Patentable subject matter, TRIPS and the European Biotechnology Directive: Australia and patenting human genes.

This paper maintains that the word ‘inventions’ in art 27.1 of the Agreement on Trade-Related Aspects of Intellectual Property Rights 19941 (‘TRIPS’) imposes an obligation on member countries to ensure that the subject matter of a patent application be scrutinised and not presumed. Article 27.1 of TRIPS provides that ‘[p]atents 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’. In other words, patentability involves satisfying a two-step test. Is the technological advance claimed in the patent application (a) an ‘invention’ (ie, patentable subject matter) and, if so, (b) is that ‘invention’ (i) novel, (ii) inventive and (iii) industrially applicable? Article 27.1 of TRIPS mandates that patent protection be afforded only to ‘inventions whether products or process ... provided that they are new, involve an inventive step and are capable of industrial application’. Accordingly, all signatories to TRIPS, including Australia, have an obligation to ensure that their patent laws are consistent with this requirement. The European Biotechnology Directive 98/44/EC2 was passed by the European Parliament in 1998. Its passage was controversial at the time and remains so today. In July 2003 the European Commission referred Germany,