10 June 2012

Generic ABILIFY (Aripiprazole) Ban to be Reviewed

Generic Health Pty Ltd v Otsuka Pharmaceutical Co Ltd [2012] FCA 412 (23 April 2012)

Practice and procedure – interlocutory injunction – whether application for leave to appeal should be referred to a Full Court

Abilify? Generic Health Pty Ltd will have the opportunity to appeal the decision of a single judge of the Federal Court of Australia granting a preliminary injunction preventing it from launching a generic version of the antipsychotic drug ABILIFY (see Australian Federal Court Blocks Generic ABILIFY (Aripiprazole)).

In general, any decision of a single judge of the Federal Court can be challenged by appeal to the Full Court – a panel of three judges.  In the case of a final ruling, i.e. after a full trial, any party to the proceedings automatically has the right to appeal.  However, a Full Court review of a preliminary judgement requires permission, i.e. ‘leave’ to appeal.

As a result, appealing a preliminary injunction is generally a two-step process – first the appellant must obtain leave to take the matter to a Full Bench of the court and then, if leave is granted, it is still necessary for the appeal proper to be heard.

In this case, Justice Katzmann has granted a request by Generic Health for its application for leave to be heard by a Full Bench of the court, and for the appeal itself to be heard either simultaneously, or immediately following the leave hearing.  Regular readers of this blog may recall that Justice Foster made a similar ruling in favour of Samsung last year (see Samsung Over First Hurdle in Bid To Overturn Apple Injunction).

Justice Katzmann, considering only written submissions from the parties, was not entirely convinced that Generic Health has a case, but at the same time considered that reaching a decision on both the leave application and any substantive appeal would require a review of substantially the same arguments and evidence (at [24]):

Generic Health may well have an uphill battle in showing that the decision of the primary judge is attended by any appealable error. On the face of the judgment, which is all I have to go by, the supposed errors in his Honour’s decision are not at all obvious. Still … I would be loathe to characterise the leave application as hopeless, particularly in the absence of full argument and when the subtleties of the argument may not be immediately apparent. This is not a case, for example, where the draft notice of appeal fails to raise an appealable error. Moreover, in part the challenge to the primary judge’s decision is based on an evaluation of the effect of the expert evidence, none of which is before me.

An appellant is not automatically entitled to have an application for leave to appeal heard by a full bench, rather than a single judge.  However, Justice Katzmann was concerned to ensure efficient use of the court’s resources, and mindful of the significance of the outcome to the parties (at [26]):

The mere fact that there will be common questions is scarcely a reason for referring a matter to the Full Court. More often than not that will be the case. But the respondents do not contradict the submission that Generic Health will suffer substantial injustice if the decision below turns out to be wrong. Consequently, the argument on the leave application will focus on the merits of the proposed appeal. I sense that it is likely that the merits will be as fully argued on the leave application as they would be on the appeal, … regardless of whether the application were heard by a single judge or a Full Court. There is certainly the potential for considerable duplication. I doubt very much whether the hearing of an appeal would be any longer than the hearing of a leave application. In these circumstances, it is more efficient for the leave application to be heard by a Full Court and, if successful, for the appeal to follow, and that is what I will order.

The application/appeal is scheduled to be heard before Justices Emmett, Bennett and Greenwood on 30 July 2012.

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