AbbVie Biotechnology Ltd Commissioner of Patents

AbbVie Biotechnology Ltd sought extensions of the terms of three Australian patents relating to the pharmaceutical substance adalimumab. The Commissioner of Patents opposed these applications. The dispute concerned whether the patents, which included "Swiss style" claims (claims to the use of a pharmaceutical substance in the manufacture of a medicament for treating a disease), were eligible for an extension of term under the Patents Act 1990 (Cth), and whether the applications were made with reference to the correct date of inclusion on the Australian Register of Therapeutic Goods (ARTG). The matter came before the Hon. D Cowdroy OAM QC, Deputy President of the Administrative Appeals Tribunal.

The primary legal issues before the Tribunal were: first, whether the "Swiss style" claims of the patents were capable of extension within the meaning of section 70(2)(b) of the Patents Act, particularly in light of amendments to the Act and previous judicial interpretations; and second, whether the applications for extension of term were disqualified because they referred to subsequent ARTG registrations for additional indications of adalimumab, rather than the first relevant inclusion of the pharmaceutical substance on the ARTG.

The Tribunal considered the historical context of patent term extensions for pharmaceutical substances, noting that prior to 1995, "method-type" claims, including "Swiss style" claims, were considered capable of extension. However, the Tribunal found that the current iteration of section 70 of the Patents Act, particularly section 70(2)(b), required a pharmaceutical substance to be claimed *per se* for an extension to be granted. The Tribunal also determined that the applications for extension of term were based on incorrect dates, referring to later ARTG registrations for specific disease indications rather than the initial ARTG approval of adalimumab on 10 December 2003.

Consequently, the Tribunal affirmed the Delegate's decision that AbbVie Biotechnology Ltd did not comply with section 71(1) of the Patents Act. The applications were found to be based on the wrong ARTG registration dates, meaning the applicant was not entitled to an extension on the basis of the applications as filed. However, the Tribunal noted that the applicant could potentially apply to correct this error.