Patents - Coloplast A/S v Salts Healthcare Limited.

Author BruceBlaus  Licence CC BY 3.0 Source Wikipedia Colostomy

Jane Lambert

Patents Court (Nicholas Caddick QC) Coloplast A/S v Salts Healthcare Limited [2021] EWHC 3 (Pat) (18 Jan 2021)

This was an action for patent infringement and a counterclaim for revocation.  The patent in suit was EP (UK) 2 854 723 for a comfort layer for a collecting bag and the claimant, Coloplast A/S, was the patentee. Coloplast complained that Salts Healthcare Limited ("Salts") had infringed the patent by marketing a product that fell within several of the claims of the patent. Salts contended that the patent was invalid for want of novelty and inventive step, insufficiency, absence of technical contribution and added matter. The action and counterclaim came on before Mr Nicholas Caddick QC sitting as a judge of the High Court. He tried the action and counterclaim between 28 and 30 Sept and on 1, 6 and 7 Oct 2020.  In Coloplast A/S v Salts Healthcare Limited [2021] EWHC 3 which he handed down on 18 Jan 2021 Mr Caddick held that the patent was bad for obviousness.

The Invention

The invention for which the patent was granted is described as follows:

"The invention relates to collecting bags for human body wastes. In particular, the invention relates to a textile comfort layer of a collecting bag providing the collection bag with an increased resistance against tearing and pulling forces".

Essentially a bag with a "textile comfort layer" would have a peel strength "at least on par" with that of a non-woven comfort layer. It would also have a significantly higher resistance to external forces, improved visual and tactile characteristics in the weld zone and an "increased resistance to common wear issues such as snagging and pilling".  Mr Caddick discussed the specification between paras [57] and [81] of his judgment.

The Alleged Infringement

Towards the end of 2017 Salts started to market a range of ostomy bags known as "Confidence BE" which Coloplast believed to infringe several of the claims of the patent.  However, according to Mr Caddick, Coloplast relied entirely on claim 6 at trial:

"A collecting bag according to any one of claims 1 - 4, wherein said textile material (10) is a woven material."

It will be noted that claim 6 is dependent on various combinations of antecedent claims, namely:

a. Claim 6 as dependent on claims 1, 2 and 3 ("Claim 6A");
b. Claim 6 as dependent on claims 1, 2 and 4 ("Claim 6B");
c. Claim 6 as dependent on claims 1, 2, 3 and 4 ("Claim 6C").

Coloplast relied on the same claims for the validity of the patent.

Want of Inventive Step

Mr Caddick dealt first with Salts's contention that the invention was obvious.  As he noted at para [83] of his judgment, one of the conditions for the grant of a patent is that the invention involves an inventive step (s.1 (1) (b) of the Patents Act 1977). He quoted s.3:

"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)."

At para [85] he said:

"In determining whether the claims would have been obvious to the skilled person having regard to the state of the art at the priority date, it is helpful to follow the so-called Windsurfing/Pozzoli approach. This involves asking the following questions:

(1) (a) Identify the notional 'person skilled in the art'
(b) Identify the relevant common general knowledge of that person;
(2) Identify the inventive concept of the claim in question or if that cannot readily be done, construe it;
(3) Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art' and the inventive concept of the claim or the claim as construed;
(4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?"

Identify the Notional Person skilled in the Art

The learned deputy judge had already identified the skilled addressee at para [23]:

"In my judgment, this person would be a product developer or designer of such bags and would have the sort of knowledge required of such a person. He or she would be aware of the sort of issues faced by and the needs and concerns of users of such bags. However, he or she would also be aware of the manufacturing processes used to make such bags and would be reasonably knowledgeable about the sort of materials that were available and their characteristics, in terms of both manufacture and end-user experience. It seems to me that this knowledge would be founded on experience in the ostomy bag sector and need not be based on any particular academic qualifications."

