Methods of medical treatment

Australian law

7.29 The Patents Act does not expressly exclude methods of medical treatment from patentability. Before 1972, Australian law recognised surgical or medical treatment of the human body, as well as non-medical procedures (such as cosmetic treatment), as an exclusion from patentability.^[41] The reason for the exception was that such treatment was considered ‘essentially non-economic’ and ‘generally inconvenient’ within the terms of s 6 of the Statute of Monopolies 1623 (Statute of Monopolies).^[42]

7.30 Based on case law,^[43] IP Australia considers that it is now ‘firmly established that methods of medical treatment are patentable subject matter’.^[44] IP Australia’s practice is that no objection to a patent application may be made to ‘methods or processes for the treatment, medical or otherwise, of the human body or part of it, only on the basis that the human body is involved’.^[45]

7.31 In Anaesthetic Supplies Pty Ltd v Rescare Ltd (Rescare),^[46] a Full Court of the Federal Court considered whether methods of medical treatment could constitute a ‘manner of manufacture’ and, if so, whether such methods should nevertheless be excluded as ‘generally inconvenient’ in terms of s 6 of the Statute of Monopolies.^[47] Lockhart J stated that there was no reason in principle why a method of medical treatment should not be considered to be a manner of manufacture and thus patentable.^[48] Wilcox J agreed that methods of medical treatment should be patentable, noting that the Parliament had an opportunity to include an exception in the Patents Act when it was re-enacted in 1990, and had chosen not to. Courts should, therefore, be hesitant to introduce the exclusion by reference to ‘the very general principles’ contained in s 6 of the Statute of Monopolies.^[49]

7.32 The approach to the patentability of methods of medical treatment taken in Rescare was affirmed by a Full Court of the Federal Court in Bristol-Myers Squibb Company v FH Faulding & Co Ltd.^[50] Black CJ and Lehane J commented on ‘the insurmountable problem, from a public policy viewpoint, of drawing a logical distinction which would justify allowing patentability for a product for treating the human body, but deny patentability for a method of treatment’.^[51]

Other jurisdictions

7.33 In the United Kingdom, methods of medical treatment of the human body are expressly excluded from patentability, on the basis that such inventions are not to be taken to be capable of ‘industrial application’^[52]—the equivalent of the criterion of usefulness in Australian law (see Chapter 6).

7.34 In other jurisdictions, including Canada and New Zealand, methods of medical treatment are excluded by reference to the patentability requirements of their legislation. In Canada, methods of medical treatment are not patentable inventions because they are generally considered not to meet the Canadian utility (usefulness) criterion.^[53] In New Zealand, case law has held that methods of medical treatment are not patentable on the basis that they do not constitute a ‘manner of manufacture’ under the Patents Act 1953 (NZ).^[54] Following a decision of the New Zealand Court of Appeal which cast doubt on this approach,^[55] the New Zealand Ministry of Economic Development has recommended that the Act be amended to provide a specific exclusion from patentability for ‘inventions concerning diagnostic, therapeutic and surgical methods of treatment of humans’.^[56]

Scope of a method of medical treatment exclusion

7.35 The medical treatment exclusion from patentability, as applied in the United Kingdom, Canada and New Zealand, relates only to treatment or diagnosis onthe human body—and not to procedures carried out in vitro, or exclusively outside the body.^[57] In particular, methods of diagnosis performed on tissues or fluids that have been permanently removed from the body are not excluded.^[58]

7.1 Article 27(3)(a) of the TRIPS Agreement permits members to exclude ‘diagnostic, therapeutic and surgical methods for the treatment of humans or animals’ from patentability. This exclusion has not been definitively interpreted but its scope may not be as broad as may appear at first glance.

7.36 It is not clear whether the TRIPS Agreement permits exceptions for in vitro procedures. While the language may be broad enough on its face to encompass in vitro procedures (for example, as a ‘diagnostic method’) these words may need to be interpreted in the light of the national laws existing at the time the treaty was negotiated.^[59] As discussed above, the medical treatment exclusion in many jurisdictions relates only to treatment or diagnosis onthe human body.

7.37 This limitation is significant when considering the possible application of a new exclusion for methods of medical treatment in the context of gene patents. Gene patents most often relate to products and processes for use outside the human body, notably in connection with genetic sequencing and diagnostic genetic testing. Even in the case of gene therapy, patents are likely to relate to processes carried out in vitro—such as inserting genes into a gene carrier (or ‘vector’) and using the vector to carry the genes into somatic cells. Procedures for introducing vectors, modified cells or stem cells into the human body (for example, by injection) could be excluded as methods of medical treatment. However, such an exclusion may have limited practical benefit if related in vitro processes remained patentable.

Submissions and consultations

7.38 In DP 68, the ALRC proposed that the Patents Act should not be amended to exclude methods of diagnostic, therapeutic or surgical treatment from patentable subject matter.^[60] This proposal received broad support.^[61] Some submissions suggested that excluding methods of medical treatment from patentability might have an adverse effect on innovation in healthcare.^[62] Others indicated that such an exclusion might not be as effective as might be hoped.^[63] In support of this view, submissions noted that, although the European Patent Convention provides that methods of treating humans are not patentable subject matter, the EPO has interpreted this provision restrictively.^[64]

7.39 While supporting the ALRC’s conclusion, the Department of Industry, Tourism and Resources (DITR) noted that the patenting of surgical methods ‘has given rise to controversy’.^[65] The Australian Centre for Intellectual Property in Agriculture (ACIPA) considered that, if protection continued to be available for methods of medical treatment, an appropriately crafted defence should be enacted to address the potential adverse consequences of patents on these types of inventions.^[66]

7.40 A small number of submissions supported the introduction of an exclusion from patentability for methods of medical treatment, primarily on the grounds that patents over such inventions are ‘incompatible with the optimal provision of healthcare’.^[67]

ALRC’s views

7.41 The ALRC does not recommend that a new exclusion from patentability for methods of medical treatment be introduced in Australia to address concerns about patents on genetic materials and technologies. The ALRC is concerned that such an exclusion would have adverse effects on investment in biotechnology, medical research and innovation in healthcare and may not be consistent with Australia’s obligations under the TRIPS Agreement.

7.42 This leaves open the possibility of introducing some form of medical treatment defence, which is discussed in Chapter 21. The introduction of a new defence—as opposed to an exclusion from patentability—may have some advantages because a defence could apply to both in vivo and in vitro procedures, and could be more targeted in its application to patented inventions. However, for the reasons discussed in Chapter 21, the ALRC has also rejected this approach.