AstraZeneca AB v Apotex Pty Ltd  FCAFC 99 (12 August 2014)
An expanded panel of five judges of the Federal Court of Australia has held that two patents owned by AstraZeneca relating to the cholesterol-lowering drug marketed as CRESTOR (active ingredient rosuvastatin) are invalid. Subject to the possibility of a High Court appeal, the decision opens the way for generic competition to CRESTOR in Australia, which has been prevented by interlocutory injunctions since 2011.
A particular point of interest in this case lies in the reason for the rare expansion of the Full Court panel from the usual three judges to five. The judge at first instance (in Apotex Pty Ltd v AstraZeneca AB (No 4)  FCA 162) had found that the AstraZeneca inventions claimed in the patents at issue lacked an inventive step based, in part, on the reasoning of an earlier Full Court panel in Apotex Pty Ltd v Sanofi-Aventis  FCAFC 134. AstraZeneca contended that the approach taken by the primary judge was wrong, and requested a panel of five judges to enable the earlier Full Court decision to be overruled, if necessary.
So, five judges is better than three, and this decision is inherently important because anything it stands for has precedence over any ‘normal’ judgment issued by a three-judge Full Court panel. In the event, the appeal court did overrule the reasoning of the primary judge on the approach to the inventive step question at issue. However, it also found a way to avoid actually overruling the earlier Full Court decision in Sanofi-Aventis.
The key question addressed by the court in this regard is: what is the appropriate ‘starting point’ for assessing whether or not a claimed invention involves an inventive step or, conversely, is obvious?
The answer to this question is that inventiveness must be assessed by reference to the relevant prior art information, in light of the ‘common general knowledge’ of the person skilled in the art. The assessment should not be influenced by the description of the invention provided in the patent specification, or by consideration of any problem that the invention is explicitly or implicitly directed at solving, except to the extent that these are, in fact, part of the prior art or common knowledge in the field.
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