53.   The issues addressed under items 3, 4 and 5 are commonly known as the triplets. These issues relate to TRIPS implementation issues and were part of the original built-in agenda under the TRIPS Agreement. Despite the call by ministers in the Doha Work Programme that these implementation issues be addressed as a matter of urgency, very little or scant attention has been given to these issues. I will address these items in turn. Review of the Provisions of Article 27.3(B) 54.   The three criteria for patentability (novelty, inventive step and industrial application) are not defined under TRIPS. Each WTO Member is free to interpret their meanings, which can determine what is patentable under local law. In addition, governments can refuse to grant patents for various reasons that may relate to public health, including inventions whose commercial exploitation needs to be prevented to protect human, animal or plant life or health (Article 27.2); diagnostic, therapeutic and surgical methods for treating humans or animals (Article 27.3a); and certain plant and animal inventions (Article 27.3b). 55.   South Africa has a depository system for the registration for patents, meaning that patent applications are examined only as to formalities and are not examined substantively. Accordingly, South Africa has not benefited from the above-mentioned exemption and limitation; and will only be able to do so once the substantive examination of patent applications has been implemented. The adoption of Phase 1 of the South Africa National IP Policy corrects this shortcoming by setting a framework for the operationalisation of substantive examination of patent applications. The IP policy also recommends statutorily codifying various approaches to assessing the patentability criteria, and this work is currently underway. 56.   Under current South African law, exceptions to patent rights are provided in Sections 25 and 36 of the Patents Act which provide: Section 25(4): A patent shall not be granted - (a) for an invention the publication or exploitation of which would be generally expected to encourage offensive or immoral behaviour; or (b) for any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological process or the product of such a process." 57.   The key impact of this flexibility is that countries can ensure that only true inventions are patented. Accordingly, in order to give full effect to the provisions of Article 27 of TRIPS, South Africa will in the near future embark on the substantive examination of patent applications and give further statutory guidance to courts regarding the interpretation Section 25(4) of the Patents Act. Relationship between the TRIPS Agreement and the Convention on Biological Diversity 58.   South Africa recalls its previous statements on this agenda item. The 2001 Doha Declaration, in paragraph 19, mandates the TRIPS Council to work on the issue of the relationship between the TRIPS Agreement and the UN Convention on Biological Diversity, as well as the protection of traditional knowledge and folklore. 59.   A large group of WTO Members have sought to introduce a mandatory disclosure requirement in patent applications. The best way to ensure the proper use of genetic resources and associated traditional knowledge is through an amendment of the TRIPS Agreement as set out in document TN/C/W/59. 60.   On the procedural side, we renew our call for Members to endorse a briefing by the CBD Secretariat on developments within the implementation of the Convention on Biological Diversity as well as for the TRIPS Secretariat to update the three technical notes contained in documents IP/C/W/368/Rev.1, IP/C/W/369/Rev.1 and IP/C/W/370/Rev.1. Protection of Traditional Knowledge and Folklore 61.   The demand for an international regime to protect traditional knowledge, genetic material or indigenous biological resource and folklore stems, for instance, from biopiracy. Historically genetic resources were accessed for free based on the world view that these were common heritage of humankind. However, with an increasing emphasis on protection of intellectual property rights and the impact of the private ownership of knowledge or products of genetic resources, this view changed - particularly through the introduction of the Convention on Biological Diversity and the Nagoya Protocol. 62.   Many Members have passed national laws and implemented the Nagoya Protocol, but biopiracy still continues to thrive, since national laws have limited territorial application. When challenging such violations, including the illegal and erroneous granting of patents in foreign jurisdictions, where patentability criteria may differ from one jurisdiction to another, enforcement and opposition costs may be prohibitive. 63.   There is no paucity of ideas in how we can deal with this matter, noting proposal TN/C/W/59. In our experience, even in light of an amendment of our Patents Act (57 of 1978, read together with the Patents Amendment Act 2005 (Act No. 20 of 2005)): Section 25(3A) requires every patent application for inventions for which protection is claimed, and that are based on or derived from an indigenous biological resource, genetic resource, or traditional knowledge or use, to disclose such information upon submission of the application with proof of prior informed consent (PIC) and ABS. Despite this requirement, biopiracy continues to occur. Amending the TRIPS Agreement to incorporate disclosure norms remains the most viable and effective way to address the issue of traditional knowledge and folklore as envisaged under Article 12 of the Doha Ministerial Declaration, noting that WIPO IGC process has not been able to make any headway in dealing with this matter.