(1) Fisher & Paykel Healthcare Ltd (a company incorporated in England and Wales) (Claimants/Part 20 Defendants) (2) Fisher & Paykel Healthcare Ltd (a company incorporated in New Zealand) v (1) ResMed Ltd (a company incorporated in Australia) and Another (Defendants/Part 20 Claimants)
| Jurisdiction | England & Wales |
| Judge | Richard Meade |
| Judgment Date | 10 November 2017 |
| Neutral Citation | [2017] EWHC 2748 (Ch) |
| Date | 10 November 2017 |
| Court | Chancery Division |
| Docket Number | Claim Nos. HP 2016 000050 & HP 2016 000054 |
[2017] EWHC 2748 (Ch)
IN THE HIGH COURT OF JUSTICE
CHANCERY DIVISION
PATENTS COURT
The Rolls Building
7 Rolls Building
Fetter Lane
London EC4A 1NL
Mr Richard Meade QC sitting as a Deputy Judge of the High Court
Claim Nos. HP 2016 000050 & HP 2016 000054
Claim Nos. HP 2016 000050 & HP 2016 000054
Iain Purvis QC and Benet Brandreth (instructed by Bird & Bird LLP) for the Claimants/Part 20 Defendants
Piers Acland QC and Tom Alkin (instructed by Bristows LLP) for the Defendants/Part 20 Claimants
Hearing dates: 10, 11 and 13 October 2017
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.
Richard Meade QC:
| INTRODUCTION | 3 |
| THE EXPERTS | 4 |
| THE SKILLED TEAM | 6 |
| TECHNICAL BACKGROUND AND COMMON GENERAL KNOWLEDGE | 6 |
| Obstructive Sleep Apnoea | 6 |
| Management of OSA | 7 |
| CPAP therapy | 7 |
| Types of CPAP Mask | 7 |
| Challenges of CPAP therapy | 8 |
| the CPAP masks in common use at the priority date | 10 |
| The General Features of CPAP masks | 10 |
| (1) Cushion | 10 |
| (2) Frame | 10 |
| (3) Forehead support | 11 |
| (4) Elbow | 11 |
| ( 5) Vent | 11 |
| (6) AAV | 12 |
| (7) Headgear | 12 |
| Materials | 12 |
| Manufacture of mask components | 12 |
| Connections between mask components | 13 |
| Interference or friction fit | 13 |
| Snap-fit | 13 |
| Bonding | 16 |
| Connections between specific elements of masks | 16 |
| Cushion to frame | 16 |
| Frame to air supply | 16 |
| Issues on the common general knowledge | 16 |
| CLAIM SCOPE – THE LAW | 18 |
| INVENTIVE STEP — THE LAW | 21 |
| THE 258 PATENT | 22 |
| The description | 22 |
| Claim 1 | 28 |
| "Snap-fit" | 29 |
| "Snap fingers" | 31 |
| Claim 2 | 34 |
| The "top end" and "bottom end" of the shroud | 34 |
| "Protrusions" | 35 |
| GEIST | 36 |
| Novelty over Geist | 39 |
| Obviousness over Geist | 41 |
| LOVELL | 44 |
| Novelty over Lovell | 48 |
| Obviousness over Lovell | 48 |
| INFRINGEMENT | 54 |
| CONCLUSION | 54 |
INTRODUCTION
Obstructive sleep apnoea ("OSA") is a sleep disorder which can be treated in various ways, including "CPAP" (which stands for "continuous positive airway pressure"). CPAP treatment requires the patient to wear a CPAP mask. These matters are explained below in relation to the common general knowledge.
The parties are medical device companies and competitors in relation to CPAP masks.
These proceedings were begun by the Claimants, to whom I will refer collectively as "FPH", seeking revocation of three patents owned by the First Defendant and concerning CPAP masks, as well as declarations of non-infringement in relation to three mask designs. The Second Defendant is an exclusive licensee and I will refer to the Defendants together as "ResMed". These proceedings were triggered by ResMed having brought infringement proceedings in Germany.
ResMed counterclaimed for infringement in the UK.
Just before trial, ResMed indicated that it consented to revocation of two of the patents in suit: EP (UK) 1 841 482 and EP (UK) 2 373 368.
The remaining patent, which I have to deal with is EP (UK) 2 707 258 ("the 258 patent"). It has a priority date of 19 March 2008.
The issues are as follows:
(1) The 258 patent is said to lack novelty and inventive step over two prior art citations, 'Geist' and 'Lovell'. They raise very similar issues.
