Alphapharm Pty Limited v Wyeth

Alphapharm Pty Limited (Alphapharm) brought proceedings against Wyeth in the Federal Court of Australia seeking a declaration of invalidity of Wyeth's method patent, which claimed a process for treating major depression or social anxiety disorder using modified release formulations of venlafaxine hydrochloride. Wyeth filed an interlocutory application seeking an interim injunction to prevent Alphapharm from marketing its generic product, Enlafax-XR, which it claimed would infringe the method patent. The Court had to decide whether Wyeth had established a reasonably strong prima facie case of patent infringement, and whether Alphapharm had established a prima facie case for invalidity of the patent on the grounds of impossibility, manner of manufacture and lack of inventive step. The Court also had to weigh the balance of convenience, considering the harm to both parties if the injunction was or was not granted.

The Court found that Wyeth had established a reasonably strong prima facie case of patent infringement by Alphapharm. However, Alphapharm had established a prima facie case for invalidity of the patent on the grounds of impossibility, manner of manufacture and lack of inventive step. The Court also considered the balance of convenience, taking into account the harm to both parties if the injunction was or was not granted. Alphapharm argued that there was no stable status quo to protect, given that Wyeth had altered its marketing strategy to shift the market from Efexor-XR to Pristiq, its new product. The Court found that Wyeth's actions in relation to Pristiq did not establish that there was no stable status quo to protect.

THE COURT ORDERS THAT:
1. Pending the determination of the proceeding or further order, Alphapharm Pty Limited (whether by itself, its directors, officers, servants, agents or otherwise) be restrained from infringing claims 4 and 27 (insofar as claim 27 is dependent on claim 4) of Australian Patent No 2003259586 (the method patent), including without limitation by, during the term of the method patent and without the licence or authority of Wyeth, importing, marketing, taking orders for, selling, supplying, offering to supply in Australia the Enlafax-XR Products or any other product comprising the same generic modified release formulation of venlafaxine hydrochloride for use by persons for the Registered Indications or otherwise exploiting the invention the subject of the method patent.
2. Alphapharm Pty Limited be restrained from applying to list the Enlafax-XR Products on the Schedule of Pharmaceutical Benefits.
3. Costs of the interlocutory application be costs in the cause.
4. The edited reasons for judgment published this day stand in lieu of the reasons provided to the parties and their legal advisers on 25 August 2009 and that the latter reasons be kept confidential and not published to any other person.