Coloplast A/S v Salts Healthcare

For patent validity, obviousness is ultimately a statutory question whether the claimed invention involves an inventive step. The Windsurfing/Pozzoli questions discipline that inquiry but do not replace it. An idea is not inventive merely because it has not previously been implemented, where the skilled person knew that it was technically possible and non-use was explained by commercial considerations. The skilled person need only be shown to have arrived at the idea without inventive effort; actual commercial implementation is unnecessary. A product claim is sufficient where the patent disclosure, together with common general knowledge, enables the skilled person to make substantially all relevant embodiments within its scope. A claim is not uncertain merely because its boundary involves comparison or degree, provided the skilled person knows the test to apply.

Coloplast claimed that Salts’ Confidence BE ostomy bags infringed EP (UK) 2 854 723, concerning a woven textile comfort layer attached to an ostomy bag’s barrier film. Salts denied infringement and counterclaimed for revocation on grounds including lack of novelty, obviousness, insufficiency, AgrEvo obviousness and added matter.

At trial, Coloplast relied on claims 6A, 6B and 6C, comprising combinations of claims 1 to 4 and claim 6. The principal issues were whether the claims involved an inventive step over common general knowledge and identified prior art, whether the specification was sufficient and certain, whether there was added matter, and, if valid, whether the Confidence BE products satisfied the tactile and visual requirements of claims 3 and 4.

1. Obviousness. The claims were invalid for lack of inventive step. The court applied the statutory test in section 3 of the Patents Act 1977, using the Windsurfing/Pozzoli questions as a structured means of analysis. The inventive concept was the use of a woven material to form an integrated ostomy-bag comfort layer with improved properties.
2. The possibility of using woven material was common general knowledge. The skilled person knew how to select materials and adjust welding methods and parameters to achieve partial embedding, adequate peel strength, and comparable tactile and visual characteristics. The failure to use woven material earlier was attributable to cost, environmental concerns, existing machinery and the absence of a perceived problem, rather than technical difficulty. The claims were therefore obvious over common general knowledge and over Watkins, the Dansac Novalife, ND13, Dircks and Willis.
3. The court rejected the submission that obviousness required proof that the skilled person would actually implement the idea. The question was whether the difference from the prior art required invention. Experimentation and commercial unattractiveness did not establish inventiveness.
4. Novelty and sufficiency. The Patent was not shown to lack novelty. The disclosure did not render the claims insufficient: the patent, coupled with common general knowledge, enabled the skilled person to make products within the relevant claim scope. Claims 3 and 4 were not uncertain because the skilled person knew to compare the tactile and visual characteristics in and outside the attachment zone.
5. AgrEvo obviousness. This added nothing on the facts. Alternatively, the claims were restricted to woven-material uses meeting the specified requirements and therefore were not invalid merely because the technical effect depended on the material and welding conditions.
6. Added matter. Replacing “not all” with “some, but not all” in claim 1 conveyed no new technical information. The skilled person would understand both expressions to describe the same result, and the amendment did not amount to an impermissible intermediate generalisation.
7. Infringement. Had the Patent been valid, the Confidence BE products would have infringed claims 6A, 6B and 6C. The tactile test was whether the welded surface had become less soft, more rigid or more inflexible; the visual test was whether it had acquired a uniform or continuous-mass appearance. The products satisfied both tests.
8. The claim was dismissed and appropriate relief was granted on the counterclaim.