The majority of the High Court (Crennan, Bell and Gageler JJ) has dismissed Alphapharm’s appeal against a decision granting Lundbeck an extension of time in which to apply to extend the term of its patent for LEXAPRO. The decision is consistent with IP Australia’s longstanding practice of considering extension of time applications for late extension of term applications provided that the patent has not yet expired.
Alphapharm argued that the Commissioner of Patents did not have power to grant the extension of time as, it argued, regulation 22.11(4)(b) of the Patents Regulations excluded applications for extensions of term from the operation of the extension of time provisions. Lundbeck argued that, properly construed, the regulation only excludes extension of time for filing an extension of term application after the initial term of the patent had expired. Lundbeck filed its extension of term application on the day before the original patent term expired.
Under section 71 of the Patents Act, an extension of term application must be filed (i) during the term of the patent and (ii) within 6 months of the latest of three set dates (one of which is the registration of goods containing the pharmaceutical substance on the Australian Register of Therapeutic Goods (ARTG)) (the “6 month deadline”).
The Commissioner has power under section 223 to extend time where a deadline is missed due to the failure to do a “relevant act”. A “relevant act” is defined as “an action (other than a prescribed action) in relation to a patent”. The “prescribed actions” for which an extension of time is unavailable are set out in regulation 22.11(4). These include regulation 22.11(4)(b), “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”.
Alphapharm argued that the action that is required to be done is filing an extension of term application and that is the very action that is prescribed by regulation 22.11(4)(b). This view was accepted by the minority (Kiefel and Keane JJ).
Lundbeck argued that by using the words “during the term of a standard patent” the regulation specifically singles out the expiry date deadline as one that cannot be extended whereas the “6 month deadline” remains capable of extension.
The majority found support for Lundbeck’s construction in the pre-existing law in which extensions of time were permitted, the legislative history in which allusion was made to the availability of extension of time provisions and the protective and remedial purpose of the extension of time provisions.
The 6 month deadline is sometimes missed as a consequence of a failure to alert the patent department in a pharmaceutical company that regulatory approval has been obtained (which triggers the deadline). Often this involves a failure by a local licensee. If the High Court had allowed Alphapharm’s appeal, a number of extensions of term granted by IP Australia would have been at risk. The High Court’s decision upholds IP Australia’s ability to grant extensions of time in appropriate circumstances.