Generics (UK) Ltd (t/a Mylan) v Novartis AG

In assessing obviousness, the court must consider the invention as a whole and avoid hindsight. The fact that a step is included in a research programme, or lacks a specific motive, does not by itself prevent the step from being obvious. The relevant question is whether the skilled team had a fair expectation of success, assessed in the circumstances of the case. Where a promising chiral lead compound has been disclosed for therapeutic use, resolving and testing its enantiomers may be a routine step for good technical reasons, even without an expectation of a particular advantage. A pharmaceutical composition containing the selected enantiomer may consequently be obvious.

Generics (UK) Ltd, trading as Mylan, sought declarations that Novartis AG’s basic patent for rivastigmine and related supplementary protection certificate were invalid. Novartis counterclaimed for infringement based on Mylan’s threatened launch of a generic product.

The sole substantive issue was lack of inventive step. The central question was whether a skilled pharmaceutical development team, starting from the Weinstock publications, would obviously select RA 7, resolve it into its enantiomers and formulate the (-)-enantiomer for treating Alzheimer’s disease.

1. Obviousness. The court applied the approach in Conor v Angiotech [2008] UKHL 49. Obviousness must be assessed on the facts of the particular case. Relevant considerations include the motive to solve the problem, the number and extent of possible research avenues, the effort involved and the expectation of success. The notion of being obvious to try is useful only where there is a fair expectation of success.
2. A specific motive is relevant but is not an essential requirement. The possibility that a step might be included in a research programme, or that it might produce a useful result, can be enough where the step itself is obvious. The approach must remain sensitive to the facts.
3. The Weinstock publications gave a sufficiently promising disclosure of RA 7 to make its selection for further development obvious. The skilled team would consider resolution of a chiral lead compound. Resolution was chemically straightforward, and the team would recognise technical reasons for resolving and testing the enantiomers, including possible differences in metabolism, blood-brain-barrier penetration and stereospecific side effects. An expectation of improved therapeutic window was unnecessary.
4. It was conceptually obvious to formulate the resolved (-)-enantiomer as a pharmaceutical for treating Alzheimer’s disease. The advantages demonstrated by the patent were no more than those expected from resolving a chiral compound. The claimed inventive concepts were therefore obvious in light of the Weinstock publications.
5. All relied-on patent claims were invalid. The supplementary protection certificate was consequently invalid. The action succeeded and Novartis’s counterclaim was dismissed.