The Australian High Court recently considered the patentability of methods of treatment of the human body in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50.The Court found that methods of medical treatment of humans are not excluded from patentability by statute, and fit the definition of an invention developed by case law.

Sanofi-Aventis is the owner of a patent having a single claim to a method of preventing or treating psoriasis which comprises administering the known compound leflunomide. Apotex intended to supply leflunomide for the treatment of the psoriatic arthritis (PsA) and rheumatoid arthritis (RA). Significantly, nearly every person with PsA has or will develop psoriasis. Sanofi-Aventis brought infringement proceedings against Apotex, and Apotex cross-claimed for revocation of the patent.

Infringement and revocation proceedings before the Federal Court of Australia

The lower courts held the patent valid, rejecting arguments by Apotex that methods of medical treatment of humans were not patentable inventions in Australia.

It was held that Apotex infringed the patent by supply. Apotex’s product information document (PID) stated that the generic leflunomide (Apo-Leflunomide) was

not indicated for the treatment of psoriasis that is not associated with manifestations of arthritic disease” (emphasis added).

Apotex argued that the use of the double negative in this statement could not be transformed into a positive instruction. The lower courts disagreed, and considered that this amounted to instructions or inducements to infringe the patent (s 117(2)(c)).

As noted by the trial judge in the Federal Court, the question of infringement depended on whether the claim should be construed as involving the purpose of the administration, or the effect of the administration. While the Full Federal Court on appeal decided that the claim should be construed as relating to a method for the purpose of treating psoriasis, it also held that infringement by supply still occurred, as Apotex had reason to believe that its supply of APO-Leflunomide would lead to an infringement of the patent (s 117(2)(b)). This finding relied on the inclusion of a psoriasis study in the PID, and the fact that it was known that PsA was coincident with psoriasis.

Appeal to the High Court of Australia

Upon appeal by Apotex, the High Court considered two questions. Firstly, whether methods of medical treatment of human beings, including surgery and the administration of therapeutic drugs, are patentable inventions in Australia. This question had not previously been before the Court. Secondly, whether Sanofi-Aventis’ patent had been infringed by Apotex.

Methods of treatment

In reviewing case law and statute relating to the patentability of treatments of the human body, the High Court discussed two main arguments put forward for excluding such methods of treatment from patentability. The first held that that such a method did not fit the definition of invention, in that it was “not economic” or “not an art of manufacture”. The Court noted that the definition of invention had developed over time within the common law. Reference was made to the decision in NRDC where the definition of an invention as requiring a “vendible product” was expanded to a requirement of utility in practical affairs, covering any end produced.

The second argument, often voiced in UK decisions considered by the Court, held that such a method was “not proper subject for letters patent”, or “not capable of industrial application”. Thus the exclusion was sustained on policy or moral grounds.

Apotex relied on both arguments, stating that methods of treatment were “essentially non-economic”, and that methods of medical treatment of the human body should not be regarded as “industrialised”, and that such treatments improve the condition of a human being, which is not an article of commerce.

It was found that arguments which had been previously been put forward to exclude methods of treatment from the definition of an invention were flawed in a number of ways. Distinctions between granting patents for therapeutic compounds and refusing patents for therapeutic methods, and between granting patents for cosmetic methods and refusing patents for therapeutic methods, were considered to be inconsistent.

The Court noted that the Australian Parliament had not legislated any exclusion on policy or moral grounds, despite having ample time and despite specifically including other subject matter from patentability, including human beings and biological processes for their generation.

The Court concluded that the methods were patentable, with Hayne J providing dissent.

In New Zealand, applications for patents for therapeutic methods are refused by the Intellectual Property Office, on the grounds that such methods do not fit the definition of “invention” in section 6 of the Statute of Monopolies, it being “generally inconvenient” to grant a monopoly for a therapeutic method, thus preventing public access to the method. Notably, Apotex disclaimed any reliance on this argument. The Patents Act 2013, to be enacted on 13 September 2014, contains specific exclusions to methods of treatment of human beings by surgery or therapy and methods of diagnosis practised on humans. However, non-surgical cosmetic methods are not excluded from patentability.

Infringement

In deciding whether Apotex had “reason to believe” that its supply of APO-Leflunomide would lead to an infringement of the patent, the Court considered a definition of infringement by supply in a report accepted by the Senate when considering the Patents Bill 1990. The definition required a positive inducement to infringe the claim in order to prove infringement by supply. It was held that Apotex did not instruct recipients to use leflunomide in accordance with the patented method.

Importantly for those drafting therapeutic method claims in Australia, this ruling suggests that the monopoly extends only to those therapeutic methods that are carried out for a purpose which is the same as that explicitly claimed. For pharmaceutical suppliers wishing to avoid infringement, a statement in the product literature and packaging of contra-indication for those purposes protected by patent should be considered.