[Home] [Databases] [World Law] [Multidatabase Search] [Help] [Feedback] | ||
England and Wales High Court (Patents Court) Decisions |
||
You are here: BAILII >> Databases >> England and Wales High Court (Patents Court) Decisions >> Cantel Medical (UK) Ltd v ARC Medical Design Ltd [2018] EWHC 345 (Pat) (23 February 2018) URL: http://www.bailii.org/ew/cases/EWHC/Patents/2018/345.html Cite as: [2018] EWHC 345 (Pat) |
[New search] [Context] [View without highlighting] [Printable PDF version] [Help]
Neutral Citation Number: [2018] EWHC 345 (Pat)
Case No: HP-2016-000047
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
Date: 23/02/2018
Before :
HIS HONOUR JUDGE HACON
(Sitting as a High Court Judge)
- - - - - - - - - - - - - - - - - - - - -
Between :
|
(1) CANTEL MEDICAL (UK) LIMITED (2) CANTEL (UK) LIMITED |
Claimants |
|
- and - |
|
|
ARC MEDICAL DESIGN LIMITED |
Defendant |
- - - - - - - - - - - - - - - - - - - - -
- - - - - - - - - - - - - - - - - - - - -
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
- - - - - - - - - - - - - - - - - - - - -
Judgment Approved
Judge Hacon :
Introduction
4. 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.
10. 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.
12. 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.
13. 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.
The Witnesses
The Experts
Witnesses of Fact
22. 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
23. 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
24. 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.
27. As can be seen, despite the flexibility of the colonoscope, it may be difficult to manage the apparatus so that the tip reaches the caecum. The clinician must rely on his or her skill to push and manoeuvre the colonoscope from outside the patient. Colons vary and advancing the colonoscope beyond a bend may not prove easy.
29. I pause here to mention the terms ‘proximal’ and ‘distal’, much used in the evidence and in the Patent. In simple terms, proximal means nearer and distal means further way. The trouble is that this depends on context. It is conventional to describe the caecal end of the colon as proximal and the anal end as distal. Thus, claim 1 of the Patent refers to ‘proximal surfaces’ of colonic folds, meaning the surfaces facing towards the caecum. However, the terms are often also used from the perspective of the physician located at the anal end of the colon. Relative to the physician, the proximal direction is towards the anus and distal towards the caecum. I will do my best to be clear about which sense of proximal and distal is meant.
Caecal Intubation Rate and Adenoma Detection Rate
30. Two standard clinical markers are used to assess the quality of a series of colonoscopies, for instance a sequence carried out by an individual clinician. The first is known as caecal intubation rate (“CIR”). It refers to how often intubation reached the caecum. The second is the Adenoma Detection Rate (“ADR”), namely the proportion of colonoscopies in which at least one adenoma is found. This is a surrogate marker in that the real measure of success is the proportion of patients who develop colorectal cancer following colonoscopy. But deriving such a measure takes years. ADR has been found to be inversely correlated with post-colonoscopy colorectal cancer rates so it is commonly used to gauge the quality of a clinician’s colonoscopies.
The person skilled in the art
The common general knowledge
The importance attached to CIR
The desire for improved visualisation
34. The idea that clinicians were unconcerned about visualisation until around 2010 does not make intuitive sense. The whole point of colonoscopy is to find polyps and among them adenomas and thus to improve ADR. Since the start of clinicians’ concern about ADR, if not earlier, it must have been the case that there was an implicit wish to improve the visualisation of the mucosal wall afforded by colonoscopes. One of the leading figures in gastroenterology is Dr Douglas Rex. I was shown papers of which he was an author dated from 1997 and 2000 in which the need and means to improve the detection rate of adenomas was discussed. In my view, for more than a decade before the priority date and probably longer, the skilled team would have wished for the best visualisation of the wall of the colon, particularly of the proximal surfaces of the folds, that was feasible.
Prior art caps
The Patent
“Firstly, the anatomy of the colon is such that the lining is thrown into folds. As the tip of the endoscope passes along the lumen of the colon, these folds hamper the endoscope’s ability to visualise the entire surface of the mucosa and in particular, detect pre-malignant and malignant lesions tucked away on the proximal face of these folds during extubation.
Secondly, the position of the tip may be difficult to maintain from the moment at which a lesion or polyp is detected to the completion of any therapeutic procedure. As the colonoscope is withdrawn the tip does not travel back at a constant speed but rather with jerks and slippages particularly when traversing a bend or length of colon where the bowel has been concertinaed over the endoscope shaft during intubation. The tip of the device may, at any moment, slip backwards thereby causing the clinician to lose position. If tip position is lost, the clinician is required to relocate the lesion or polyp for the therapeutic procedure to be continued.”
Claim 1 of the unconditional application to amend
43. Claim 1 in the unconditional application to amend the Patent (which I will call ‘amended claim 1’) is as follows, excluding reference numerals:
“1. A cover for a colonoscope shaft, the cover comprising an elongate tubular member and being arranged for application over a distal tip of the colonoscope shaft with the cover extending along at least a part of the length of a distal end of the shaft, the tubular member comprising an inner surface at least a part of which grips the shaft and holds the cover in place and an outer surface comprising a plurality of spaced projecting elements, characterized in that the spaced projecting elements are hinged and attached to an outer surface of the elongate tubular member, each projecting element having a tip and a base, the projecting elements being moveable about their hinged bases by an angle of between 0o, wherein the tips of the projecting elements point towards a proximal end of the colonoscope, to an angle of 170-180o wherein that the tips of the projecting elements point towards the distal end of the colonoscope or any angle between 0 to 170-180o, wherein the projecting elements are positioned in one or more rings running circumferentially around the cover, and wherein projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
44. One embodiment of such a cover, very like the Endocuff, is shown in figure 11B:
Applications to amend the UK Patent
45. Claim 1 of the unconditional application to amend the UK Patent is in similar, though not identical form to amended claim 1 of the Patent. It raises no additional issues.
