189. The representative of Australia, reacting to the various issues related to the interaction between biotechnology and intellectual property to which delegations had referred to in the debate, said that her delegation believed that the differences of public policy perspective had been greatly overstated, particularly in some of the reporting on the work of the Council. There was no objective evidence of a sharp dichotomy of interests in this field. A large number of WTO Members were wrestling with the same basic policy issues concerning the interaction between the intellectual property system and biotechnology and looking for practical solutions. It was neat and perhaps tempting to assume that the world was divided into two on the issue. However, that assumption could, in itself, impede positive progress on the interlocking issues that arose as it would deny an opportunity to benefit from each other's practical experience.
190. The view had been advanced that the text of Article 27.3(b) as it stood was unsatisfactory and that it was a matter of immediate priority to amend it; negotiations should commence in earnest on a host of proposals aimed at bringing about mandatory exceptions on the scope of patentable subject matter, new mandatory conditions on the grant and exercise of both patents and plant variety rights, and the creation of new forms of intellectual property, specifically for traditional knowledge. Others had advanced that it was necessary to look at how Members had applied their national intellectual property systems to the domain of biotechnology within the general framework of existing TRIPS standards; that a checklist approach should be employed so as to guide the work of the Council by the actual content of national laws, rather than debating the matter in a largely abstract way. Australia had suggested that the Council look at its broader mandate under Article 71 and at how Members had undertaken intellectual property policy processes in active endeavours to secure the expected benefits according to general policy themes. From Australia's perspective, the overall policy objectives were shared with many other delegations. Those objectives had already been set out and endorsed in the TRIPS Agreement and in complementary legal instruments such as the CBD. The question was whether these objectives could be achieved in a top-down way by modifying prescriptive treaty language before the effect of the current settings had been assessed in a collective manner. In Australia's view, embarking on negotiations for new treaty language such as modified TRIPS rules on patents would pre-empt and impede the policy development process by moving attention away from the areas where solutions needed to be found. Moreover, in whatever way the mandate under Article 27.3(b) was to be interpreted, it could not possibly entail a wholesale re examination of the range of TRIPS provisions that had been touched upon in the debate. For instance, questions had been raised about the application of the criteria of novelty, inventive step and industrial applicability in the biotechnology domain (Article 27.1); the very definition of an invention (Article 27.1); other public policy exceptions to patentability such as for ethical, environmental or public health reasons (Article 27.2 and 27.3(a)); the nature of the patent right and exceptions to it, including for research and development (Articles 28 and 30); the patentee's disclosure obligation (Article 29); compulsory licensing and government use (Article 31); misuse of patents to restrain technology transfer and engage in anti-competitive practices (Article 40). Other forms of intellectual property such as geographical indications, collective marks and copyright had been used in various ways to protect traditional knowledge and cultural heritage and, therefore, were also directly relevant to the broader debate. To suggest that all the interlocking issues could be dealt with in the context of the Article 27.3(b) review, however generously that might be construed, had the effect of artificially constraining the range of available policy responses to those somehow related to the scope of patentable technology. Presumably, those who were seeking an early modification of treaty language were favouring the Article 27.3(b) review as the locus for the debate, because that might provide a mandate for the immediate changes to TRIPS standards that they placed priority on. In her delegation's view, however, regardless of the text of Article 27.3(b), forward movement on the issues raised was dependent upon the conscious cultivation of consensus, which could only occur if there was a common appreciation of the nature of the problems that should be addressed and a clearer sense that the measures proposed were the most effective way of dealing with those problems. Domestically and internationally, Australia was actively involved in a range of policy analysis and development processes that directly dealt with concerns as had been raised under Article 27.3(b): i.e. what was a workable mechanism for benefit-sharing in relation to genetic resources that took account of indigenous interests and concerns; how to ensure that agricultural producers gained equitable access to the benefits of gene technology; how would an intellectual property system within the TRIPS framework respond to the need to protect expressions of indigenous culture and duly recognize and reward those working within those traditions. Australia had the additional concern that infringing reproduction of indigenous artworks had been made in overseas jurisdictions, in apparent contravention of international copyright standards. The experience of Australian right holders had also been the subject of case studies in the framework of WIPO in approaches to protect traditional knowledge reflecting the range of practical mechanisms that had been applied. Australia would not claim to be at the cutting edge of policy-making in each of those areas; such processes could be slow and did not always yield immediate solutions. However, as far as the intellectual property system was concerned, each of the processes had explored a wide range of practical options and policy-making choices within the general framework of the TRIPS Agreement. They were, in effect, part of Australia's modest attempt to implement and make use of TRIPS standards in a way that promoted the TRIPS objectives and the broader public policy interests that arose under the item. Consequently, in her delegation's view, a circumspect approach was necessary to the various proposals that TRIPS provisions should be modified before there had been a collective consideration of the actual nature of their implementation. Her delegation's approach was not to disparage the general policy concerns behind the proposals made.
