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 [2013] 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.

High Court Summary (click for full document link)

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.