Patents - Generic Drugs - Supplementary Protection Certificate - Trade Name - Pharmaceutical Products - Patent

In the case of Generics (UK) Ltd (t/a Mylan) v Novartis AG [2011], Generics (UK) applied to the courts for an application to declare a Supplementary Protection Certificate (SPC) GB9B/038 invalid, as it extended the life of a granted basic patent, and the UK Patent No 2 203 040 for a drug called rivastigmine for the symptomatic treatment of Alzheimer's disease (AD).

Generics (UK) was seeking to market a generic version of rivastigmine. In earlier research back in 1985, Marta Weinstock heading a team of scientists developed a product named RA7, the unresolved (-) enantiomer of rivastigmine, called racemic. She published a paper in which RA7 was one of a number of compounds which were proposed for the treatment of AD, but no mention was made of resolving it into its individual enantiomers.

Novartis, marketed rivastigmine under the trade name Exelon. In its counter-claim, Novartis claimed that if Generics (UK) were to market a generic version of rivastigmine, this would infringe the SPC and they sought appropriate remedies.

Generics (UK)'s ground of opposition was lack of inventive step. The issue to be decided by the court was whether a relevantly skilled pharmaceutical development team, without knowledge of the patent in suit, would find it obvious in the light of the Weinstock publications to resolve the racemic mixture of RA7 into its individual enantiomers.

The court allowed the claim by Generics (UK) and dismissed the counter-claim by Novartis. The court held:-

·         A pharmaceutical composition for treatment of AD comprising rivastigmine was conceptually obvious in the light of Weinstock’s publication and would immediately occur to a skilled team;

·         The skilled team would have to consider whether resolving RA7 into its enantiomers was a worthwhile step to take for good technical reasons;

·         The team would find that the chemistry involved in so doing was trivial;

·         The inventive step was obvious in the light of Weinstock;

·         The objective technical effect demonstrated by the patent in comparison with the Weinstock prior art was simply that which one would expect from resolution of a chiral compound;

·         The skilled person would know how to solve the problem of achieving those effects by an application of the common general knowledge about chiral compounds; 

·         All the claims relied on were invalid, and the SPC was accordingly invalid.