Alphapharm Pty Ltd v H Lundbeck A/S

The matter before the court was an application by Alphapharm Pty Ltd to extend the term of their patent 623144, which was opposed by H Lundbeck A/S. The central issue was whether the patent term should be extended in accordance with section 77 of the relevant legislation, which allows for extensions based on regulatory approval of a pharmaceutical product. Specifically, the application hinged on the Australian Register of Therapeutic Goods (ARTG) registration of the drug CIPRAMIL.

The court examined whether the ARTG registration met the criteria for an extension under section 77. The primary legal question was whether the regulatory approval process in Australia, as evidenced by the ARTG registration, qualified as an "approval" under the statute. The court considered the statutory language and the legislative intent behind the provision, ultimately determining that the ARTG registration indeed constituted an approval warranting an extension of the patent term. The opposition's arguments that the registration did not meet the necessary criteria were rejected by the court.

Following the determination that the patent term should be extended, the court directed that the Register would not be updated until 28 days from the date of the decision, or if an appeal was filed within that period, until the stay application was resolved. This approach was deemed appropriate to balance the interests of the patent holder and the need for judicial review. The court also mandated that the Commissioner notify the applicant of the extension in writing, as required by section 76(2). Finally, the court awarded costs to the applicant, in line with the parties' submissions that costs should follow the event.