COURT OF APPEAL (CIVIL DIVISION)
ON APPEAL FROM THE HIGH COURT OF JUSTICE
CHANCERY DIVISION (PATENTS COURT)
The Hon Mr Justice Arnold
Strand, London, WC2A 2LL
B e f o r e :
THE RT HON LORD JUSTICE JACOB
THE HON MR JUSTICE KITCHIN
| KCI Licensing Inc
KCI Medical Resources
KCI Medical Limited
Appellants by cross- appeal
|- and -
|Smith & Nephew plc
Smith & Nephew Inc
Smith & Nephew Medical Limited
Smith & Nephew Healthcare Limited
|Defendants/Appellants/Respond-ents to cross- appeal
for the Claimants/Respondents
James Mellor QC and Andrew Lykiardopoulos (instructed by Bristows)
for the Defendants/Appellants
Hearing dates: 18/19 October 2010
Crown Copyright ©
Lord Justice Jacob:
i) the Patents are entitled to the priority date claimed;
ii) S&N's attacks on the validity of claim 5 of '504 and claims 7 and 8 of '950 failed;
iii) S&N's GO and EZ pumps and canisters fall within the scope of the relevant parts of claim 5 of '504 and claims 7 and 8 of '950;
iv) S&N have infringed claim 5 of '504 pursuant to section 60(2) of the Patents Act 1977 by sales of the GO pumps and canisters;
v) S&N have infringed claims 7 and 8 of '950 pursuant to section 60(2) of the Act by sales of the EZ canisters, but not by sales of the GO canisters.
i) Does the GO system infringe claim 5 of '504 and, in particular, does it have:
a) "means for detecting when the canister is substantially filled with liquid and generating a signal which causes the pump to be deactivated", and
b) "a guide for aligning the container in a recess in the housing such that the suction port is connected to the pump"?
ii) Were sales of the GO canisters intended to put the inventions of claims 7 and 8 of '950 into effect within the meaning of section 60(2)?
iii) In relation to obviousness:
a) whether it was obvious in 1994 to use reticulated foam as the dressing for NPWT - the invention of claim 5 of '504 and claim 8 of '950. S&N sought permission to appeal.
b) whether it was obvious in 1994 to put a gel-forming substance in the canister to prevent spillage of liquid – the invention of claim 7 of '950. Again, S&N sought permission to appeal.
Applicable legal principles
 It follows that, even if information is neither disclosed by a specific item of prior art nor common general knowledge, it may nevertheless be taken into account as part of a case of obviousness if it is proved that the skilled person faced with the problem to which the patent is addressed would acquire that information as a matter of routine. For example, if the problem is how to formulate a particular pharmaceutical substance for administration to patients, then it may be shown that the skilled formulator would as a matter of routine start by ascertaining certain physical and chemical properties of that substance (e.g. its aqueous solubility) from the literature or by routine testing. If so, it is legitimate to take that information into account when assessing the obviousness of a particular formulation. But that is because it is obvious for the skilled person to obtain the information, not because it is common general knowledge.
Where the application of a legal standard such as negligence or obviousness involves no question of principle but is simply a matter of degree, an appellate court should be very cautious in differing from the judge's evaluation per Lord Hoffmann in Biogen v Medeva  RPC 1 at p.45
The skilled team, prior art and common general knowledge
"The screen means is placed over substantially the expanse of the wound to prevent its overgrowth. The size and configuration of the screen can be adjusted to fit the individual wound. It can be formed from a variety of porous semi-rigid materials. The material must be sufficiently porous to allow oxygen to reach the wound, and sufficiently rigid to prevent wound overgrowth. Most preferred is the use of an open-cell polymer foam, which permits direct connection of the screen means to the vacuum means through a flexible hose inserted into the foam. Such foam can vary in thickness and rigidity, although it is preferred that a spongy material be used for the patient's comfort if the patient must lay [sic] upon the device during its operation. It can also be perforated to reduce its weight. Another embodiment comprises a section of honeycombed polyethylene sheet cut to the shape of the wound." (83-19).