Identify the Relevant Common General Knowledge

Mr Caddick defined "common general knowledge" at para [25] as:

"the information which at the priority date of 25 May 2012 would have been widely known to those engaged in the art and regarded by such persons as a good basis for further action. It includes not only information within the memory of the skilled person but also information that the skilled person knows exists and would, if needed, look up as a matter of course."

He set out his findings between paras [26] and [56] of his judgment.

Identify the Inventive Concept 

It appeared to Mr Caddick to be common ground that the inventive concept was as follows:

"The patent for the first time teaches that a woven fabric can be used and welded in such a way to form an integrated comfort layer with improved properties".

Pozzoli Questions 3 and 4

The third Pozzoli question is:

"Identify what, if any, differences exist between the matter cited as forming part of the 'state of the art' and the inventive concept of the claim or the claim as construed."

The fourth is:

"Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention?"

The deputy judge took those two questions together.  He directed himself at para [90]:

"The third and fourth Pozzoli questions require me to compare that inventive concept with (i) each of the five specific pieces of prior art relied on and (ii) the common general knowledge as at the priority date and to ask (without reference to the alleged invention and without using hindsight) whether any differences identified involved steps that would have been obvious to the skilled person."

He reminded himself at [91] of Lord Hodge's dicta at para [59] of his judgment in Actavis Group PTC EHF and others v ICOS Corporation and another [2019] Bus LR 1318, [2019] UKSC 15 that "the skilled person, while having the compendious knowledge of the state of the art which section 2 (2) requires, has no inventive capacity."  He also referred to para [74] of Mr Justice Kitchin's judgment in Generics (UK) Ltd v H Lundbeck [2007] EWHC 1040 (Pat) which had been approved by Lord Hoffmann in Conor Medsystems Inc v Angiotech Pharmaceuticals Inc and anther [2008] RPC 28, [2008] UKHL 49 at para [74] pf his speech and Lord Hodge in Actavis at [63]:
 

"The question of obviousness must be considered on the facts of each case. The court must consider the weight to be attached to any particular factor in the light of all the relevant circumstances. These may include such matters as the motive to find a solution to the problem the patent addresses, the number and extent of the possible avenues of research, the effort involved in pursuing them and the expectation of success."

Mr Caddick observed at [93] that:

"In order to establish obviousness, it is enough to show that the idea said to be an invention would have occurred to the skilled person. It is not necessary to show that the skilled person would actually have implemented that idea."

He added at [96]:

"In answering the statutory question, it is important to bear in mind what inventive means. An idea may be technical and may achieve a technical result. However, to be inventive, it must be adding something to the existing stock of knowledge. This addition might be the idea of using an existing technique to do something which no-one had previously thought of doing. Or it might involve finding a way to do something which people had wanted to do but had not been able to think how. Or it might be finding a way of solving a problem standing in the way of achieving a goal (see Lord Hoffmann in Biogen Inc. v Medeva Plc [1997] RPC 1 at 34)."

Finally, he cautioned himself as follows at [97]:

"The fact that an idea had not previously been implemented, or that there had been an unexplained delay in adopting an idea, can help show that that idea was inventive. This is the argument that: "if obvious, why was it not done before?" on which Coloplast relies in this case. However, some care is needed in this regard. In particular, as Laddie J pointed out in Brugger v Medic-Aid Ltd [1996] R.P.C. 635 at p.654,

'The court has to be alert to the difference between commercial attractiveness and technical obviousness. They are not always the same. Failure to modify a piece of prior art, even if that delay extends over a long period, may be due to commercial factors rather than perceived technical obstacles.'

Laddie J went on to note that there may be numerous explanations as to why a particular step had not been taken, such as, for example, a "commercial constraint" caused by a reluctance to change existing tooling, or "complacency in relation to existing products or processes", or the "adequacy of existing products". He concluded (on p.655) that:

'It is only when the answer to the question 'why was this not developed earlier' is 'a likely and reasonable explanation is that people looking for a way around an existing problem did not see this as the answer' that the age of the prior art should play a part in meeting an obviousness attack. If it is likely that in the real world no one was looking for an answer the fact that none was found says nothing about whether the answer proposed by the patent under attack was obvious.'