46. There is a further and conditional application to amend the UK Patent. Claim 1 of the conditional application, which I will call ‘UK conditionally amended claim 1’ is as follows, with the amendments over claim 1 of the UK unconditional application marked:
“1. A
cover for a colonoscope shaft, the cover comprising an elongate tubular member
and being arranged for application over the colonoscope shaft with the cover
extending along at least a part of the length of a distal end of the shaft, the
tubular member comprising an inner surface at least a part of which grips the
shaft and holds the cover in place and an outer surface comprising a
plurality of 8 evenly spaced projecting elements having a tip and a
base that are moveable between a resting position to a position wherein the tip
of the projecting element is substantially parallel to a longitudinal axis of
the colonoscope and to a position that is at an angle approximately
perpendicular to the longitudinal axis of the colonoscope shaft so that the
projecting elements are fanned out to contact with and provide support for and
to dilate a lumen wall of a colon into which the colonoscope has been inserted,
wherein the projecting elements are constructed of a biocompatible material
so that they are flexible and resiliently deformable and are positioned in one
or more a single rings running circumferentially around the
cover at the distal end of the elongate tubular member, and
wherein the projecting elements in a distal ring are adapted to
flare outwards on withdrawal from the colon to keep the instrument tip in the
central part of the colon as the instrument moves backwards, and to evert
colonic folds enabling their proximal surfaces to be viewed, and wherein the
projecting elements are in the form of tapered bristles.”
Construction
47. There were three points on the construction of amended claim 1.
Adapted to
48. The latter part of the claim states:
“… projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
(Here, the proximal surfaces of the colonic folds are those which at rest face towards the caecum and away from the lens of the colonoscope.)
50. Pausing there, as I said earlier, the Patent states that the invention reduces both the problem of the colonoscope camera viewing the proximal side of folds and also the problem of rapid slide-by. But the final part of claim 1 requires only that the projecting elements are suitable to evert colonic folds enabling their proximal surfaces to be viewed. There is no requirement for any impact on rapid slide-by.
51. Returning to ‘adapted’, in F H Brundle v Perry [2014] EWHC 475 (IPEC) I considered the meaning of a claim which required that the product be ‘adapted in use’ to fulfil a stated function. I said this:
“[45] … I accept that as a matter of ordinary English usage, ‘adapted’ carries a connotation of adaption or modification in design to achieve the purpose stated in the feature. However in my view, like feature (i) these are to be construed such that they contain no subjective element. To my mind it is irrelevant where the designer started and what adaptations were made in the design process.
[46] Because these features must be assessed objectively, it seems to me that ‘adapted to’ and ‘adapted in use to’ mean the same thing as ‘suitable for’. I am reinforced in this view by the judgment of Birss J in Schenck [Schenck Rotec GmbH v Universal Balancing Ltd [2012] EWHC 1920 (Pat)] in which he found ‘constructed to receive’ had the same meaning as ‘suitable for receiving’. As in the present case the relevant claim was a product claim for a mechanical device: for fastening balancing weights to rotors.
[47] I do not say that in the context of other claims it will never be possible to discern a difference between ‘suitable for’ on the one hand and ‘adapted to’ or ‘adapted in use to’, or ‘constructed to’ for that matter, on the other. But I think in this claim the first three mean the same thing.”
54. A similar point arose in the context of the application for the Patent as filed. Here the relevant words were ‘designed to’. The application states (at p.22):
“In use, the distal row of the projecting elements are designed to flare outwards on withdrawal.”
Eversion
56. There is no definition of ‘evert’ in the Patent. Mr Campbell referred me to an OED definition:
“turn (a structure or organ) outwards or inside out.”
57. This gives some idea, but ‘eversion’ of folds during a colonoscopy, though not it seems an established term of art, must be understood in that context. The term is barely used in the Patent. Therefore the explanations given by the experts were particularly helpful.
58. Professor Rees defined the term this way (second witness statement, paragraph 6):
“ ‘Everting’, in the context of colonic mucosal folds, describes what happens when an object makes contact with the surface of the fold, and then gently moves the fold in the distal direction (i.e. towards the anus) so that the proximal side of the fold is turned into the field of vision.”
Tapered bristles
61. A point arose on the construction of UK conditionally amended claim 1, namely the meaning of ‘tapered bristle’. Page 18 of the UK Patent states that Figure 8A shows a projecting element 2 in the form of a bristle:
The prior art
63. There were three items of prior art: two Japanese patents and one United States patent application. Olympus was the proprietor of all three and apparently responsible for all three claimed inventions. The inventor in one of the Japanese patents and in the US application was the same person, Hiroki Moriyama. It was not clear whether the name has been rendered into English with the family name first or second. The parties used ‘Hiroki’ as the abbreviated name for the Japanese patent and ‘Moriyama’ for the US application.
64. In chronological order of filing date, the prior art was:
(1) JP-A-2003-033319A (“Hiroki”);
(2) JP-A-2003-339631A (“Hitoshi”);
(3) US-A-2004/0077926 (“Moriyama”).
