Fisher & Paykel Healthcare Ltd v Flexicare Medical Ltd
| Jurisdiction | England & Wales |
| Judge | Mr Justice Meade |
| Judgment Date | 08 December 2020 |
| Neutral Citation | [2020] EWHC 3282 (Pat) |
| Date | 08 December 2020 |
| Docket Number | Case No: HP-2019-000016 |
| Court | Chancery Division (Patents Court) |
[2020] EWHC 3282 (Pat)
IN THE HIGH COURT OF JUSTICE
BUSINESS AND PROPERTY COURTS OF ENGLAND AND WALES
Royal Courts of Justice
Strand, London, WC2A 2LL
Mr Justice Meade
Case No: HP-2019-000016
Benet Brandreth QC and David Ivison (instructed by Bird & Bird LLP) for the Claimant
Charlotte May QC and Tom Alkin (instructed by DAC Beachcroft LLP) for the Defendants
Hearing dates: November 3, 4 and 9 2020
Approved Judgment
I direct that no official shorthand note shall be taken of this Judgment and that copies of this version as handed down may be treated as authentic.
| Introduction | 3 |
| The issues | 3 |
| The witnesses | 4 |
| Mr Pierro | 4 |
| Dr Dixon | 4 |
| The Skilled Addressee | 7 |
| The common general knowledge | 10 |
| Agreed CGK | 10 |
| Assisted breathing | 11 |
| A typical breathing circuit | 11 |
| Breathing tubes | 12 |
| Tube materials | 13 |
| Humidification | 13 |
| Condensation or ‘rainout’ | 15 |
| Knowledge of breathable materials | 17 |
| Disputed and potentially disputed issues of common general knowledge | 17 |
| Expiratory flow rates | 17 |
| Process drying | 18 |
| Safety issues and the standards | 18 |
| The patent | 18 |
| Claims in issue | 19 |
| Issues of Claim interpretation | 20 |
| “Flexible breathing tube” | 20 |
| Location of the breathable material | 20 |
| “Singular exhalation flow passage” | 21 |
| “Drying the humidified gases” | 22 |
| Integers 1G and 1H | 23 |
| Validity | 23 |
| Anticipation | 23 |
| Teaching of Psaros | 23 |
| Obviousness | 25 |
| The law | 25 |
| Obviousness over Kertzman | 26 |
| Obviousness over Psaros | 30 |
| Obviousness over Inoue | 32 |
| Lack of technical contribution and insufficiency | 36 |
| Conclusions | 37 |
INTRODUCTION
In this action, the Claimant (“ F&P”) sues for infringement of European Patent (UK) 2 025 359 B1 (“ the Patent”).
The Patent concerns the expiratory limbs of breathing circuits, and in particular the use of breathable materials to reduce or eliminate condensation.
The Defendants (together, “ Flexicare”) have admitted that their products fall within the Patent's claims but say that the Patent is invalid and counterclaim for its revocation.
Mr Benet Brandreth QC appeared for F&P with Mr David Ivison and Ms Charlotte May QC appeared for Flexicare with Mr Tom Alkin. I am grateful for their submissions and for the summary of agreed common general knowledge (“ CGK”) provided after the oral hearing, to which I refer below.
Owing to the COVID pandemic the trial was conducted entirely remotely. This worked well and there were no significant difficulties. I am grateful for the support I received from the parties in terms of providing bundles and the like.
The pandemic also meant that the Claimant's witness Mr Pierro could not travel from California. This was accommodated by conducting the oral evidence starting at 2pm each day and continuing until 6. 30 or 7.30 pm. The parties and witnesses are to be commended for their flexibility, but special thanks are due to the Court staff for dealing with this on top of everything else.
THE ISSUES
The issues for me to decide are as follows:
i) Whether the Patent is anticipated by European Application 0 535 379 A1 (“ Psaros”). This depends on claim scope and proper interpretation of the disclosure of Psaros, there being no dispute about the facts.
ii) Whether the Patent is obvious over:
a) Psaros; or
b) International Patent Application WO 88/01903 A1 (“ Kertzman”); or
c) Japanese Patent Application 2000–24111 (“ Inoue”).
iii) Whether the Patent is obvious for lack of a technical contribution or insufficient for lack of enablement. These were run as squeezes and as I will explain below they did their job and thereupon faded away. I will address them only briefly below, therefore.
