Patents - Coloplast AS v MacGregor Healthcare Ltd

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Author Basher Eyre

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Jane Lambert

Intellectual Property Enterprise Court (HH Judge Hacon)  Coloplast AS v MacGregor Healthcare Ltd [2018] EWHC 2797 (IPEC) (24 Oct 2018)

This was a claim by the Danish company, Coloplast AS, against MacGregor Healthcare Ltd for damages and other relief for the alleged infringement of European Patent (UK) No. 1 145 729. The defendant, MacGregor, counterclaimed for the patent to be declared invalid on grounds of anticipation, obviousness and insufficiency. The action and counterclaim came before His Honour Judge Hacon on 10 and 11 July 2018.  The judge dismissed the claim.  He found that the patent was invalid for want of an inventive step and insufficiency but added at para [159] of his judgment that had the patent been valid he would have held it to have been infringed.

The Invention
The invention for which the patent was granted is a ready-to-use urinary catheter assembly. Catheters are inserted into a patient's urethra to empty the bladder. To avoid discomfort catheters should slide easily through the urethra without damaging its walls. This is achieved by lubricating the surface of the catheter with a "hydrophilic surface layer" (in most cases water) immediately before use in order to make the surface slippery. A difficulty that sometimes arises is finding a source of water that is sufficiently aseptic to activate the hydrophilic coating. The solution is to store the catheter in packaging along with sterile water.

Infringement

S.60 (1) of the Patents Act 1977 provides:

"Subject to the provisions of this section, a person infringes a patent for an invention if, but only if, while the patent is in force, he does any of the following things in the United Kingdom in relation to the invention without the consent of the proprietor of the patent, that is to say;

(a) where the invention is a product, he makes, disposes of, offers to dispose of, uses or imports the product or keeps it whether for disposal or otherwise ...."

Where, as in this case, the invention is a product, the patent for which it is granted is infringed if the alleged infringer does any of the above acts in relation to a product that falls within any of the claims of the patent.  That is because art 69 of the European Patent Convention provides that the extent of the protection conferred by a European patent shall be determined by the claims. 

The Claims alleged to have been infringed

Coloplast claimed that claims 1, 3 and 5 had been infringed.  The judge set them out at para [10] of his judgment without reference numerals but with the elements of the claims numbered in the manner used by the parties:

"1. 1.1 A urinary catheter assembly
1.2 comprising at least one urinary catheter,
1.3 the catheter having a catheter tube
1.4 coated on its external surface on a substantial part of its length from its distal end with a hydrophilic surface layer in the form of a hydrophilic coating
1.5 intended to produce a low-friction surface character of the catheter by treatment with a liquid swelling medium prior to use of the catheter
1.6 and a catheter package
1.7 made of a gas impermeable material formed by a multiple layer thermoplastic film material comprising aluminium,
1.8 the package having a cavity for accommodation of the catheter,
1.9 wherein the cavity accommodates said liquid swelling medium for provision of a ready-to-use catheter assembly.

3. 3.1 A urinary catheter assembly as claimed in claim 2 [which requires the whole of the catheter package to be made of gas impermeable material], characterized in that
3.2 the catheter package is formed from two sheets of the gas impermeable film material connected with each other by a gas impermeable joint
3.3 defining the cavity for accommodating the catheter and the liquid swelling medium.

5. 5.1 A urinary catheter assembly as claimed in claim 3 or 4, characterized in that
5.2 said joint is arranged [to] provide said cavity with a cross-section narrowly surrounding the catheter."

Construing the Claims

There was no dispute that MacGregor Healthcare marketed and supplied ready-to-use urinary catheter assemblies without Coloplast's consent.  The only question was whether MacGregor's products fell within the scope of any of the above claims.  In order to decide that question, the judge had to determine what those claims meant.  That is a process known as "construction".

A judge has to construe the claim without any regard to the allegedly infringing product.  He or she must remember that patents are directed to skilled addressees who are sometimes called "persons skilled in the art".   When construing a claim the judge must decide what (if anything) such persons would have made of the patent's wording.   That requires the judge to identify "those likely to have a practical interest in the subject matter of [the] invention" who are likely to be "persons with practical knowledge and experience of the kind of work in which the invention was intended to be used" (see Catnic Components Ltd v Hill & Smith Ltd [1982] R.P.C. 183 at 242).  

