Patents and Designs: Cantel Medical (UK) Ltd v ARC Medical Design Ltd.

The Rolls Building
Author Basher Eyre 
Source Wikimedia Commons

Jane Lambert

Patents Court (HH Judge Hacon): Cantel Medical (UK) Ltd and another v ARC Medical Design Ltd [2018] EWHC 345 (Pat)

This was a claim by Cantel Medical (UK) Ltd and Cantel (UK) Limited for the revocation or declarations of non-infringement of the following patents, registered Community designs ("RCD") and unregistered design rights:
ARC Medical Design Ltd., which is the registered proprietor of those patents and RCD and the owner of the design rights, counterclaimed for the usual remedies for infringement of those rights.

The Endocuff and Endocuff Vision
The Endocuff and Endocuff Vision are plastic cuffs about 2 cm long with radially projecting arms that are fitted to the ends of colonoscopes.  Colonoscopes are devices that are inserted into colons to detect polyps, and in particular malignant polyps known as adenomas.  They are fitted with lights and cameras.  Cuffs are inserted just behind those lens and lights of colonoscopes.  A video entitled Endocuff - How it works explains how the device operates.  A further video shows the advantages of the Endocuff Vision.

The Dispute
Between 2012 and 2016 the claimants' parent company, the Cantel Medical Corporation ("CMC"), distributed the Endocuff in the USA.  In 2015 the Dutch Pharmaceuticals company Norgine BV acquired a majority of ARC.s shares, terminated CMC.s distribution agreement and appointed the US subsidiary of Olympus in its place. CMC responded by developing its own colonoscope cuff known as the AmplifEYE® Endoscopic Device. Cantel's  brought these proceedings in September 2016 to clear the path for lawful marketing of the AmplifEYE and modified versions of the product known respectively as AmplifEYEs 2 and 3.

The Issues
The action and counterclaim came on before His Honour Judge Hacon sitting as a judge of the High Court.  The issues before him were:
  • whether the European and UK patents are invalid;
  • if so, whether those patents should be amended;
  • if they could, whether the amended patents would be infringed;
  • whether the RCD have been infringed; and
  • whether the unregistered design rights had been infringed.
Whether the Patents were invalid
ARC admitted that its patents were invalid but asked for permission to amend the first claims of both its European and British patents.

Whether the Patents should be amended
The amendment of those claims proved  crucial because the Cantel companies could not argue that any of the versions of the AmplifEYE fell outside the amended claim. 

They therefore opposed the application to amend on the grounds that
  • the amended claim in the case of each patent lacked novelty, 
  • was obvious, 
  • disclosed added matter, 
  • failed to disclose the invention clearly enough and completely enough for it to be performed by a person skilled in the art, and 
  • was not supported by the description.
Lack of Novelty - One of the conditions for the grant of a patent is that the invention is new (see s.1 (1) (a) of the Patents Act 1977.). S.2 (1) further provides that "an invention shall be taken to be new if it does not form part of the state of the art." If, for example, an earlier invention falls within one of the claims of a subsequently granted patent then, by definition, the invention for which the latter patent was granted cannot be new.

The previous subject matter may not be described in exactly the same way as the invention and not all its features may be spelt out.  However, "prior art contains an implied disclosure only if the information derived from the prior art by the skilled person would have inevitably included the implied element" (see Judge Hacon's earlier decision in Edwards Lifesciences LLC v Boston Scientific Scimed, Inc. and others [2017] EWHC 405 (Pat)).

The Cantel companies relied heavily on implied disclosure.  The invention that came closest to ARC's was an “Endoscope insertion assistance tool” for which a Japanese patent had been granted: 

This was significantly different in appearance from the patented invention:

More importantly, it operated in a different way.  Reminding himself of his decision in Edwards Lifesciences, Judge Hacon concluded at para [92] that the invention had not been anticipated.

