Alphapharm Pty Ltd v H Lundbeck A/S

In the matter of Alphapharm Pty Ltd versus H Lundbeck A/S, the Federal Court of Australia was tasked with resolving several issues pertaining to the interpretation and application of the Patents Act 1990. The primary dispute centred on the definition of a "pharmaceutical substance per se" as outlined in section 70(2)(a) of the Act. Specifically, the court needed to determine whether this term referred to an isolated molecule as claimed in the patent or to a part of goods containing that molecule that had already been included on the Australian Register of Therapeutic Goods. Another key issue was whether the prior inclusion of a pharmaceutical good on the Register before the isolation of the molecule could be used to extend the term of the patent in question under section 70.

The court also examined whether an earlier invalid extension of the patent term constituted a "previous extension" for the purposes of section 70(4) of the Act. Furthermore, it considered whether an extension that was affected by a jurisdictional error could be deemed not a decision at all, and whether a new extension could be granted after the removal of the earlier invalid extension from the Register. Additionally, the court assessed whether the Commissioner erred in granting an extension of the patent term immediately following the decision on an opposition and before the appeal from that decision was determined. The court recognised its plenary and express powers under sections 192 and 160 of the Act to correct the Register of Patents.

The court concluded that the Commissioner did not err in his decision-making process. It held that the earlier invalid extension did not constitute a previous extension for the purposes of section 70(4), and that an extension could be granted even after the removal of a previous invalid extension from the Register. Furthermore, the court found no error in the Commissioner's decision to grant the extension immediately after the opposition decision and before the appeal was determined. Consequently, the court dismissed the appeal and ordered the appellants to pay the respondent’s costs.