Novelty
The law
65. Cantel’s case on novelty rested significantly on implied disclosures in the prior art. I considered implied disclosure in Edwards Lifesciences LLC v Boston Scientific Scimed, Inc [2017] EWHC 405 (Pat):
“[139] … It is not essential that an item of prior art should expressly disclose all the features of an invention for that prior art to deprive the invention of novelty. It may be that one or more integers are disclosed by inference. But this must be an inevitable inference drawn by the skilled person reading the prior art. In Smithkline Beecham Plc’s (Paroxetine Methanesulfonate) Patent [2005] UKHL 59; [2006] RPC 10, Lord Hoffmann, with whom the rest of the House of Lords agreed, considered the observations of Lord Westbury L.C. in Hill v Evans (1862) 31 L.J. Ch (NS) 457 at 463 and those of the Court of Appeal in General Tire and Rubber Co v Firestone Tyre and Rubber Co Ltd [1972] R.P.C. 457, at 485-486. On the facts of Smithkline Beecham Lord Hoffmann was concerned with the knowledge of the author of the prior art, but also emphasised that if the prior art allows even for the possibility that its performance would not result in the claimed invention, it will not deprive that invention of novelty:
“[22] If I may summarise the effect of these two well-known statements, the matter relied upon as prior art must disclose subject-matter which, if performed, would necessarily result in an infringement of the patent. That may be because the prior art discloses the same invention. In that case there will be no question that performance of the earlier invention would infringe and usually it will be apparent to someone who is aware of both the prior art and the patent that it will do so. But patent infringement does not require that one should be aware that one is infringing: “whether or not a person is working [an] … invention is an objective fact independent of what he knows or thinks about what he is doing”: Merrell Dow Pharmaceuticals Inc v H N Norton & Co Ltd [1996] RPC 76, 90. It follows that, whether or not it would be apparent to anyone at the time, whenever subject-matter described in the prior disclosure is capable of being performed and is such that, if performed, it must result in the patent being infringed, the disclosure condition is satisfied. The flag has been planted, even though the author or maker of the prior art was not aware that he was doing so.
[23] Thus, in Merrell Dow, the ingestion of terfenadine by hay-fever sufferers, which was the subject of prior disclosure, necessarily entailed the making of the patented acid metabolite in their livers. It was therefore an anticipation of the acid metabolite, even though no one was aware that it was being made or even that it existed. But the infringement must be not merely a possible or even likely consequence of performing the invention disclosed by the prior disclosure. It must be necessarily entailed. If there is more than one possible consequence, one cannot say that performing the disclosed invention will infringe. The flag has not been planted on the patented invention, although a person performing the invention disclosed by the prior art may carry it there by accident or (if he is aware of the patented invention) by design.”
Hitoshi
70. The straightening process as disclosed in Hitoshi was summarised by Dr East:
“[97] … Figure 6 shows the endoscope being inserted into the colon. Figure 7 shows the physician withdrawing the endoscope (in the direction of the arrow B), causing the projecting fins of the cover to engage with the colon wall, causing the walls behind the tip of the scope to concertina, and the colon itself to straighten. Figure 8 shows the result of the physician continuing to pull the endoscope back from the position in Figure 7, further concertinaing the wall behind the scope tip and straightening both the colon and the colon wall ahead.
[98] The purpose of the projecting fins is to provide traction against the colon wall. The force exerted by the projecting fins on the colon wall through the physician pulling the scope backwards, causes both the walls of the colon to be drawn back (see Figure 7) and straightens the colon ahead of the scope (see Figure 8). This enables the physician to recommence intubation.”
71. Arc argued that Hitoshi did not disclose the final part of claim 1 of the Patent:
“… and wherein projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
72. The issues were whether the projecting fins disclosed by Hitoshi were:
(a) adapted to flare outwards on withdrawal of the instrument from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards; and
(b) adapted to evert colonic folds enabling their proximal surfaces to be viewed.
73. Cross-examination and argument were directed to whether the projecting fins of Hitoshi were
(1) located sufficiently at the distal end of the endoscope (from the clinician’s perspective) to satisfy (b); and
(2) of a length, shape and flexibility to satisfy both (a) and (b).
Cantel’s argument
75. If there were any doubt about this, the argument continued, one need only compare Figures 6-8 of Hitoshi with Figure 12C of the Patent. Figure 12C showed eversion of folds and visualisation during withdrawal using a cover within amended claim 1. It was in all material respects the same as what was shown in Figures 6-8 of Hitoshi:
Discussion
“The clear difference is between intubation and extubation. In intubation, you advance, deflate, advance, deflate. You suck, suck, suck because the more air you put in, the more you stretch the colon and the harder it is to get round and the more it loops. In extubation, it is very important that you inflate to stretch the lining of the colon.”
“… would have needed to be nearer the distal end of the scope in order to be able to manoeuvre the colonic folds in a way which the folds could be visualised, they would also have needed to be longer, softer, more flexible (since the eversion of the folds would be taking place when the colon was expanded rather than deflated and their function would no longer be to tightly grip) and narrower (so as not to block the potential view of the proximal surfaces of the folds).” (para. 188)
79. Dr East, when comparing Hitoshi with the Patent, said nothing about inflation or deflation. And they were not put to him in cross-examination. Mr Campbell submitted that accordingly the whole matter of intubation and withdrawal of the colon had not been established on the evidence.
“3. Deflate the colon (without losing the view) to shorten it and make it as pliable as possible.”
