Coloplast AS v Macgregor Healthcare Ltd

Patent claims are construed in the context of the specification as a whole. A general term such as “catheter” is not confined to one type without a strong indication in the specification. A claim requiring treatment with a liquid swelling medium “prior to use” may include treatment during manufacture where the specification makes that clear.

For anticipation, a prior publication must give clear and unmistakable directions to the claimed invention. Evidence of long-felt want and commercial success cannot support inventive step where the inventive concept was already part of the common general knowledge. Sufficiency requires the skilled team to make or obtain the claimed product without undue burden, but does not require disclosure of a commercially marketable embodiment.

Coloplast was proprietor of a UK patent for a ready-to-use urinary catheter assembly containing a hydrophilic coating and liquid swelling medium. It claimed damages for infringement before expiry of the patent. MacGregor denied infringement and counterclaimed for invalidity.

The issues were construction, infringement, novelty over Rødsten and Israelsson, inventive step over those documents and Shibatani, and sufficiency under section 72(1)(c) of the Patents Act 1977. The central questions were whether the claims covered both intermittent and indwelling catheters, whether they included ready-wetted and user-activated configurations, and whether the patent enabled the skilled team to make the claimed assembly.

1. Construction. The word “catheter” in the claims had its usual meaning. The claims covered assemblies for both intermittent and indwelling administration. The specification did not provide the strong indication needed to confine the term to intermittent catheters.
2. Claim 1 covered both ready-wetted assemblies and assemblies in which the user activated the coating immediately before use. The reference to an intention to produce a low-friction surface was objective: the coating had to be suitable for producing that result. “Prior to use” could include treatment during manufacture. The water could not be stored in a completely closed, separate ampoule made of gas-impermeable material, because claim 1 required the catheter and water to be accommodated in the same cavity. The claims covered assemblies suitable for storage for up to five years.
3. Novelty. Applying the test in General Tire & Rubber Co v Firestone Tyre & Rubber Co Ltd [1971] FSR 417, neither Rødsten nor Israelsson gave clear and unmistakable directions to the claimed combination. Claim 1 was therefore novel, and claims 3 and 5 were also novel.
4. Inventive step. The idea of a water-stored catheter was common general knowledge. Thermoplastic film comprising aluminium was a known and obvious packaging material. Claims 1, 3 and 5 consequently lacked inventive step over the cited prior art. Long-felt want could not assist because there was no long-felt want for an invention consisting only of an already-known concept. Commercial success added nothing.
5. Insufficiency. Under section 72(1)(c) of the Patents Act 1977, the specification need not enable a commercially marketable product. It must enable the skilled team, using common general knowledge and without undue burden, to make or obtain a product as claimed. The evidence showed that finding a suitable catheter material and stable hydrophilic coating required significant research and development rather than routine trials. The patent therefore failed to disclose the invention clearly and completely enough.
6. The patent was invalid for lack of inventive step and insufficiency. Had it been valid, MacGregor’s products would have infringed.