Posted: November 7th, 2018
Coloplast A/S v. MacGregor Healthcare Limited, UK Intellectual Property Enterprise Court, 24 October 2018,  EWHC 2797 (IPEC)
This is a first instance decision from the UK Intellectual Property Enterprise Court “IPEC” on the validity and infringement of European Patent (UK) 1 145 729. The patent claimed a ready-to-use urinary catheter assembly which is stored in packaging along with sterile water, the water being used to coat the catheter to improve ease of insertion.
The proprietor, Coloplast, alleged that the patent was infringed by MacGregor. MacGregor argued that the patent lacked novelty, was obvious and was insufficient. The patent had expired in September 2017 and the claim was therefore for damages for infringement prior to the date of expiry.
There was a dispute between the parties as to whether there was demand for a particular type of catheter and therefore whether this type of catheter formed part of the common general knowledge. Being a question of fact, this was made the subject of a disclosure exercise. However, being in the IPEC, this exercise was carefully limited to some narrow requests for specific disclosure. There was little information on this issue when Coloplast’s disclosure was given. This was because the order for disclosure had been limited to specific categories of documents which could be found in a set of documents which had been disclosed by Coloplast in proceedings brought against a third party in 2005 for infringement of a different patent. However, evidence filed by Coloplast in the earlier proceedings, was made available at trial. This evidence showed that Coloplast must have other documents which were highly relevant to issue of whetherthere was demand at the priority date for the particular type of catheter.
The conduct of any disclosure exercise ordered in the IPEC is designed to minimise the time and costs incurred. However, HHJ Hacon’s judgment states that this should not be allowed to result in a likelihood that the Court will reach a false understanding of an important issue. The judge commented that he considered it was unsatisfactory that an order for specific disclosure, however framed, should result in a party concluding that it need not disclose documents which to its knowledge relate to a material and central issue in the case. He noted that the impending disclosure pilot scheme for the Business and Property Courts of England and Wales (due to enter into force on 1 January 2019) provides for parties to disclose known adverse documents. Although the pilot scheme does not apply to proceedings in the IPEC, HHJ Hacon indicated that it is likely that an equivalent requirement for disclosure of known adverse documents will be imposed by Judges when disclosure is ordered in IPEC cases.
Construction and infringement
The dispute between the parties on infringement turned on a point of construction. Coloplast had not advanced a case on infringement based on the doctrine of equivalents and both parties’ counsel argued their case on construction on the basis of the principles as they stood before the law was considered by the Supreme Court in Actavis v Eli Lilly  UKSC 48. HHJ Hacon commented in this context that he was not convinced that the first stage of the test in Actavis, as explained recently by the Court of Appeal in Icescape v Ice-World  EWCA Civ 2219 is exactly the same as the approach prior to Actavis. However, he went on to construe the 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 judge ultimately found that the sales of MacGregor’s catheters would infringe the patent if valid.
Novelty and obviousness
The patent was held not to be anticipated by the prior art cited by MacGregor. However, it was held to lack inventive step over three prior art citations. Coloplast unsuccessfully advanced inventive step arguments based on secondary evidence of a long felt want for the claimed catheter assembly and commercial success. However, given Coloplast’s case was that the inventive concept of the patent was the idea of a water-stored catheter, an idea which the judge had found to be common general knowledge, there could have been no long-felt want for an invention made possible only by that concept. Commercial success added nothing to the case on inventive step in the absence of any long-felt want.
There was evidence from MacGregor’s expert witness that the skilled person would not have been able to make a ready-wetted catheter at the priority date as the assembly would not have been suitable for storage for the period of time required by the patent. The product would have suffered problems such as change in colour, odour, loss of flexibility and detachment of the coating. Some of these problems, such as odour and colour change, would only have prevented the team from making a marketable product. Others, however, such as loss of flexibility and detachment of the coating would have prevented the skilled person from making a catheter falling within the claims. Since the patent did not teach the skilled person how to solve the problem of finding a suitable catheter material and coating, it was held to be insufficient.
A copy of the judgment can be found here.
Headnote by Chloe Dickson, Bristows LLP