The common general knowledge
34.There were two issues of dispute between the parties about the common general knowledge. 35.The first I have already referred to: whether the skilled team would have been familiar with indwelling catheters. I have decided that the answer is yes because the claims cover indwelling catheters. However, since the parties did not address the scope of the claim in the sense of whether it covers indwelling catheters, I will also consider the evidence of what would have been known to a developer of intermittent catheters. 36.Two such developers gave evidence. Both Mr Torstensen and Ms Israelsson worked exclusively on intermittent catheters. Mr Torstensen thought that there may have been manufacturers who made both types of catheter, but he was not sure. I will assume that they were typical and that a developer of intermittent catheters in 1997 would have had no experience of developing indwelling catheters. 37.Mr Torstensen accepted that the two types of catheter are regulated differently and unlike intermittent catheters, insertion of the indwelling variety is carried out by healthcare professionals since the procedure is more invasive. He maintained that nonetheless the two types of catheter do much the same job and that information about indwelling catheters could be a source of information for a skilled person working on intermittent catheters. 38.Ms Israelsson said that the skilled person who was experienced in developing intermittent catheters would have been familiar with only the basic features of an indwelling catheter. She gave an example of an inflatable balloon which may be incorporated in an indwelling catheter. Ms Israelsson said that such a skilled person would not know the details of how to incorporate such a balloon. 39.Although there was a difference in emphasis, the evidence from the two experts was not far apart on this issue. A person skilled in intermittent catheters would probably have had no experience in developing indwelling catheters and possibly not much experience of them at all. But he or she would know what they are and, as part of the common general knowledge, know broadly their structure, function and how they are used. 40.The second and more important dispute was whether the skilled team would have been aware that there was a demand among users of intermittent catheters for an intermittent catheter with a pre-wetted hydrophilic layer. 41.In its argument on inventive step Coloplast laid heavy emphasis on the fact that over a decade passed from the introduction of the LoFric product in 1983 to Coloplast’s realisation, as it claimed, that such a product could be improved by allowing patients to use the catheter without the need to find an external source of clean water. That constituted a very long-felt want, Coloplast argued. 42.MacGregor’s response was that there was nothing new or inventive in September 1997 about the mere idea of a pre-wetted catheter. Patients had asked for it and the skilled team would have had that goal well in mind. The difficulty was that there were technical barriers in the way of achieving this result. Coloplast may have been the first to overcome such barriers leading to the launch of Coloplast’s SpeediCath. Coloplast may or may not be entitled to patent production for a solution to the practical problems and indeed Coloplast has been granted such protection. But the basic idea was still obvious. 43.I will develop these contentions in more detail below. I mention them now to emphasise the importance of a key part of MacGregor’s case: the skilled team knew well before September 1997, as part of its common general knowledge, that it would be a good idea to make a pre-wetted catheter if such a thing could be developed into a marketable product. 44.Ms Cahill said that there were three main problems with the existing hydrophilic intermittent catheters in September 1997. First, adding water was fiddly, especially for patients with limited manual dexterity. Second, some patients disliked waiting for 30 seconds for the coating to become fully hydrated. Third, filling catheter packages with water led to spending a long time in a toilet cubicle and this led to embarrassment. Ms Cahill went on to say in her expert report that in the years leading up to September 1997 she and her colleagues had repeatedly told the catheter manufacturers that patients wanted a catheter package with the right amount of water contained in the package or a catheter that required no preparation and which could be used as soon as the package was opened. 45.Mr Torstensen confirmed that user demand for a catheter packaged with water had reached Coloplast. He said that he had heard from users that they would like a catheter that contained water in the package or alternatively a catheter which was already wetted. It was put to him in cross-examination that he had provided no documents from catheter manufacturers confirming that a request along those lines had been made. That was true, but Mr Torstensen had been employed by Coloplast. He did not have had access to Coloplast’s records and there was no reason to believe that he had access to the records of other manufacturers either. 46.Ms Cahill said that among the manufacturers she approached before September 1997 with her request for a catheter package containing water was the market leader, Astra. Yet Ms Israelsson was clear that despite brainstorming sessions at Astra about how to provide a better hydrophilic catheter, this was not considered. I have no reason to doubt what either Ms Cahill or Ms Israelsson said about this. I reconcile their evidence by concluding that Ms Cahill and her colleagues did tell Astra, among other manufacturers, that patients would welcome a catheter package containing water but that at the brainstorming sessions referred to by Ms Israelsson it was not thought to be an idea worth following up. Astra was a commercial organisation and there may have been reasons why such an idea was not perceived by that company as having commercial potential. 47.It does not follow automatically from the evidence of Mr Torstensen and Ms Cahill that the idea of an intermittent catheter stored in water, or in a package otherwise containing water, had attained the status of common general knowledge among developers by September 1997. Documents recording their knowledge of such an idea were lacking. 48.There was disclosure from Coloplast. The only relevant document in this regard was an analysis dated February 1995 of focus groups consisting of users of the existing hydrophilic intermittent catheters and how they might be improved. In the executive summary there is a reference to: “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.” 49.This does not necessarily refer to the water being contained in the catheter package. In fact, under two lists of ‘Suggestions for Improvements’, taken from two separate meetings, the document refers to ‘Product without water’ and ‘Catheter without water’. These further lists suggested that the executive summary was referring to a dry catheter that would not require wetting before use. 50.However, there was evidence filed in other litigation which was made available in this trial. In about 2005 Coloplast brought proceedings in the Patents County Court against Hollister Limited for infringement of a different patent, European Patent (UK) 0 923 398 (“the PCC Action”). I was told that the action settled. Coloplast’s evidence in the PCC Action included an expert report of Mogens Svanum dated 15 September 2005, which was exhibited to the expert report of Mr Torstensen in these proceedings. In the mid-1990s Mr Svanum was the Manager of the Development Department for the Continence Care Division at Coloplast. He was in charge of the team that developed what became the SpeediCath. Mr Torstensen was part of the team. 51.I have mentioned Astra’s LoFric product, first sold in 1983. For many years it was the only hydrophilic coated urinary catheter on the market. Ten years later Coloplast launched a similar product called Conveen EasiCath, generally referred to in the evidence as the EasiCath. Mr Torstensen described this as being essentially a copy of the LoFric catheter. As with the LoFric product, the catheter was stored dry. The user opened the packaging, added water, waited for 30 seconds during with the hydrophilic coating was activated and then used the catheter. 52.In his report Mr Svanum discussed information received by his team at Coloplast regarding the EasiCath as part of the development of the SpeediCath product (essentially the product of the Patent): “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.” 53.It is apparent that by around June 1996 Coloplast had received feedback from the medical profession, clinical advisory boards, focus groups and end users. The results from this feedback were collated over a period of time. They indicated a demand for a kit which would have water with it. The documents recording these results were not disclosed by Coloplast in the present litigation. 54.The executive summary dated February 1995, which was disclosed, reflects only results from three focus groups organised in Denmark and Italy. There is no mention of results from the medical profession, clinical advisory boards, end users other than through focus groups or indeed other focus groups. The executive summary does not convey the key point identified by Mr Svanum, namely that in around 1995 and 1996 the main concern among end users was that they wanted a catheter kit with water and that this was known to Coloplast. 55.Mr Svanum’s evidence in the PCC action is entirely consistent with what Mr Torstensen said in the present action: it was common general knowledge among developers of intermittent catheters in September 1997 that there was a market demand for a catheter packaged with water so that the coating of the catheter was ready to insert. I accept that evidence.