191. Fundamental questions had been raised, such as: what would be the social and economic benefits of a mandatory global ban on patenting of inventive micro-organisms? Would such a ban lead to a reduced incentive for conservation and for benefit-sharing arrangements with researchers? In the meantime, while negotiations on these issues proceeded, could Members not be overlooking immediately available practical mechanisms to achieve their policy goals? Many of the issues raised did not seem to concern deficiencies in TRIPS rules but questions about their implementation. For instance, the question had been raised in the Council and elsewhere as to whether the patent system was inappropriately extending patent rights to genetic materials that already occurred in nature. A number of individual patents had been the subject of much controversy. From a patent law point of view, this raised a host of questions. How had the definition of "invention" been applied? Had an individual patent been granted which was not novel, lacked an inventive step or was not in its full scope of claims capable of industrial application? Was the patent right as granted actually enforceable in a way that would cause a negative impact? Did the nature of the patent right as granted actually amount to ownership of or control over the genetic material as such or did it concern its application in a specific technological context? Did the actual technological subject-matter of a patent fall under a possible exception under Article 27.2, 27.3(a) or 27.3(b)? Each of those questions concerned the implementation of existing TRIPS rules. The concern widely expressed in the international debate, that some patents were granted for claimed inventions that actually lacked inventive step or were obvious, represented an implementation issue and not a matter for renegotiation. For these reasons, Australia strongly advised Members to look at these implementation issues in a holistic manner. For practical as well as conceptual and legal reasons, it was mistaken to attempt to resolve such issues in the narrow confines of the Article 27.3(b) review. It could not be determined what the actual effect of TRIPS provisions were until it was understood how they had been implemented at the national level. Sharing the experiences of practical implementation was a task the TRIPS Council should take up immediately in line with its important obligation under Article 71.1. Even in relation to the subject matter of Article 27.3(b), Australia believed that the interests of all Members would be served by considering what choices Members had made in implementing the TRIPS Agreement at the national level. For example, there had been considerable discussion about whether or not the term "micro-organism" should be allowed to stand in the TRIPS text as a point of distinction between optional and required patentable subject-matter or whether concerns about its definition should lead to a modification of the TRIPS Agreement to exclude patenting of organisms. Individual Members determined and applied the term in their national jurisdiction in accordance with Article 1.1. It was noteworthy that the term "micro-organism" was the direct subject of an entire treaty, the Budapest Treaty, which did not seek to define the term. The fact that there was no one definitive determination of what that term should mean in the TRIPS context made it no different from any other term in the Agreement. For example, the fundamentally important term "invention" was left to Members to determine according to their own national law. It would be helpful for the Council to consider what approach had been taken in each Member's legal framework to determine the nature of inventions in the biotechnology domain. Such a flow of information would be a useful basis to achieve a collective understanding of the nature of the provisions under discussion and for clearing up concerns or grey areas. That was why Australia had been advocating the active collection and dissemination of such information regarding the review under Article 27.3(b) and it was unfortunate that the information so far collected was dominated by the approach taken by a relatively small number of WTO Members. Australia supported the continuation of work on the review agenda and supported the suggestion that developing countries and transitional economies respond to the survey of national laws in connection with Article 27.3(b). The TRIPS Council should also monitor developments in other international fora which had overlapping (WIPO) or complementary (CBD) competencies. Many broader issues which had been raised in other fora such as the CBD, the FAO and WIPO, were not intellectual property questions as such, but rather related to domestic regulations and access regimes. A way forward might be to clearly define the concerns in an intellectual property context, determining where and how they might fit in with other initiatives and developing a shared understanding of practical or domestic measures to address these concerns. In Australia's experience, much of the work on addressing concerns should be done at the domestic level, and the exact choice of policy instrument was a domestic matter for national and provincial governments. That was not to say, however, that these issues were not valid subjects of international concern and should not be considered in multilateral processes. Australia believed that genuine solutions could only be found after the range of existing domestic options has been understood. In order to help the Council understand those domestic options, the Australian delegation invited the Andean Pact countries to describe their experience in carrying out the new intellectual property system to be introduced under the Andean Community Decision 486, in particular in relation to Articles 15, 26(h), (i) and (j), 75(g), (h) and 136 (g).