Novartis Ag v Focus Pharmaceuticals UK Ltd, UK, Court of Appeal, Lord Justice Kitchin, Lord Justice Floyd and Lord Justice Hamblen, 21 December 2016

This judgement was an appeal from a decision of Mr Justice Arnold who had previously found Novartis’ patent for transdermal patches containing rivastigmine used to prevent, treat or delay the progression of Alzheimer’s disease (the Patent) to be invalid on the grounds of obviousness and added matter.

On appeal, Kitchin LJ, delivering the judgement of the Court upheld Arnold J’s decision on added matter and obviousness.

In contrast to the Patent, there was no disclosure in the application as originally filed of any starting dose of rivastigmine. The only reference to a starting dose in the application was qualified and said no more than that the invention may allow a higher starting dose and hence a reduced number of titration steps to arrive at the appropriate therapeutic dose. The application presented the structure and composition of the transdermal patch it described as the core of the invention. However, the Patent disclosed that the claimed starting dose could be delivered by a patch that did not have the structural and compositional features disclosed in the application.

Arnold J had found that the only difference between the invention claimed and the prior art relied upon by the defendants was that the cited prior art did not disclose a starting dose and had concluded that the selection of a starting dose was obvious.

On appeal, Kitchin LJ found that Novartis’ attack on the judge’s findings on obviousness had some substance with regard to whether or not the skilled team would follow the teaching of the prior art concerning the size of the patch and try to match the starting dose to that of the lowest known therapeutic dose contained in existing rivastigmine capsules. However, the Court concluded that even if the judge at first instance had erred in failing to consider the teaching of the prior art as a whole and in the light of the common general knowledge, the judge was correct to conclude that it would have been obvious to try to administer the starting dose specified in the Patent in a small-scale clinical trial, because the skilled team would think it had a reasonable prospect of success in light of the food effect and the release profile of a transdermal patch. And the original judgement on obviousness was therefore upheld.

The judgment can be found here.

Headnote: Nicholas Fox, Simmons & Simmons LLP