The validity of Wake Forest’s patent (EP (UK) 0620720) was in issue in two English cases running concurrently, Wake Forest v Smith & Nephew [2009] EWCA Civ 848 and Mölnlycke Health Care AB v Wake Forest [2009] EWHC 2204. The patent related to an apparatus for closing wounds and treating infection avoiding the localised stresses on the wound of suturing. It disclosed an apparatus for sealing open wounds by maintaining reduced pressure on the wound using an open-cell polymer foam covered by a flexible polymer sheet adhered to the skin surrounding the wound.

Mölnlycke Health Care AB commenced invalidity proceedings in March 2008 and the trial was listed for July 2009. At that time Mölnlycke had not released details of any potential product and so there was no counterclaim for infringement.

Smith & Nephew released details of a new product in December 2008 and Wake Forest commenced infringement proceedings. Wake Forest made an application for an interim injunction prohibiting the launch of Smith & Nephew’s product which was granted. As a consequence of this an expedited trial was listed for March 2009. Smith & Nephew counterclaimed for invalidity citing a single piece of prior art, Bagautdinov. It was directed that the two actions should proceed in parallel as at that time Mölnlycke had not yet cited Bagautdinov but relied on other pieces of prior art as well as insufficiency and added matter attacks. In addition, Mölnlycke would not be ready for the earlier trial date.

Smith & Nephew action

The Judge held at First Instance that all the claims pleaded were invalid except claims 4, 16 and 19 which were inventive over Bagautdinov. The Judge also held claims 4, 16 and 19 were infringed by Smith & Nephew’s product. The parties appealed against the validity finding.

The Court of Appeal rejected Wake Forest’s appeal in relation to novelty and held that claim 1 was anticipated by Bugautdinov. The Court upheld the Judge’s finding that claims 4, 16 and 19 were novel.

As to obviousness, there was no challenge in relation to the nature of the skilled addressee or their common general knowledge as set out by the Judge. The Judge adopted an “anticipation or nothing” approach in assessing obviousness. The Judge held that the teaching and purpose of Bagautdinov was directed to draining wound secretions and not to wound healing. He held that there was no indication in Bagautdinov that would have led the skilled addressee to develop Bagautdinov to produce the wound healing apparatus of the patent. As such the Judge held that Bagautdinov could not be a starting point for assessing obviousness and therefore that claims 4, 16 and 19 were not obvious. The Court of Appeal held that the Judge

had failed to carry out an overall evaluation of the evidence in assessing obviousness. It considered that the Judge had made an error of principle in failing to apply Pozzoli. It is an established principle that an appellate court should exercise caution in overturning a finding of fact. However, as the Judge had adopted the wrong approach in assessing the obviousness of claims 4, 16 and 19 over Bagautdinov the Court of Appeal could make its own assessment.

The Court applied the Pozzoli approach to assessing obviousness and held that claims 4, 16 and 19 were obvious developments of the Bagautdinov apparatus. The claims of the patent were apparatus and not process claims. It held that application of the apparatus described in Bagautdinov by the skilled addressee using its common general knowledge to seal a wound would have led to an apparatus which infringed claims 4, 16 and 19.

Mölnlycke action

Wake Forest requested the Mölnlycke trial be adjourned following the Court of Appeal’s indication (before giving reasons) that it would find the patent invalid. This was rejected on the basis that a delay in considering the additional cited prior art and arguments raised in the action would cause Mölnlycke commercial uncertainty. The Judge in this case held that claims 4, 16 and 19 were novel over Bagautdinov but were obvious both over Bagautdinov and another piece of cited prior art. The Judge also held that claim 1 was invalid for added matter owing to a post-grant correction. The insufficiency attack was not made out.