1. Methods of Treatment

On 4 December 2013 the High Court confirmed that methods of medical treatment involving the administration of therapeutic drugs are patentable subject matter in Australia in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd1. Sanofi commenced infringement proceedings against Apotex before the Federal Court in 2008, alleging that its patent would be infringed by Apotex’s proposed supply of leflunomide to treat psoriatic arthritis (PsA). Apotex cross-claimed seeking revocation of Sanofi’s patent on several different grounds, one being that a method of medical treatment of the human body is not a patentable invention under Australian law. On appeal to the High Court, a 4-1 majority held that Sanofi’s patent is valid and in doing so confirmed that medical treatments involving the administration of therapeutic drugs define patentable subject matter. Despite being unsuccessful in challenging the validity of Sanofi’s patent, Apotex’s proposed supply of leflunomide to treat psoriatic arthritis was nonetheless found not to infringe Sanofi’s patent.

This decision of the High Court confirms the eligibility of medical treatment methods for patent protection in Australia, particularly those methods which require the administration of therapeutic drugs. The patentability of purely medical procedures such as surgery was not however specifically confirmed by High Court and hence may be subject to further consideration.

For more information, please refer to here.

  1. Isolated Gene Sequence

In Cancer Voices Australia & Anor v Myriad Genetics Inc & Ors2, the Federal Court of Australia affirmed that a valid patent may be granted for a claim that covers naturally occurring nucleic acid that has been isolated. Importance was placed in “isolated” state of the nucleic acid that is the product of human intervention. The decision made it clear that there is no requirement for changes in chemical composition of the claimed nucleic acid.

This decision by the Federal Court is in contrast with the ruling by the US Supreme Court which found that Myriad’s isolated genes are not patentable. Whilst the single-judge decision at the Federal Court is currently under appeal before the full bench of the Federal Court, isolated nucleic acids sequences currently remain a patentable subject matter in Australia.

For more information, please refer to here.

  1. Ambiguity on the question of patentability of computer-implemented inventions to be carried on into 2014

2013 has seen two contrasting decisions by the Federal Court of Australia on the question of patentability of software and computer-related inventions.

The current position of IP Australia is that, if the computer, or the physical effect involved in its use, is not central to the operational purpose of the method, incorporation of limitations regarding the computer in the claim does not make the claimed invention a patentable subject matter.

The decision of Research Affiliates LLC v Commissioner of Patents3 handed down by the Federal Court on 13 February 2013 affirmed the position of IP Australia. In the decision, Emmett J. noted that the steps that are asserted as a patentable invention in the specification could readily be carried out manually, and the aspect of computer implementation which is nothing more than the use of a suitable computer does not confer patentability.

On 30 August 2013, the same court found a computer-implemented method and system for automated collection of evidence of skills and knowledge to be a patentable subject matter in RPL Central Pty Ltd v Commissioner of Patents4. Middleton J. stated that the binding Australian decisions does not “expressly import any such requirement of substantiality of or centrality of physical effect”, in an apparent dissent with the finding in Research Affiliates.

Both decisions have been appealed to the Full Federal Court and clarification of the matter is eagerly awaited.