The TRIPS Agreement and medical treatment defences

21.23 Any new medical treatment defence should be drafted to be consistent with Australia’s obligations under the TRIPS Agreement, and particularly art 27 and 30.

21.24 Article 27(1) of the TRIPS Agreement provides that patent rights shall be enjoyable without discrimination as to the field of technology. This non-discrimination provision places constraints on the extent to which gene patents may be singled out for special treatment, including through new defences to claims of patent infringement. Article 27 does not ‘prohibit bona fide exceptions to deal with problems that may exist only in certain product areas’.[20] It may be possible to craft a medical treatment defence that is specific to some defined subset of gene patents, such that the provision does not discriminate by field of technology within the terms of art 27. However, there would need to be strong arguments to justify differentiating a relevant category of gene patents from patents in other fields of technology.

21.25 Article 30 provides for limited exceptions to the exclusive rights conferred by a patent. Unlike experimental use exceptions, which are found in the laws of most members of the WTO, only the United States has enacted a medical treatment defence to claims of patent infringement and, because it is limited to medical activities ‘on a body’, it would not address the exploitation of most healthcare-related gene patents. The United States medical treatment defence has come under scrutiny as part of the review of the implementation of the TRIPS Agreement.[21]

21.26 The TRIPS Agreement allows member States to exclude ‘diagnostic, therapeutic and surgical methods for the treatment of humans or animals’ from patentability.[22] It might be argued that, as an exclusion from patentability is permissible, a defence cast in similar terms should also be permissible, because it is less prejudicial to patent rights than an exclusion. However, the position is not clear. It has been suggested, for example, that while member States may exclude diagnostic, therapeutic and surgical techniques from patentability, if they make patents available, they must accord full rights under the TRIPS Agreement.[23] Further, as discussed in Chapter 7, it is not clear whether the TRIPS Agreement permits exceptions for in vitro procedures.

[20]Canada: Patent Protection of Pharmaceutical Products: Complaint by the European Communities and their Member States, 17 March 2000, WT/DS114/R, 170–171.

[21] The European Communities and their member States asked the United States to explain how this provision complies with the TRIPS Agreement. See Review of Legislation in the Fields of Patents, Layout-designs (Topographies) of Integrated Circuits, Protection of Undisclosed Information and Control of Anti-competitive Practices in Contractual Licences: United States, 1 May 1998 (1998) World Trade Organization.

[22] TRIPS Agreement, art 27(3)(a). The Australia-United States Free Trade Agreement contains an identical provision: Australia and United States, Australia–United States Free Trade Agreement, 18 May 2004 art 17.9.2(b).

[23] The Office of the United States Trade Representative opposed the legislation that eventually became the United States medical treatment defence on this basis. See J Duffy, ‘Harmony and Diversity in Global Patent Law’ (2002) 17 Berkley Technology Law Journal 685, 722, fn 122.