Yesterday, the High Court of Australia issued a decision in the case of ALPHAPHARM PTY LTD v H LUNDBECK A/S & ORS. The High Court held that the Commissioner of Patents had the power to extend the time within which Lundbeck could apply for an extension of the term of its patent for the antidepressant drug escitalopram (sold as LEXAPRO). This decision confirms the earlier findings of the Patent Office, the Administrative Appeals Tribunal, and the Federal Court of Australia.
Australian law provides for extensions to the term of certain patents to compensate for delays incurred in obtaining marketing approval for pharmaceutical products.
Section 71(2) sets out the prescribed timing for an extension application:
An application for an extension of the term of a standard patent must be made during the term of the patent and within six months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3);
(c) the date of commencement of this section.
Lundbeck applied for the patent term extension one day before the 20 year term of the patent was about to expire. Therefore, while the application was made during the term of the patent, it was outside the latest of the three dates specified in s71(2). Lundbeck claimed that the delay was due to an error or omission, and sought an extension of time from the Commissioner of Patents under s223(2). Alphapharm and the third to fifth respondents opposed Lundbeck's application for the grant of an extension of time.
The Court held, by majority, that s71(2) imposed two cumulative time requirements. Firstly, an application for an extension of the term of a patent was to be made during the term of the patent. Secondly, an application was to be made within six months after the latest of the three dates specified in s71(2). Properly understood, s223(2) permitted the Commissioner to enable an application for an extension of term to be made during the term of the patent but more than six months after the latest of the three dates specified in s71(2).
This decision shows that one should never conclude that an extension is not possible without a thorough investigation of the facts.