Method of treatment claims can be patentable in Australia.
The High Court of Australia, Australia’s highest court, has concluded that method of treatment claims can relate to patentable subject matter. This issue was decided in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50 issued on 4 December 2013, and this is the first time that this issue has been considered by the High Court.
This decision was an appeal from the Full Federal Court of Australia, and concerned Australian Patent No 670,491 (“the Patent”), held by Sanofi-Aventis. The main issue for determination in the appeal was whether or not the sole claim of the patent relates to patentable subject matter. Claim 1 of the patent is for “[a] method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide]”.
Under Australian law, the scope of what is considered to be patentable subject matter is defined by subsection 18(1)(a) of the Australian Patents Act. That is, an invention, so far as claimed in any claim, must be “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies”. A body of law in Australia has developed around the meaning of this phrase.
After giving consideration to previous Australian decisions, as well as to the law and practice in foreign countries, four of the five judges decided that method of treatment claims can indeed relate to patentable subject matter. In this regard Crennan J and Kiefel J stated that assuming that all other requirements for patentability are met, a method (or process) for medical treatment of the human body which is capable of making a contribution to a useful art having economic utility, can be a manner of manufacture and hence a patentable invention as required by subsection 18(1)(a) of the Patents Act.