In this case, it was agreed that the skilled addressees would be a team that would include a developer of catheters and a clinician with knowledge of the needs of patients. Judge Hacon held at [25] that the team would have expertise in catheters that remain in a patient's urethra for some time which are usually inserted by clinicians known as "indwelling catheters" and single-use catheters that can be inserted by the patients themselves known as "intermittent catheters."

MacGregor argued the words "liquid swelling medium prior to use of the catheter" in claim 1 meant that the catheter was put into contact with the water just before use and therefore excluded devices that were placed in contact with water in the factory and were delivered in that form to the end-user. Coloplast argued that the claim applied to both types of catheter.

Art 69 (1) of the Convention permits the description and drawings in the patent specification to be used to interpret its claims. Courts are guided by the following protocol on the interpretation of art 69:
"Article 1
General principles
Article 69 should not be interpreted as meaning that the extent of the protection conferred by a European patent is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims. Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

Article 2
Equivalents
For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims."

Guidance on the application of those principles has been provided by the Supreme Court in Eli Lilly v Actavis UK Ltd and others [2017] UKSC 48, [2017] RPC 21, [2017] Bus LR 1731 which I discussed in The Supreme Court's Judgment in Eli Lilly v Actavis UK Ltd and Others: how to understand it and why it is important 13 July 2017 and more recently by the Court of Appeal in Icescape Ltd v Ice-World International BV and Others [2018] EWCA Civ 2219 (10 Oct 2018).

Applying those principles in accordance with those cases the learned judge concluded at para [93] that claim 1 covered both types of catheters including those supplied by MacGregor.  It followed that the patent would have been infringed had it been valid.

Anticipation

A patent can be granted only if an invention is new and it cannot be new if it has already been invented.  In  General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1971] FSR 417 (CA), the Court of Appeal gave the following guidance at page 444:

"To anticipate the patentee's claim the prior publication must contain clear and unmistakable directions to do what the patentee claims to have invented: Flour Oxidizing Co. Ltd. v. Carr & Co. Ltd. (1908) 25 RPC 428 at 457, line 34, approved in B.T.H. Co. Ltd. v. Metropolitan Vickers Electrical Co. Ltd. (1928) 45 RPC 1 at 24, line 1. A signpost, however clear, upon the road to the patentee's invention will not suffice. The prior inventor must be clearly shown to have planted his flag at the precise destination before the patentees."

MacGregor relied on two applications under the Patent Cooperation Treaty, namely Coloplast's for an applicator and method of use in a non-contaminating application of a medical catheter under application number WO9630277 and Astra AB's for a hydrophilic urinary catheter having a water-containing sachet under application number W)9726937. His Honour considered both applications and held that neither amounted to a flag at the precise destination.

Obviousness

 S.1 (1) (b) of the Patents Act 1977 provides that one of the conditions for the grant of a patent is that the invention involves an "inventive step".  S.3 states that:

"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)."

In Pozzoli Spa v BDMO SA and another [2007] FSR 37, [2007] EWCA Civ 588, [2007] BusLR D117, [2007] Bus LR D117, the Court of Appeal laid down the following four-stage test of obviousness at para [23]:

"(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?£

Judge Hacon followed that approach in relation to the two applications mentioned above plus the Japanese JP-A-55-012265 and concluded that claims 1, 3 and 5 of Coloplast's patent were obvious having regard to the prior art and the skilled addressees' common general knowledge.

Insufficiency

S.14 (3) of the Patents Act 1977 requires a specification to be clear enough and complete enough for the invention to be performed by a person skilled in the art.  If it does not, s.72 (1) (c) enables the court or the Comptroller (Chief Executive of the Intellectual Property Office) to revoke a patent. There was evidence before the judge that the invention could not have been made with the technologies and materials known at the time. That enabled His Honour to find at [156] that the specification did not disclose the invention clearly and completely enough for it to be performed by the team skilled in the art.

Comment

It seems curious that an invention that could not be made from following the specification was at the same time capable of being obvious but that is what the case appears to say and it is not obvious from his reasoning that the judge was wrong.   The patent was in force for its full term and is now expired so the only relief that Coloplast could have recovered were damages.  If it only became possible to make the invention towards the end of the term they may not have anounted to much.

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