The patentability of methods of medical treatment has been a long debated issue in patent legislation and different jurisdictions have taken very different approaches to this very controversial question. The issue is not only based on patent law but also on medical law, and is further complicated by numerous ethical considerations such as cost and access to medical treatment. In the last hundred years, some countries have moved towards recognising the patentability of methods of medical treatment. However, patent protection still remains excluded in the majority of countries.
This article examines the position taken in Australia and New Zealand in light of recent case law and legislative changes.
Australia
The Australian Patent Office (APO) initially considered that methods of medical treatment to be ‘essentially non-economic’ and ‘generally inconvenient’, and therefore unpatentable.
In Maeder v Busch [1938] HCA 8 the High Court found it “very doubtful” that a method or process of conducting an operation on the human body could be considered patentable subject matter (i.e. “manner of manufacture” under Australian law). Such doubts were reiterated in National Research Development Corporation v Commissioner of Patents [1959] HCA 67, where the High Court considered that methods of medical treatment of the human body are “conceived as essentially non-economic” and therefore unpatentable.
However, the APO changed its practice in 1972 following a decision in Joos v Commissioner of Patents [1972] HCA 38. In that case, the High Court overturned a decision by the Commissioner of Patents to refuse grant of a patent for a process of treating human hair and nails, distinguishing this from the “method of treatment of a disease, malfunction, disability or incapacity of the human body or of any part of it”, which was unpatentable. As such, the APO narrowed its patentability exclusion accordingly.
The patentability of methods of medical treatment was considered by the Full Bench of the Federal Court of Australia in Anaesthetic Supplies Pty Ltd v Rescare Ltd (Rescare) [1994] 50 FCR 1, a case concerning a patent for the treatment of sleep apnoea. In that case, the Court held that there was no justification in law or logic, when considering patentability, to distinguish between a process of curative treatment of the human body to that of cosmetic treatment, and that both of these forms of treatment may constitute a manner of manufacture provided they have commercial application.
Subsequently, the Full Bench of the Federal Court of Australia, in Bristol-Myers Squibb Company v FH Faulding & Co. Ltd (Bristol-Myers Squibb) [2000] FCA 316 affirmed that methods of medical treatment of humans are patentable in Australia.
Based on the decisions in Rescare and Bristol-Myers Squibb, the APO revised its position to accept that methods or processes for the treatment, medical or otherwise, of the human body or part of it, to be patentable subject matter, and that no objection can be made on such grounds.
Recently, the question of whether methods of medical treatment of humans were patentable in Australia was considered for the first time by the High Court in Apotex Pty Ltd v Sanofi-Aventis Australia Pty Ltd [2013] HCA 50. At first instance, Sanofi-Aventis brought proceedings claiming that Apotex’s supply of a leflunomide formula to treat rheumatoid arthritis and psoriatic arthritis infringed their patent. Apotex cross-claimed seeking revocation of Sanofi-Aventis’ patent on a number of grounds, including that a method of medical treatment of the human body was not a patentable invention. On appeal, the High Court (by a majority of 4 to 1) held that a method of medical treatment, specifically the administration of therapeutic drugs to humans, constitutes patent-eligible subject matter in Australia.
In light of the High Court’s decision, there is now no doubt that methods of medical treatment are patentable subject matter in Australia and the decision provides clear support for the existing practice of the APO in granting such patents.
New Zealand
In stark contrast to the Australian position, New Zealand case law has held that methods of medical treatment of humans are not patentable on the basis that they do not constitute a ‘manner of manufacture’ under the Patents Act 1953 (“the NZ Act”).
The patentability of methods of medical treatment was first tested in New Zealand in Wellcome Foundation Ltd v Commissioner of Patents (Wellcome) [1983] NZLR 385, where the Court of Appeal overturned the decision of the trial judge and held that methods of medical treatment did not constitute a patentable invention. The Court further noted that the patentability of such subject matter could only be decided by the legislature.
In Pharmaceutical Management Agency Ltd v Commissioner of Patents [2000] 2NZLR 529, the Court of Appeal, in considering Wellcome, maintained the patentability exclusion of methods of medical treatment, but upheld the patentability of “Swiss style” claims (i.e. claims in the form ‘the use of compound X in the manufacture of a medicament for a new therapeutic use Y’).
Most significantly, the Court of Appeal in Pfizer Inc. v The Commissioner of Patents [2005] 1 NZLR 362, held that methods of medical treatment do not meet the definition of “invention” under section 2(1) of the NZ Act. Following this decision, it has been the practice of the Intellectual Property Office of New Zealand (IPONZ) to reject claims directed to methods of treatment of humans by therapy or surgery, as well as methods of diagnosis that are performed directly on the human body.
Although medical treatment in relation to treatment or diagnosis on the human body are excluded from patentability, procedures carried out in vitro or exclusively outside the body are not.1 In particular, methods of diagnosis performed on tissues or fluids that have been permanently removed from the body are not excluded. In addition, cosmetic methods of treating humans can be patentable provided the method has no therapeutic effect, e.g. toothpastes or a method of treating hair loss.
IPONZ has continued to refuse patent claims to methods of medical treatment on the basis that a change in policy relating to the patenting of methods of medical treatment of humans is a matter for the legislature. In 2003, the New Zealand Ministry of Economic Development recommended that the NZ Act be amended to provide a specific exclusion from patentability for ‘inventions concerning diagnostic, therapeutic and surgical methods for the treatment of humans’.2
This patentability exclusion is to be codified in the new Patents Act 2013 (the new NZ Act), which is due to commence on 13 September 2014. The new NZ Act will expressly exclude methods of medical treatment and diagnosis from patentability.3 However, such protection may still be pursued in New Zealand, to a certain extent, as Swiss-type claims.
1 Intellectual Property Office of New Zealand. Practice guidelines – 5.3. Medical treatment of humans.
2 New Zealand Ministry of Economic Development.Review of the Patents Act 1953 Stage 3: Boundaries to Patentability (2003). Pt 1, recommendation 2(ii).
3 Patents Act 2013, s16(2) and (3).