02 September, 2015

High Court Dismisses AstraZeneca Appeal

High Court Dismisses AstraZeneca Appeal

In our recent article of 26 June 2015 we reported on the High Court of Australia hearing on 13 and 14 May 2015 of the Appeal in the rosuvastatin case from the Full Federal Court decision (AstraZeneca AB v Apotex Pty Ltd [2014] FCAFC 99). As we reported in our article of 31 March 2015, the High Court of Australia granted AstraZeneca leave to Appeal despite the Full Federal Court sitting 5 judges (instead of the usual 3) in the Appeal from the first instance decision (Apotex Pty Ltd v AstraZeneca AB (No. 4) [2013] FCA 162).

The High Court of Australia today handed down their decision (AstraZeneca AB v Apotex Pty Ltd [2015] HCA 30) in which they upheld the finding of the Full Federal Court that the Low Dose Patent (AU 2000023051) lacked an inventive step within the meaning of s 7(2) and 7(3) of the Patents Act 1990 (Cth) (“the Act”) and consequently dismissed AstraZeneca’s Appeal.


Construction of Sections 7(2) and 7(3)

As discussed in our article of 26 June 2015, one of the arguments put forward by AstraZeneca was that there was an impermissible comparison by the experts of documents located in a literature search in deciding whether Watanabe, one of the prior art documents, satisfied the “threshold requirements” of s 7(3). This argument was dismissed by each High Court judge, with Nettle J stating at paragraph [120]: “As French CJ and Kiefel J conclude, there is nothing in ss 7(2) or 7(3) which precludes the person skilled in the art from looking at more than one document (whether sequentially or comparatively or otherwise) for the purposes of determining the relevance of any single document”.

The High Court also agreed with the Full Federal Court that it was irrelevant, when considering whether an invention involves an inventive step under s 7(2), that there may be multiple documents that satisfy the s 7(3) threshold requirements, one of which may teach towards the invention while others teach away from the invention. As stated by Gageler J and Keane J at paragraph [113]:

What s 7(2) requires, by the plain and ordinary meaning of its language, is that where multiple pieces of prior art information are available and capable of being regarded as relevant, each must be considered, one at a time, together with the common general knowledge to answer the question whether the invention is obvious. 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.”


Starting Point Issue

In our article of 26 June 2015 we also discussed the other issue in relation to inventive step before the High Court which arose from the generic parties Notice of Contention, namely, the “starting point” issue. In view of the decision of the High Court to dismiss AstraZeneca’s Appeal, the High Court did not find it necessary to consider the “starting point” issue.

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