On 4 December 2013 the High Court issued its decision in is Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors.
Sanofi-Adventis Australia patented the use of the pharmaceutical drug, Leflunomide, as a method to treat or prevent psoriasis. The Australian patent on the preparation and composition of Leflunomide had expired. Apotex intended to supply Leflunomide products in Australia under the name Apo-Leflunomide for the treatment of active psoriatic arthritis and rheumatoid arthritis. The product information of Apo-Leflunomide stated that it was "not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease".
Sanofi-Adventis Australia sued Apotex for infringement of the patent. Apotex counter-sued for revocation of the patent on multiple grounds.
The High Court held that medical treatment methods that make use of a previously unidentified therapeutic use of a pharmaceutical product are patentable in Australia, unlike in New Zealand and the UK. The Court came to this view because it found that a method of medical treatment can be seen to be a "manner of manufacture", a requirement in order for an invention to be patentable.
Accordingly, Apotex's application for the revocation of Sanofi-Adventis' patent was refused. However, it was found that Apotex had not infringed the patent because the product information stated that Apo-Leflunomide was not to be used for the purpose that was the subject of that patent.
CONCLUSION
It is now clear that it is possible to patent methods of medical treatment using a pharmaceutical product to treat a particular disease.
It is still unclear whether surgical methods are patentable. In their joint judgment Justices Crennan and Kiefel said that the patentability of methods used by medical staff and doctors when physically treating patients is a different issue that did not need to be further considered in this case.
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