This is a guest post from Bill Bennett of Pizzeys in Australia. It covers Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd  HCA 50 (4 December 2013). (A copy of the full decision is available at the end of this post.)
The Australian High Court has handed down a 4:1 majority decision confirming that a method of medical treatment can be a “manner of manufacture” (i.e. patentable subject matter). This is the first time that this issue has been directly considered by the Australian High Court.
Sanofi is the owner of a patent which claims a method of preventing or treating psoriasis by using a compound called leflunomide.
Apotex registered leflunomide on the Australian Register of Therapeutic Goods with the intention of selling it for the purpose of treating rheumatoid arthritis and psoriatic arthritis. Most persons with psoriatic arthritis either have, or will develop, psoriasis. Thus, the treatment of psoriatic arthritis will often simultaneously involve the treatment of psoriasis.
There were two issues considered by the High Court.
- Firstly, is a method of medical treatment a “manner of manufacture” (i.e. patentable subject matter)?
- Secondly, can a person infringe such a patent by supplying a product with instructions that it be used to treat a different disease?
Four of the five judges (French CJ, Crennan J, Kiefel J & Gageler J, with Hayne J dissenting) found that a method of medical treatment can be a “manner of manufacture” and hence patentable. This was unsurprising, given previous decisions by lower courts in Australia.
However, it is noteworthy that the majority arrived at this conclusion in the context of a patent directed to a method of medical treatment involving the use of a pharmaceutical. Members of the court made statements (obiter dicta) which were adverse to the patentability of methods of medical treatment which involve “the activities or procedures of doctors (and other medical staff) when physically treating patients”.
Specifically, Crennan J and Kiefel J, in their joint judgement, stated (at paragraph 287):
There is, however, a distinction which can be acknowledged between a method of medical treatment which involves a hitherto unknown therapeutic use of a pharmaceutical (having prior therapeutic uses) and the activities or procedures of doctors (and other medical staff) when physically treating patients. Although it is unnecessary to decide the point, or to seek to characterise such activities or procedures exhaustively, speaking generally they are, in the language of the NRDC Case, “essentially non-economic” and, in the language of the EPC and the Patents Act 1977 (UK), they are not “susceptible” or “capable” of industrial application. To the extent that such activities or procedures involve “a method or a process”, they are unlikely to be able to satisfy the NRDC Case test for the patentability of processes because they are not capable of being practically applied in commerce or industry, a necessary prerequisite of a “manner of manufacture”.
The medical device industry might take issue with the characterisation of a portion of their business as “essentially non-economic”. Further, they might be concerned that the Australian High Court has foreshadowed a possible future move towards a more restrictive approach to non-pharmaceutical methods of medical treatment.
Infringement by Supply
Where use of a product would infringe, then supply of that product can also be an infringement in certain circumstances which are set out in Section 117 of the Patents Act. One of those circumstances is supply with instructions or inducement to use the product in an infringing manner. Another circumstance is supply (of a non-staple product) where the supplier had reason to believe that the product would be put to the infringing use.
Apotex’s instructions specifically said that its product was not indicated for non-arthritic psoriasis. According to the majority, the requisite instructions or inducement was not present. Further, the court held that the evidence did not show, and did not allow the inference to be drawn, that Apotex had reason to believe that its products would be used in the infringing manner. In doing so, they overturned the Full Federal Court on this point.
The full decision can be found here: Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd