Case No. IP-2017-000132

on novelty 120.Claim 1 is not anticipated by either Rødsten or Israelsson. Consequently neither are claims 3 and 5. Inventive step Rødsten Primary evidence121.The features of claim 1 of the Patent missing from Rødsten were the ideas of a waterstored catheter and a package made of a thermoplastic film comprising aluminium. 122.I have found that the notion of a ready-wetted catheter was part of the common general knowledge. Ms Israelsson said that if this were the case, the disclosure in Rødsten would lead the reader to think that it was referring to a ready-wetted catheter. Mr Torstensen stated that the reader would believe this even without assuming such common general knowledge. I was not able to accept that evidence for reasons I have explained, but what Mr Torstensen said is consistent with Ms Israelsson’s position once such common general knowledge is assumed. 123.Both experts indicated that if the skilled team had the idea of a ready-wetted catheter, thermoplastic film comprising aluminium was a known and obvious material to use for packaging the catheter. 124.On the primary evidence alone claim 1 is obvious over Rødsten. Secondary evidence125.Coloplast laid great emphasis on long felt want and commercial success. Taking first the question of long-felt want, it is important that the want must be for the invention as claimed, the invention having been made possible by the inventive concept. In the present case, as Dr Baran asserted, the alleged inventive concept was the idea (no more) of a water-stored catheter, one embodiment of which was a ready-wetted catheter. He then added that the inventive concept also included the idea of thermoplastic film comprising aluminium to be used for packaging the catheter. The latter adds nothing since such material was shown on the evidence to be a known and obvious material to use if, as would be the case, it was necessary to prevent evaporation of the water. 126.I have found that the key idea of a ready-wetted catheter was part of the common general knowledge. There can have been no long-felt want for an invention made possible by only that concept. 127.The lack of a water-stored catheter on the market until the development of the SpeediCath could be explained by reasons other than a water-stored catheter being outside the obvious contemplation of the skilled team. The most likely candidate in the present case was the inability on the part of the manufacturers to come up with a commercially viable product until Coloplast managed it. But the fact that the inventive concept was known at the priority date is by itself fatal to Coloplast’s argument of longfelt want. 128.In the absence of a long-felt want, Coloplast’s evidence of commercial success can add nothing to its case on inventive step. 129.Claim 1 lacks inventive step over Rødsten. Israelsson 130.The difference between Israelsson and the invention of the Patent is that although Israelsson discloses a kit with water, it discloses neither a ready-wetted catheter nor a user-activated catheter, the latter defined above to exclude the ampoule embodiment. In Israelsson water is stored with the catheter but in a separate sachet. 131.Mr Torstensen’s evidence was that if the skilled team had the idea of a ready-wetted catheter, the invention of claim 1 would be obvious over Israelsson. It would be obvious to store the water with the catheter rather than in a separate sachet. I did not understand Mr Baran to challenge this. The main distinction relied on by Ms Israelsson, namely that the invention of the Patent required the catheter and the water to be stored in the same cavity, ceases to be a meaningful distinction if the idea of a ready-wetted catheter is part of the common general knowledge. 132.Thus, according to both experts it was obvious to package a catheter containing sterile water with gas impermeable packaging such as a thermoplastic film containing aluminium. 133.Claim 1 lacks inventive step over Israelsson. Shibatani 134.Shibatani is a Japanese patent which discloses a drug-delivery device using a catheter. The catheter is an indwelling catheter with a hydrophilic layer. The catheter is stored in contact with the drug in a sterile casing. Two embodiments are described. In both it is stated that the hydrophilic resin coating layer of the catheter is held in the drug for some days and so that the catheter could be used immediately to administer the drug. The specification states that the catheter has shown best results when applied as a urinary catheter. 