83. Earlier, in cross-examination, Dr East had maintained that the level of grip of the projecting fins in Hitoshi would serve to evert colonic folds on withdrawal as claimed in the Patent. In fact he said that he found it difficult to conceive that they would not (day 2, 183-184). However, he might have said this having ignored deflation and inflation, or possibly he was making some other unstated assumption.
85. I find that the skilled team reading Hitoshi would have taken the technique represented in Figures 6-8 to be a process carried out in a deflated colon, whereas visualisation during withdrawal, as contemplated in the Patent and shown in Figure 12C, will be carried out in an inflated colon.
86. I accept what Professor Rees said in paragraph 198 of his first witness statement:
“The projections which were suitable for gripping the colon wall for the purposes of concertinaing the deflated colon during the intubation phase would not be suitable for improving visualisation of the colon walls during the withdrawal phase.”
87. Putting this another way (going back to Professor Rees’s paragraph 188 quoted above) the skilled team would have understood the projecting fins of Hitoshi to be of a length, shape, flexibility and a position relative to the end of the endoscope cuff such that they were suitable for gripping the colon wall during intubation. It is far from inevitable that such projecting elements would satisfy the requirements of amended claim 1 of the Patent.
88. The third difficulty with Cantel’s argument is that it is not legitimate to compare Figures 6-8 of Hitoshi with Figure 12C of the Patent and conclude that they are delivering the same information just because they look similar. Figures in a patent are as much part of the patent’s disclosure as any other. But they are generally diagrammatic, as in Hitoshi and the Patent. They are to be interpreted by reference to their respective written descriptions.
90. The skilled team looking at Figure 12C in the Patent would similarly understand that the projecting elements are not illustrated with precision. The team would have in mind the idea that the elements must be of length, shape, flexibility and position suitable for everting the colonic folds during withdrawal, so as to improve visualisation of the proximal surfaces.
91. The information that the skilled person would derive from Figures 6-8 of Hitoshi is not the same as that which would be derived from Figure 12C of the Patent.
92. For those three reasons I find that amended claim 1 is not anticipated by Hitoshi.
Hiroki and Moriyama
Inventive step
The law
96. Mr Alexander referred to Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819; [2010] RPC 33, particularly the passage in which Jacob LJ quotes with approval the list of questions set out by Laddie J in Haberman v Jackel International Ltd [1999] FSR 683, at 699-701. Leaving out the annotations, they were:
(a) What was the problem the patented development addressed?
(b) How long had that problem existed?
(c) How significant was the problem seen to be in the trade?
(d) How widely known was the problem and how many were likely to be seeking a solution?
(e) What prior art would have been likely to be known to all or most of those who would have been expected to be involved in finding a solution?
(f) What other solutions were put forward in the period leading up to the publication of the patentee’s development?
(g) To what extent were there factors which would have held back the exploitation of the solution even if it was technically obvious?
(h) How well has the patentee’s development been received commercially?
(i) To what extent can it be shown that the whole or much of the commercial success is due to the technical merits of the development, i.e. because it solves the problem.
97. To these, Jacob LJ in Schlumberger (at [81] to [83]) added two further questions:
(j) What was the reaction of experts at the time of the invention, both before and after?
(k) Has another party thought the development sufficiently important to apply itself to patent the development?
102. There can sometimes be a broad-brush assumption that the parties would not be spending time and money litigating the patent in suit if the claimed invention were not of commercial value and that the commercial potential must have been apparent in the industry at the priority date. The preliminary questions are then presumed answered and possibly also (c). Such a presumption, if adopted, is plainly rebuttable.
103. In the present case there was no evidence directly addressing the commercial appreciation of those in the industry at the priority date regarding the technical development claimed in the Patent. There was an answer given in passing by Mr Hansen, now CEO of Cantel, in which he said that when Cantel distributed the Endocuff, they did so at a loss. But the fact of this litigation suggests that the parties today believe that Arc’s claimed invention has commercial value. Also, I have found that for at least a decade before the priority date the skilled team would have wished for the best feasible visualisation of the wall of the colon, particularly of the proximal surfaces of the folds. The evidence as a whole gives me no reason to doubt that at the priority date those in the industry would have believed that a device which improved visualisation in such a way would be of potential commercial value. The two preliminary questions are answered. The others (apart from (h) and (i)) are relevant to the assessment of inventive step in this case.
The two arguments on inventive step
Hitoshi – amended claim 1
121. This is also consistent with what happened at the start of the Endocuff project. The history of a claimed invention can be another matter to be added to the non-exhaustive list of factors which a court may take into account by way of secondary evidence. Mr Axon explained in cross-examination (day 5, 592-5) that a prototype called ‘Bog Brush 1’, a name which would reassure any patient, was used on Mr Axon’s forgiving father. Bog Brush 1 had been created to improve caecal intubation rates, not ADR. It was happenstance that Mr Axon noticed that a cuff of this design improved visualisation of the colonic folds during withdrawal. Though I give it less weight, what Mr Axon did not expect would probably not have been expected by the skilled team either.
122. I find that amended claim 1 does not lack inventive step over Hitoshi.
Hiroki – amended claim 1
Moriyama – amended claim 1
125. Cantel relied on Figure 5 of Moriyama:
Conclusion on amended claim 1 and inventive step
128. Amended claim 1 does not lack inventive step over any of the prior art.
Conditional amendment to claim 1 of the UK Patent
(i) 8 evenly spaced projecting elements, as opposed to a plurality of them;
(ii) the 8 elements should be in the form of tapered bristles.
