In Apotex Pty Ltd v Sanofi Aventis Australia Pty Ltd the High Court has held in a majority judgment that methods of medical treatment of the human body are patentable inventions within the meaning of s 18(1) of the Patents Act 1990. This confirms the practice by IP Australia following the Full Court of the Federal Court’s 1994 decision 28ipr383 Anaesthetic Supplies Pty Ltd v Rescare Ltd. In that decision the Court held that there was no justification in law or logic to distinguish a process of curative treatment of the human body from that of cosmetic treatment and that both of these forms of treatment may constitute a manner of manufacture provided they have commercial application.
Sanofi-Aventis Deutschland GmbH, the second respondent, has the patent which claimed a method of preventing or treating psoriasis by the administration of the compound leflunomide. Apotex intended to supply leflunomide in Australia for the treatment of rheumatoid arthritis and psoriatic arthritis. Almost every person with psoriatic arthritis has or will develop psoriasis. The respondents commenced proceedings in the Federal Court claiming, among other things, that Apotex would infringe the patent by supplying their leflunomide product to treat psoriatic arthritis. By cross-claim, Apotex sought to have the patent revoked for not claiming a patentable invention under s 18(1) of the Patents Act. Both the primary Judge and the Full Court of the Federal Court found that the patent to be valid and not excluded from patentability.
The High Court, by majority, held that the patent claimed a “manner of manufacture” within the meaning of s 18(1) of the Patents Act and thus is a patentable invention. Chief Judge French acknowledged that the patentability of methods of medical treatment creates tensions between otherwise laudable values, but held that in the absence of legislative direction to the contrary they should be patentable.
They may involve competing philosophies of proprietarianism and instrumentalism and the relative values to be accorded to different public goods: alleged incentives to innovation on the one hand, and the widest possible availability of new methods of medical treatment to relieve suffering on the other. To decide that the concept of “manner of new manufacture” does not logically exclude methods of medical treatment from patentability does not engage with those large questions, although it may have significant consequences for public policy. This is a case in which such considerations are best left to the legislature. In my opinion the application of the rubric “manner of new manufacture” in a logically and normatively coherent way is not served by excluding from its scope methods of medical treatment of human beings. Methods of medical treatment can fall within the scope of a manner of new manufacture within the meaning of s 6 of the Statute and therefore within s 18(1)(a) of the 1990 Act. Nor, on the reasoning which supports that conclusion, does “general inconvenience” (upon which, in any event, Apotex placed no reliance) appear to provide any basis for their exclusion.
In New Zealand the Courts have consistently excluded methods of medical treatment of the human body from patentability. However, methods of non-medical treatment of the human body, such as non-surgical cosmetic treatments, are currently patent eligible. The current judicially applied exclusions of methods of medical treatment will be legislatively applied when the Patents Act 2013 comes fully into force in September 2014.