135.Coloplast’s primary position was that Shibatani would have been of no interest to the skilled team because it concerned an indwelling catheter used for a purpose quite different from that of an intermittent urinary catheter. I do not accept that. I have found that claim 1 covers an indwelling urinary catheter. Therefore the skilled team would include a developer interested in improvements to indwelling catheters. Even if the skilled team did not contain such a developer and were interested only in intermittent catheters, to the extent that the structure and function of the two types of catheter overlap, new information about indwelling catheters in the area of overlap would have been of interest to a skilled developer of intermittent catheters. It would have been perverse to ignore such information. This would include a means of providing a lowfriction catheter with the minimum of fuss from the user’s point of view. 136.Given my finding that that the idea of a ready-wetted catheter was part of the common general knowledge and that it was common ground that the LoFric and EasiCath products were also part of the common general knowledge, the argument on inventive step in respect of Shibatani becomes somewhat artificial. However, with that common general knowledge, claim 1 is also obvious over Shibatani. Claims 3 and 5 137.Little was said about claims 3 and 5. It is enough for me to consider them in relation to Rødsten. The further features of claim 3 over claim 1 were that (a) the catheter as a whole is made of a gas impermeable material and (b) the package is formed from two sheets of the material connected by a gas impermeable joint. Mr Torstensen said that Rødsten discloses the first of these and that the second is inevitable if aluminium-plastic laminates are used to make the package. He was not challenged on this. Ms Israelsson said nothing in her report about claim 3 being inventive over claim 1. 138. Coloplast did not allege that there was anything separately inventive in claim 5 139. Claims 3 and 5 lack inventive step over Rødsten. Insufficiency 140.As I have said, MacGregor’s answer to Coloplast’s case on long-felt want was that the idea of a water-stored catheter was known, yet implementing the idea to make a marketable product was not possible until technical difficulties had been resolved. This feeds into MacGregor’s argument on insufficiency. MacGregor argued that the Patent explained the known idea of a water-stored catheter but did not inform the reader how to make such a thing – how to overcome the technical difficulties. 141.During the trial a variation on the theme began to emerge, a case on what is sometimes called Biogen insufficiency, i.e. an alleged failure to disclose the invention sufficiently across the breath of the claim. It was not pursued by Mr Mitcheson in closing. If ever there was an intention to plead Biogen insufficiency, in my view that allegation did not emerge with adequate clarity in the Amended Grounds of Invalidity. The law 142.It was common ground between Mr Mitcheson and Dr Baran that s.72(1)(c) of the Patents Act 1977 does not require that the specification enables the skilled person to make a commercially marketable embodiment of the invention. In Mentor Corp v Hollister Inc [1993] RPC 7, the Court of Appeal discussed insufficiency on the assumption that producing a workable prototype would be enough (at p.17). Whether in the form of a prototype or otherwise, if the Patent enables the skilled person, using his common general knowledge and without undue burden, to make or otherwise obtain a product as claimed or carry out a process as claimed, the subsection is satisfied (see Eli Lilly & Co v Human Genome Sciences Inc [2008] EWHC 1903 (Pat) at [239], the ruling on insufficiency approved by the Supreme Court at [2011] UKSC 51; [2012] RPC 6, at [132]-[139].) When discussing undue burden in Eli Lilly, the Supreme Court approved the frequently used distinction between a research programme and routine trials (at [132]). The evidence 143.Mr Torstensen said in his report that if a skilled person had tried to make a ready-wetted catheter at the filing date he or she would have discovered that it could not be done with the hydrophilic coatings known at the time. Mr Torstensen referred to experiments done by Coloplast mimicking the effect of leaving the catheter in water for one to two years. I have found that the claims require that the assembly be suitable for storing the catheter for up to five years, but there was no reason to believe that this made any difference. 144.The problems that emerged from these experiments were an unpleasant smell, a change of catheter colour, loss of flexibility in the PVC catheter and the hydrophilic coating becoming detached from the catheter. Mr Torstensen said that it was apparent to the team that a catheter packaged in water would require complex and lengthy research work and that such work was beyond the capability of the team. According to Mr Torstensen the known hydrophilic coatings were not suitable for storing the catheter in contact with water. He also said that the gas impermeable packaging would require the use of electron beams as a means of sterilisation and that this tended to cause the hydrophilic layer to lose its low friction character. 145.A separate team at Coloplast, specialising in materials technology, took over the project. The goal of this team was to identify a catheter material other than PVC and a suitable hydrophilic coating. 146.Ms Israelsson conceded in cross-examination that the skilled team, having read the Patent, would have to embark on a research project in order to make a catheter assembly as claimed. That sounded like Coloplast’s own expert finishing off its case on insufficiency, but although a witness may agree with counsel’s use of magic terms such as ‘research project’ or ‘research programme’, it is still necessary to know what the witness means by such terms. 