134. In my view, UK conditionally amended claim 1 is not separately inventive over claim 1 of the unconditional application to amend the UK Patent.
Other claims
Added matter
The law
136. The law on added matter was reviewed by Floyd LJ (with whom Longmore and Lewison LJJ agreed) in AP Racing Ltd v Alcon Components Ltd [2014] EWCA Civ 40; [2014] RPC 27:
“[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.’”
137. Intermediate generalisations were explained by Kitchin LJ (with whom Laws and Etherton LJJ agreed) in Nokia Corporation v IPCom GmbH & Co KG [2012] EWCA Civ 567; [2013] RPC 5.
138. In the present case Arc raised a general and primary defence to Cantel’s allegations of added matter. It was that Cantel had confused the scope of a claim with disclosure. I discussed this in Edwards Lifesciences at [227] to [232], relying in particular on what Floyd LJ said in AP Racing. For the reasons given in Edwards Lifesciences, I will also here assume that a claim covering an embodiment would imply to the skilled addressee that the invention as disclosed in the Patent includes such an embodiment.
Objections raised to amended claim 1
139. Cantel drew attention to the final part of the claim:
“… wherein the projecting elements in a distal ring are adapted to flare outwards on withdrawal from the colon to keep the instrument tip in the central part of the colon as the instrument moves backwards, and to evert colonic folds enabling their proximal surfaces to be viewed.”
(1) If ‘adapted’ means more than ‘suitable for’, the claim adds matter.
(2) The application as filed is silent as to how the projecting elements are adapted to flare outwards in use.
(3) The limitation in the claim that the projecting elements “in a distal ring” are adapted to flare outwards adds matter.
“…the projecting elements being moveable about their hinged bases by (a) an angle of between 0o, wherein the tips of the projecting elements point towards a proximal end of the colonoscope, to an angle of 170-180o wherein that the tips of the projecting elements point towards the distal end of the colonoscope or (b) any angle between 0 to 170-180o, …”
142. Cantel’s further argument, not one raised by the Comptroller, was:
(4) The alleged support for this part of the claim is at page 11 of the application as filed, penultimate paragraph. However the disclosure in the application was limited to a preferred embodiment having further limitations. That context has been abandoned in amended claim 1 and therefore constitutes an intermediate generalisation.
Discussion
144. With regard to the second, the application as filed includes the following at page 22:
“In use, the distal row of the projecting elements are designed to flare outwards on withdrawal. They keep the instrument tip in the central part of the bowel lumen as the instrument moves backwards, gently holding the mucosa to prevent the tip from flipping backwards, they maintain position during therapy and improve all-round visualisation. During extubating they evert the folds enabling their proximal surface to be viewed.”
Objections raised to UK conditionally amended claim 1
(1) tapered bristles, nor
(2) 8 evenly spaced elements positioned in a single ring at the distal end of the elongate tubular member.
Conclusion on added matter
152. Amended claim 1 does not disclose added subject-matter. UK conditionally amended claim 1 does.
Lack of clarity
Amended claim 1
154. Cantel also adopted an objection raised by the Comptroller in the IPO’s letter of 5 October 2017 which applies only to the proposed unconditional amendment to claim 1 of the UK Patent: it is not clear how the requirement that the projecting elements are to ‘flare outwards’, introduced by the proposed amendment, differs from the earlier requirement in the claim that the projecting elements are, in a certain position, ‘fanned out’. In my view, the skilled person reading the specification as a whole would understand that projecting elements flared out means the same thing as projecting elements fanned out. For neatness, within claim 1 it would be better to stick to one term or the other, but I see no formal lack of clarity.
UK conditionally amended claim 1
155. No objections were raised other than those made in relation to added matter.
Lack of support
Amended claim 1
UK conditionally amended claim 1
158. No objections were raised other than those made in relation to added matter.
Infringement
159. In their closing submissions Cantel did not submit that any version of the AmplifEYE fell outside the claims of the Patent and the UK Patent as unconditionally proposed to be amended.
Conclusion on the Patent case
160. Arc has permission to amend the Patent and the UK Patent in the forms of the unconditional applications to amend. In those forms both Patents are valid and infringed.
Registered Community Designs
163. Arc alleges that both are infringed by sales of Cantel’s AmplifEYE, which looks like this:
The Regulation
Recital 14:
The assessment as to whether a design has individual character should be based on whether the overall impression produced on an informed user viewing the design clearly differs from that produced on him by the existing design corpus, taking into consideration the nature of the product to which the design is applied or in which it is incorporated, and in particular the industrial sector to which it belongs and the degree of freedom of the designer in developing the design.
Article 3(1)(a):
… “design” means the appearance of the whole or a part of a product resulting from the features of, in particular, the lines, contours, colours, shape, texture and/or materials of the product itself or its ornamentation.
Article 4(1):
A design shall be protected by a Community design to the extent that it is new and has individual character
Article 5:
1. A design shall be considered to be new if no identical design has been made available to the public:
…
(b) in the case of a registered Community design, before the date of filing of the application for registration of the design for which protection is claimed, or, if priority is claimed, the date of priority.
2. Designs shall be deemed to be identical if their features differ only in immaterial details.
Article 6:
1. A design shall be considered to have individual character if the overall impression it produces on the informed user differs from the overall impression produced on such a user by any design which has been made available to the public:
…
b) in the case of a registered Community design, before the date of filing the application for registration or, if a priority is claimed, the date of priority.
