ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.4 Intellectual property rights

Q23 Are countries allowed to exclude life forms from being patented?

Articles 27.2 and 27.3 of the TRIPS Agreement contain the exceptions to patentability which countries are allowed, but not obliged, to implement in their national laws.

Article 27.2, for instance, establishes that countries may exclude products and processes from patentability in cases where the prevention of their commercial exploitation is 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." Exceptions on these bases follow the need to balance the protection of patents with the broader public interest. Exactly what is excluded differs from country to country, as morality depends, for the purposes of the TRIPS Agreement, on the particular culture of a country or region (UNCTAD-ICTSD, 2005). Given the concerns raised by biotechnology, the exclusion of at least certain biotechnology products on the basis of ethical and moral considerations is fairly common. For instance, in an OECD survey of the intellectual property practices of a number of its member states, most answers reported exclusions of biotechnology products from patentability on the basis of ethical or moral concerns, particularly relating to human beings (OECD, 1999). For example, the German Biotechnology Law of 1990 foresees the protection of the environment and human life and health "against the potential dangers of biotechnology". In addition, the EU Biotechnology Directive considers the following not patentable on the basis of ethical or moral concerns: processes for cloning human beings; processes for modifying the genetic identity of human beings; uses of embryos for industrial or commercial purposes; processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial benefit to man or animal, and also animals resulting from such processes (EC, 1998 at Article 6). The Australian Patents Act establishes that "human beings, and the biological processes for their generation, are not patentable inventions".

Article 27.3 establishes specific products and processes that Members may exclude from patentability, including "plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes". As a result, the TRIPS Agreement allows the exclusion of certain products and processes while obliging countries to protect others. Micro-organisms, for example, must be protected. Although the concept remains controversial, it is clear it does not require the patenting of cells, genes or other sub-cellular components (UNCTAD-ICTSD, 2005). Moreover, it does not require WTO Members to grant patents on micro-organisms if they are not an invention or if they fail to meet all the relevant patentability criteria. Non-biological processes, which include the methods used in modern biotechnology, must also be protected (as opposed to conventional plant breeding methods, which are considered essentially biological processes).

The different elements of Article 27.3(b) reflect the compromise reached between the strong interests of some developed countries in the protection of biotechnology, other developed countries that granted such protection but in different degrees, and developing countries that questioned whether patents were at all appropriate in the biotechnology context (UNCTAD-ICTSD, 2005). Article 27.3, moreover, included an early review provision. The review, which started in 1999, has still not been achieved, with differences remaining between countries as to whether the "review" is one of implementation or of the provision itself (UNCTAD-ICTSD, 2005).

Increasingly, however, limitations on the use of these facultative exceptions come from outside the WTO. Recent intellectual property provisions agreed through bilateral trade negotiations such as US-Chile and US-DR-CAFTA, for example, oblige parties to undertake best efforts to introduce legislation making available patent protection for plants.