Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd

Sanofi-Aventis Australia Pty Ltd sought an interlocutory injunction against Apotex Pty Ltd, which sought to market a generic version of Sanofi-Aventis's patented drug. The dispute centred on whether Apotex's proposed Product Information for the generic drug infringed Sanofi-Aventis's patent. The case was heard in the Federal Court of Australia.

The primary legal issue was whether the court should vary the interlocutory orders previously made by Lindgren J, in light of Apotex's amended Product Information. Apotex argued that there was no serious question to be tried on the pleadings, as the Product Information no longer contained the language that Sanofi-Aventis claimed infringed the patent. Apotex further argued that Sanofi-Aventis could not rely on the evidence of Professor Brooks, as Apotex itself had filed this evidence in the proceedings. The court had to decide whether the existence of a serious question to be tried was still present, and whether it was appropriate to vary the interlocutory orders in light of the changed circumstances.

The court examined the evidence of Professor Brooks, who stated that there is an overlap between rheumatoid arthritis and seronegative arthropathies, and that psoriatic arthritis is a form of seronegative arthropathy. Apotex argued that if Sanofi-Aventis wished to rely on Professor Brooks' evidence, it would have to amend its pleading to that effect, which Sanofi-Aventis would not do as it would concede invalidity of the patent. The court considered the discretion to vary the interlocutory orders, and whether it would be unjust not to vary the orders in light of the changed circumstances. The court found that there was still a serious question to be tried and that it was appropriate to vary the interlocutory orders in light of the changed circumstances.

The court varied the interlocutory orders, allowing Apotex to market its generic drug subject to certain conditions. The court found that there was still a serious question to be tried and that it would be unjust not to vary the orders in light of the changed circumstances. The court emphasised that it was not discharging the previous orders, but merely varying them in light of the changed circumstances.