What is the correct start date for calculating the term extension of pharmaceutical patents?
The main issue her Honour had to determine was the correct start date for calculating the extension of pharmaceutical patents. Section 77 of the Patents Act 1990 calculates the extension of term by reference to the period beginning on the date of the patent and ending on the earliest “first regulatory approval date” reduced by 5 years. The phrase “first regulatory approval date” is relevantly defined in section 70 as “the date of commencement of the first inclusion in [ARTG] of goods that contain, or consist of, the substance”. Norvasc was first included in the ARTG as “listed goods” for export only. It was later included in the ARTG as “registered goods” on the date that Pfizer was granted approval to market the substances in Australia. In its application for the term extension, however, Pfizer had given the later registration date as the date of first inclusion in the ARTG. Export only vs marketing Therefore, was “the first inclusion” in the ARTG the earlier date of listing for expor