Finally, in response to an argument that because of the success of existing products it had not been obvious to make any modifications to the existing prior art, Laddie J stated that:

'That, it appears to me, is a non sequitur. The fact, if it be one, that existing commercial products are highly successful and satisfactory does not indicate that there are no obvious modifications to make to them. It merely demonstrates that there may be little incentive to those already making those products to change the design—a quite different matter.' "

Applying these principles, Mr Caddick said at [98] that he was satisfied that the use of a woven to make a comfort layer with improved properties was not inventive at the priority date when viewed in the light of the common general knowledge at that time and set out his reasons between [99] and ]112].  He then turned to each of the pieces of prior art:
a. US Patent Application No. 2005/0273064, published 8 December 2005 and referred to as "Dircks";
b. GB Patent GB No. 2 064 333B, published 23 January 1985 and referred to as "Watkins"
c. PCT Application No. WO 2008/112337 A1, published 18 September 2008 and referred to as "Willis";
d. Salts' own ND13 ostomy bag (the "ND13") which had been made available to the public in the United Kingdom before the priority date of the Patent; and
e. The Novalife 915-10 ostomy bag made by Dansac Limited (the "Dansac Novalife") which had, again, been made available to the public in the United Kingdom before the priority date of the Patent.

Starting with Watkins between [113] and [122], the deputy judge found the invention was obvious.  He said at [122] that a skilled person who implemented Watkins would end up within the claims of the patent. He considered the Dansac Novalife between [123] and [132] and decided that the patent was obvious over that product. He came to a similar conclusion in respect of the ND13 which he discussed between [133] and [139].  He covered Diricks between [140] and [158] and held that the patent was obvious over that application.  Finally, he addressed Willis between [159] and [166] and found that the invention was also obvious over that item.

Novelty

Another condition for the grant of a patent is novelty. Mr Caddick said at [167]:

"Under ss.1 and 2 of the Patents Act 1977, to be patentable, the claimed invention must be new, meaning that it did not form part of the state of the art. Thus, where a piece of prior art clearly and unambiguously discloses the features of a claim, or discloses matter which, if performed, would inevitably fall within the claim, then that claim is not novel. Thus, a lack of novelty is a ground for invalidating a patent."

Although novelty had been pleaded, it was not pushed at trial.   The deputy judge said at [167] that Salts was right not to have pushed the issue because the invention would not have lacked novelty over any of the prior art:

"a. Watkins says nothing about the embedding of comfort layer fibres in the barrier film material, about peel strength or about the tactile and surface characteristics of the surface in the weld zone and, as the experts agreed, it was not inevitable that in implementing Watkins, the skilled person would end up within the claims of the Patent in those regards.
b. The disclosures of the Dansac Novalife and ND13 products would have been limited to the precise characteristics of those products. They did not therefore involve the use of a woven integrated comfort layer.
c. As set out above, Dircks may teach the partial embedding of the fibres of the comfort layer in the barrier film material and the use of a woven. However, it says nothing expressly about peel strength. Moreover, as set out above, because Dircks requires full-face attachment of the comfort layer, there can be no surface of the comfort layer outside the zone of attachment. It does not, therefore, disclose claims 3 and 4.

d. The position as regards Willis is the same as that for Dircks."

The learned deputy judge found that the invention satisfied the condition of novelty.

Insufficiency

S.14 (3) of the Patents Act 1977 requires applicants for patents to disclose the invention in the specification in a manner which is clear enough and complete enough for the invention to be performed by a person skilled in the art.  Failure to do is a ground for revocation under s.72 (1) (c). The Supreme Court had recently considered this issue in Regeneron Pharmaceuticals Inc v Kymab Ltd. [2020] Bus LR 1394, [2020] UKSC 27. Lord Briggs had said at para [56] of his judgment in that case:

"i) The requirement of sufficiency imposed by article 83 of the EPC exists to ensure that the extent of the monopoly conferred by the patent corresponds with the extent of the contribution which it makes to the art.
ii) In the case of a product claim, the contribution to the art is the ability of the skilled person to make the product itself, rather than (if different) the invention.
iii) Patentees are free to choose how widely to frame the range of products for which they claim protection. But they need to ensure that they make no broader claim than is enabled by their disclosure.
iv) The disclosure required of the patentee is such as will, coupled with the common general knowledge existing as at the priority date, be sufficient to enable the skilled person to make substantially all the types or embodiments of products within the scope of the claim. That is what, in the context of a product claim, enablement means.
v) A claim which seeks to protect products which cannot be made by the skilled person using the disclosure in the patent will, subject to de minimis or wholly irrelevant exceptions, be bound to exceed the contribution to the art made by the patent, measured as it must be at the priority date.
vi) This does not mean that the patentee has to demonstrate in the disclosure that every embodiment within the scope of the claim has been tried, tested and proved to have been enabled to be made. Patentees may rely, if they can, upon a principle of general application if it would appear reasonably likely to enable the whole range of products within the scope of the claim to be made. But they take the risk, if challenged, that the supposed general principle will be proved at trial not in fact to enable a significant, relevant, part of the claimed range to be made, as at the priority date.
vii) Nor will a claim which in substance passes the sufficiency test be defeated by dividing the product claim into a range denominated by some wholly irrelevant factor, such as the length of a mouse's tail. The requirement to show enablement across the whole scope of the claim applies only across a relevant range. Put broadly, the range will be relevant if it is denominated by reference to a variable which significantly affects the value or utility of the product in achieving the purpose for which it is to be made.
viii) Enablement across the scope of a product claim is not established merely by showing that all products within the relevant range will, if and when they can be made, deliver the same general benefit intended to be generated by the invention, regardless how valuable and ground-breaking that invention may prove to be."

At para [173] Mr Caddick said:

"The sufficiency issue is whether the disclosure of the Patent 'coupled with the common general knowledge' would have allowed the skilled person to make the product(s) as claimed."

He concluded at [174]:

"As set out above, in my judgment the Patent did not involve an inventive step because it was well known that a woven could be used in such a way as to achieve claims 1 to 4, and because the means of achieving the requirements of claims 1 to 4 involved using materials and techniques that were part of the common general knowledge. The corollary of this must be that the disclosure of the Patent was not insufficient."

AgrEvo Obviousness

In Actavis, Lord Hodge said at para [61] of his judgment that an alternative to the Windsurfing/Pozzoli approach that I discussed above was the so-called “problem-and-solution approach” which the EPO often adopts.  In T 0939/92 (Triazoles) of 12.9.1995, the Technical Board of Appeal explained:

“it has for long been a generally accepted legal principle that the extent of the patent monopoly should correspond to and be justified by the technical contribution to the art. … [T]his general legal principle was applied in relation to the extent of the patent protection that was justified by reference to the requirements of articles 83 and 84 EPC, the same legal principle also governs the decision that is required to be made under article 56 EPC, for everything falling within a valid claim has to be inventive.”

Mr Caddick referred to para [49] of Lord Justice Floyd's judgment in Generics (UK) Limited v Yeda Research and Development Co. Ltd [2013] EWCA Civ 925:

"i) Article 56 of the EPC is in part based on the underlying principle that the scope of the patent monopoly must be justified by the patentee's contribution to the art;
ii) If the alleged contribution is a technical effect which is not common to substantially everything covered by a claim, it cannot be used to formulate the question for the purposes of judging obviousness;
iii) In such circumstances the claim must either be restricted to the subject matter which makes good the technical contribution, or a different technical solution common to the whole claim must be found;
iv) A selection from the prior art which is purely arbitrary and cannot be justified by some useful technical property is likely to be held to be obvious because it does not make a real technical advance;
v) A technical effect which is not rendered plausible by the patent specification may not be taken into account in assessing inventive step;
vi) Later evidence may be adduced to support a technical effect made plausible by the specification;
vii) Provided the technical effect is made plausible, no further proof of the existence of the effect is to be demanded of the specification before judging obviousness by reference to the technical effect propounded."

