Background
The patenting of methods of medical treatment is a particularly complex area of IP law, with some methods being allowed in certain jurisdictions, and specifically excluded in others.
While initially it was considered that such methods did not constitute patentable subject matter in Australia, the Australian patent office changed its practice in 1972 following the decision in Joos v Commissioner of Patents. In this case, the court overturned a decision by the commissioner to refuse grant of a patent for a process of treating of parts of the human body, in particular hair and nails. Nevertheless, while the Australian patent office has proceeded to grant patents to methods of medical treatment for the last 40 years, the patentability of such claims had never been judicially tested in Australia’s highest court.
Decision
On 4 December 2013, a majority of the High Court has 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.
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.