F. Hoffman-La Roche AG v Sandoz Pty Ltd

In the Federal Court of Australia, F. Hoffman-La Roche AG initiated proceedings against Sandoz Pty Ltd, asserting patent infringement concerning rituximab, a biologic therapy used in the treatment of various conditions. Roche sought interlocutory injunctive relief to prevent Sandoz from supplying rituximab without its authorisation. The primary legal issues revolved around establishing a prima facie case for patent infringement, assessing the strength of Sandoz’s challenge to the validity of the asserted patents, and determining the balance of convenience in favour of granting or denying the injunction.

The Court found that Roche had established a prima facie case for patent infringement based on admissions by Sandoz. The Court also acknowledged that Sandoz had an arguable case for invalidating the patents, primarily focusing on the lack of an inventive step. However, the Court concluded that Sandoz's evidence did not rise above the level of an arguable case and thus did not sufficiently counter Roche's infringement claims. Furthermore, the Court determined that the balance of convenience favoured Roche, given the imminent expiry of some of the patents and the significant impact of Sandoz’s actions on Roche’s market position and revenue.

Consequently, the Court granted Roche's application for interlocutory injunctive relief. The orders restrained Sandoz from supplying or offering to supply rituximab without Roche’s authorisation until the patents expired or the proceedings were finally determined. Additionally, Sandoz was required to notify relevant government departments of the injunction and its inability to provide assurance of supply for PBS listing purposes. The Court also set a timeline for the parties to confer on the pre-trial timetable and listed a case management hearing. The costs of the interlocutory application were awarded to Roche.