Proposed Directive on the legal protection of biotechnological inventions
The European Commission has presented a new proposal for a Directive on the legal protection of biotechnological inventions. This new proposal follows the rejection, in March 1995, of a previous proposal by the European Parliament. The present proposal aims to ensure the free movement of patented biotechnological products by harmonizing Member States' laws in this area. Whilst the European Patent Convention (EPC) has largely harmonized patent law within Member States, advances in molecular biology since the conclusion of that Convention mean that such inventions are not adequately or consistently covered by Member States' patent laws. The Commission is concerned about the disadvantages to European companies, relative to those from third countries, which the lack of Community legislation in this area may bring, and both the Council and European Parliament have agreed that there is a pressing need for legislation in this area. The proposed Directive would make biotechnological inventions patentable, with the exception of parts of the human body, and its elements in their natural state. Inventions whose exploitation would be considered to be contrary to public policy or morality are unpatentable. Inventions which are specifically excluded from patentability include "methods of human treatment involving germ line gene therapy", and processes modifying the genetic identity of animals without any substantial benefit to man or animal. Farmers are granted a specific privilege to use breeding stock, and propagating material on their own farms. The Commission's proposal envisages Member States implementing the Directive by 1 January 2000 at the latest. However, since the original proposal's passage was so difficult, and the ethical issues involved are as contentious as before, the new proposal is likely to have a lengthy journey before becoming law.