(2) FPH denies (but only faintly and only as a squeeze), and ResMed asserts, that the 258 patent is infringed by FPH's Simplus and Eson masks (there were three masks in issue originally but the third, the Eson 2, dropped out when ResMed gave up on the other two patents, any allegation that it infringed the 258 patent having been dropped earlier on).
By the time of this trial it was apparent that the real issue was validity, since although there was a squeeze FPH's primary position was a claim scope on which there would be infringement, and there was no factual dispute about infringement.
Accordingly, Mr Purvis QC (who appeared with Mr Brandreth) opened the case for FPH. Mr Acland QC argued the case for ResMed, with Mr Alkin.
THE EXPERTS
ResMed put in reports from Ms Stephanie Romiszewski, a sleep physiologist, to explain OSA and to cover which CPAP masks were in use at the date of the 258 patent. FPH did not have an equivalent expert but this did not matter because Ms Romiszewski's evidence was accepted.
So the real issues arose on the evidence of the CPAP mask designers. ResMed called Mr Stuart Plascott and FPH relied on the evidence of Mr John Shi-Nash.
Each side criticized the other's expert to some degree, but it was not disputed that each had real practical experience of CPAP design at around the priority date.
Mr Plascott worked for ResMed until 2015, still retains a shareholding in the company, and worked closely with the inventors of the 258 patent during his time at ResMed. Indeed the work on the 258 patent was a precursor to a design he had worked on. Understandably, FPH submits that this could cause him, and did cause him, to lack objectivity and independence.
I do not accept this, however, because I did not detect any such lack during his oral evidence.
FPH also pointed to the fact that Mr Plascott's written evidence defended positions (the inventiveness of the two abandoned patents and ResMed's construction of "shroud") which even ResMed had abandoned. I have no way of knowing what happened on the other patents (other than that ResMed gave up) and I did not think Mr Plascott's position on "shroud" was so weak as to be capable of founding a criticism of him personally; I think ResMed probably abandoned it for tactical reasons. So I do not attach weight to that either.
I did think Mr Plascott was on the stubborn side (but then so was Mr Shi-Nash) and I thought he overstated the difficulty of CPAP mask design, but while I take them into account these are minor matters.
Turning to Mr Shi-Nash, ResMed pointed out that he has numerous patents to his name, and describes himself as a "serial innovator" in his LinkedIn profile. He clearly is a person capable of innovation, but that does not mean that he exercises the capability all the time. The question for me is whether he was able to put it aside when giving his views on obviousness, and I am sure that he was. He was plainly well aware that he should put himself in the shoes of a skilled team with no inventive capability and I find that he did so.
Mr Shi-Nash was also criticized for the way he dealt with the cited prior art. Both citations describe the engagement between the shroud and the collar as being an interference fit, but in each case Mr Shi-Nash left this out and referred to there being a "snap-fit", which is the phrase used in the claims of the 258 patent but which does not appear in the prior art.
Mr Shi-Nash was adamant that he had formed his views on the prior art before he saw the 258 patent, and ResMed accepted (and so do I) that he was truthful in this. But it remains, rather unsatisfactorily, something of a mystery how it happened that he used only the expression "snap-fit". I accept in relation to both citations that it is apparent that there is a degree of snap-fit (which does not exclude there also being interference), but there was still a lack of care in the way Mr Shi-Nash dealt with this. However, it was not in any way dishonest and I do not think it should lead me to discount his evidence generally.
I have already said that, like Mr Plascott, I found Mr Shi-Nash on the stubborn side.
The upshot is that I have two well-qualified experts trying to assist the Court on matters of opinion, with each being subject only to minor criticism that did not materially undermine their reliability or objectivity. I have to decide whose views I prefer on the objective basis of what they said.
THE SKILLED TEAM
From the written evidence and skeletons there appeared to be some disagreement about the identity of the skilled team. The main disputes concerned whether the team would have manufacturing as well as design expertise and whether the team would need a member who could provide input about clinical aspects of OSA.
All of this fizzled out. There would need to be a CPAP mask designer, but no reason for distinguishing manufacturing from design remained. The team would need to understand the basics of the clinical characteristics of OSA and its treatment with CPAP. Whether they obtained this from their own experience, reading, or having someone in the team such as Ms Romiszewski is immaterial to what I have to decide.
References to "the skilled team" below should be understood in this light.
TECHNICAL BACKGROUND AND COMMON GENERAL KNOWLEDGE
The following account of the agreed common general knowledge is based on the skeleton argument of ResMed, which I have edited as necessary for brevity and clarity.
I have shortened it a good deal because it included quite a lot of material that, I suspect, was only relevant to the patents which were abandoned. I have also removed most references to specific marketed designs of CPAP masks, not because I disagreed but because it is not of much relevance and can be confusing.
There were minor areas of disagreement on the...
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