Sanofi-Aventis Australia Pty Ltd v Apotex Pty Ltd (No 3) [2011] FCA 846 (29 July 2011)
Claim construction – scope and construction of second medical use claims – ‘objective purpose’ of administration of therapy – actual effect of administration
Novelty – application and limitations of the ‘reverse infringement test’
Infringement – infringement by supply of products
In a decision issued by
Justice Jagot in the Federal Court of Australia, Sanofi-Aventis has been handed what seems to amount to an effective 10-year extension on its patent monopoly for the pharmaceutical compound leflunomide, which it markets in Australia under the names ARAVA and ARABLOC.
Briefly, Sanofi-Aventis had an Australian patent on the compound, which expired in 2004. This, of course, enabled it to prevent the supply of leflunomide for any purpose during the life of the compound patent. The approved purposes for which the drug is registered for use relate to the treatment of rheumatoid and psoriatic arthritis.
But Sanofi-Aventis also has a patent covering a subsequent medical use of the drug, not envisaged in the original patent, namely in the treatment of the skin condition psoriasis. Until 2014, when this further patent expires, Sanofi-Aventis therefore has a monopoly on the use of leflunomide for the treatment of psoriasis. However, the drug is not currently approved in Australia for this purpose.
Based on the above description of the present circumstances, you might think that a generic manufacturer, such as Apotex, would now have the right to market a competing leflunomide product for the purposes covered by the existing approvals, i.e. treatment of rheumatoid and psoriatic arthritis.
According to the Federal Court, however, you would be wrong. Justice Jagot has found – generously (to Sanofi-Aventis) – that Apotex’s proposed supply of a generic leflunomide product for the treatment of arthritis would infringe the psoriasis treatment patent, and that Sanofi-Aventis is thus entitled to an injunction preventing such supply.
It is difficult to see how this decision does not effectively ‘evergreen’ the compound patent, making the supply of leflunomide for any therapeutic purpose that might incidentally treat psoriasis an infringement of the Sanofi-Aventis patent, for an additional ten years (until 2014).