Construction
The law 70.The law on construction and the scope of claims set out by the Supreme Court in Actavis UK Ltd v Eli Lilly Co [2017] UKSC 48; [2017] RPC 21 was recently considered and further explained by the Court of Appeal in Icescape Ltd v Ice-World International BV [2018] EWCA Civ 2219. 71.Icescape was handed down after the trial but that creates no difficulty because Coloplast did not run a case on equivalents. Counsel on both sides were content to argue construction on the basis that I should construe the claims according to the principles which applied before Actavis. I am not sure that the first stage referred to by Lord Neuberger (see Actavis at [54]), as explained in Icescape, is an approach exactly the same as construction of a claim according to the principles set out in Kirin-Amgen v Hoechst Marion Roussel Ltd [2005] RPC 9. In any event, I will construe each claim according to what the person skilled in the art, reading the claim in the context of the specification as a whole, would have understood the patentee to be using the language of the claim to mean.
The parties’ statements of case on construction 72.The main issue between the parties on construction concerned two potential embodiments of the invention claimed in the Patent. In the first, the water is introduced into contact with the catheter during manufacture of the assembly. The hydrophilic catheter is thus stored in a wet and activated form. I will call this the ‘ready-wetted’ configuration. 73.In the second embodiment, the catheter is dry until activated by the user squeezing the sponge. There could be means of storing the water other than in a sponge, but counsel spoke mostly of the sponge means. The water thus activates the hydrophilic layer just before the catheter is used. I will call this the ‘user-activated’ configuration. I will refer to both collectively as ‘water-stored catheters’. 74.At the CMC the parties agreed to exchange statements of case on construction, which proved to be helpful. 75.MacGregor’s statement said: “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’. 76.It also said: “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.” 77.In other words, claim 1 is confined to the user-activated configuration. 78.Coloplast’s statement on construction said: “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.” 79.Although this was not as clear as it might have been, Dr Baran stated that Coloplast’s construction of claim 1 encompassed both the ready-wetted and user-activated configurations. In the latter case, although the water would be stored separately there could be no liquid or vapour impermeable barrier between the water and the catheter.
The description of the invention in the Patent 80.I begin with paragraphs [0011] and [0013]: “[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.” 81.Whatever other embodiments there may be, these paragraphs leave no doubt (subject to the wording of the claims) that the invention is intended to encompass the readywetted configuration. 82.The specification continues with a more detailed description of this ‘first series of embodiments’. Paragraph [0017] states: “[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. 83.Paragraph [0018] states: “[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.” 84.Figures 1 and 2 look like this:
85.Paragraph [0023] is part of the commentary on figures 1 and 2: “[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.” 86.Mr Mitcheson submitted that the reader would assume that paragraph [0018] was moving on from the ‘first series of embodiments’ of paragraph [0011] to a new set of embodiments. I agree. Figure 1 as explained, particularly bearing in mind the word ‘confined’ in paragraph [0023], does not seem to illustrate the ready-wetted configuration. 87.But I do not see that this supports MacGregor’s construction. The specification continues by making it clear that the ready-wetted configuration as well as the useractivated configuration is intended to fall within the scope of the invention claimed: “[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.” 88.I therefore take the view that the description indicates to the reader that the invention covers both the ready-wetted and user-activated embodiments. This must be subject to the words of claim 1.
Claim 1 89.In MacGregor’s skeleton and statement on construction, an argument relating to claim 1 itself was raised. Integer 1.5 was relied on:
[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 90.MacGregor’s statement on construction (in a passage not quoted above) implied that the ‘intention to produce’ requires such an intention on the part of the user of the catheter. Therefore the claim could only cover the user-activated embodiment. I disagree. I take the view that the invention does not include a subjective element and I construe this part of the claim to mean that the coating must be suitable for producing a low-friction surface. 91.MacGregor’s argument continued: a natural reading of ‘treatment with a liquid swelling medium prior to use of the catheter’ meant immediately prior to use. It did not mean during manufacture, which could be years prior to use. 92.Again, I disagree. If there is any ambiguity in the meaning of ‘prior to use of the catheter’ in claim 1, the body of the specification clears it up: it could be during manufacture of the assembly. 93.I accept Coloplast’s contention that claim 1 covers both embodiments. 94.Coloplast went further, arguing that claim 1 did not cover embodiments in which the water was in a completely closed and separate compartment made of thermoplastic film containing aluminium – what Dr Baran called the ‘ampoule embodiment’. 95.Paragraph [0022] refers to the water being accommodated in a ‘compartment’, but paragraph [0021] identifies the compartment to be a widened end section of the cavity containing the catheter. The cavity is created and defined by the part-aluminium thermoplastic film surrounding it. This is confirmed by figures 1 and 2 to which paragraphs [0021] and [0022] refer. 96.Figures 1 and 2 do not show any barrier separating the compartment accommodating the water from the cavity storing the catheter. Paragraph [0025] indicates that when the spongy body is squeezed, the water is allowed to flow freely into the cavity. 97.Claim 1 expressly states that the same cavity accommodates both the catheter and the water. If the water were contained in an ampoule made of gas impermeable material, on a straightforward reading of claim 1 the water would not be in the same cavity as the catheter. I therefore agree with the further part of Coloplast’s construction: that the water may not be contained in a part-aluminium thermoplastic film. It follows that the user-activated configuration of the invention does not encompass the ampoule embodiment. Nor, therefore, is the ampoule embodiment included within the term ‘water-stored catheter’ as I have defined it above. 98.There was one further issue of construction, relevant to MacGregor’s case on insufficiency. The claims do not expressly state that the catheter assembly must be suitable for storing the catheter for any stated period of time. However, the gas impermeable material used is defined in the specification: “[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.” 99.In my view, the skilled team would construe the claims to cover assemblies suitable for accommodating a catheter for up to five years.