Les Laboratoires Servier v Apotex Pty Ltd

Les Laboratoires Servier, the appellant, sought leave to appeal a decision of Emmett J, which dismissed its application for leave to amend its patent under s 105 of the Patents Act 1990 (Cth). Apotex Pty Ltd, the respondent, opposed the application for leave to appeal. The dispute centred on whether the primary judge had miscarried in his discretion to refuse Servier's application for leave to amend its patent, particularly in light of the validity issues that arose from proceedings in the United Kingdom. The Federal Court of Australia was tasked with determining whether the primary judge's exercise of discretion was erroneous and whether the proposed amendments were allowable under s 102 of the Patents Act.

The legal issues before the court included whether Servier had fully and frankly disclosed its reasons for seeking the amendment, the impact of Servier’s delay in seeking the amendment, and the validity of the proposed amendments under s 102 of the Patents Act. The court also needed to decide if the primary judge’s discretion to refuse leave to amend had been exercised improperly.

The court found that the primary judge did not miscarry in his discretion. Servier had not made a full and frank disclosure of its reasons for seeking the amendment, particularly concerning the validity issues arising in the UK proceedings. The primary judge’s findings on this matter were open to him and not erroneous. Furthermore, the court noted that the proposed amendments were not allowable under s 102 of the Patents Act, as they did not fairly disclose the matter in the body of the specification. Consequently, the court held that the primary judge’s decision to deny leave to amend was correct, and there was no need to address the issue of the validity of the claims. The appeal was dismissed, and Servier was ordered to pay Apotex’s costs of the application for leave and of the appeal.