e :
LORD JUSTICE ETHERTON
and
LORD JUSTICE LEWISON
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MOLYLYCKE HEALTH CARE |
Appellant |
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- and - |
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BRIGHTWAKE |
Respondent |
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WordWave International Limited
A Merrill Communications Company
165 Fleet Street, London EC4A 2DY
Tel No: 020 7404 1400 Fax No : 020 7831 8838
Official Shorthand Writers to the Court)
The Respondent did not appear and was not represented.
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Crown Copyright ©
Lord Justice Lewison:
"A method and an arrangement for manufacturing wound dressings, and a wound dressing manufactured in accordance with the method."
Its priority date is the 30 March 1992. Although the patent claims both a process and a product, we are concerned only with one of the product claims, claim 6. Claim 6 divided into suitable integers and without the reference numbers is in the following terms:
"i) A wound dressing comprising
ii) a perforated carrier material and
iii) a layer of hydrophobic silicone gel which lies against the wound surface when the dressing is worn,
iv) characterized in that
v) the carrier material is impervious to air and fluid, or only slightly permeable to air and fluid in the parts thereof lying between the perforations;
and in that
vi) the carrier material is coated with silicone gel on only one side thereof."
"The present invention relates to a method and to an arrangement of apparatus for manufacturing wound dressings of the kind which comprise a perforated carrier material and a layer of hydrophobic silicone gel which lies against the wound or sore when the dressing is worn. The invention also relates to a wound dressing manufactured in accordance with the inventive method."
"In order to prevent the silicone mixture from being blown from the carrier material, it is essential that the carrier material is impervious to air, or at least so impervious that essentially all air will flow through the perforations. However, material which permits air to diffuse therethrough can be used beneficially when practicing the invention. The carrier material shall also be impervious to fluid, or at least have a fluid-permeability which is so low that the thick-viscous fluid, i.e. the silicone mixture prior to curing, is unable to run therethrough."
"Thus the carrier material needs to be sufficiently impervious to air such that when the air is being blown on the underside, the air flow will be through the perforations rather than through the carrier material itself. However the carrier material can be "breathable" – i.e. allow air to diffuse through to the wound when in use. The material also has to be sufficiently impermeable to fluid that the uncured or partially cured silicone mixture does not just run through."
"That side of the carrier material which is not coated with silicone gel will preferably have a uniform and smooth surface, so as to have low adherence to any dried wound fluid which may have exuded through the perforations as the dressing is worn. This is particularly important when the dressing is used together with an overlying absorbent body or pad, since it must be possible to remove the absorbent body without the dressing being disturbed as a result of wound fluid that has dried on the absorbent body adhering to the carrier material and entraining the material in the initial stages of removing the absorbent body."
"One of the points being made here is that because the outside of the carrier material is not coated with silicone gel, it needs to have a uniform and smooth surface in order to give it a low adherence to exudate coming through the perforations so that an absorbent pad placed on top can be readily removed."
"This invention thus provides a simple and effective method of manufacturing a wound dressing having a layer of hydrophobic silicone gel which is intended to lie against the wound or sore, and a layer of carrier material which when the dressing is worn faces outwardly and which is not sticky and will not adhere to clothing and the like. As in the case of the aforesaid known dressing, the layer of hydrophobic silicone gel which lies against the wound or sore is soft and adheres to dry skin, and the inventive dressing will therewith facilitate healing of the wound in the same beneficial fashion as the known dressing. According to the present invention, the silicone gel is comprised of chemically cross-linked, two-component addition-curing silicone gel."
"Weighing up these factors, I am reminded that the words of the claim are paramount. I do not accept that this patent should be construed in such a way that a concept which is not mentioned in the claim (tackiness) should be read in as if it were. In my judgment the skilled reader would understand that the patentee had used the term 'silicone gel' to refer to the material itself. The skilled reader would understand that the patentee had not intended to import into the claim any particular level of tackiness or adherence to dry skin."
"A wound dressing comprises, in one embodiment, a layer of apertured material, such as a cotton gauze, coated with a tacky silicone gel or a non-tacky silicone elastomer. In an alternative embodiment, the dressing has a tacky silicone gel on one surface and a non-tacky silicone elastomer on the other surface. The gel and elastomer may be formed by crosslinking a mixture of a vinyl-substituted poly (dimethylsiloxane) and a hydride-containing poly (dimethylsiloxane)."
"Example 1 involves cotton fabric 'coated on both surfaces' with a silicon mixture. When cured 'the resultant gel was tacky to touch but remained firmly attached to the gauze'. Example 1 is proposed to replace tulle grasse. Example 2 coats the same fabric in the same way but with a mixture in different proportions. Once cured the 'gel would dry and non-tacky to the touch' and 'admirably suited to be used in place of a conventional non-adherent dressing'. Example 3 involves the same gauze as example 1. It is coated on one surface with the silicone mix of example 2 and after curing the other surface is coated with a silicone mix of example 1. After curing the dressing had one tacky and one non tacky surface."
"The apertured material which forms the substrate for the silicone coating may, if desired, be an apertured plastics film. Alternatively, it may, for example, be a woven or non-woven or knitted mesh, such as a cotton gauze. The effectiveness with which silicone elastomers can encapsulate the fibres of a fabric means that low quality, inexpensive fabrics may be used without sacrificing the quality of the resultant dressing. Moreover, the effectiveness of encapsulation by silicone elastomers means that the apertured material may be printed or dyed with decorative or informative matter with little danger of the ink or dye being released into the wound to which the dressing is applied."
"The document as a whole always contemplates coating both sides of the wound dressing with silicone. This can be seen very clearly in all the examples and also from the passage from col 5 line 62 to col 6 line 26. Nowhere does Brassington state on terms that the non-wound contacting face of the dressing need not be coated with silicone."
