15 January, 2014

Medical Treatments Patentable in Australia

Patents related to medicine or treatments carry quite the oomph when discussed in the public sphere. The recent examples of genetics patents, or even the potential to choose your future child's genetic traits, always spark a conversation about patents and whether certain areas of research should even be allowed to be patentable. In Australia medical treatment methods have been assumed to be patentable, but this has never been judicially tested. Finally, the High Court of Australia had to decide whether this was the case under law.

The case in question was Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd, which concerned the drug Leflunomide, which is used for the treatment of psoriatic and rheumatoid arthritis. A patent for leflunomide's composition and preparation were owned by Aventis, which had expired almost 10 years ago. A subsequent patent was also held by Sanofi-Aventis (after its merger in 2004), which utilized the drug in the treatment of the aforementioned conditions; or as is worded in the application: "A method of preventing or treating a skin disorder, wherein the skin disorder is psoriasis, which comprises administering to a recipient an effective amount of a pharmaceutical composition containing as an active ingredient a compound of the formula I or II". After the expiration of the initial composition and preparation patent, Apotex proceeded to manufacture and sell its generic version of the drug, selling it as a treatment for both psoriatic and rheumatoid arthritis. Subsequently they were sued for patent infringement by Sanofi-Aventis for allegedly infringing their medical treatment patent. 

Some treatments are much more enjoyable than others
What the High Court had to answer was whether medical treatments would fall under the definition of a manner of manufacture in the Statute of Monopolies 1623 (a more in-depth discussion of what a 'manner of manufacture' is can be found here). This entails that the invention would have to be a vendible product, and has to provide economic utility through a possible new function or effect. The current position of the law, as was accepted by the courts, was cited in the case of Anaesthetic Supplies Pty Limited v Rescare Limited by Justice Lockhart: "If a process which does not produce a new substance but nevertheless results in 'a new and useful effect' so that the new result is 'an artificially created state of affairs' providing economic utility (emphasis added), it may be considered a 'manner of new manufacture' within s 6 of the Statute of Monopolies". The Patents Act 1990 does not expressly exclude methods of treatment, and the courts have struggled in distinguishing methods of treatment and the drugs which produce the same results, with Justices Black and Lehane discussing "the difficulty ... of drawing any logical distinction between a method of treatment and a patentable pharmaceutical product that produces the same beneficial results" in Bristol-Myers Squibb Co v F H Faulding & Co Ltd. A method of treatment can introduce a new function of effect which provides economic utility; however the question is not necessarily that easily answered.

The High Court, in its deliberation, came to the conclusion that methods of treatment could be patented under Australian law. Their emphasis was clearly in economic utility: "It could not be said that a product claim which includes a therapeutic use has an economic utility which a method or process claim for a therapeutic use does not have". Finally the Court summarized its position with relation to methods of treatment: "Assuming that all other requirements for patentability are met, a method (or process) for medical treatment of the human body which is capable of satisfying the NRDC Case test, namely that it is a contribution to a useful art having economic utility, can be a manner of manufacture and hence a patentable invention within the meaning of s 18(1)(a) of the 1990 Act". As the Court accepted that these methods can be patented, Apotex's claim for the revocation of Sanofi-Aventis' patent failed. However, the Court did not find that Apotex had infringed Sanofi-Aventis' patent, as they merely provided the generic version of the drug without the provision of the treatment itself.

As one can see the Australian High Court almost unanimously accepted the patentability of methods of treatment, bar the dissenting judgment of Justice Hayne. Patents relating to methods of treatment are important, and do not in themselves necessarily provide a barrier for innovation. Whether the Australian legislature will take the initiative and legislate on this matter in more express terms will remain to be seen.

Source: JDSupra

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