High Court concludes that methods of medical treatment are patentable

On 4 December 2013, the High Court judgment in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] HCA 50 was delivered. This is the first occasion the High Court has considered whether methods of medical treatment of the human body are patentable inventions within the meaning of section 18(1) of the Patents Act 1990 (Cth). The majority of the High Court concluded they were, whilst providing important guidance on contributory (or indirect) infringement in the context of patents which claim methods of medical treatment.

SUMMARY OF THE MATTER

Parties and the patent

By way of background, the patent in issue was Australian Patent No 670491, entitled Pharmaceutical for the treatment of skin disorders. Relevantly, the patent claims:

[a] method of preventing or treating a skin disorder wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of [leflunomide]. Sanofi-Aventis Australia Pty Ltd (Sanofi) markets leflunomide in Australia under the brand name ARAVA®.

In 2008, Apotex Pty Ltd (Apotex) obtained registrations for a generic leflunomide product. Shortly thereafter, Sanofi commenced infringement proceedings largely relying on section 117 of the Patents Act 1990 (Cth) which relates to contributory (or indirect) infringement.

Apotex responded by filing a cross-claim for revocation. Importantly, one of the grounds relied upon in making the argument for revocation was that the patent did not disclose a patentable invention, effectively challenging the patentability of methods of medical treatments.

Pursuant to the Patents Act, amongst other things, a patentable invention must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. Apotex argued that methods of medical treatment do not fall within this definition as they are "essentially non-economic" and "not capable of being industrially applied." They further argued that a method of medical treatment involving the administration of a pharmaceutical substance differs to a medicine in that it "improved the condition of a human being, which is not an article of commerce."1

This is the first occasion that the High Court has been required to considered whether a method of medical treatment "is a proper subject of letters patent according the principles which have been developed for the application of s 6 of the Statue of Monopolies."2

PATENTABLE SUBJECT MATTER

Issues

The majority of the High Court (French CJ...