(1) Cantel Medical (UK) Ltd v ARC Medical Design Ltd
| Jurisdiction | England & Wales |
| Judge | Judge,Hacon |
| Judgment Date | 23 February 2018 |
| Neutral Citation | [2018] EWHC 345 (Pat) |
| Docket Number | Case No: HP-2016-000047 |
| Court | Chancery Division (Patents Court) |
| Date | 23 February 2018 |
[2018] EWHC 345 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
INTELLECTUAL PROPERTY LIST
PATENTS COURT
Royal Courts of Justice, Rolls Building
Fetter Lane, London, EC4A 1NL
HIS HONOUR JUDGE Hacon
(Sitting as a High Court Judge)
Case No: HP-2016-000047
Douglas Campbell QC and Geoffrey Pritchard (instructed by DLA Piper UK LLP) for the Claimants
Daniel Alexander QC and Henry Ward (instructed by Carpmaels & Ransford LLP) for the Defendant
Hearing dates: 16–19, 22–23, 25–26 January 2018
Approved Judgment
I direct that pursuant to CPR PD 39A para 6.1 no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
HIS HONOUR JUDGE Hacon
Introduction
Colonoscopy is a procedure by which the colon is viewed using a camera and light positioned at the end of a flexible tube which has been inserted into the colon. It is a type of endoscopy which has been practised since the late 1960s. The apparatus used is a colonoscope. A principal application of the procedure is the detection of polyps: growths in the lining of the colon. A subset of polyps consists of a type known as adenomas; these are cancerous growths. The removal of adenomas can prevent the development of colorectal cancer and the potential spread elsewhere. Colonoscopy has become a primary tool in the detection and treatment of bowel cancer.
Colonoscopes are almost entirely supplied, in Europe anyway, by three giant Japanese manufacturers of optical equipment which I will refer to by their abbreviated names: Olympus, Pentax and Fujifilm.
Between 2008 and 2011 a product used with colonoscopes called the ‘Endocuff,’ was developed. The Endocuff was a plastic cuff, about 2 cm in length, fixed to the end of the colonoscope just behind the camera lens and light, with radially projecting elements. It assisted the colonoscopist in the detection of adenomas.
In October 2008 the Defendant (“Arc”) was incorporated as a vehicle for the exploitation of the Endocuff, principally by Patrick Axon, identified as the designer. The design was finalised in December 2010. The product was launched on the market in the UK in August 2011.
In September 2012 Arc and Cantel Medical Corporation entered into a distribution agreement under which the latter marketed the Endocuff in the United States. Cantel Medical Corporation is the US parent of both Claimants. Since there is no need to distinguish the Cantel companies, I will refer to them collectively and individually as ‘Cantel’.
In April 2014 an amended design of the Endocuff was finalised. The new product was named the ‘Endocuff Vision’ and was launched in the Netherlands in February 2015. Arc's case is that Mr Axon designed this too.
Images of the Endocuff Vision were presented to Cantel in August 2013 and early samples of the product were sent to Cantel for their consideration in August 2014.
In 2015 a majority of the shares in Arc were sold to Norgine BV, a Dutch pharmaceutical company. Cantel's distribution rights came to an end in June 2016. Since then Arc's products have been distributed in the US by a subsidiary of Olympus.
In anticipation of losing the distribution rights, Cantel developed their own colonoscope cuff. The design was created by a company in the Cantel group called Medivators, Inc (“Medivators”). There will generally be no need for me to distinguish Medivators from Cantel as a whole. Cantel's new design was finalised in January 2016 and the product was launched later that year under the trade name ‘AmplifEYE’. The AmplifEYE is now sold in many countries, including the UK.
Cantel brought these proceedings in September 2016 to clear the path for lawful marketing of the AmplifEYE, seeking revocation and/or declarations of non-infringement of Arc's rights. Arc has counterclaimed for infringement. The rights in question are:
(1) European Patent (UK) No. 2 575 590 (“the Patent”);
(2) UK Patent No. 2 478 081 (“the UK Patent”);
(3) Registered Community design No. 001856121-0001 (“the Endocuff RCD”);
(4) Registered Community design No. 002523191-0001 (“the Vision RCD”);
(5) UK unregistered design right in the design of the Endocuff;
(6) UK unregistered design right in the design of the Endocuff Vision.
Cantel have also sought declarations of non-infringement in relation to two alternative versions of the AmplifEYE, neither of which has yet been marketed, and which were referred to as AmplifEYEs 2 and 3.
