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You are here: BAILII >> Databases >> Intellectual Property Enterprise Court >> Coloplast AS v Macgregor Healthcare Ltd [2018] EWHC 2797 (IPEC) (24 October 2018) URL: https://www.bailii.org/ew/cases/EWHC/IPEC/2018/2797.html Cite as: [2018] EWHC 2797 (IPEC) |
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BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY ENTERPRISE COURT
Fetter Lane, London, EC4A 1NL |
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B e f o r e :
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COLOPLAST A/S |
Claimant |
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- and - |
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MACGREGOR HEALTHCARE LIMITED |
Defendant |
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Thomas Mitcheson QC and Tim Austen (instructed by Wiggin LLP) for the Defendant
Hearing dates: 10-11 July 2018
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Crown Copyright ©
Judge Hacon :
Introduction
The Patent
1. 1.1 A urinary catheter assembly
1.2 comprising at least one urinary catheter,
1.3 the catheter having a catheter tube
1.4 coated on its external surface on a substantial part of its length from its distal end with a hydrophilic surface layer in the form of a hydrophilic coating
1.5 intended to produce a low-friction surface character of the catheter by treatment with a liquid swelling medium prior to use of the catheter
1.6 and a catheter package
1.7 made of a gas impermeable material formed by a multiple layer thermoplastic film material comprising aluminium,
1.8 the package having a cavity for accommodation of the catheter,
1.9 wherein the cavity accommodates said liquid swelling medium for provision of a ready-to-use catheter assembly.
3. 3.1 A urinary catheter assembly as claimed in claim 2 [which requires the whole of the catheter package to be made of gas impermeable material], characterized in that
3.2 the catheter package is formed from two sheets of the gas impermeable film material connected with each other by a gas impermeable joint
3.3 defining the cavity for accommodating the catheter and the liquid swelling medium.
5. 5.1 A urinary catheter assembly as claimed in claim 3 or 4, characterized in that
5.2 said joint is arranged [to] provide said cavity with a cross-section narrowly surrounding the catheter.
The issues
(1) Infringement, which turned on a point of construction.
(2) Novelty over either of two items of prior art:
(a) PCT Application no. WO 96/30277 ("Rødsten"), and
(b) PCT Application no. WO 97/26937 ("Israelsson").
(3) Inventive step over the prior art relied on for lack of novelty and one further citation:
(c) Japanese patent no. JP-A-55-012265 ("Shibatani")
(4) Insufficiency.
The person skilled in the art
"those likely to have a practical interest in the subject matter of [the] invention",
such individuals being
"persons with practical knowledge and experience of the kind of work in which the invention was intended to be used"
per Lord Diplock in Catnic Components Ltd v Hill & Smith Ltd [1982] R.P.C. 183, at p.242-3.
"Urinary catheters of the kind to which the invention pertains are known, inter alia from [14 identified items of prior art]."
It was not suggested by Coloplast that all 14 disclosed only intermittent catheters. If they do not, this would severely undermine the contention that the scope of claims 1, 3 and 5 is limited to intermittent catheters.
"[0004] An important feature of any urinary catheter used for intermittent catheterisation of the bladder of an incontinent user is the ability of the catheter to slide easily through the urethra without exposing the urethral walls to any risk of damage. Catheters of the kind to which the inventions pertains [sic] have been developed to meet this need by imparting an extremely low friction character to at least part of the surface of the catheter which is actually introduced into the urethra. …"
"[0006] When catheters of this kind are used directly by end users outside the medical environment of a hospital or a clinic, e.g. by or [sic] tetraplegic patients who often have a very poor dexterity, and therefore need a very simple insertion procedure, the most common liquid swelling medium used for preparation of the catheter immediately prior to use would be normal tap water."
"[0008] On this background, it is the object of the invention to improve and facilitate the performance of the intermittent urinary catheterisation in any type of environment by providing a ready to use urinary catheter assembly comprising a catheter which can be withdrawn from its package and is prepared for direct insertion in the urethra and in a substantially sterile condition, whereby the general quality of life for users of intermittent catheterisation would be greatly improved."
The witnesses
The common general knowledge
"A 'ready for use' catheter. It is recommended to make a catheter with the same low friction as the existing one, but make it ready for use as soon as the catheter bag is opened."
"31. Feedback continued to be received from the medical profession, our clinical advisory boards, focus groups, and end users and the results collated over a period of time. What emerged from these results was that whilst the EasiCath was generally well received and accepted, there were a number of practical issues that were significant concerns to end users. One of the main concerns was the need for water to activate the hydrophilic coating of the catheter. Water can be messy but a greater difficulty arises when the end user is away from home or travelling. In such circumstances the end user had not only to rely upon facilities with water being available, but also facilities that are accessible and reasonably hygienic. Importantly, even if water was available it needed to be of a satisfactory quality to avoid risk of infection.
…
33. Further, many end users also have poor manual dexterity and filling the catheter bag through a narrow opening proved difficult. Those difficulties were made worse when outside of the normal environment, for example trying to get the open end of a long package under a tap to fill it. There were also difficulties with connecting the catheter to a collecting bag when no toilet was available. Users reported that they wanted an easier system, a set or kit that would have the necessary water with it, but that was also hygienic and maintained sterility.
