The Impact of TRIPS on the Validity of the European Biotechnology Directive

Abstract

In July 2003, the European Commission referred Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands and Sweden to the Court of Justice of the European Communities (Court of Justice) for their failure to transform arts. 1 to 11 of the European Biotechnology Directive,1 (the Directive) into their national patent laws by July 2002. This action by the European Commission, eight years after the European Parliament passed the Directive against eight out of fifteen Member States that made up the European Community (EC) at the time, demonstrates that the patentability of subject matter that comes within arts. 3.2 and 5.2 Directive2 continues to be controversial in Europe and that the passage of the Directive has not yet resolved this controversy. The fact that by the end of October, 2004 the Court of Justice confirmed that Germany had breached the Directive3 and that by early December 2004 Germany’s Bundestag had conceded the debate by passing legislation transforming the Directive into German patent law does not address the complaint which is made against the European Parliament, the European Commission and those Member States that have complied with the Directive. They are each individually and collectively in violation of art. 27.14 of the Agreement On Trade-Related Aspects Of Intellectual Property Rights (TRIPS) and consequently, of art. XVI.45 of the World Trade Agreement (WTA). The fact that these violations have been allowed to persist together with the actions of the European Commission in pursing enforcement, is today a matter of paramount importance not only to those nations that have refused to adopt the Directive but to all one hundred and forty eight members of the World Trade Organisation (WTO). It must be understood that all WTO members are bound to “ensure the conformity of [their] laws, regulations and administrative procedures with [their] obligations as provided in the annexed Agreements,”6 with TRIPS being one of these. Relevantly, TRIPS contains a detailed set of minimum international legislative and regulatory standards that are designed to “promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade.”7 Clearly, these standards must be uniformly adhered to if the WTO is to function fairly and efficiently and if the stated objectives of TRIPS are to be met multilaterally. Daniel Gervais in his authoritative work8 on the drafting history of TRIPS described it as one of the Luigi Palombi*