"Suitable vacuum means includes any suction pump capable of providing at least 0.1 pound suction to the wound, and preferably up to 3 pounds suction, and most preferably up to 14 pounds suction, and a flexible hose that leads from the pump to a point within the pressurized volume created by the sealing means. The pump can be any ordinary suction pump suitable for medical purposes that is capable of providing the neces[s]ary suction. The dimension [sic] of the tubing are limited only by the pump's ability to provide the suction level neede[d] for operation. A 1/4 inch diameter tube has proven suitable. The vacuum means may operate substantially continuously, or may operate cyclically with alternate periods of application and nonapplication of pressure to the wound." (836-913).
The removable canister slides into the aperture on the right.
It does not go wholly in – part sticks out.
"In accordance with the present invention, there is provided a therapeutic apparatus for stimulating healing of wounds, said apparatus including a housing that contains a vacuum pump and a chamber for holding a disposable wound drainage collection canister. The canister preferably resides within the chamber and connects at an outlet with the vacuum pump and at an inlet with a porous pad." (158-27).
"Microcontroller 72 controls pump motor 83 by varying the amount of voltage received by pump motor 83. That is, microcontroller 72 receives the 12V DC signal from DC power supply 71 and outputs a voltage between 0 and 12V DC to pump motor 83 to control its speed in accordance with the user selected vacuum pump pressure value. Accordingly, microcontroller 72 employs feedback to ensure that the wound experiences the user selected vacuum pump pressure. If the target pressure is not reached after a period of five minutes, microcontroller 72 deactivates motor 83 and sounds the audible alarm. Additionally, the feedback signal prevents maximum vacuum pump pressure from being exceeded. If the wound pressure measured by transducer 75 exceeds a maximum safe vacuum pump pressure, microcontroller 72 deactivates pump motor 83." (1136-52).
Note that the passage is also concerned with what happens if the desired pressure is not reached (in the example after 5 minutes). The motor is "deactivated" and an alarm sounded. Clearly here and in all other contexts in the body of the specification, as the judge accepted, "deactivated" means switched off.
"Control system 70 includes fill sensor 64 to provide a signal to microcontroller 72 that indicates when canister 19 is completely filled with wound fluids. After receiving a signal from fill sensor 64, microcontroller 72 deactivates pump motor 83 and fan 74 and activates alarm 95 to signal the user that canister 19 must be replaced." (127-14)
 a therapeutic apparatus for stimulating healing of a wound in mammals which comprises
 a porous pad which is permeable to fluids for introduction into the wound,
 a dressing for covering the wound and providing an air-tight seal therearound,
 a drainage tube connecting the pad to a suction pump contained in a housing so that negative pressure can be applied to the wound, to draw fluids therefrom,
 said tube being connected to the pump via a disposable canister for collecting fluids sucked from the wound,
 said canister having an inlet connected to the drainage tube and a suction port connected to the pump,
 said suction port incorporating a filter to prevent passage of liquid therethrough
 and said canister and said housing having a guide for aligning the container in a recess in the housing such that the suction port is connected to the pump,
 a latch for engaging with and releasably holding the canister in the recess and
 means for detecting when the canister is substantially filled with liquid and generating a signal which causes the pump to be deactivated.
 wherein said pad is a polymer foam having interconnecting cells.
 wherein the foam is a reticulated foam having at least 90% of interconnecting cells.
 A disposable canister for use in wound dressing treatment apparatus comprising a wound dressing pad and a suction pump for applying negative pressure to the wound dressing pad,
 said canister comprising a moulded plastics container having an inlet connected to a flexible inlet tube and an outlet for connection to the suction pump,
 said outlet incorporating a bacterial filter and said inlet tube having a quick disconnect coupling device for connection to a flexible drainage tube leading to the wound dressing pad
 and said inlet tube including clamp means for preventing escape of liquid from the container.
 [the canister] includes a gel-forming substance which is capable of immobilising drainage fluids within the canister."
