In Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 (4 December 2013), the matter before the High Court of Australia involved a consideration of whether the Sanofi-Aventis patent having claims directed to a method of preventing or treating a skin disorder, psoriasis, through the administration of an effecting amount of Leflunomide could be the proper subject matter for the grant of a patent and as such fall within the scope of a manner of new manufacture within the meaning of the Patents Act 1990 (Cth). Whilst this question had been considered by various tribunals and courts in a number of major jurisdictions it was the first time that the High Court of Australia had the opportunity to decide the question in the context of the law in Australia.

The High Court by a majority of 4:1 held that the invention was indeed a manner of manufacture within the meaning of section 18(1)(a) of the Act and proper subject matter for letters patent.

In three separate judgements, Chief Justice French, Justices Crennan and Kiefel and Justice Gageler concluded that the requirements of section 18(1)(a) of the Act had been met notwithstanding the statements and views of earlier courts on the patentability of methods of medical treatment claims. As noted by His Honour Chief Justice French, the application of the rubric ‘manner of new manufacture’ in a logically and normatively coherent way would not be served by excluding such claims. At [50] French CJ stated

“Whatever views may have held in the past, methods of medical treatment, particularly the use of pharmaceutical drugs, cannot today be conceived as ‘essentially non-economic’”.

Likewise Justices Crennan and Kiefel concluded in favour of the patentability of these types of inventions. Their Honours listed seven reasons for concluding in favour of the patentee including inter alia that critically no clear distinction could be drawn between the subject matter of a product claim and a combined product/method claim which are both patentable from a method of medical treatment claim in terms of economics or ethics. At [282] Crennan and Kiefel JJ concluded that

“In each case the subjeccould not be contended that a patient free of psoriasis is of less value as a subject matter of inventive endeavour than a crop free of weeds. Patent monopolies are as much an appropriate reward for research into hitherto unknown therapeutic uses of (known) compounds, which uses benefit mankind, as they are for research directed to novel substances or compounds for therapeutic use in humans. It is not possible to erect a distinction between such research based on public policy considerations.”

Justice Gageler agreed with the reasoning provided by Justices Crennan and Kiefel in relation to this issue, adding at [315] that

“[To now] substitute a negative answer would depart from that orthodoxy; disappoint commercial expectations legitimately formed and acted upon for at least 13 years; undermine the legislative assumption made seven years ago; and render the current legislative definition in part redundant.”

Whilst this decision of the High Court of Australia merely confirms the judicially sanctioned orthodoxy that an invention directed to a method of medical treatment is proper subject matter for letters patent, it is nevertheless significant as it now provides patentees in the life sciences industry with greater certainty as to what is patentable subject matter within the meaning of section 18(1)(a) of the Patents Act. This decision also represents a divergence in the position in Australia as compared to that adopted by our major trading parties such as in Europe and the United Kingdom particularly in the context of Art 27(3) of the TRIPs Agreement. However, as stated by Justices Crennan and Kiefel, to do otherwise would simply undermine the specific intention of Parliament to not enact Art 27(3) into the Australian domestic law.