The Australian High Court (the ultimate court of appeal in Australia) has for the first time had to determine whether methods for medical treatment of the human body can be patentable subject matter. In a 4:1 ruling, the High Court confirmed that they can be1.

It is common for Australian patents to protect the use of pharmaceuticals to treat one or more specific medical conditions. These patents are very valuable to inventive pharmaceutical companies who identify and develop pharmaceutical products to be used to treat specific medical conditions. If the High Court had accepted Apotex’s argument, those patents would have been susceptible to revocation.

Instead, the High Court recognised that patent monopolies are an appropriate reward for research into previously unknown therapeutic uses of pharmaceutical compounds. This decision provides reassurance to patent owners and other parties dealing with those patents that they are valid, and that investment in development of pharmaceutical compounds will be properly recognised.

At issue was the patentability of an invention relating to the use of the pharmaceutical compound leflunomide (distributed by sanofi-aventis as ARAVA) in the prevention or treatment of the skin disorder psoriasis. That is, medical treatment of the human body (using the pharmaceutical compound leflunomide).

Apotex Pty Ltd submitted that inventions relating to methods of medical treatment of the human body make a human being a “better working organism” and are “essentially non-economic” and therefore do not fall within the accepted bounds of patentable subject matter.

The majority of the High Court did not accept that argument. The High Court accepted that economic utility of an invention is the cornerstone for determining whether that invention is patentable. Inventions for the use of pharmaceutical compounds to treat medical disorders (ie, leflunomide to treat psoriasis) were considered to have sufficient economic utility to be patentable.