Patents: Fisher & Paykel Healthcare Ltd v Flexicare Medical Ltd

Jane Lambert

 






Patents Court (Mr Justice Meade) Fisher & Paykel Healthcare Ltd v Flexicare Medical Ltd and another [2020] EWHC 3282 (Pat) (8 Dec 2020)

This was an action for the infringement of European patent (UK) No 2 025 359 B1 and a counterclaim for revocation. The action and counterclaim came on before Mr Justice Meade who tried them on 3, 4 and 19 Nov 2020. His lordship delivered his judgment on 8 Dec 2020. The learned judge held at paragraph [226] of his judgment that the patent was valid and that it had been infringed.

The Patent

The patent had been granted for components for breathing circuits.  The abstract is as follows:

"A breathing circuit component (4) includes an inlet, an outlet and an enclosing wall (1). The enclosing wall (1) defines a gases passageway between the inlet and the outlet. At least a region (2,3) of the enclosing wall is formed from a breathable material that allows the passage of water vapour without allowing the passage of liquid water or respiratory gases. The breathing circuit component may be the expiratory limb of a breathing circuit."

The drawings referred to in the abstract are here.

The Issues

The claimant, Fisher & Paykel Healthcare Ltd ("F & P), owns the patent.  It complained that the defendants, Flexicare Medical Ltd and Flexicare Group Ltd ("Flexicare") had infringed claim 1 of the patent as proposed to be amended.  Flexicare did not oppose the amendment and admitted that their products fell within the amended claim but contended that the patent was bad for want of novelty and/or inventive step. The issues in this case were very similar to those in The Janger Ltd v Tesco Plc [2020] EWHC 3450 (IPEC) (16 Dec 2020 ) which I blogged in Patents: The Janger Ltd v Tesco Plc on 5 Jan 2921. Readers who are new to patents will find it easier to understand this case if they read the paragraphs headed "The Basics" in my article on The Janger,

Claim 1

The relevant claim as amended broken down into integers was as follows:
 

Int  

Claim Wording

1A

A flexible breathing tube

1B

which is an expiratory limb of a breathing circuit, and

1C

is adapted to be located between a patient and a ventilator

 

the tube comprising

1D

an inlet

1E

an outlet, and

1F

a singular exhalation flow passage between said inlet and said outlet defined by an enclosing wall

1G

wherein said enclosing wall bounds the singular exhalation flow passage and ambient air

1H

wherein at least a region of said enclosing wall is of a material that allows the passage of water vapour by diffusion without allowing the passage of liquid water or respiratory gases thereby providing a water vapour flow path from said exhalation flow passage to ambient air through said material

1I

wherein the region or regions is or are distributed over the length of the tube

1J

such that the tube allows said diffusion of water vapour from the expiratory limb of the breathing circuit along said singular exhalation flow passage

1K

thereby drying the humidified gases during their flow through the expiratory limb

 

Want of Novelty


Flexicare argued that the patent had been anticipated by European patent application 0 535 379 A1("Psaros") a 1993 patent application for an invention that addressed the same problem as the patented invention.

Want of Inventive Step


Flexicare also contended that the patent was obvious over Psaros,  International Patent Application WO 88/01903 A1 ("Kertzman") or Japanese Patent Application 2000-24111 ("Inoue").

The Flexicare companies also ran a squeeze defence contending that the invention was obvious for lack of a technical contribution or insufficient for lack of enablement.   The judge observed that those arguments "did their job and thereupon faded away."  


Anticipation


Because there was no dispute over the applicable legal principles, Mr Justice Meade did not discuss the law beyond observing that there has to be clear and unambiguous disclosure of all the features of the claim. If any reader is unsure of what they are, I mentioned them together with the leading authorities in my case note on   The Janger.  His lordship found that Psaros had not been anticipated because:

"i) The dehumidifying device 8 is a breathing tube but is just part of the expiratory limb whereas the claim requires a tube that is the expiratory limb.
ii) Alternatively, if the whole tube from patient to ventilator is to be regarded as the breathing tube of the claim then the breathable regions of device 8 are along only part and not distributed all along the length as I have held is required.
iii) There are in any event multiple flow passages in drying device 8, not just a "singular" flow passage."

Obviousness

In my case note on The Janger, I discussed the law on obviousness in some detail including, in particular, the Pozzoli test.  Mr Justice Meade applied that test except for identifying the inventive concept of the patented invention.  He said at [153]:

"[153] As to Pozzoli, while it is a useful approach the second question, the identification of the inventive concept, can be difficult, and it is not mandatory to undertake it. The Court may instead use the claim features themselves. See MedImmune v. Novartis [2012] EWCA Civ 1234 at [86], referring to Lord Hoffmann in Conor v. Angiotech [2008] UKHL 49 at [19].
[154] I do not find this a case where it is useful to try to define the inventive concept separately from the claim. It can be helpful to do so in some cases to allow focus on what really matters and strip away what has been called unnecessary verbiage, but at the same time, as the cases cited above make clear, it can lead to unproductive arguments about paraphrasing the claim.
[155=. As it happens, the parties characterised the inventive concept in very different terms, in particular in that Flexicare left out integer 1K as being unnecessary verbiage on the basis that any degree of drying would meet the claim."

