The High Court has dismissed an appeal by AstraZeneca AB in its fight with Apotex Pty Ltd over the validity of its low dose patent of rosuvastatin for the treatment of high cholesterol (AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30). Five judges of the High Court were in agreement that AstraZeneca’s patent was invalid for lack of inventive step, affirming the decision of the Full Court of the Federal Court of Australia. AstraZeneca appealed on the basis that the Full Federal Court had erred in finding that the patent was invalid on the ground of obviousness.

The High Court affirmed the reasoning of Jessup J of the Full Court. French CJ held that section 7(2) of the Patents Act 1990 (Cth) (the Act) would defeat a claim for want of inventive step unless one of the alternative conditions set out in section 7(2), read with section 7(3), was satisfied. On the interaction between sections 7(2) and 7(3), the High Court agreed with Jessup J’s conclusion that section 7(2) does not operate as an “embargo upon the skilled person using combinations of sources of information”1 in finding information that is relevant under section 7(3). The requirement that any documents, found to be relevant under section 7(3), be considered separately only applies at the stage of enquiry under section 7(2). Kiefel J added, provided “the information in [a] document has the attributes stipulated by section 7(3), the document may be used for the purposes of the enquiry under section 7(2)”.2

The High Court also rejected AstraZeneca’s argument that section 7(2) limited the way in which a court could decide on the question of inventive step. French CJ stated that there was nothing in the text that would suggest the court was precluded from coming to a conclusion on the basis that the only course available to the skilled person was that identified in a relevant document under section 7(3), added to the prior art base. It was considered that “if the invention is obvious in light of the common general knowledge plus any one of the ascertained pieces of prior art information, then the patent is invalid for want of an inventive step”.3

Of note, the Court considered that AstraZeneca placed too much emphasis on the hypothetical choice of a “person skilled in the art”. Affirming the decision of the primary judge, the Court held that the question was not whether it would be obvious to the skilled person to choose one statin or the other, as different statins were suggested by different documents under section 7(3), but whether, in light of the common general knowledge, plus either of the documents identified under section 7(3), the skilled person would have been led to try rosuvastatin.