 A canister as claimed in any of the preceding claims in combination with a wound dressing pack,
 the wound dressing pack comprising a reticulated open-celled foam pad having at least 90% of interconnecting cells
 and being connected to a drainage tube terminating in a quick disconnect coupling device adapted to couple with coupling device, attached to the inlet tube which is attached to the inlet of the canister,
 said drainage tube including clamp means to prevent the drainage tube leaking liquid when the coupling devices are disconnected.
Issue (i)(a) – The meaning of element  of '504 and does the GO device fall within that meaning?
Issue (i)(b): The meaning of element  of '504 and does the GO system fall within it?
Issue ii) – Were sales of the GO canister intended to put the invention of claims 7 and 8 of '950 into effect?
"Subject to the following provisions of this section, a person (other than the proprietor of the patent) also infringes a patent for an invention if, while the patent is in force and without the consent of the proprietor, he supplies or offers to supply in the United Kingdom a person other than a licensee or other person entitled to work the invention with any of the means, relating to an essential element of the invention, for putting the invention into effect when he knows, or it is obvious to a reasonable person in the circumstances, that those means are suitable for putting, and are intended to put, the invention into effect in the United Kingdom."
"In the light of this evidence I find that it is probable that from time to time some medical personnel using the GO system have clamped the end of the inlet tube when changing the canister. Moreover, I consider that it would have been obvious to a reasonable person supplying GO canisters that this would be likely to occur. "
"…I understand the GO canisters are only provided with a cap and are not provided with a separate clamp. I have explained the importance of disposing of infected material safely. Without a clamp on the tube, fluid could and would be likely to seep out before that tube was capped. This would lead to infected material potentially being spread around the hospital or treatment environment. In my view, given that clamps are cheap and very easily available in hospitals, it is overwhelmingly likely that a large number of hospital practitioners using the GO device would add a clamp to the tube. Indeed, as I described in paragraph 77 above, clamping tubes when changing a canister has been routine practice in hospitals for many years. I believe that anyone selling that device would be aware of that likelihood."
"…… It was put to Dr Téot in cross-examination that the T-connector was a bleed valve and that the vacuum in the tube would prevent fluid escaping. As counsel for KCI pointed out, however, there are two problems with this proposition. First, there is no evidence that the T-connector is a bleed valve. Dr Téot did not even know what the English expression "bleed valve" meant. Secondly, the manual tells the user to switch the pump off before disconnecting the tube to change a full canister. In those circumstances there would be no vacuum to stop fluid escaping. "
212. Importantly, however, the effect of the evidence is that, when medical personnel did this, they will have done it on their own initiative when faced with the need to change a filled canister without risking the escape of fluids. There is no evidence that GO canisters have been purchased by medical institutions with the intention that the canisters should be used in conjunction with a clamp on the inlet tube.
213. In my judgment it follows that S&N have not committed an infringement under section 60(2), because at the time the means in question were supplied they were not "intended to put the invention into effect". The invention has only been put into effect, on the occasions it was, as a matter of happenstance after the means were supplied. "
i) The required intention is to put the invention into effect. The question is what the supplier knows or ought to know about the intention of the person who is in a position to put the invention into effect – the person at the end of the supply chain, .
ii) It is enough if the supplier knows (or it is obvious to a reasonable person in the circumstances) that some ultimate users will intend to use or adapt the "means" so as to infringe, [107(i)] and .
iii) There is no requirement that the intention of the individual ultimate user must be known to the defendant at the moment of the alleged infringement, .
iv) Whilst it is the intention of the ultimate user which matters, a future intention of a future ultimate user is enough if that is what one would expect in all the circumstances, .
v) The knowledge and intention requirements are satisfied if, at the time of supply or offer to supply, the supplier knows, or it obvious to a reasonable person in the circumstances, that ultimate users will intend to put the invention into effect. This has to be proved on the usual standard of the balance of probabilities. It is not enough merely that the means are suitable for putting the invention into effect (for that is a separate requirement), but it is likely to be the case where the supplier proposes or recommends or even indicates the possibility of such use in his promotional material, .