The Patent and the UK Patent are for the same invention. The Patent is still the subject of opposition proceedings before the European Patent Office. The Patent was upheld in amended form but that decision is currently subject to appeal before the Technical Board of Appeal, so s.73(2) of the Patents Act 1977 does not yet bite.
Arc has implicitly conceded that both Patents are invalid in their current forms and has therefore advanced unconditional amendments. Alternative conditional amendments have also been sought. Cantel argue that none of the proposed amendments is allowable.
Douglas C ampbell QC and Geoffrey Pritchard appeared for Cantel, Daniel Alexander QC and Henry Ward for Arc.
The Witnesses
The Experts
I had the benefit of evidence from Dr James East for Cantel and Professor Colin Rees for Arc. Dr East is a Consultant Gastroenterologist and Endoscopist, and Honorary Senior Clinical Lecturer who is based at the Translational Gastroenterology Unit, John Radcliffe Hospital, Oxford. Professor Rees is a Consultant Gastroenterologist at South Tyneside NHS Foundation Trust, where he is a Director of Research. Professor Rees is also Honorary Professor of Gastroenterology at Newcastle University. I found the evidence of both experts clear and helpful.
Witnesses of Fact
Cantel had several witnesses, of whom four were cross-examined. Their evidence was concerned with the development of the AmplifEYE by Cantel and much of it was directed to Arc's allegation that the project had involved copying the designs of the Endocuff and Endocuff Vision.
John Schreiner was until the end of September 2017 the Director of Research and Development at Medivators. I have no doubt that Mr Schreiner was doing his best to give a true account of what happened in the course of creating the AmplifEYE. But I think that on the question of whether and the extent to which the designs of the Endocuff and Endocuff Vision influenced that of the AmplifEYE, Mr Schreiner had by the time of the trial minimised that influence in his own mind, possibly out of loyalty to his former employer. My impression was that Mr Schreiner was not always comfortable reviewing the history of how the AmplifEYE came to look the way it does, which may reflect well on his honest instincts.
Anoopam Nath is Design Engineer and Manager of Technical Standardization, R&D, at Medivators. Mr Nath was the lead designer of the AmplifEYE under the overall direction of Mr Schreiner. I found that Mr Nath answered questions in cross-examination honestly and to the best of his ability, but like Mr Schreiner I think he had persuaded himself that the designs of the Endocuff and Endocuff Vision played much less of a role the AmplifEYE project than was the case. I will discuss below why I take that view.
Loyalty to his employer probably also influenced the evidence of Brent Geiger. Mr Geiger has been Senior Director Global Regulatory Compliance at Medivators since September 2015. He played a central role in obtaining regulatory approval for the AmplifEYE.
The fourth witness from Cantel who was cross-examined was Jørgen Hansen, currently President and Chief Executive Officer of Cantel, and at the time of the development of the AmplifEYE Chief Operating Officer. Mr Hansen gave his evidence clearly and I am sure accurately.
The remaining witnesses from Cantel were not cross-examined and the evidence given in their witness statements stood unchallenged. None of it played a significant role.
Aside from Ian Kirby, a partner in the firm acting for Arc who gave evidence regarding a procedural matter and was not cross-examined, Arc's only witness of fact was Patrick Axon, who stated how the Endocuff and Endocuff Vision came to be created. Mr Axon is a surgeon specialising in otology at Addenbrooke's Hospital, Cambridge (otology is a branch of medicine dealing with the physiology and diseases of the ear). I have no reason to doubt that Mr Axon gave honest answers to all questions put to him.
The Patents
There was no difference of substance between the arguments relating to the Patent and those relating to the UK Patent. They had the same specification. I will refer largely to the Patent because its paragraphs are numbered.
Colonoscopy
The Patent states that a colonoscopy may take anywhere from 20 minutes to 2 hours. The evidence indicated that around 30 minutes is typical, but with some patients the procedure can be difficult and take longer.
There are two stages. First there is intubation, which involves introducing the colonoscope into the rectum and progressing it along the colon. When intubation reaches its end point, there follows the withdrawal of the colonoscope, sometimes referred to as extubation. It is during the gradual process of withdrawal that the search for adenomas takes place.
Ideally the physician would like the chance to see the whole of the mucosal lining of the colon. The first main difficulty is that it is not always possible to reach the far end of the colon, the caecum. Intubation may therefore be incomplete. This is a diagram of the colon:
As can be seen, despite the flexibility of the...
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