7. Exclusions from Patentability

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 on the 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 on the 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.

[41] Joos v Commissioner of Patents (1972) 126 CLR 611, 619 where Barwick CJ decided that a process for the cosmetic treatment of hair and nails could be patentable, but distinguished this from medical treatment of disease, malfunction or incapacity.

[42] IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [8.2.13.1].

[43] Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1; Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 170 ALR 439.

[44] IP Australia, Patent Manual of Practice and Procedure Volume 2: National (2002), [8.2.13.3].

[45] Ibid, [8.2.13.1].

[46] Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1. The case concerned the patentability of a method and device for the prevention of sleep apnoea.

[47] The ‘generally inconvenient’ proviso in the Statute of Monopolies is discussed below.

[48] Anaesthetic Supplies Pty Ltd v Rescare Ltd (1994) 50 FCR 1, 19.

[49] Ibid, 42–43.

[50] Bristol-Myers Squibb Co v FH Faulding & Co Ltd (2000) 170 ALR 439. The case concerned the validity of a patent for the method of administering a drug used to treat cancer.

[51] Ibid, 444.

[52] See Patents Act 1977 (UK) s 4(2). The European Patent Convention contains a similar provision: European Patent Convention, (entered into force on 7 October 1977), art 52(4).

[53] Canadian Biotechnology Advisory Committee, Patenting of Higher Life Forms and Related Issues: Report to the Government of Canada Biotechnology Ministerial Coordinating Committee (2002), 31.

[54] Wellcome Foundation Ltd v Commissioner of Patents [1983] 2 NZLR 385.

[55] Pharmaceutical Management Agency Limited v Commissioner of Patents [2000] 2 NZLR 529, [29]. The Intellectual Property Office of New Zealand 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.

[56] New Zealand Ministry of Economic Development, Review of the Patents Act 1953 Stage 3: Boundaries to Patentability (2003), Pt 1, rec 2(ii). To date, amendments to the Patents Act 1953 (NZ) to implement this recommendation have not been introduced into the New Zealand Parliament.

[57] Canada: Ontario Ministry of Health and Long-Term Care, Genetics, Testing & Gene Patenting: Charting New Territory in Healthcare: Report to the Provinces and Territories (2002), 51. United Kingdom: United Kingdom Patent Office, Manual of Patent Practice (5th ed, 2003).

[58] United Kingdom Patent Office, Manual of Patent Practice (5th ed, 2003).

[59] The general rules of treaty interpretation permit recourse to supplementary means of interpretation, including the preparatory work of the treaty (travaux préparatoires) and the circumstances of its conclusion: Vienna Convention on the Law of Treaties, [1974] ATS 2, (entered into force on 27 January 1980), art 31–32.

[60] Australian Law Reform Commission, Gene Patenting and Human Health, DP 68 (2004), Proposal 7–2.

[61] Walter and Eliza Hall Institute of Medical Research, Submission P71, 13 April 2004; Medicines Australia, Submission P75, 15 April 2004; Commonwealth Department of Health and Ageing, Submission P79, 16 April 2004; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004; Royal College of Pathologists of Australasia, Submission P82, 16 April 2004; GlaxoSmithKline, Submission P85, 16 April 2004; IP Australia, Submission P86, 16 April 2004; Sydney IVF Limited, Submission P98, 19 April 2004; Cancer Council Victoria, Submission P101, 20 April 2004; Queensland Government, Submission P103, 22 April 2004; Centre for Law and Genetics, Submission P104, 22 April 2004; G Suthers, Submission P116, 4 May 2004; Department of Industry Tourism and Resources, Consultation, Canberra, 25 March 2004.

[62] Walter and Eliza Hall Institute of Medical Research, Submission P39, 17 October 2003; GlaxoSmithKline, Submission P33, 10 October 2003; Genetic Technologies Limited, Submission P45, 20 October 2003; IP Australia, Submission P56, 4 November 2003; Sydney IVF Limited, Submission P98, 19 April 2004; Queensland Government, Submission P103, 22 April 2004.

[63] For example, Centre for Law and Genetics, Submission P104, 22 April 2004. In contrast, the Department of Health Western Australia commented that a narrow interpretation of such an exclusion was not inevitable: Department of Health Western Australia, Submission P89, 16 April 2004.

[64] A McBratney and others, Submission P47, 22 October 2003; IP Australia, Submission P56, 4 November 2003.

[65] Department of Industry Tourism and Resources, Submission P97, 19 April 2004. DITR commented that inventions involving surgical methods might not satisfy a requirement of commercial application. Even if such patents are granted, DITR noted that monitoring compliance with such patents is difficult.

[66] Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003; Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004. Medical treatment defences are discussed in Ch 21.

[67] Caroline Chisholm Centre for Health Ethics Inc, Submission P69, 2 April 2004. See also Breast Cancer Network Australia, Submission P22, 30 September 2003; Department of Health Western Australia, Submission P53, 3 November 2003; Department of Health Western Australia, Submission P89, 16 April 2004.