ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.4 Intellectual property rights

Q21 Which biotech products are patentable?

At the international level, the minimum standards of patent protection, including the cases in which patents must be granted, are established by the TRIPS Agreement. Article 27.1 of the TRIPS Agreement states that "patents shall be available for any inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application." While international rules in place before the TRIPS Agreement allowed countries to exclude certain areas from patentability, or to establish special rules for them, the TRIPS Agreement means that governments can no longer distinguish between different fields of technology, including biotechnology (UNCTAD-ICTSD, 2005). As will be explained below, however, countries may choose not to grant patents in certain cases, including patents on plants and animals other than micro-organisms.

By allowing the granting of patents on genetic material, the TRIPS Agreement thus adhered to the reasoning famously established by the US Supreme Court in Diamond v. Chakrabarty. Ananda Chakrabarty, a biochemist, applied for a patent in the US on a bacterium bioengineered to break down crude oil. The US Patent Office denied him the patent, arguing that the ba
cterium, as a living organism, was a product of nature. In 1980, however, the Supreme Court, by a slim margin, held that the fact that the invention was alive was irrelevant since it had been created by man and thus deserved a patent. In 1998, the European Union Biotechnology Directive also established that the fact that an invention concerns either a product or process related to biological material does not place it outside the scope of patenting.

To qualify for patent protection, patent applications related to biotechnology must nevertheless demonstrate compliance with all the other criteria for patentability, as well as prove they are not contained in an exception to patentability established by national legislation. The TRIPS Agreement establishes three minimum criteria for patentability: An invention must be new, inventive and industrially applicable. However, the Agreement does not harmonise the way in which patents have to be implemented, leaving countries considerable leeway (UNCTAD-ICTSD, 2005). In general terms, however, an invention must be new in that it must not have been available to the public before - patents cannot be put on material that is already in the public domain. It must also be inventive, that is it must involve a development over the state of the art, though the degree of inventiveness required by different countries varies significantly. Finally, the invention is considered 'industrially applicable' by some national laws if "it can be made or used in any kind of industry, including agriculture" and by others if it can be "made or used in economic activities". It should be noted, however, that countries may decide that, even if an invention is technically eligible for a patent, it should not be granted such protection on the basis of broader policy reasons.