A/70/279 rights may have an adverse impact on the welfare of a wider public. The objective of intellectual property rights law is not to provide the maximum possible return to rights holders, but to strike the proper balance of private and public interests”. 6 States must ensure that their patent laws are well-designed to promote the right of the public to participate in scientific progress, both through universal access to essential technologies and by eliminating or overcoming barriers to scientific research and technological development. A. Promoting the right to science and culture through exclusions, exceptions and flexibilities 63. Several flexibilities to patents can be used by national Governments when implementing multilateral treaties. These are key to striking the proper balance between private and public interests, and to ensuring respect for a wide range of human rights. Yet, their effectiveness is limited by the infrequency of their use, for reasons ranging from capacity constraints to commercial and political pressures against their use. 24 64. Article 27.1 of the TRIPS Agreement relates to patentability requirements. It leaves States significant freedom to determine the degree of strictness to be applied for judging novelty, the inventive step and industrial applicability. These terms are not further defined in the Agreement. The World Bank has suggested that developing countries could set high standards for the inventive step, thereby preventing routine discoveries from being patented. 6 65. Exclusions from patentability preclude a given subject matter from protection and can lead to the non-granting of a patent. 6 For example, under article 27 of the TRIPS Agreement, States may exclude from patentability diagnostic therapeutic and surgical methods for the treatment of humans and animals. States may also exclude plants and animals other than microorganisms, and essentially biological processes for the production of plants and animals other than non -biological and microbiological processes (however plant varieties shall be protected either by patents or by an effective sui generis system or a combination thereof). 66. This latter point has raised considerable concern, in particular among developing countries, as article 27, while providing some flexibility, simultaneously obliges States to protect microorganisms, certain biotechnological processes and plant varieties. Specific concerns relate to the protection of biological resources and traditional knowledge, and the need to reconcile article 27 with the Convention on Biological Diversity, particularly on the free, prior informed consent of indigenous and local communities and benefit sharing. The patenting of plant variety raises concerns about the impact on farming practices, genetic diversity and food security. 6 67. Under article 30 of the TRIPS Agreement, States may provide limited exceptions to the exclusive rights conferred by a patent, allowing use by third parties, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the interests of the patent owner, taking into account the legitimate interest of third parties. Such __________________ 24 15-12543 Carlos M. Correa, “Pro-competitive measures under TRIPS to promote technology diffusion in developing countries”, Global Intellectual Property Rights: Knowledge, Access and Development, Peter Drahos and Ruth Mayne, eds. (Palgrave Mcmillan, 2002). 17/26

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