The Patent
expired in September 2017. No injunction is therefore in issue but Coloplast seeks damages for infringement before the date of expiry. As part of its defence MacGregor counterclaims for a declaration that the Patent was invalid. 3.Stuart Baran appeared for Coloplast, Thomas Mitcheson QC and Tim Austen for MacGregor. The Patent 4.Urinary catheters were well known at the filing date, 18 September 1997. The Patent claimed two earlier priority dates but these were not relied on by Coloplast. 5.Catheters are inserted into the patient’s urethra to assist in the emptying of the bladder. An important feature is its ability to slide as easily as is possible through the urethra giving minimum discomfort and without damaging the urethra walls. It was known to coat the relevant part of the catheter with a hydrophilic surface layer. Immediately prior to use this layer was exposed to what the Patent calls ‘a liquid swelling medium’, causing the layer to expand and impart a very slippery character to the catheter and thus facilitate insertion. Typically the liquid swelling medium is water. For brevity I will hereafter refer just to water, save in the case of one item of prior art in which the liquid swelling medium is a drug solution. 6.Urinary catheters were divided into two relevant types. The first, indwelling catheters, consists of catheters which remain in the urethra for a prolonged period, possibly some weeks. They are used for patients who are infirm or who are undergoing either surgery or other lengthy treatment in hospital. They are administered by nursing staff and require a means to fasten the catheter securely in place for the period required. 7.The second type are ‘intermittent catheters’. These are used for a one-off insertion to empty the bladder, generally several times a day, after which they are removed and very often discarded without reuse. Intermittent catheters are usually administered by the patient themselves at home or elsewhere outside a hospital. Ease of insertion and removal is therefore of particular importance for intermittent catheters. 8.The specification points out that a user may find it difficult to find a source of water of a sufficiently aseptic standard to activate the hydrophilic coating. The solution is to store the catheter in packaging along with sterile water. 9.The packaging of the assembly is ‘gas-impermeable’ which, as the Patent explains, means that it should prevent evaporation of the water for a period exceeding the shelf life of the catheter assembly. 10.Claims 1, 3 and 5 were in issue. I set them out here without reference numerals and with the elements of the claims numbered in the manner used by the parties:
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.