147.Mr Torstensen accepted in cross-examination that the problems of smell and colour would not prevent the skilled team from making a product, even though it would not be a marketable product. Thus, if the research project had involved only solving these two problems the Patent would not lack sufficiency. 148.The difficulties of finding a suitable material for the catheter and a suitable hydrophilic coating fell into in a different category. This was because it was necessary to solve those two problems into order to make a urinary catheter assembly falling within claim 1 as I have construed it. 149.Mr Svanum discussed the work facing Coloplast at the time in his evidence in the PCC Action: “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.” 150.Mr Svanum’s report was apparently made available in proceedings before the EPO Technical Board of Appeal concerning the Patent. Coloplast filed a corrective statement from Mr Svanum dated 21 April 2009 in the TBA proceedings, explaining what he had meant in his earlier paragraph 38. He said that finding a suitable hydrophilic coating was only regarded as a ‘major development’ because Coloplast had no specialist knowledge of its own in the field of hydrophilic coatings. He added that that for environmental reasons and because Coloplast’s supplier of uncoated PVC catheters was developing a rival product, Coloplast decided to find a non-PVC alternative. He suggested that nonetheless the existing EasiCath PVC catheter could possibly have been used to make a catheter assembly as claimed. 151.In the end I must primarily rely on the evidence from the witnesses in these proceedings. As I have indicated, Mr Torstensen in his report stated that the two problems of finding a suitable catheter material and a suitable hydrophilic coating would have prevented the skilled team from making a catheter package as claimed without a significant amount of research and development. 152.In cross-examination he accepted that there were ways forward which the skilled team could have adopted. But this did not establish that the work to be done by the skilled team would be routine, particularly with regard to the coating. 153.Mr Torstensen was taken to one of the 13 patents and one design referred to in paragraph [0002] of the Patent, namely the first of them: EP A 0 217 771 (“the 771 Patent). This was an Astra patent claiming a method of applying a hydrophilic coating, but not concerned with coatings for water-stored catheters. Mr Torstensen accepted that of the many coatings disclosed by this document, the preferred coating was polyvinylpyrrolidone (PVP). The significance was that Ms Israelsson had said that in the course of the Astra trials, during which there was simulated storage of the catheter in water for 1-2 years, a catheter dipped in PVP had proved satisfactory. Dr Baran argued that on this evidence it must have been a routine matter to find a suitable coating for a catheter that would survive storage in water. 154.One reason I am unable to accept this argument is that it has the character of hindsight reasoning. Paragraph [0002] merely sets the scene by identifying the sort of catheter with which the invention is concerned. It does not expressly tell the reader that a suitable hydrophilic coating is to be found among the prior art listed. Even if the skilled team were to interpret the paragraph in this way, there was no reason to focus on the preferred coating of the 771 Patent. 155.Another difficulty I have is that in cross-examination Ms Israelsson said that Astra’s coating was proprietary and its formula not available to others. It was not established that merely being told to use PVP would be sufficient information to enable the skilled team to make a coating that could be stored in water for up to five years. It seems that PVP worked, but it may have been a particular formula using PVP that was needed. 156.The third problem is that, as I have found, Astra had been told that the market wanted a water-stored product. It was put to Ms Israelsson that the reason Astra did not meet that demand before Coloplast was that Astra could not find a coating sufficiently stable in water. Ms Israelsson answered (Day 2, p.240): “No, I do not think so, but I cannot be sure. I do not know. It could be others.” 157.I think that if finding a stable coating had really been a routine matter for Astra Ms Israelsson would have unequivocally dismissed the problem of finding such a coating as a realistic reason why Astra had not marketed a water-stored product sooner than it did. 158.In my view, based on the evidence of both Mr Torstensen and Ms Israelsson, the specification does not disclose the invention clearly and completely enough for it to be performed by the team skilled in the art. Conclusion 159. The Patent is invalid for both lack of inventive step and insufficiency. Had it been valid, MacGregor would have infringed the Patent.