Wednesday, 8 January 2014
5 Points from Pharma Patents Case Law in the UK in 2013
This is the first part of a talk given by Neil Jenkins at the CIPA Life Sciences Conference on 14 November 2103. In the second part of the talk Neil addressed the issue of Regulatory Data Exclusivity which can be accessed here.
1. There was not much in the way of developing substantive patent law in 2013. Instead there more developments concerning procedure. There were 3 first instance pharma cases, of which 2 were ‘clearing the path’ cases and one concerned infringement. There were 4 cases at the Court of Appeal, of which 3 were ‘clearing the path’ cases. Essentially the finding of the first instance decisions were mostly upheld.
2. In Generics v Yeda there was the issue of whether post dated evidence could be used to demonstrate that the technical effect described in the specification did not occur. The first instance had said it could not, but the Court of Appeal disagreed and said a party could rely on post dated evidence to show a technical effect did not occur.
3. In Actavis v Lilly there was the issue or whether a UK Court could give a declaration of non-infringement on the French, German, Italian and Spanish designations of a European Patent. The Court of Appeal confirmed a UK Court did have the right to give a declaration in respect of the foreign patents which represents a shift in the attitude of the English judiciary.
4. On the issue of whether UK proceedings should be stayed whilst EPO opposition proceedings are pending the pendulum has shifted over the years. In the 80s and 90s the UK Courts were reluctant to stay based on the fact EPO opposition proceedings take so long, and therefore this is a case of justice denied. From 2000 onwards there was more consideration of the issue and in Glaxo v Genetech in 2008 it was decided that in the normal course of events a stay would not granted.
This summer in Virgin v Zodiac before the UK Supreme Court the Unilin issue came up, which concerns the situation where damages given on a patent later found by the EPO to be invalid or where the patent was subsequently amended at the EPO to a scope where infringement did not occur. The Supreme Court decided that the case law up to that point was incorrect, and that damages were not appropriate where the EPO revoked or amended the patent.
5. In Novartis v Hospira the Court of Appeal decided that an interim injunction could remain pending during an appeal, even where the first instance decision had found the patent to be invalid. This means that generics companies will need to now also consider the time taken for appeal when attempting to ‘clear the path’.