Wyeth's application for Venlafaxine XR generics identity discovery in Australia denied

In January 2009, Wyeth filed an application in the Federal Court seeking preliminary discovery from the Department pursuant to O 15A of the Federal Court Rules of the names of the persons who have applied to the ARTG and for documentary information relating to those applications. Until early March this year, Efexor-XR was the only brand of venlafaxine registered by the Australian Register of Therapeutic Goods (“ARTG”). However, towards the end of last year, Wyeth apparently suspected that other companies had applied to the ARTG to register medicines containing venlafaxine. Wyeth therefore requested the Department of Health and Ageing (“the Department”) to provide it with information under the Freedom of Information Act 1982 (Cth) (the “FOI Act”) in relation to those applications.
Under the relevant provisions of the National Health Act 1953 (Cth), the effect of a listing of the generics on the PBS will be to apply a 12.5% price reduction to the generics and to the three varieties of Efexor-XR marketed by Wyeth. It is the prospect of this price reduction, and the administrative processes involved in implementing it, which underlies Wyeth’s desire for early resolution of the question of whether the marketing of the generics would constitute an infringement of Wyeth’s method patent. Thus, Wyeth seeks to obtain preliminary discovery at the earliest possible date, in order to provide the foundation for injunctive proceedings, including a claim for interlocutory injunctive relief.
When analyzing Wyeth’s evidence as to prospects of success, Court stated that
· Patent claims “A method of providing a therapeutic blood plasma concentration of venlafaxine over a 24 hour period ... that provides a peak blood plasma level of venlafaxine in from about 4 to 8 hours after administration”
Section 4.3.1 of the ARGPM goes on to say that applications for essentially similar medicines can be made in Australia under a number of different circumstances. These include:-in lieu of safety and efficacy data, an appropriate bioavailability study or studies should normally be submitted. Provided that the essentially similar product has a sufficiently similar plasma concentration/time profile to a leading brand in Australia, the two products may be considered bioequivalent. (emphasis added)
· There was no medical evidence to support the proposition that the pharmacology of venlafaxine hydrochloride is such that it lends itself to only one possible method of achieving the same time/peak blood concentration as is produced in Efexor-XR.
The court however denied Wyeth’s motion stating the following
“it is not in the interests of justice to order identity discovery on this application. There are two reasons for this. First, I am not satisfied on the evidence before me that Wyeth has good prospects of success at a final hearing. The most that can be said is that it has a provisional working hypothesis which would need to be supplemented by further evidence, including expert evidence, to determine the strength of Wyeth’s case.Moreover, there are a number of factors which suggest that the hypothesis is not correct, or, at least, that those factors cannot be displaced in the absence of further evidence. I referred to them at . Second, the assumption which underlies Wyeth’s claim for identity discovery is that if I were to make an order now, it would be in a position to have a claim for interlocutory relief determined by 20 July 2009. This is the date which is shown in Wyeth’s chronology of steps required for it to obtain information discovery and, thereafter, to have heard and determined a claim for interlocutory relief. The corresponding date shown on the chronology, upon the assumption that Wyeth has to wait for ARTG listing on 15 May 2009, is 2 September 2009. I cannot be confident that the Court would be in a position to give judgment on a contested claim for interlocutory relief prior to the anticipated PBS listing of the generics on 1 August 2009. It follows that in my view, the commercial inconveniences and possible difficulties in restoring Wyeth to the status quo will arise in any event.

The application for identity discovery was dismissed with costs