Wyeth v Secretary, Department of Health and Ageing

The case of Wyeth v Secretary, Department of Health and Ageing was heard in the Federal Court of Australia, where Wyeth sought an order for identity discovery from the Secretary of the Department of Health and Ageing, in relation to generic versions of Wyeth's patented drug Efexor-XR. The primary issue before the Court was whether it was necessary in the interests of justice for the Court to make an order for identity discovery, prior to the listing of the generic drugs on the Australian Register of Therapeutic Goods. The Court was also required to determine whether Wyeth had made reasonable inquiries into the identity of the sponsors and whether the proceeding for which discovery was sought was interlocutory or final. The Court concluded that Wyeth had not established a real prospect of success on the merits of the case, and that it was not necessary in the interests of justice to make the order for identity discovery.

The Court found that Wyeth's working hypothesis, which was based on the opinion of its Director of Regulatory Affairs, did not provide sufficient evidence to support a real prospect of success in the proceedings. The Court also noted that the seriousness of the consequences of a false certificate under the Therapeutic Goods Act 1989 (Cth) meant that Wyeth's hypothesis fell to be tested against this standard. Additionally, the Court found that there was no medical evidence to support the proposition that the pharmacology of venlafaxine hydrochloride was such that it lent itself to only one possible method of achieving the same time/peak blood concentration as Efexor-XR. Finally, the Court found that Wyeth's hypothesis was provisional and depended on the examination of a large volume of documentary material in the possession of the sponsors and/or the Therapeutic Goods Authority. As such, the Court dismissed Wyeth's application for identity discovery and ordered that Wyeth pay the respondent's costs of the application.