A majority of the High Court has today held that methods of medical treatment may be patentable subject matter.
In three separate judgements forming Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50, French CJ, Crennan and Kiefel JJ and Gageler J all concluded that the requirement of section 18(1)(a) of the Patent Act 1990 (Cth) that an invention be “a manner of manufacture within the meaning of section 6 of the Statute of Monopolies” did not preclude the granting of patents for such methods.
Central to each of the judgments was the lack of a basis for distinguishing between a claim to a new product for therapeutic use and a claim to a new method for the use of a product having a known therapeutic use. Crennan and Kiefel JJ found that the two types of subject matter “cannot be distinguished in terms of economics or ethics”, while French CJ stated that:
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”.
Crennan and Kiefel JJ concluded 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 satisfying the NRDC Case test, namely that it is a contribution to a useful art having economic utility, can be a manner of manufacture and hence a patentable invention within the meaning of s 18(1)(a) of the 1990 Act.
In a dissenting judgement, Hanye J held that the manner of manufacture test stipulated by NRDC required that the product of a process (rather than the process itself) must be of commercial significance. His Honour found that while a method of medical treatment might possess such characteristics, the product of that method (the treated individual) did not.
Accordingly, the validity of the patent was upheld. There was however a sting in the tail for the patentee with the Court allowing an appeal against the Full Court’s finding of infringement.