Evergreen or deciduous? Australian trends in relation to the 'evergreening' of patents

Abstract

The so-called ‘evergreening’ of pharmaceutical patents has become an issue of major public concern in the wake of the Australia–United States Free Trade Agreement and the amendments it requires to the Therapeutics Goods Act 1989 (Cth). The effect of these amendments was to place additional obligations on manufacturers of generic (unpatented) pharmaceuticals. Some additional provisions were also included in an attempt to safeguard against potentially ‘illegitimate’ patent infringement action taken by patentees against such manufacturers. This article examines these provisions and their likely effect on the patent protection strategies adopted by the pharmaceutical industry. It also considers recent responses to these strategies by the patents administration system and the courts — in particular, the decision of Arrow Pharmaceuticals Ltd v Merck & Co Inc.