2. In assessing individual character, the degree of freedom of the designer in developing the design shall be taken into consideration.
Article 7:
1. For the purpose of applying Articles 5 and 6, a design shall be deemed to have been made available to the public if it has been published following registration or otherwise, or exhibited, used in trade or otherwise disclosed, before the date referred to in Articles 5(1)(a) and 6(1)(a) or in Articles 5(1)(b) and 6(1)(b), as the case may be, except where these events could not reasonably have become known in the normal course of business to the circles specialised in the sector concerned, operating within the Community.
Article 8
1. A Community design shall not subsist in features of appearance of a product which are solely dictated by its technical function.
Article 10:
1. The scope of the protection conferred by a Community design shall include any design which does not produce on the informed user a different overall impression.
2. In assessing the scope of protection, the degree of freedom of the designer in developing his design shall be taken into consideration.
The case law
Solely dictated by technical function – art.8(1)
166. It has been held by what was then the OHIM Board of Appeal that art.8(1) of the Design Regulation deprives a feature of protection solely where the need to achieve the product’s technical function was the only relevant factor when the feature in question was selected to be part of the overall design. If aesthetic consideration played any part, art.8(1) does not bite. This is to be assessed objectively from the standpoint of a reasonable observer. See Lindner Recyclingtech GmbH v Franssons Verkstäder AB (R 690/2007-3) [2010] ECDR 1, at [28] to [36].
167. Lindner was followed by Arnold J in Dyson Ltd v Vax Ltd [2010] EWHC 1923 (Pat); [2010] FSR 39, at [31] and apparently also approved by the Court of Appeal in Samsung Electronics (UK) Ltd v Apple Inc [2012] EWCA Civ 1339; [2013] FSR 9, at [31].
Scope of protection – art.10
Comparison with the design corpus
169. A registered Community design (“RCD”) which is markedly different from any member of the design corpus will confer protection of a scope greater than would be conferred by a RCD only incrementally different from a member of the design corpus, see Procter & Gamble Co v Reckitt Benckiser (UK) Ltd [2007] EWCA Civ 936; [2008] FSR 8, at [35(ii)].
170. Designs which are strikingly new in every way will be unusual. More often some features will be commonly found in the design corpus, others not. In such a case the correct approach is to give little or no weight to common features. In Grupo Promer Mon Graphic SA v OHIM (Case T-9/07) EU:T:2010:96; [2010] ECDR 7, the General Court said at [72]:
“… in so far as similarities between the designs at issue relate to common features…, those similarities will have only minor importance in the overall impression produced by those designs on the informed user.”
Designer freedom
171. The designer in question is the designer of the RCD, whether considering freedom of design under art.6, see Proctor v Gamble Co v Reckitt Benckiser (UK) Ltd [2006] EWHC 3154 (Ch); [2007] FSR 13 at [42], or under art.10, see Dyson Ltd v Vax Ltd [2011] EWCA Civ 1206; [2012] FSR 4, at [18].
172. The General Court discussed designer freedom in H&M Hennes & Mauritz BV & Co. KG v OHIM (Case T-525/13) EU:T:2015:617; [2015] E.C.D.R. 20 and placed it in the context of the whole assessment of overall impression:
“[28] As regards the degree of freedom of the designer of a design, it is apparent from the case law that that is determined, inter alia, by the constraints of the features imposed by the technical function of the product or an element thereof, or by statutory requirements applicable to the product. Those constraints result in a standardisation of certain features, which will thus be common to the designs applied to the product concerned (judgment of 9 September 2011 in Kwang Yang Motor Co Ltd v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM) - Honda Giken Kogyo (Internal combustion engine) (T-10/08), judgment of 9 September 2011, not yet reported, [2011] EUECJ T-10/08, at [32], and judgment in Wristwatch case EU:T:2013:214 at [112]).
[29] Therefore, the greater the designer’s freedom in developing a design, the less likely it is that minor differences between the designs at issue will be sufficient to produce different overall impressions on an informed user. Conversely, the more the designer’s freedom in developing a design is restricted, the more likely it is that minor differences between the designs at issue will be sufficient to produce different overall impressions on an informed user. Consequently, if the designer enjoys a high degree of freedom in developing a design, that reinforces the conclusion that designs that do not have significant differences produce the same overall impression on an informed user (judgments in Internal combustion engine at [33], and Wristwatch case EU:T:2013:214 at [113]).
[30] In the present case, the Board of Appeal correctly found that, in the context of fashion items like handbags, the designer’s degree of freedom was high. Moreover, the applicant does not contest that assessment. However, it submits, in essence, that the Board of Appeal erred inasmuch as the ‘freedom of the designer’ test should have been an integral part of the analysis of the individual character of the contested design and that the Board of Appeal inverted the steps involved in that analysis. Accordingly, the applicant maintains that the Board of Appeal’s approach of, first, comparing the two designs at issue in order to conclude that they did not produce the same overall impression on the informed user and, secondly, examining the argument relating to the freedom of the designer, is incorrect. Furthermore, it takes the view that the differences between the designs at issue are not significant enough to produce a different overall impression on the informed user.
[31] First, it must be stated that a ‘two-step test’, such as advocated by the applicant, is not required by either the applicable legislation or the case law.
