Sanofi-Aventis & Ors v Apotex Pty Ltd

Sanofi-Aventis and others (the applicants) sought to prevent Apotex Pty Ltd (the respondent) from infringing their Australian Patent No 2004203177, which claimed a pharmaceutical product. The applicants alleged that the respondent's proposed product, a generic version of their drug Plavix (clopidogrel bisulphate), would infringe the patent. The dispute concerned the validity of the patent, specifically whether it was obvious and whether it had sufficient utility. The matter came before the Full Federal Court of Australia.

The primary legal issues before the Full Federal Court were whether the patent was invalid for obviousness under section 60(1) of the *Patents Act 1990* (Cth) and whether it lacked sufficient utility under section 40(2)(b) of the *Patents Act 1990* (Cth). The applicants contended that the patent was valid and infringed, while the respondent argued for its invalidity on these grounds.

The Court considered the established principles of patent law regarding obviousness and utility. In relation to obviousness, the Court applied the "mosaic approach," assessing whether a person skilled in the art, with the benefit of the common general knowledge, would have arrived at the claimed invention without undue burden or an inventive step. The Court examined the prior art and the evidence presented to determine if the claimed invention was a predictable or obvious development. Regarding utility, the Court considered whether the patent disclosed a practical and useful application of the invention, ensuring that the patent was not granted for a mere theoretical concept. The Court analysed the evidence concerning the therapeutic use of clopidogrel bisulphate to assess whether the patent's asserted utility was substantiated.

The Full Federal Court found that the patent was invalid for obviousness and therefore dismissed the applicants' claim for infringement.