ICTSD Outputs and Activities on Biotechnology, Trade and Sustainble Development

Biotechnology: Addressing Key Trade and Sustainability Issues

B.4 Intellectual property rights

Q22 Is the identification or isolation of genes an invention?

Patent protection is based on the premise that protection should only be given to the result of a creative idea. Since the identification of the relative positions of genes on a DNA molecule, or even their isolation, is a discovery rather than an invention, it is thus argued that patents should not be granted as a result of this gene mapping. However, it is also argued that genes, in isolation, can be utilised in new manners and yield useful results. US patent guidelines, for example, state that the discovery of a gene can be the basis for a patent "on the genetic composition isolated from its natural state and separated from other molecules naturally associated with it", as long as there is a "specific, substantial, and credible utility for the claimed isolated and purified gene" (DoC, 2001). The EU Biotechnology Directive also establishes that biological material isolated from its natural environment or produced by a technical process is patentable, even if it is identical to a natural element, although "a mere DNA sequence without indication of a function does not contain any technical information and is therefore not a patentable invention."

Patents on genes may have unforeseen consequences. For instance, major similarities in the genetic make-up of biological organisms may determine that patents on specific gene sequences also extend to other species, genera and classes. The patent application related to the mapping of the rice genome, for example, extends to the genes that regulate flower formation in other major cereals and plants in general (Oldham, 2004).