Pfizer Corp v Commissioner of Patents (No 2)

In the matter of Pfizer Corp v Commissioner of Patents (No 2), the Federal Court of Australia was called upon to determine the legal implications of exporting patented pharmaceutical products from Australia and the requisite regulatory requirements for inclusion in the Australian Register of Therapeutic Goods (ARTG). The dispute involved Pfizer Corp, which held patents for certain pharmaceutical products, and the Commissioner of Patents, with Spirit Pharmaceuticals Pty Limited joining as a respondent to provide evidence relevant to the regulatory requirements and patent exploitation. The central issue was whether the inclusion of a product in the ARTG for export purposes qualified as the "first inclusion" under the Patents Act 1990 (Cth) for calculating the extension of patent terms.

The court had to decide whether an export-only listing of a patented product in the ARTG constituted the "first inclusion" under section 70 of the Act, thereby affecting the calculation of patent term extensions under section 77. The crux of the legal issue was the interpretation of the statutory language concerning "first inclusion" and "first regulatory approval date," and whether the export-only listing of a patented product in the ARTG could be considered a form of regulatory approval that triggers the commencement of the patent term extension period. Additionally, the court needed to assess the relevance and admissibility of expert evidence from Dr Walter regarding the regulatory requirements for Listed Goods and the extent to which an export-only listing enabled patent exploitation.

The Federal Court held that an inclusion in the ARTG, including an export-only listing as Listed Goods, qualifies as the "first inclusion" for the purposes of section 70 of the Act. The court determined that this inclusion, if it precedes registration for marketing in Australia and no "pre-TGA marketing approval" was given, constitutes the "first inclusion in the ARTG" and the "first regulatory approval date" for calculating the period of extension under section 77. The court dismissed the application on the grounds that the appeal against the Commissioner's decision should not succeed. Furthermore, the court ordered that the applicants pay the costs of the Commissioner, although Spirit Pharmaceuticals, having joined the proceeding as a respondent, had agreed not to seek costs. The court reserved the matter of Pfizer’s application for a stay, its associated costs, and any undertaking regarding damages for further submissions from the parties.