Carved out indications and patents in Australia: The story continues

Abstract

The decision of the Australian High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (the leflunomide case) gave the highest judicial endorsement to the practice of “carving out” patented treatment indications from the registered indications for a new generic drug. The High Court held in that case that the removal of reference to any patented treatment indication was sufficient for the generic entrant to avoid liability for contributory or secondary patent infringement. It remained to be seen, however, how this judicial authority would be applied in other circumstances. We now have further judicial guidance on the approach that courts are likely to take to this issue and this article examines a recent decision of the Australian Federal Court applying the “leflunomide principle” in the context of a preliminary injunction application.