The issues are to be determined by reference to unconditionally amended claims, in which the feature of dependent claim 3 of the granted claims was added into claim 1. There is no opposition to the amendment other than that it does not cure the alleged invalidity.
THE WITNESSES
The parties each submitted expert reports from two witnesses, a product design engineer and a materials scientist. The materials scientists were mainly concerned with infringement and the significance of their evidence faded away so that in the end they were not cross-examined. So I heard oral evidence from Mr Brian Pierro for F&P and Dr Paul Dixon for Flexicare. Somewhat unusually those two gentlemen work for the same company called Vyaire, although nothing turned on this.
There was no attack of significance on the qualifications of either witness. Minor points were made in relation to Dr Dixon's experience which I deal with below but which were not material in my view.
Mr Pierro
Flexicare limited its comments on Mr Pierro to the observation that his views on obviousness were influenced too much by his perception of the technical challenges that would have to be overcome to construct an expiratory limb, pointing out that he made frequent references to them even though he accepted that they could in fact be overcome by routine means in the light of the CGK.
This was, rightly, not made as a personal criticism of Mr Pierro, who I thought was a very good and fair witness. It is however a relevant point as directed against the nature of F&P's case as it developed. I return to this in relation to Flexicare's obviousness/insufficiency squeeze below. For reasons given there, the point has some force and I have taken it into account, both generally and in assessing Mr Pierro's written and oral evidence.
Dr Dixon
There were, by contrast, significant problems with Dr Dixon as a witness.
As to his qualifications and experience, F&P submitted that he was not a good approximation to the notional addressee because his degree was in mathematics and because he only worked on medical devices for a year before the priority date.
These were not important issues. In this field there was no one undergraduate discipline that was universal or necessary, and Dr Dixon's pre- and post-priority date experience gave him the necessary knowledge of medical devices.
The difficulty, rather, was the way that Dr Dixon let in hindsight in the preparation of his written evidence and in his oral evidence.
I will say straight away that I would reject any assertion that Dr Dixon lacked honesty, and I do not understand any to have been made. He was direct and open in his oral evidence and in general accepted the points put to him about the preparation of his reports. However, I do think that the way his evidence was put together and a general lack of care and thought about how he should avoid hindsight means that his views on obviousness have to be treated with a good deal of scepticism. I will explain why.
After the nature of the likely attack on Dr Dixon became apparent, I asked the parties to provide submissions in their closing submissions about the right legal approach. They did so, and there was for practical purposes complete agreement. They both referred to the judgment of Arnold J as he then was in MedImmune v. Novartis [2011] EWHC 1669 (Pat) at [99] to [114]. In addition, F&P referred to Akebia Therapeutics v. Fibrogen [2020] EWHC 866 (Pat) at [36], a decision of Arnold LJ sitting as a trial judge, and Flexicare referred to HTC v. Gemalto [2013] EWHC Pat at [273] where Birss J commented on MedImmune.
As can be seen from those judgments, in recent years there has been a heightened focus on the way in which expert evidence in patent cases is prepared and especially the sequence in which experts are shown documents. The main driver behind this is that if experts are shown the patent in suit before they have said what the CGK is or, more importantly, before they have said what they consider to be obvious over the prior art, then there is a risk of hindsight.
It is therefore preferable for experts to be asked about the CGK, then shown the prior art, and only then shown the patent in suit ( MedImmune). But this is a counsel of perfection since the expert may well already know what the invention of the patent in suit is, for example from the patentee's commercial embodiment of it ( HTC, Akebia).
Where the expert already knows the invention there may yet be value in sequencing the documents that he or she reviews to focus the mind on avoiding hindsight, but the opportunity to give a completely untainted view of the prior art does not exist; the expert has to discipline themself carefully to avoid hindsight. If they do so well then there is no reason why they cannot give cogent evidence on obviousness, but in such a situation I think it must be important for the expert to identify how they knew about the invention and when, and to reflect carefully on how that might influence them. This is really where the problem with Dr Dixon arose and it is an issue of the assessment of his evidence, not a disagreement between the parties on the applicable principles.
The sequencing of an expert's involvement can cause other practical problems. It is not usually sensible to ask an expert “what was the common general knowledge in your field?” without some guidance, as it will lead to far more information being given than is relevant ( Akebia). So it was sensible and really inevitable to ask Dr Dixon to address himself to expiratory limbs and to rainout when he was originally asked about the case. But this led to a criticism that he had, in his reports,...
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