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

In a judgment handed down on 4 December 2013, the High Court, by majority (4:1), has held that methods of medical treatment of the human body can be patentable inventions within the meaning of section 18(1) of the Patents Act 1990 (Cth).  This is the first time in which the High Court has had to consider this issue.

This issue came before the High Court for consideration after Apotex sought and was granted special leave to appeal from a decision of the Full Federal Court concerning a method patent owned by Sanofi-Aventis for the use of leflunomide to treat the skin condition, psoriasis.

History of the proceeding

In 2008, Sanofi commenced Federal Court proceedings against Apotex claiming that Apotex's proposed supply of leflunomide to treat psoriatic arthritis (PsA) would infringe its patent.  Sanofi's patent covers the use of leflunomide to treat psoriasis.  (Sanofi previously held a patent for the compound, leflunomide and its use to treat arthritis, but that had since expired.)  Given that almost every person with PsA has or will develop psoriasis, it was asserted that use of Apotex's leflunomide product to treat PsA would inevitably treat psoriasis.

Apotex cross-claimed seeking revocation of Sanofi's patent on a number of grounds, including that a method of medical treatment of the human body is not a patentable invention under section 18(1) of the Patents Act 1990 (Cth).

In 2011, the Federal Court dismissed Apotex's cross-claim and found that Apotex had threatened to infringe Sanofi's patent.  On appeal to the Full Federal Court in July 2012, the Full Court upheld the trial judge's decision.

Apotex subsequently applied for special leave from the High Court to appeal from the decision of the Full Federal Court, which was granted in December 2012.

Issues before the High Court

The key issues for consideration by the High Court (comprising French CJ, Hayne, Crennan, Kiefel and Gageler JJ) were:

  1. whether Sanofi's patent was valid, which required the High Court to determine whether methods of medical treatment are patentable subject matter; and
  2. if Sanofi's patent was valid, whether Apotex's leflunomide product infringed the patent.

Patentability of methods of medical treatment

The majority of the High Court (Hayne J dissenting) upheld the previous findings of the Federal Court and found that a method or process for medical treatment of the human body that has some useful application and economic utility can be a "manner of manufacture" and hence a patentable invention within the meaning of s 18(1) of the Patents Act 1990.

Infringement of Sanofi's Patent

Despite the majority of the High Court finding that Sanofi's patent was valid, it nevertheless found that Apotex's leflunomide product did not infringe the patent.  This was because:

  • the product information document for Apotex's leflunomide product expressly stated that the product was "not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease"; and
  • the product's listing on the Australian Register of Therapeutic Goods (ARTG) excluded the indication "psoriasis".

On that basis, the High Court did not consider Apotex's product information document instructed consumers to use its leflunomide product for psoriasis.  Nor did it consider that Apotex had any reason to believe that consumers would use its leflunomide product in accordance with Sanofi's patent, contrary to the approved indications in Apotex's product information document.

Final note

This decision is significant in that it provides certainty that methods of medical treatment are patentable inventions in Australia.