Alphapharm Pty Ltd v H Lundbeck A/S [2008] FCA 559

This decision of the Federal Court is the culmination of a full-scale attack on Lundbeck's Escitalopram Patent (AU 623144) by Alphapharm and Arrow Pharmaceuticals (Arrow). Although the validity of the patent was upheld, the patent term was slashed by five years after it was held that Lundbeck's application for an extension of term was made outside the required time frame. The patent's adjusted expiry date is June 2009.

This decision potentially jeopardizes the validity of extensions of term and reduces the data exclusivity period under the Therapeutic Goods Administration (TGA) Act for "new pharmaceuticals" such as enantiomers and new formulations that are contained in pharmaceutical compounds previously listed in the Australian Register of Therapeutic Goods (ARTG).