Skilled Addressee

The first step of the Pozzoli test is to identify the skilled addressee. The judge noted at [31] that the parties had agreed that the skilled addressee should be a team consisting of a design engineer and a materials scientist and that most of the work would be done by the design engineer with the materials scientist called upon for certain matters of detail relating to the selection of the precise characteristics of the materials to be used.

Common General Knowledge

The second step is to identify the common general knowledge of the skilled addressee.  Some of it was agreed by the parties.  The judge set out his findings between paragraph [50] and ]101].

Construing the Patent

His lordship construed the specification between paragraph [102] and [111]. He construed claim 1 between [113] and [139].

The Third and Fourth Questions

For each of the items of prior art, the judge identified the difference between claim 1 of the patent and the item.  In the case of Kertzman, for example, he said at [168]:

"For question 3 and the assessment in question 4, the differences between Kertzman and claim 1 are that Kertzman's sampling tube is not a breathing tube, is not an expiratory limb of a breathing circuit, and is not adapted to be located between a patient and a ventilator. So at least features 1A to 1C are missing (with a knock-on consequence for the later features insofar as they refer to expiratory limbs). The parties disagreed about precisely which integers were missing, just as they did about how to characterise the inventive concept, but it does not matter because the issue is whether it was obvious to modify Kertzman's sampling tube so as to use it as the expiratory limb of a breathing circuit."

He found that the difference between the claim and the prior was not obvious in respect of all three cases pf prior art.

The Squeeze

As I did not cover this point in The Janger I should explain that Lord Hodge appeared to approve two approaches to determining obviousness in Actavis Group PTC EHF and others v ICOS Corporation and another [2019] UKSC 15 (27 March 2019).  One was the Pozzoli approach which he considered at paragraph [60] of his judgment. The other was the "problem and solution" approach used by the European Patent Office which he discussed at paragraph [61]:

"The EPO has described the approach in these terms:

'the Boards of Appeal consistently decide the issue of obviousness on the basis of an objective assessment of the technical results achieved by the claimed subject-matter, compared with the results obtained according to the state of the art. It is then assumed that the inventor did in fact seek to achieve these results and, therefore, these results are taken to be the basis for defining the technical problem (or, in other words, the objective) of the claimed invention. … The next step is then to decide whether the state of the art suggested the claimed solution of this technical problem in the way proposed by the patent in suit …' (Agrevo/Triazoles Case T-939/92) [1996] EPOR 171, para 2.4.3)

The test is helpfully summarised in the EPO’s Guidelines for Examination in the EPO (November 2017) (Part G - Chapter VII) para 5:

'Problem-and-solution approach
In order to assess inventive step in an objective and predictable manner, the so-called ‘problem-and-solution approach’ should be applied. Thus deviation from this approach should be exceptional.

In the problem-and-solution approach there are three main stages:
(i) determining the ‘closest prior art’,
(ii) establishing the ‘objective technical problem’ to be solved, and
(iii) considering whether or not the claimed invention, starting from the closest prior art and the objective technical problem, would have been obvious to the skilled person.'”

Flexicare had submitted that:

"223. The alleged inventive contribution of the Patent is the use of a `breathable' material to dry the humidified gases that flow through the expiratory limb of a breathing circuit. But as we have seen from the prior art, that is not inventive at all: the need to dry exhaled gases was already known - there is no dispute that the problem that the Patent aims to solve was CGK; and the use of "breathable" material to achieve drying is disclosed by the prior art.
224. As an attempt to overcome this fundamental problem and to try to imbibe superficial novelty into the claim, the drafter has packed it full of verbiage. But the words do not add anything of technical value and the claim does not provide a technical advantage over the prior art."

Mr Justice Meade rejected that submission as circular at paragraph [223] of his judgment.  

"[223]. ......... The argument would not arise if it was in fact obvious to make something within the claims, i.e. if the conventional obviousness attacks over the specific cited art had succeeded. On the assumption that they failed, however, then it was inventive to make the products within the claims of the Patent and the question on lack of technical contribution would be whether they achieved any useful purpose. Compared with Kertzman they do because they solve a problem in a different application; compared with Psaros they do because they provide a simpler solution; compared with Inoue they do because they allow a different and simpler product to be used for a different purpose. And in a general sense without specific reference to any particular art they provide real products which provide a simple solution to a real problem.
224. As to insufficiency, this was really a squeeze which did its job on the obviousness side of the case, as I have already said several times. Right at the end of Flexicare's closing skeleton (paragraphs 226-227) it was perhaps asserted in addition to the squeeze ("Moreover" in paragraph 227) that if F&P relied on uncertainty as to drying levels that could be achieved from modifications of the prior art, then the Patent would be insufficient because it does not contain data on drying levels and leaves it to the empirical efforts of the SDE. I was unable to see how this added to the squeeze and I have dealt with the interplay between the SDE's abilities from the prior art and from the Patent above anyway."

The judge rejected both obviousness attacks.

Further Information

Anyone wishing to discuss this article or case specifically or patents generally may call me on 020 7404 5252 during UK office hours or send me a message through my contact form at any other time.

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