…
39. In June of 1996 whilst work was progressing on the New Conveen EasiCath product we received a request from Coloplast's Italian and German subsidiaries that we develop and produce a kit or set type product which would have water with it to activate the catheter coating, so that the user would no longer be dependent upon locating facilities or be concerned with their adequacy. This would be of particular benefit amongst other things when travelling, allowing the user a much greater degree of freedom.
40. We considered this request and realised that a product of this type was potentially viable as there was already some demand."
Disclosure in the IPEC
Construction
The law
The parties' statements of case on construction
"The liquid swelling medium is not in contact with the catheter immediately following manufacture of the assembly, but is put into contact with the catheter by the eventual user of the catheter assembly. In the context of claim 1 of the Patent, 'prior to use' therefore means 'immediately prior to use'.
"Claim 1 does not require that the liquid swelling medium is accommodated in a compartment separate from that of the catheter. It may be stored within the cavity of the catheter package in any manner separate from the catheter itself."
"Within the meaning of the terms used in the claim, the liquid swelling medium and the catheter are introduced into the cavity of the catheter package made of gas impermeable material by the manufacturer during manufacture. The liquid swelling medium may not be in a closed and separate compartment having walls of a gas impermeable material but may be in a storage element or separate compartment which is liquid or vapour permeable."
The description of the invention in the Patent
"[0011] In a first series of embodiments of the urinary catheter assembly of the invention the catheter package as a whole is made of a gas impermeable material and the compartment for the liquid swelling medium is in liquid flow communication with the cavity for accommodation with the catheter."
…
"[0013] The compartment for the liquid swelling medium is entirely integrated with the cavity for the catheter, whereby the hydrophilic surface layer of the catheter will be activated immediately after completion of the production process, when the swelling medium has been introduced into the package. The gas-impermeable walls of the package will then product the activated coating from drying out and provide a long time preservation of the low friction surface characteristic of the catheter until the moment of actual use."
"[0017] In the following, the invention will be explained in more detail by means of various embodiments illustrated in the accompanying drawings …"
There follow references to figures 1 to 3. There is also reference to figures 4 to 6 which, a little confusingly, are said not to form part of the invention, and to figures 12 and 13. There are no other figures in the Patent as granted. The skilled reader would assume that there had been substantial editing of the specification during prosecution, which may be an explanation for an occasional lack of clarity.
"[0018] In the embodiments shown in figs. 1 and 2 the urinary catheter assembly of the invention is intended for intermittent catheterisation of the bladder of a user and comprises a urinary catheter 1 having a catheter tube 2 with cross-sectional and longitudinal dimensions suitable for introduction of the catheter through the urethra."
"[0023] In order to maintain the swelling medium in liquid state until the actual preparation of the catheter the liquid swelling medium is confined in the embodiment shown in a storage body 14 which as described above may be of a spongy or gel-like material located in the compartment or end section 12."
"[0029] Due to the gas-impermeability of the package 7 it is not necessary to use a body 14 of spongy material to accommodate the liquid swelling medium. The swelling medium may be introduced in the package during the assembling operation prior to completion of the welding and will thereby immediately prepare the hydrophilic coating. The package will itself prevent the coating from drying out and preserve the low friction character of the surface coating to keep the catheter in a ready to use condition at all times. This would have the inherent advantage that no preparation step is required immediately prior to use, whereby the operation will be reduced to opening of the package 7 for immediate withdrawal of the catheter without the delay resulting from the required preparation period.
[0030] Since the preparation period is very short and the possible presence of surplus swelling liquid in the package may be uncomfortable to the user who in many situations will have to carry one or more catheter assemblies with him or her, it would frequently be preferred, however, to keep the swelling medium confined in the spongy body 14 until the moment of actual use."
Claim 1
[a hydrophilic coating] intended to produce a low-friction surface character of the catheter by treatment with a liquid swelling medium prior to use of the catheter
"[0010] The term 'gas impermeable' material should be understood in this context to mean any material that will be sufficiently tight against diffusion by evaporation of the actual liquid swelling medium for a period exceeding the recommended shelf life time of the catheter assembly which could be up to five years, typically 36 months."
Infringement
Novelty
The law
"To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 RPC 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 RPC 1 at 24, line 1. A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentees."
Rødsten
"The method and the applicator according to the invention is not restricted to use in connection with a catheter of the kind which requires moistening prior to the application, but may to the same extent be used with a catheter with is packed in a ready-for-insertion state."
Israelsson
"In the exemplary embodiments hereinabove described with reference to the Figures of drawings the supply of wetting fluid for wetting of the hydrophilic urinary catheter takes the form of a separate sachet integrated into the wetting receptacle. It will be appreciated by those versed in the art that the supply could also take the form of an integrally formed chamber in the material of the wetting receptacle without departing from the spirit if the invention."
Conclusion on novelty
Inventive step
Rødsten
Primary evidence
Secondary evidence
Israelsson
Shibatani
Claims 3 and 5
Insufficiency
The law
The evidence
"38. The hydrophilic coating we then used for the EasiCath was not suitable as it could not be kept in a wetted condition for long and certainly not for the proposed shelf life of the new product. A new hydrophilic coating would be needed which would be a major development and which would take some time. A new catheter would also be required as PVC swells when immersed in water for any length of time. The product would need a shelf life of 3 years. As an initial step Coloplast's Research Centre had been instructed to start research and to begin work on developing a new hydrophilic coating."
"No, I do not think so, but I cannot be sure. I do not know. It could be others."
Conclusion