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
On 4 December 2013, a majority of the High Court has held that
methods of medical treatment may be patentable subject
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
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
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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