[32] The text of art.6 of Regulation 6/2002, concerning the assessment of individual character, lays down, in para.1 thereof, the criterion of the overall impression produced by the designs at issue and states, in para.2, that the degree of freedom of the designer must be taken into consideration for those purposes (see para.20 above). It is apparent from those provisions, and in particular from art.6(1)(b) of Regulation 6/2002, that the assessment of the individual character of a Community design is the result, in essence, of a four-stage examination. That examination consists in deciding upon, first, the sector to which the products in which the design is intended to be incorporated or to which it is intended to be applied belong; secondly, the informed user of those products in accordance with their purpose and, with reference to that informed user, the degree of awareness of the prior art and the level of attention in the comparison, direct if possible, of the designs; thirdly, the designer’s degree of freedom in developing his design; and, fourthly, the outcome of the comparison of the designs at issue, taking into account the sector in question, the designer’s degree of freedom and the overall impressions produced on the informed user by the contested design and by any earlier design which has been made available to the public (see, to that effect, judgment of 7 November 2013 in Budziewska v Office for Harmonisation in the Internal Market (Trade Marks and Designs) (OHIM) - Puma (Bounding feline) (T-666/11) EU:T:2013:584 at [21] and the case law cited).
[33] As is apparent from the case law and from the case law cited in [29] above and referred to by the applicant itself, the factor relating to the designer’s degree of freedom may ‘reinforce’ (or, a contrario, moderate) the conclusion as regards the overall impression produced by each design at issue. It is not apparent either from the alleged pattern which the applicant identifies in the case law or even from the extract from the judgment of the Bundesgerichtshof (Federal Court of Justice, Germany) reproduced in para.29 of the application that the assessment of the designer’s degree of freedom constitutes a preliminary and abstract step in the comparison of the overall impression produced by each design at issue.”
“[23] … according to the case-law cited in paragraph 19 above, the designer’s degree of freedom may be limited by the constraints of the features imposed by the technical function of the product or by statutory requirements applicable to the product. However, a general design trend cannot be regarded as a factor that restricts the designer’s freedom (Joined Cases T‑83/11 and T‑84/11 Antrax It v OHIM – THC (Radiators for heating) [2012] ECR, paragraph 95).”
Whether the informed user discriminates between elements of the design
178. This seems to be what the General Court had in mind in Sachi Premium-Outdoor Furniture Lda v OHIM (T-357/12) EU:T:2014:55. A design for armchairs and loungers was alleged to be invalid over an earlier design for the same products. The Board of Appeal had found that the only relevant difference between the two designs in issue was that the later design included three cushions:
“[37] In the contested decision, the Board of Appeal took account of the fact that the cushions were not a fixed element, but elements that were easily separated from the main product, and that they were often sold and purchased separately, at a relatively low cost compared to that of the structure of an armchair. It inferred therefrom that those factors decreased the importance that could be attributed to the cushions in assessing the overall impression and that the informed user would attribute far more importance to the overall impression produced by the structures of the armchairs. The Board of Appeal added that the informed user might perceive the cushions as a mere optional accessory and that they could hardly be considered to be ‘a significant part of the design’.
[38] The Board of Appeal was right in taking the view that, because they are not fixed, the informed user will perceive the cushions as less important and be more sensitive to the overall structure of armchairs. It found that the overall impression produced by the designs at issue was dominated by the structure of the armchairs itself and not by the cushions, which could be regarded as secondary elements. Contrary to what the applicant claims, it is not irrelevant to assessing the individual character of the contested design that the cushions are removable elements.”
Summary of the approach to comparison of overall impressions
(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.
Discussion
The relevant sector
183. The relevant sector is colonoscopy.
The informed user
The design corpus
The level of attention paid by the informed user in the comparison
Solely dictated by technical function
190. I reject this. The evidence convincingly showed that, viewed objectively, aesthetic considerations would be seen to have played a part in the design of all the features of both RCDs. Although the most important considerations when designing a cover for a colonoscope will be functional, it was clear that the designer will always also have in mind aesthetic considerations. Clinicians resist using a product that might cause concern to a patient about to receive it. The experts were agreed on this. Professor Rees said that “aesthetics are really, really important” (day 3, 381). Dr East said that what the products look like mattered in terms of their acceptability to both medics and patients (day 2, 211).
Designer freedom
195. Mr Campbell’s suggested less rigid constraints are barely constraints at all.
Whether any elements of the designs would be accorded particular significance
200. It emerged from the evidence, as appears from my discussion above in relation to the Patent, that the key design features of products such as the Endocuff, Endocuff Vision and AmplifEYE are the position, length and shape of the projecting elements. In my view the informed clinician would be alive to this and therefore those aspects of the designs would be accorded particular weight in the overall impression they produce.
Overall impression of the Endocuff RCD compared with the design corpus
Overall impression of the AmplifEYE compared with the Endocuff RCD
203. Cantel relied on the following differences between the Vision RCD and the AmplifEYE:
(a) The shapes of the projections.
(b) The lack of slits in the barrel of the AmplifEYE.
(c) The raised internal surface pattern in the barrel of the AmplifEYE.
(d) The cog-like indentations of the inner surface of the barrel of the Vision RCD, absent from the AmplifEYE.
Overall impression of the Vision RCD compared with the Endocuff RCD
Overall impression of the AmplifEYE compared with the Vision RCD
(1) They are longer in the AmplifEYE.
(2) The elements in the AmplifEYE have rounded tips.
(3) In plan view, the projecting elements in the AmplifEYE are elongated triangles whereas those of the Vision RCD are more rectangular.
(4) In side view, the projecting elements of the AmplifEYE have a constant cross-section whereas those of the Vision RCD taper.
