Breaking News – High Court hands down important decision in relation to infringement of pharmaceutical patents

A few hours ago, the High Court handed down its long awaited decision in Apotex v Sanofi. While the High Court confirmed that methods of medical treatment of the human body are patentable inventions within the meaning of s18(1) of the Patents Act 1990 (Cth), it found that Apotex did not infringe Sanofi’s patent relating to the use of leflunomide to treat psoriasis.

Importantly, the Court found that Apotex’s product information did not instruct use of the drug in accordance with the patented method such that s117(2)(c) of the Patents Act was not engaged.  Similarly, the Court found that Sanofi had not established, nor could it be inferred, that Apotex had reason to believe that its product would be used in an infringing manner, in circumstances where that infringing use was contrary to the approved indications for Apotex’s product.

Stay tuned for more detailed analysis to come.