101. The representative of the Holy See said that Article 27.3(b) allowed Members to exclude from patentability plants and animals, but not micro organisms, and allowed Members to exclude from patentability biological processes which were essential for the production of plants and animals but not non biological or microbiological ones. The rationale behind this provision was to reinforce the international protection of patent and other intellectual property rights on non biological and microbiological life developments by linking such protection to the general legal framework and trade of other goods and services. Such protection, however, should be promoted fairly and in full accord with the development objectives established by Article 7 of the TRIPS Agreement, with the provisions of Article 8 related to the political freedom of States to protect public health and nutrition and to promote the public interest in sectors of vital importance to their socio economic and technological development, and with the provisions of Article 27.2 which allowed Members to exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which was necessary to protect ordre public or morality, including to protect human, animal or plant life or health or to avoid serious prejudice to the environment.
102. He said that the patenting of life forms could sometimes serve as a tool to support biotechnology that was problematic both from the ethical point of view and from the point of view of a development friendly intellectual property system. In relation to human life, Article 4 of the Universal Declaration on the Human Genome and Human Rights stated that "The human genome in its natural state shall not give rise to financial gains"5 while Article 21 of the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine, stated that: "The human body and its parts shall not, as such, give rise to financial gains".6 In this regard, the United Nations Declaration on Human Cloning7 acknowledged the ethical concerns that certain applications of rapidly developing life sciences might rise with regard to human dignity, human rights and the fundamental freedom of individuals, and called States to adopt all measures necessary to protect adequately human life in the application of life science. Thus, the TRIPS Agreement, other WTO rules, and all other international, regional and bilateral trade and intellectual property agreements should not reduce the ability of States to govern the aspect of intellectual property rights related to human life and dignity.
103. He said that mere commercial control of production and distribution of new life forms could affect both food security and development prospects of poor countries. Private monopolistic rights should not be imposed over those biological resources, from which the basic food and medicine requirement of human life was derived. An inclusive approach to intellectual property rights should not ignore the major economic environmental and ethical concern over the patenting of life, since such action would exert a negative impact on consumer rights, biodiversity conservation, environmental protection, indigenous rights, scientific and academic freedom, and ultimately, the economic development of many developing countries insofar as it depended on new technologies. Among agents of development, there was a significant concern about patenting of varieties of seeds that were genetically engineered. An unlimited application of patent procedures to biological, scientific and technical developments could be harmful to both traditional and modern methods of research and production, especially with regard to new varieties that were beneficial in the developing world. Concentration of seed ownership could threaten the autonomy of local farmers, who were forced to buy seeds every season from a handful of companies with whom they had little power to negotiate competitive prices. The international community should render due attention to concerns about the concentration of technology and resources in food production by a small group of entities and companies that were driven by purely commercial goals. Special attention should also be given to intellectual property protection of seeds discovered by individual farmers – both from developed and developing countries, to the rights of indigenous people, and to the traditional use and ownership of those plants that were essential to their livelihoods and cultures.
104. He said that the main goal of the international community should be to promote the common good. Moreover, international trade rules and negotiations should aim towards the good of all, especially of those who were poor and vulnerable, and should ensure both the means for human sustenance, such as food, water, medicines, health environment, and the means for the cultural, social and spiritual development of people. Discussions of international protection of intellectual property rights and scope and consequences of Article 27.3(b) should be guided in all sincerity by the promotion of the common good and human dignity, as stated in the Marrakesh Declaration, the Final Act, the Preamble of the Marrakesh Agreement Establishing the World Trade Organization.
