Rivastigmine - UK

On Dec 21, 2016, the court of appeal (UK) in Novartis Ag v Focus Pharmaceuticals UK Ltd upheld the Arnold J’s decision on added matter and obviousness.

In these actions the claimants (“Novartis”) alleged that the defendants (“Focus” and “Actavis” in action HP-2013-000011 and “Teva” in action HP-2013-000012) had infringed European Patent (UK) No. 2,292,219 entitled “Transdermal therapeutic system for the administration of rivastigmine”. The defendants denied infringement and counterclaimed for revocation of the Patent on the grounds of added matter, obviousness and insufficiency. 

Arnold J in his judgment, handed down on 27 April 2015 [2015] EWHC 1068 (Pat), found that the Patent lacked inventive step over a single piece of prior art, US Patent No. 6,335,031 (“US 031”), and was also invalid for added matter.  He rejected the allegation of insufficiency.  He also held that if the Patent had been valid, the defendants would have infringed it. Novartis appealed the order revoking the Patent.

On appeal, Kitchin LJ, delivering the judgement of the Court upheld Arnold J’s decision on added matter and obviousness. T appeal he 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.