Obviousness  A patent can be granted only if it involves as inventive step. S.3 provides:
"An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of section 2(2) above (and disregarding section 2(3) above)."The parties agreed that the patent was addressed to a team consisting of a gastroenterologist and developers of devices to be used with colonoscopes. 

The Cantel companies argued that it would have been obvious to such a team to vary the position, length, flexibility and shape of the fins of the Japanese endoscope insertion assistance tool shown above. Had they done so, they would have created a product that would have fallen within the amended claim.   Alternatively, they contended that the team would have achieved the same result upon considering ways of improving the visibility of the folds of the colon during the removal of the probe from the patient's body.

The judge found no evidence for the first argument but considered the second with regard to all the prior art relied upon. He found that none of the earlier matter led inevitably to a product within the scope of the amended claim.  Consequently, the invention as defined by the amended claim was not obvious.

Added Matter  S.76 (3) of the Patents Act 1977 requires that:
"No amendment of the specification of a patent shall be allowed under section 27(1), 73 or 75 if it -
(a) results in the specification disclosing additional matter, or 
(b) extends the protection conferred by the patent."
That subsection raises the question "what is additional matter?"  The Court of Appeal has answered that question in  AP Racing Ltd v Alcon Components Ltd  [2014] RPC 27, [2014] EWCA Civ 40 at para [9]:
"In the end the question is the simple one posed by Jacob J. (as he then was) in Richardson-Vick Inc's Patent [1995] R.P.C. 568 at p.576 (approved by him as Jacob L.J. in Vector Corp v Glatt Air Techniques Ltd [2007] EWCA Civ 805, [2008] RPC 10 at [4]):
‘I think the test of added matter is whether a skilled man would, upon looking at the amended specification, learn anything about the invention which he could not learn from the unamended specification.’”
Judge Hacon applied that test to each of the objections raised to the amendment and concluded that none of the proposed amendments disclosed additional matter.

Lack of Clarity   S.14 (3) of the Act requires the specification to disclose the invention in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.  If it fails to do so, the patent can be revoked under s.72 (1) (c) of the Act.  The Cantel companies objected to the words "flare outwards" in substitution to the words "fanned out."  The judge had no doubt that the skilled team would understand that both expressions meant exactly the same thing and saw no lack of clarity.

Lack of Support S.14 (5) (c) requires the claims of a patent to be supported by its description. The Cantel companies argued that the final part of the amended claim referred only to the patent's drawings. The learned judge disagreed.  In his view they referred to the whole inventions and the drawings were simply possible embodiments.

As each and every one of the objections had failed, the judge allowed ARC to amend its European and British patents.

Whether the Amended Patents had been infringed
In the absence of any argument to the contrary, the judge held at para [160] that both amended patents were valid and both had been infringed.

Whether the RCD had been infringed
ARC has registered the following design to protect the Endocuff under RCD 001856121-0001;

and this design to protect the Endocuff Vision under RCD 002523191-0001:

ARC alleged that the Cantel companies infringed both RCD by importing and distributing the AmplifEYE and by threatening to import and distribute the AmplifEYE 2 and 3 in the UK.

The corresponding views of the AmplifEYE are as follows:

In order to determine this issue, Judge Hacon reviewed para 14 of the recitals and arts 3 (1) (a), 4 (1), 5 (1) (b) and (2), 6 (1) (b), 7 (1), 8 (1) and 10 (1) and (2) of the Community Design Regulation (Council Regulation (EC) No 6/2002of 12 December 2001 on Community designs(OJ EC No L 3 of 5.1.2002, p. 1). On art 8 (1) he referred to paras [28] to [36] of Lindner Recyclingtech GmbH v Franssons Verkstäder AB (R 690/2007-3) [2010] ECDR 1, Dyson Ltd v Vax Ltd [2010] ECDR 18, [2011] Bus LR 232, [2010] EWHC 1923 (Pat), [2010] FSR 39, [2011] ECC 9 and Samsung Electronics (UK) Ltd v Apple Inc  [2013] EMLR 10, [2013] FSR 9, [2013} FSR 9, [2012] EWCA Civ 1339, [2013] ECDR 2.  On the scope of design protection, he considered Procter & Gamble Company v Reckitt Benckiser (UK) Ltd [2008] FSR 8, [2008] ECDR 3, [2007] EWCA Civ 936, [2008] Bus LR 801 and Case T-9/07 Grupo Promer Mon Graphic v OHMI and another ECLI:EU:T:2010:96, [2010] ECDR 7, [2010] EUECJ T-9/07, EU:T:2010:96, [2011] Bus LR D13. He mentioned Case T-525/13 H&M Hennes & Mauritz BV & Co. KG v OHIM  EU:T:2015:617; [2015] E.C.D.R. 20 on design freedom 