Mr Caddick did not think on the facts of this case that AgrEvo added anything to the grounds of obviousness or insufficiency that he had already discussed.  However, he said at [186] that if he had held that there had been an inventive step on the Windsurfing/Pozzoli analysis he would not have held that the patent was invalid for obviousness under the AgrEvo approach.

Added Matter

One of the grounds of revocation is that matter disclosed in the specification of the patent extends beyond that disclosed in the application for the patent, as filed (s.72 (1) (d) of the Patents Act 1977). Salts had argued that claim 1 of the patent had added matter over what was contained in the application in that it had sought to take a feature from the disclosures in the application but without the context in which that feature had been disclosed.   The particular words complained of are the words "some but" which were added to claim 1 in the patent.   In Vector Corporation v Glatt Air Techniques Inc   [2007] EWCA Civ 805, [2008] RPC 10, [2008] Bus LR D101, Lord Justice Jacob had said:

"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."

The issue was, therefore, whether these words told the skilled person anything that he or she could not have learned from the application.  Mr Caddick compared the application, body of the specification and claim and found that he or she would not.

Infringement

Having previously construed claim 6 of the patent on a normal construction the deputy judge considered whether Salts products would have fallen within any of the combinations of dependent claims.   The claimant's expert had constructed the following table:

Claim Integers		Claim 6A	Claim 6B	Claim 6C
1.1	A collecting bag (1) for human body waste comprising	✓	✓	✓
1.2	a barrier film (20a, 20b)	✓	✓	✓
1.3	covered by a comfort layer	✓	✓	✓
1.4	wherein the comfort layer is a textile material (10) having a number of threads (15) each comprising a plurality of fibre filaments (17, 18)	✓	✓	✓
1.5	and said textile material (10) is attached to said barrier film (20a, 20b) in one or more zones of attachment	✓	✓	✓
1.6	characterized in that some but not all of the fibre filaments (18) of the textile material (10) in said zone(s) are embedded in the barrier film material (20a, 20b)	✓	✓	✓
2.1	wherein the peel strength between said comfort layer and said barrier film (20a, 20b) is above 5 N/12.5mm width in said zone(s)	✓	✓	✓
3.1	wherein those fibre filaments (18) that are not embedded in the barrier film material (20a, 20b) provide a surface of the comfort layer having the same tactile characteristics as the surface of the comfort layer outside the zone(s) of attachment	✓	x	✓
4.1	wherein those fibre filaments (18) that are not embedded in the barrier film material (20a, 20b) provide a surface of the comfort layer having the same visual characteristics as the surface of the comfort layer outside the zone(s) of attachment	x	✓	✓
6.1	wherein said textile material (10) is a woven material.	✓	✓	✓

Several allegations were admitted and others not seriously contested.   The issues that were resisted were whether the surface of the comfort layer of Salts's Confidence BE products in the welding zone(s) had the same tactile characteristics (claim 3.1) and/or the same visual characteristics (claim 4.1) as the surface of the comfort layer outside the welding zone(s).  Mr Caddick found at [212] that the surface of the comfort layer in the weld area of Salts's Confidence BE products had the same visual characteristics as the remainder of the comfort layer in that the fibre filaments on the surface in the weld zone remained perfectly visible and distinct. The surface did not appear to be a "continuous mass" any more than the surface of the rest of the comfort layer did.  Had the patent been valid, Salts's products would have infringed.

Conclusion

In view of the finding of obviousness the infringement claim failed.   Anyone wishing to discuss this article or any of the matters discussed in it may call me on +44 (0)20 7404 5252 during office hours or send me a message through my contact form.