Methods of Medical Treatment Patentable in Australia
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.
Design Around a Headache for Patent Owner
In GlaxoSmithKline Australia Pty Ltd v Reckitt Benckiser Healthcare (UK) Limited the Full Federal Court (FCAFC) removed an injunction that had prevented GSK from supplying its liquid Children’s Panadol 1-5 years range with a liquid dispensing apparatus. Reckitt had initially obtained an interlocutory injunction against GSK when GSK supplied a liquid dispensing apparatus that was likely to fall within the claims of Reckitt’s patent for a flat nosed syringe that seals with the bottle neck insert allowing liquid to be removed from an inverted bottle without spillage. GSK then came up with an alternative syringe apparatus in an attempt to design around Reckitt’s patent. The alternative syringe differed from the original syringe on account of the flat nosed tip end being proportionately narrower than the main body of the syringe. However, the trial Judge again held that Reckitt had a sufficiently strong prima facie case of infringement and granted an injunction against the alternative syringe. In coming to that conclusion the trial Judge refused to admit further evidence relating to balance of convenience as he considered the only issue to be whether there was a prima facie case of infringement, with previous findings applying to the remaining issues.
On appeal GSK claimed that the trial Judge erred in construing the patent and also should have admitted further evidence. GSK argued that claim 1 required the barrel of the syringe to have a uniform diameter along the entire length of the syringe from its flat-nosed distal tip to its other end, while Reckitt argued that only the flat-nosed distal tip of the syringe had to have a uniform diameter. The FCAFC held that while Reckitt had an arguable case of infringement, it was not as strong as GSK's case for non-infringement. In making that assessment the FCAFC emphasised that, when evaluating whether a product infringes a particular claim of a patent, the substance or idea of the invention should only be considered if all of the “essential integers” of the claim have been taken. The FCAFC also held that the new evidence which GSK sought to rely on was relevant and important to making an assessment of the balance of convenience, and so should not have been excluded.
European Law and Practice on Software Patents Summarized
The European Patent Office has produced a publication setting out information on European law and practice on software patents and includes sections on: computer-implemented inventions; patents for computer-implemented inventions and EPO examination practice.
Global Patent Prosecution Highway Being Constructed
In an effort to speed up prosecution and reduce duplication of work efforts IP Offices of many (mainly OECD) countries have bi-lateral Patent Prosecution Highway (PPH) agreements covering sharing and recognition of IP Office and increasingly PCT work products. However, the profusion of these bi-lateral PPH agreements has created issues with managing and interpreting the differing criteria utilized by the various IP Offices.
In an effort to harmonize these agreements and create further efficiencies 13 IP offices have created a Global PPH (GPPH) which allows for mutual recognition of IP Office work products, including, where relevant, PCT work products. Amongst these IP Offices the GPPH will take precedence over the pre-existing PPH agreements. This will represent a significant expansion of Australia’s PPH options, since the GPPH will replace IP Australia’s only PPH arrangement with the United States of America. The GPPH pilot will commence on 6th January 2014 and involve the IP Offices of Australia, Canada, Denmark, Finland, Japan, Korea, Norway, Portugal, Russia, Spain, United Kingdom, United States of America and the Nordic Patent Institute.
The GPPH pilot will allow patent applicants to request accelerated examination at any of the offices involved in the pilot if at least one of their claims has been accepted by another office involved in the pilot. Examination at the other offices will only be made in respect of claims corresponding to the accepted claims and a claim correspondence table needs to be submitted. The respective applications must have the same effective filing date (such as the priority date). The applications for which the applicant wants to make use of the GPPH cannot have commenced substantive examination, but substantive examination must be requested before or at the time of requesting the GPPH procedure for those applications. The option of using the GPPH can be particularly useful in participating jurisdictions where there is a big examination backlog.