Drug: esomeprazole

The Court found the allegations of invalidity as to lack of sound prediction of utility and of obviousness justified and dismissed the application. The Court construed the promise of the patent to be an improved therapeutic profile for highly pure esomeprazole. The Court found that the patent essentially claimed a previously known compound having a particular purity. No particular use of the compound was expressed in the claim. The Court then held that there was no evidence from any witness to say that any part of the disclosure would inform the person skilled in the art that purified esomeprazole salts fulfilled this promise. The Court held that the facts of the case do not show that the inventors had either a factual basis for a prediction that esomeprazole salts of a particular purity would have the utility indicated in the patent nor did they have an articulable and sound line of reasoning for inferring such a result. Thus, there was no proper disclosure in the patent in that respect.

The Court found the allegations of anticipation not to be justified as the testing provided by the parties showed that following the prior art would only occasionally result in a product with the purity level stipulated by the claims. Thus, there was no enablement to support an allegation of anticipation. However, the Court did find that the allegation as to obviousness was justified as it was known that esomeprazole could be separated into its enantiomers and one could readily be motivated to create a purer esomeprazole product given that it was to be used as a pharmaceutical.