211. As against those, aside from the similarity in length of the projecting elements:
(1) The designs have the same number of projecting elements (eight).
(2) The projecting elements are evenly spaced around a single ring.
(3) The single ring is located near the distal end of the central barrel.
(4) The projecting elements are tapered with rounded ends.
(5) The projecting elements are at a similar angle to the central barrel in side view (in the case of the AmplifEYE, the resting angle).
“I would accept that they look similar and there are no two ways about that, …” (day 4, 408)
215. The AmplifEYE infringes the Vision RCD.
AmplifEYEs 2 and 3
UK Unregistered Design Right
The Act
219. The relevant provisions of the Copyright, Designs and Patents Act 1988 (“the Act”), as amended, are these:
“213 Design right.E+W+S+N.I.
(1) Design right is a property right which subsists in accordance with this Part in an original design.
(2) In this Part “design”
means the design of any aspect of the shape or configuration (whether
internal or external) of the whole or part of an article.
(3) Design right does not subsist in—
(a) a method or principle of construction,
(b) features of shape or configuration of an article which —
(i) enable the article to be connected to, or placed in, around or against, another article so that either article may perform its function,
…
226 Primary infringement of design right.E+W+S+N.I.
(1) The owner of design right in a design has the exclusive right to reproduce the design for commercial purposes —
(a) by making articles to that design, or
(b) by making a design document recording the design for the purpose of enabling such articles to be made.
(2) Reproduction of a design by making articles to the design means copying the design so as to produce articles exactly or substantially to that design, and references in this Part to making articles to a design shall be construed accordingly.
…
227 Secondary infringement: importing or dealing with infringing article.E+W+S+N.I.
(1) Design right is infringed by a person who, without the licence of the design right owner —
(a) imports into the United Kingdom for commercial purposes, or
(b) has in his possession for commercial purposes, or
(c) sells, lets for hire, or offers or exposes for sale or hire, in the course of a business,
an article which is, and which he knows or has reason to believe is, an infringing article.
…
228 Meaning of “infringing article”.E+W+S+N.I.
(1) In this Part “infringing article”, in relation to a design, shall be construed in accordance with this section.
(2) An article is an infringing article if its making to that design was an infringement of design right in the design.
(3) An article is also an infringing article if —
(a) it has been or is proposed to be imported into the United Kingdom, and
(b) its making to that design in the United Kingdom would have been an infringement of design right in the design or a breach of an exclusive licence agreement relating to the design.
… ”
Points of law in dispute
221. The first concerned whether Arc was relying impermissibly on rights in abstractions of designs. I discussed this part of the law in Action Storage Systems Ltd v G-Force Europe.Com Ltd [2016] EWHC 3151 (IPEC); [2017] FSR 18, at [9]-[16] and [52]-[56]. I repeated a view given in DKH Retail Ltd v H Young Operations Ltd [2014] EWHC 4034 (IPEC); [2015] FSR 21, that the deletion of the words ‘any aspect of’ from section 213(2) of the Act (marked in the subsection as set out above) by s.1(1) of the Intellectual Property Act 2014 probably removed any right there may have been to claim unregistered design right in abstractions of a design, i.e. anything other than the precise design of an article which exists or has existed. I went on in Action Storage to say that the same result may in any event be achieved by the effect of s.213(3)(a). As I indicated, neither view is free from argument although Arnold J has agreed with the first in Whitby Specialist Vehicles Ltd v Yorkshire Specialist Vehicles Ltd [2014] EWHC 4242 (Pat); [2016] FSR 5, at [41] and the second is drawn from Mann J’s judgment in Rolawn Ltd v Turfmech Machinery Ltd [2008] EWHC 989 (Pat); [2008] RPC 27, at [79]-[80] and [93]-[94].
223. Next, Mr Campbell referred to was what has been called a claim to a ‘dynamic design right’. Where a design right is claimed in article with moving parts may the owner claim rights to the design in any of its potential configurations? In Neptune (Europe) Ltd v DeVol Kitchens Ltd [2017] EWHC 2172; [2018] FSR 3, a case about kitchen units, Henry Carr J took the view that it would not be possible to consider the functionality of moving parts if their dynamic features were excluded from consideration, at [61]. Dynamic design rights, if there are any here, were not part of Arc’s case.
226. Turning back to the law on Cantel’s primary point, I discussed the ‘must fit’ objection to design right in Action Storage. I referred to Ocular Sciences Ltd v Aspect Vision Care Ltd [1997] RPC 289:
“[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]).”
“[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 remaining issues
229. The remaining points in issue were:
(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.
Ownership
232. I find that the unregistered design rights are owned by Arc.
Must fit
Whether Cantel copied
The evidence
“We really cannot come out with a Endocuff clone, nor do we want to. I think that it is reasonable for us to incur the cost of three molds and the parts …”
“AmplifEYE is directly based on and substantially equivalent to…Arc Endocuff…and Arc Endocuff Vision”
The form did not say that the AmplifEYE was based on any other product.
Conclusion on copying
Whether the AmplifEYE is an article substantially to either of Arc’s designs
Knowledge or reason to believe
Conclusion on UK unregistered design rights
Overall Conclusion
254. Arc has permission to amend the UK designation of the Patent and the UK Patent in the form of the respective unconditional applications to amend. Both Patents are valid and infringed. Infringement has occurred by acts done in relation to the AmplifEYE and would occur by acts done in relation to AmplifEYEs 2 or 3.