Scintilla – a flash, a spark, an iota. Shorthand for creativity and an indicator of inventiveness under Australian law.

Wednesday, August 13, 2014

AstraZeneca v Apotex: five-judge bench allows AZ appeal on 'starting point' but upholds trial judge on invalidity

By Clare Young, Managing Associate

Australia's appetite for cholesterol-lowering drugs shows no sign of abating. According to a recent news report, rosuvastatin (brand name: CRESTOR) has pushed atorvastatin (brand name: LIPITOR) off the top generic spot. Those generic sales of rosuvastatin were 'at risk' of infringing AstraZeneca's patents, but yesterday's Full Court judgment has given generics the go-ahead to continue sales (although an application for leave to appeal to the High Court is still open).

To recap, Watson, Ascent and Apotex all wanted to sell generic versions of rosuvastatin. AstraZeneca alleged infringement of three patents. The three patents in issue relate to rosuvastatin but are not patents for the invention of the compound rosuvastatin – specifically they relate to a dosage range, a method of treatment and a pharmaceutical composition.

At first instance, Justice Jagot found all three patents invalid on several grounds, including lack of novelty, lack of inventive step and lack of entitlement.

It was the argument on obviousness, known as the 'starting point' issue, which has garnered the most attention. 'Starting point' was a key issue on appeal and the reason why a bench of five judges (as opposed to the usual three) sat on this appeal. In the end, all five judges accepted AstraZeneca's argument on 'starting point' and allowed the appeal on that point, although that finding did not change the end result.

In a nutshell, the 'starting point' issue is whether a valid patent may be obtained for an invention that comprises a solution to a problem in the relevant art where the solution is obvious, but where the problem is neither common general knowledge nor information to which regard may be had pursuant to s7(3) of the Patents Act. Put another way, if the inventor has knowledge of a compound, which is not within the common general knowledge of those skilled in the art or could not have reasonably been found and thought relevant by those skilled persons, is the 'starting point' for the assessment of obviousness allowed to include that compound? 

In short, Justice Jagot at first instance thought that it should; the Full Court found that it should not.

Justice Jagot reasoned that the test for patentability focuses on the invention and because each of the inventions in the three AstraZeneca patents – as described in the complete specifications -  assumed the existence and nature of rosuvastatin, the skilled person is entitled to assume knowledge of that compound too. The Full Court disagreed with that reasoning. A key reason given in the joint judgment of Justices Besanko, Foster, Nicholas and Yates is that the 'notion that the question of inventive step can be answered by reference to information which has not been made publicly available is antithetical to patent law'.

Patentees should be pleased that the Full Court has restored a tighter test for obviousness and clarified the correctness of some earlier decisions on this point.

We will be providing more in-depth analysis of this decision in the coming days.

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