In the light of those cases his lordship directed himself at para [181] of his judgment that:
"The court must:
(1) Decide the sector to which the products in which the designs are intended to be incorporated or to which they are intended to be applied belong;
(2) Identify the informed user and having done so decide
(a) the degree of the informed user’s awareness of the prior art and
(b) the level of attention paid by the informed user in the comparison, direct if possible, of the designs;
(3) Decide the designer’s degree of freedom in developing his design;
(4) Assess the outcome of the comparison between the RCD and the contested design, taking into account
(a) the sector in question,
(b) the designer’s degree of freedom, and
(c) the overall impressions produced by the designs on the informed user, who will have in mind any earlier design which has been made available to the public.
(5) Features of the designs which are solely dictated by technical function are to be ignored in the comparison.
(6) The informed user may in some cases discriminate between elements of the respective designs, attaching different degrees of importance to similarities or differences. This can depend on the practical significance of the relevant part of the product, the extent to which it would be seen in use, or on other matters."

Applying this methodology to a comparison of the AmplifEYE to RCD number 001856121-0001, he concluded at [205]:
"notwithstanding the wide scope of the Endocuff RCD, the AmplifEYE would produce a different overall impression on the informed user. Significance would be attached to the projecting elements. Apart from anything else, the difference between one and two rows by itself causes the overall impression to be different. The AmplifEYE does not infringe the Endocuff RCD."

However, the Endocuff Vision RCD was different for the Endocuff RCD, After comparing the AmplifEYE with the Endocuff Vision RCD in accordance with the above methodology, the judge held at [214]:
"Considering the designs as whole, given that the Endocuff is part of the design corpus, given the design freedom afforded to the designer illustrated by the alternative designs shown above and taking into account the significance that would be attached by the informed user to the position, length and shape of the projecting elements, in my judgment the AmplifEYE would not produce on the informed user a different overall impression to that produced by the Vision RCD."

It followed that RCD 001856121-0001 had not been infringed but RCD 002523191-0001 had been.  He added at [217] that AmplifEYEs 2 and 3 would not infringe either RCD.

Whether ARC's Unregistered Design Rights had been infringed
ARC claimed that unregistered that design right subsisted in the designs of the Eudocuff and the Endocuff Vision. that it owned those design rights and that that the Cantel companies had infringed them by importing, marketing and distributing the AmpliffEYE attachments in the UK.  The Cantel companies denied that ARC owned the design rights and that the designs had been copied. Even if they had, the companies argued that the designs were excluded from protection by the must fit exemption and that the the AmpliffEYE had not been copied substantially to either design. Finally, they contended that they had no knowledge or reason to believe that the AmpliffEYE was an "infringing article".

