The development of new chemical compounds (and increasingly of biologics) for the treatment of human medical ailments remains the primary focus of the world's major pharmaceutical companies. However, the immense cost associated with the development of new chemical entities and biologics provides great incentive for pharmaceutical companies to research new uses for existing drugs. Australia is one country which offers incentive in the development of new uses for known drugs by permitting such developments, which are novel and inventive, to be patented. Against this background, this article examines second medical use patents, indication carve-outs, and the recent Australian High Court decision in the leflunomide case.

This article is part of the multi-jurisdictional guide to life sciences. For a full list of jurisdictional Q&As visit www.practicallaw.com/lifesciences-mjg.