Issue (iii)(a) - Reticulated foam
"152. …. The first is that I have concluded that, although the design engineer would be aware of the existence of reticulated foam as part of his common general knowledge, he would not be aware of the use of reticulated foam in connection with the treatment of patients. It follows that, if the clinician asked the design engineer to propose suitable foams for use as a wound dressing, the design engineer would not be conscious of reticulated foam as being a suitable material. S&N's case is really that it would nevertheless be obvious for the design engineer faced with the problem of finding an open-celled foam to implement Argenta to search for a suitable foam and to select reticulated foam as a result. In my view, however, the evidence does not establish that the design engineer would as a matter of routine carry out a search which would lead him to reticulated foam.
153. The second reason is that, as I have said, the skilled team would in any event have regarded the mechanical properties of the foam as secondary to its clinical suitability. Even if the design engineer had come up with the idea of using reticulated foam, the clinician would have rejected it for the reasons explained above."
"As I state in paragraph 23 above, clinicians in 1994 were concerned with keeping wounds moist and free from infection. When treating wounds, they would have looked for dressings that retained fluid to achieve the former. They would have looked for a dressing that could be changed easily to achieve the latter. It would not have been desirable from a clinical perspective to use a material with an extremely open structure such as reticulated foam (which would not retain fluid and into which tissue would grow, increasing the difficulty and pain of removal) in wound care."
Issue (iii)(b) – Gel-forming substance
"It has become common practice in the art to add a material to the canister to convert the liquid to a solid or a semisolid so that, if an accident should occur, any spill will be confined to the immediate area and cleanup will be quicker and safer."
"When placed in a suction canister containing body fluids, the packet degrades so that the polyacrylate comes into contact with and immobilises the fluid as a gel."
"Thus Karakelle discloses the addition of gelling agents to suction containers which have been filled with body fluids. The main difference between Karakelle and claim 7 of '504 is that Karakelle does not teach adding a gel-forming agent to a canister for use in applying negative pressure to a wound before the canister is filled with fluid. "
"167. While Karakelle seems like a promising starting point for an obviousness attack on claim 7 of '504, the difficulty which S&N face is that, due to the manner in which Karakelle came into the case, there is simply no evidence that this would be an obvious step to take. While it may seem obvious to a lay person with the benefit of hindsight, the law is clear that expert evidence is almost invariably required to establish that an invention was obvious to the person skilled in the art at the relevant date: see Mölnlycke AB v Proctor & Gamble Co (No 5)  RPC 49 at 113 (Sir Donald Nicholls V-C, as he then was) and Panduit Corp v Band-It Co Ltd  EWCA Civ 465,  FSR 8 at - (Aldous LJ).
168. The dangers of making a finding which is not based on expert evidence are illustrated by the fact that in the present case counsel for KCI submitted in his closing submissions that there were clinical reasons why it would not be obvious to take the step from Karakelle to claim 7. To that counsel for S&N replied there was no evidence from the clinical experts as to such reasons. If, however, Karakelle had been pleaded at the outset and so addressed by the experts in their reports, there might well have been such evidence.
169. I am therefore driven to the conclusion that S&N have not proved that claim 7 is obvious over Karakelle."
"If the container is disposable, it would clearly be preferable to immobilise the exudate by turning it into a gel so that it may be hygienically discarded with the container with no risk of the contents escaping during that process. I believe, therefore, that it would be immediately evident to at least the engineers and medical scientists in the skilled team in 1994 that it would be a beneficial and obvious option to use a gel-forming substance on drained wound exudates in a container."
i) the GO system does not infringe claim 5 of '504; S&N's appeal on this issue is allowed;
ii) S&N have infringed claim 8 of '950 pursuant to section 60(2) by sales of the GO canisters; KCI's appeal on this issue is allowed;
iii) S&N's appeal against the finding of validity of claim 5 of '504 and claim 8 of '950 (the reticulated foam issue) is dismissed;
iv) S&N's appeal against the finding of validity of claim 7 of '950 (the gel-forming substance issue) is allowed; the claim is invalid for obviousness over Karakelle.