Alphapharm has been granted special leave to appeal to the High Court against the decision in Aspen Pharma Pty Ltd v H Lundbeck A/S  FCAFC 129.
Leave was granted in relation to the Full Court’s findings that patentee Lundbeck could rely on section 223 (extensions of time) in respect of its application for an extension of term of a pharmaceutical patent pursuant to section 70.
Section 223 applies in respect of “relevant acts” which are in part defined in section 223(11) as being an action (other than a prescribed action). Regulation 22.11(4)(b) defines one prescribed action as “filing, during the term of a standard patent as required by subsection 71 (2) of the Act, an application under subsection 70 (1) of the Act for an extension of the term of the patent;”.
Section 71 requires that an extension of term application be filed (a) during the term of the patent and (b) within 6 months of the latest of three defined dates. The Full Court held that while Regulation 22.11(4)(b) precludes section 223 from applying in circumstances where the patent term had expired (the first requirement), it did not preclude an extension of time in respect of the second requirement.
In its application for special leave, Alphapharm argued that the regulations prescribed actions rather than time limits, the relevant action being the filing of an extension of term application, with the result that section 223 had no application. A secondary argument was that while subsection 71(2) contained a number of conditions, it ultimately defines a single time limit by which an application must be made such that Regulation 22.11(4)(b) could not apply to one requirement but not the other.