It was intended to harmonise the laws of Member States regarding the patentability of biotechnological inventions, including plant varieties (as legally defined) and human genes.

Nevertheless, the ECJ decision does not preclude a further test of the validity of the directive on the ground that it is inconsistent with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

It is clearly arguable that merely isolating a human gene or protein from its natural environment is not an activity that can come within the meaning of the word 'invention'.

[7] On 14 January 2002, the Commission submitted an assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable as required under Article 16(b) of this directive.

[8] According to SmithKline Beecham lobbyist Simon Gentry, the company allocated 30 million ECU for a pro-Directive campaign.