Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd

The High Court of Australia considered a dispute between Apotex Pty Ltd and Sanofi-Aventis Australia Pty Ltd concerning the patentability of medical treatments. The core of the disagreement revolved around whether a method of medical treatment of the human body constitutes a patentable invention under the *Patents Act 1990* (Cth).

The legal issues before the Court included whether a method of medical treatment of the human body is a patentable invention within the meaning of s 18(1)(a) of the *Patents Act 1990* (Cth), and whether such a method, or a product or process for it, qualifies as a "manner of manufacture" under s 6 of the *Statute of Monopolies*. Additionally, the Court was required to consider whether a novel therapeutic use of a known substance is patentable and, in the context of infringement, whether supplying a drug with an indication for a different condition infringes a patent.

The High Court's reasoning acknowledged that, as a general proposition, the exclusion of medical treatments from patentability has been a long-standing, albeit anomalous, qualification on the principles of patentability. The Court noted that previous decisions, such as those in *Rescare* and *Wellcome Foundation*, lent support to the idea that this exclusion might be dispensed with as a development of existing principles. However, the Court also observed that the question of whether to expand patentability to cover methods of medical treatment was a matter for the legislature, rather than the judiciary, to determine, particularly given the complex public and private interests involved. The Court found that Apotex's submissions regarding the historical position in Australia were not as definitively supported by prior case law as contended.

In Matter No S1 of 2013, the appeal was dismissed with costs. In Matter No S219 of 2012, special leave to appeal was granted on a specific ground, and the appeal was allowed with costs. The orders of the Full Court of the Federal Court of Australia were set aside and replaced with new orders, including that the appeal to the Full Court be allowed in part and that certain parts of Apotex's amended application be dismissed. The matter was remitted to the Full Court for determination of costs.