"A skilled reader would see that in terms of what Brassington teaches them to do, all three general kinds of coating which are disclosed -- tacky both sides, non-tacky both sides and tacky/non-tacky on opposite sides -- are equally applicable to a substrate of apertured plastics film as they are to the alternatives such as gauze. In my judgment a two-sided tacky/non-tacky wound dressing in which the substrate is an aperture plastic film is disclosed by Brassington."
"The thrust of this aspect of Brassington's disclosure is to employ tacky silicone gels on one side and non-tacky materials on the other side. In my judgment Brassington can be regarded as disclosing a continuum of non-tacky silicones ranging from gels to more cross-linked silicone elastomers, which Brassington calls silicone rubbers and which are not gels on any view. Although the skilled person would not be aware of claim 6 of course, in fact the tacky gel on the wound contact side would be a "silicone gel" in claim 6 while a more cross-linked non-tacky silicone rubber would not be a silicone gel as referred to in claim 6. However bearing in mind Dr Reddy's v Eli Lilly (above) in my judgment an individualised disclosure of a combination of plastic film as the substrate, tacky silicone gel on the wound side and non-tacky silicone rubber (and not gel) on the other side is not in Brassington."
"In summary, Brassington discloses a wound dressing with features (i), (ii) and (iii) of claim 6. The relevant wound dressing is one with an apertured plastics film carrier material, tacky silicone gel on the wound contacting side and non-tacky silicone on the other. Features (iv) and (v) are not disclosed in combination with the others and thus claim 6 is novel."
Thus the judge concluded that Brassington did not anticipate the patent.
"(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;
(4) 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?"
"Starting from Brassington and taking the step of coating with silicone on only one side is the kind of step which looks obvious in retrospect. However in my judgment it was not obvious, viewed without hindsight. It is not contemplated in the document itself and does not form part of the common general knowledge. The silicone coated wound dressing in the common general knowledge in 1992 (Silicone N-A) was coated on both sides. Coating on one side only is a simple step to take but that is entirely different from saying it was an obvious step to take."
"Apertured plastics films were used in wound dressings already and formed part of the common general knowledge (e.g. Melolin). Plastics films without apertures were also used in wound dressings already as part of the common general knowledge (e.g. OPSITE). Brassington expressly mentioned dressings with plastic wound contacting layers at col 2 line 58. It is perfectly true that examples 1 to 3 use cotton fabric/gauze, and gauze is mentioned elsewhere too but the skilled reader would see the relevant part of the document as a clear teaching about the kind of materials which can be used as the substrate for the wound dressing described. It would be understood to be equally applicable to all of the three arrangements of silicone described in Brassington – tacky silicone gel on both sides, non-tacky silicone on both sides, and tacky/non tacky on opposite sides."
"What kind of silicone would be used on the outside of the dressing? Brassington expressly gives the skilled reader a solid motivation to coat only the wound facing side with tacky silicone gel and put non-tacky silicone on the outside (col 6 lines 2-7)."
"In my judgment employing a silicone rubber as the non-tacky silicone in the tacky/non-tacky dressing would be entirely obvious. It is really no more than putting the relevant part of Brassington into practice. Such a silicone would not be a silicone gel within claim 6. I do not doubt that another obvious way forward over Brassington would be to use a non-tacky silicone gel, after all Brassington says as much as well. However that does not detract from the obviousness of employing a silicone rubber for the non-tacky component.
Accordingly in my judgment it would be obvious for a skilled team to propose making a wound dressing with tacky silicone gel on the wound side, a different non-tacky silicone on the outer face which would not be a silicone gel and a carrier material made of an apertured plastic film like polyurethane. This proposed product would satisfy claim 6. This is akin to a finding that such a product would be "obvious to try" in the sense of being obvious to try to make and so two further factors need to be considered. First would there be sufficient doubt that such a product could be made to put off a skilled team from even trying and secondly, even if they thought it was worth making, would the skilled team in fact succeed without invention?"
"69. I have been asked whether the skilled person seeking to put Brassington into practice would attach importance to the fact that in the examples, silicone is applied to both sides of the dressing and in particular whether it would be technically obvious to him/her that a dressing could be made and used which had silicone applied to only one side. There is no obvious clinical reason for the skilled person to coat a dressing with silicone on both sides, particularly a multi-layer dressing. The skilled person would appreciate that what is important is the character of the wound contact surface of the dressing. Indeed, Brassington opens with the statement 'This invention relates to dressings such as wound dressings, and more particularly to dressings having a crosslinked silicone coating on a skin-contacting surface thereof'. The skilled person would understand that the use of non-tacky silicone on the non-wound contact surface in examples 2 and 3 may reduce adherence to clothing or bed linen, but he would not consider this necessary.
70. As for example 1, the benefit of having tacky silicone on both sides is nothing more than a convenience of having a dressing that is not 'sided' and so cannot be applied the wrong way up.
71. In circumstances where the substrate is a plastic film, it would strike me as wasteful and pointless to coat the reversed side of the dressing with non-tacky silicone."
"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. It would in my view be wrong to treat Benmax as authorising or requiring an appellate court to undertake a de novo evaluation of the facts in all cases in which no question of the credibility of witnesses is involved. Where the application of a legal standard such as negligence or obviousness involves no question of principle but is simply a matter of degree, an appellate court should be very cautious in differing from the judge's evaluation."
"The primary evidence will be that of properly qualified expert witnesses who will say whether or not in their opinions the relevant step would have been obvious to a skilled man having regard to the state of the art. All other evidence is secondary to that primary evidence."
Lord Justice Etherton:
Lord Justice Ward:
Order: Appeal allowed