The TRIPS Agreement and experimental use

13.71 Any proposed new experimental use defence needs to be consistent with Australia’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights 1994 (TRIPS Agreement).[126] Of particular importance are art 27, which requires that member States make patent protection available without discrimination by field of technology; and art 30, which allows member States to provide only limited exceptions to patent rights.

13.72 The TRIPS Agreement places significant constraints on the allowable ambit of exceptions to the exclusive rights conferred by patents. While the precise extent of these constraints is uncertain, the ALRC considers that the enactment of an experimental use exemption, covering acts done for experimental purposes relating to the subject matter of the patented invention, is unlikely to conflict with the provisions of the TRIPS Agreement.[127]

13.73 In the Canada–Patent Protection case[128] (discussed in Chapter 4), both parties accepted that experimental use defences, which are found in the laws of most members of the World Trade Organization (WTO), comply with the TRIPS Agreement.[129] It was stated that there was no conflict with the normal exploitation of the patent because it is a consequence of the ‘basic patent deal’ that others may use the patent holder’s invention to further develop the state of the art. The patent holder’s legitimate interests do not include a monopoly on research and, therefore, there is no need to balance those interests with those of third parties.[130] The WTO Panel noted that experimental use defences are ‘based on the notion that a key public policy purpose underlying patent laws is to facilitate the dissemination and advancement of technical knowledge’ and that both society and scientists have a ‘legitimate interest’ in using patent disclosure to support the advance of science and technology.[131]

13.74 The position becomes more uncertain if it is proposed to provide protection for acts extending beyond experimentation relating to the subject matter of an invention. The broader the classes of experimental or research activity given protection, the more likely an exception will conflict with the TRIPS Agreement. A significant uncertainty concerns the extent to which any exemption could extend beyond experimental use to broader research use—for example, all ‘pure’ or ‘basic’ research that does not have immediate commercial application—and still comply with the TRIPS Agreement.

13.75 Article 27 of the TRIPS Agreement does not ‘prohibit bona fide exceptions to deal with problems that may exist only in certain product areas’.[132] It might be possible to craft a broader research use exception that is specific to some defined subset of gene patents, so that the provision does not discriminate by field of technology in terms of the TRIPS Agreement. However, there would need to be strong arguments to justify differentiating a relevant category of gene patents from patents in other fields of technology.

13.76 The ALRC received some comments on the implications of the TRIPS Agreement for any experimental or research use defence. In consultations it was suggested that, so long as any such defence applied only to non-commercial research, there would be minimal interference with the rights of the patent holder, helping ensure the reform was TRIPS–compliant.[133] GlaxoSmithKline considered that reform along the lines of the European Union model would comply with the TRIPS Agreement as long as the defence was technology-neutral.[134] ACIPA noted that the European Union and the United States have long recognised research use defences as ‘a legitimate limited exception to the exclusive rights conferred by a patent’.[135]

[126]Agreement on Trade-Related Aspects of Intellectual Property Rights (Annex 1C of the Marrakesh Agreement Establishing the World Trade Organization), [1995] ATS 8, (entered into force on 1 January 1995).

[127] ACIPA submitted that the ALRC’s proposed new experimental use defence would be ‘entirely consistent’ with Australia’s obligations under the TRIPS Agreement: Australian Centre for Intellectual Property in Agriculture, Submission P81, 16 April 2004.

[128]Canada: Patent Protection of Pharmaceutical Products: Complaint by the European Communities and their Member States, 17 March 2000, WT/DS114/R. The complaint concerned the patent protection of pharmaceutical products and the operation of regulatory review provisions contained in the Patents Act 1985 (Canada), but provides some guidance on the allowable extent of experimental use defences under the TRIPS Agreement.

[129] Ibid, 56, 75.

[130] Ibid, 56.

[131] Ibid, 165.

[132] Ibid, 170–171.

[133] Institute of Patent and Trade Mark Attorneys of Australia, Consultation, Melbourne, 5 September 2003.

[134] GlaxoSmithKline, Submission P33, 10 October 2003.

[135] Australian Centre for Intellectual Property in Agriculture, Submission P12, 29 September 2003.