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 that 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, while providing important guidance on contributory (or indirect) infringement in the context of patents which claim methods of medical treatment.

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…

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