Breaking News – High Court of Australia Confirms That Methods of Medical Treatment are Patentable
Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd & Ors  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:
- 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).
- 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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