Novartis AG v (1) Focus (2) Actavis [2016] EWCA Civ 1295

21 December 2016

Daniel Alexander QC and Henry Ward successfully represented the respondents, Focus and Actavis, in the first of two linked appeals concerning Novartis’ patent for a transdermal patch to deliver the drug Rivastigmine. Daniel Alexander QC and Mark Chacksfield represented the respondent, Teva, in the second appeal, on which the parties reached a settlement before the hearing.

At first instance Arnold J had found the patent invalid for added matter and for obviousness, but rejected the claim that it was also insufficient. He also found that, had the patent been valid, it would have been infringed by Focus and Teva.

The Court of Appeal upheld the judge’s decision and dismissed the appeal. In construing the patent, the judge had been right to prefer Novartis’ case that it claimed a transdermal patch delivering a specific starting dose of Rivastigmine, and was not limited to patches of a particular composition. The Court held, however, that the neither the specification of a specific starting dose, nor that the starting dose could be delivered by patches of different compositions, were matters clearly and unambiguously disclosed in the priority application. Further, in light of the teaching of a US prior art patent and the skilled person’s common general knowledge, the judge had been entitled to find that it would have been obvious for the skilled person to run a small scale clinical trial of a transdermal delivery device for Rivastigmine at the starting dose specified in the patent. The judge had therefore been entitled to find the patent invalid for both obviousness and added matter.

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