Prima facie case

The essential question for the Full Court (comprised of Allsop CJ, Jagot and Nicholas JJ) was whether Pfizer had established that Apotex had 'reason to believe' (as required by section 117(2)(b) of the Patents Act) that Apotex's pregabalin product, indicated only for the treatment of seizures, would nevertheless be used to treat pain. Such use would infringe Pfizer's patent covering the use of pregabalin for the treatment of pain.

The Full Court concluded that Pfizer had established a prima facie case that it was entitled to the relief sought. Contrary to the first instance decision, the Full Court held that Pfizer's evidence demonstrated, on a prima facie basis:

• the seizure market was "extremely small" – the implication being that Apotex's product was also likely to be used to treat pain;
• practically speaking, there were circumstances where Apotex's product could be substituted for Pfizer's product; and
• there was conflicting evidence on whether Apotex's 'carve-out' of the pain indication, as evidenced in its ARTG registrations, PI, CMI and promotional materials, would be sufficient to deter pharmacists and prescribers from substituting Apotex's products for Pfizer's product 'off-label'.

The Full Court referred to the High Court's decision in Apotex v Sanofi [2013] HCA 50, where Apotex's 'carve-out' was sufficient to establish that Apotex did not have 'reason to believe' under section 117(2)(b). However, the Full Court observed that the High Court's finding involved a question of fact which in this case could not be resolved before trial. The message in this case therefore, is that a generic party should not assume that carving out a patented indication will alone be sufficient to avoid an interlocutory injunction.

Balance of convenience

The Full Court found that the balance of convenience favoured granting interlocutory relief. The major factor influencing this finding appears to have been their Honour's view on prima facie case. The Full Court also found that a number of additional factors supported granting the interlocutory injunction, the most significant being that:

• Pfizer enjoys a well-established market for pregabalin in Australia, and therefore it is important to maintain the status quo; and
• the usual undertaking as to damages was likely to provide Apotex with an adequate remedy should it prevail at final hearing (despite the Full Court noting the potential difficulty around calculating those damages).

With the substantive trial due to commence in October, we expect that this matter will continue to generate interesting results.