After considering s.213 (1) (2) (a) and (b), s.226 (1) and (2), s.227 (1) and s.228 (1), (2) (3) (a) and (b) of the Copyright, Designs and Patents Act 1988 Judge Hacon identified two points of law in dispute:
  • how far can design right protection was excluded altogether by the must fit exception; and
  • what constitutes an article copied substantially to the design.
On the first issue, the judge referred to paras [67] and [68] of his own judgment in Action Storage Systems Ltd v G-Force Europe.Com Ltd and Another  [2016] EWHC 3151 (IPEC), [2017] FSR 18:
“[67] Thus a feature of the design of an article which promotes stable interaction with another article may be excluded from design protection under s.213 (3)(b) (i). That need not be the only function of that article, see the passage from Ocular Sciences quoted above and Dyson Ltd v Qualtex (UK) Ltd [2006] EWCA Civ 166; [2006] RPC 31, at [40]-[44].
[68] There will be a limit to the exclusion of design right protection under this provision. I take the view that the shapes of the relevant parts of the connecting articles must be such that there is a degree of precision in the interrelationship between one article and the other, i.e. the designs afford some precision in the fit. For example, it would be surprising if the handle of a coffee mug were refused design protection solely because it is shaped to enable a human hand to connect to it to pick up the mug. (I use the convenient term ‘fit’ but this does not imply that the articles must touch. Section 213 (3)(b) (i) can apply to features of shape or configuration of an article which enable it to be placed around another article and so there may be a gap between them, see Dyson at [31]-[38]).”

On the second, he considered paras [58] and [59] of his judgment in  DKH Retail Ltd v H. Young (Operations) Ltd [2015] FSR 21, [2014] EWHC 4034 (IPEC):
“[58] In Virgin Atlantic Airways Ltd v Premium Aircraft Interiors Group Ltd [2009] EWHC 26 (Pat); [2009] ECDR 11, Lewison J said this:

33. Although, at least in theory, two separate criteria must be satisfied viz. copying and making articles exactly or substantially to the copied design, it is not easy to conceive of real facts (absent an incompetent copyist) in which a design is copied without the copy being made exactly or substantially to the copied design. In practice, if copying is established, it is highly likely that the infringing article will have been made exactly or substantially to the protected design. If copying is not established, then whether the article is the same or substantially the same as the protected design does not matter. However, similarity in design may allow an inference of copying to be drawn.
[59] In this last paragraph Lewison J drew on what the House of Lords had said in Designers Guild Ltd v Russell Williams (Textiles) Ltd [2001] 1 All ER 700; [2001] FSR 11. Both judgments come close to endorsing “the rough practical test that what is worth copying is prima facie worth protection” without quite going that far. This comes from the judgment of Peterson J in University of London Press Ltd v University Tutorial Press Ltd [1916] 2 Ch 601, at 610, in the context of whether examination papers were original copyright works, though the majority in Ladbroke (Football) Ltd v William Hill (Football) Ltd [1964] 1 WLR 273 (HL) found force in Peterson J’s maxim in the context of copyright infringement (Lord Reid at 279, Lord Hodson at 288 and Lord Pearce at 294.)”

The judge directed himself at para [229] to consider the following questions:
"(1) Whether Arc owned the design rights relied on.
(2) Whether subsistence of the design rights was excluded pursuant to s.213(3)(b)(i) (‘must fit’).
(3) Whether Cantel copied the designs of the Endocuff and/or the Endocuff Vision.
(4) If so, whether the AmplifEYE is an article substantially to either of those designs.
(5) Whether Cantel knew or had reason to believe that AmplifEYE cuffs imported into the United Kingdom were infringing articles, within the meaning of ss.227 and 228 of the Act."
After considering the evidence, he decided all those issues in ARC's favour.  The Cantel companies were entitled to a licence of right in relation to the Endocuff design but not the Endocuff Vision.

Except in respect of the alleged infringement of RCD 001856121-0001 ("the Endocuff RCD") by the AmplifWYE, the claim failed and the counterclaim succeeded. There is a lot of good stuff in this judgment on patents, registered Community designs and unregistered design right, It is rare to find so much law on so many different issues in a single case.  The judgment is closely reasoned and well documented and will not be easy to overturn. 

Further Information
Anyone wishing to discuss this case or patents, design registration or design right generally may call me on 020 7404 5252 or send me a message through my contact form.


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