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
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.
1Apotex Pty Ltd v Sanofi-Aventis Australia
Pty Ltd  HCA 50
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