Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable

Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors [2013] HCA 50

The High Court of Australia yesterday issued its long awaited decision in a dispute between Apotex Pty Ltd (Apotex) and Sanofi-Aventis Australia Pty Ltd and related entities (collectively, Sanofi) concerning Sanofi’s Australian patent entitled “Pharmaceutical for the treatment of skin disorders” (Patent). In summary:

  1. The majority (French CJ, Crennan, Keifel and Gageler JJ, Hayne J dissenting) held that assuming all other requirements for patentability are met, a method (or process) for medical treatment of the human body can be a “manner of manufacture” and therefore patentable for the purposes of section 18 of the Patents Act 1990 (Cth) (Act).
  2. The Court unanimously held that Apotex did not indirectly infringe the Patent pursuant to section 117 of the Act by supplying Apo-Leflunomide. It was not shown, nor could it be inferred, that Apotex had reason to believe that Apo-Leflunomide would be used in accordance with the patented method, and Apotex’s approved product information document did not instruct recipients to use Apo-Leflunomide in accordance with the patented method.

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