Esomeprazole in the Australian courts: The acid test

Abstract

A number of decisions have already been handed down this year by the Australian Federal Court in a series of pharmaceutical patent challenges. The most recent of them is the decision in the esomeprazole case. At issue was the validity and infringement of three patents:

the so-called purity patent claiming an optically pure salt of the (−)- enantiomer of omeprazole, including the magnesium salt;

the so-called multiple unit tableted dosage form patent claiming, amongst other things, omeprazole or one of its single enantiomers or an alkaline salt thereof in a tablet form with defined characteristics; and

the so-called 774 patent claiming an oral pharmaceutical dosage form comprising, amongst other things, a proton pump inhibitor including omeprazole or the (−)- enantiomer of omeprazole.

This case is another example of the Federal Court complying with the parties’ express desire for a prompt delivery of reasons for judgement. After a hearing of some weeks, which concluded on 28 March 2013, there were final written submissions filed on 12 April 2013. The parties (and in particular Ranbaxy) requested a determination preferably by no later than 23 April 2013. That gave Justice Middleton just under one month from the conclusion of the hearing and only 10 days after the final written submissions to deliver a judgement with respect to the validity of three separate patents, each of which was attacked on numerous bases including lack of novelty, a lack of inventive step and manner of manufacture. His Honour’s judgement extends to 1017 separate paragraphs over 148 pages. Although the decision does not traverse any astoundingly new ground or offer any particularly insightful new approach to the conventional validity attacks that were mounted, some general observations may be of interest.