Patents and copyright: Decision in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2)

The Federal Court has handed down its judgment in the case of Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd (No 2) [2012] FCAFC 102, dismissing the appeal and ordering the appellant to pay the respondent’s costs. The case involved patents and copyright, with the decision dated 18 July 2012. 

The first respondent, Sanofi-Aventis Australia Pty Ltd, supplies leflunomide in Australia under the names “Arava” and “Arabloc,” used for treating psoriasis. In July 2008, the appellant, Apotex Pty Ltd registered its generic version of leflunomide, Apo-Leflunomide, on the Australian Register of Therapeutic Goods in order to implement its intention to supply it in Australia for use as a medicament for Psoriatic Arthritis and Rheumatoid Arthritis.

In the initial proceedings, the respondents brought proceedings in the Court claiming that the patent is valid and that it would be infringed by the appellant’s supply in Australia of its leflunomide product for the treatment of PsA.  The appellant disputed the validity of the patent on a number of grounds, and, in the alternative, denied that the patent excluded the appellant from supplying leflunomide for the treatment of PsA.

The primary judge found in favour of the respondents and ordered that the appellant be restrained from supply its generic leflunomide product for the treatment of psoriatic arthritis. In the current case on appeal, the appellant argued that the claim in the patent does not support the order which was made at first instance.  That is because it is a method of preventing or treating only the specified ailment psoriasis.  The appellant also argued that the patent is invalid, principally on the ground of want of novelty.

In his reasoning, Keane CJ considered that the construction of the claim which was preferred by the primary judge failed to recognise that the claim is for a method of treating or preventing a specific ailment.  Bennett and Yates JJ considered that the issues arising on appeal concerned whether the primary judge erred on a number of bases:

• in the construction that her Honour adopted for the purpose of      determining the questions of infringement and validity that arise in the present appeal;

• in finding that s 117 applied to the circumstances of the present case and whether, by operation of that provision, Apotex threatened to infringe the patent because of its threatened supply of its leflunomide products;

• in finding that the invention as claimed was novel in light of the publication of the 341 specification;

• in finding that the invention as claimed is a manner of manufacture within the meaning of section 6 of the Statute of Monopolies; and

• in failing to find that Sanofi-Aventis was bound by an implied licence that permitted Apotex to reproduce a substantial part of each of the Arava works.

Each ground of appeal was dismissed, and it was the unanimous decision of the court that the appeal should be dismissed with costs.

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