For many years the European Commission, Council and Parliament have been laboring to produce a directive for protection of biotechnological inventions. Motivation for the directive was a perception that the biotechnology industry in Europe was lagging behind that in Japan and the United States. In fact the substantive law as it is developing in the European Patent Office seems to be very much in line with that of the United States and Japan. However, the directive was intended to ensure a uniform approach throughout Europe to wording in the European Patent Convention that states that a patent could be refused on the ground that it was contrary to morality. This wording also appears in the laws of most of the EU members. (It will be recalled that this was a key issue in the European Patent Office's consideration of the Harvard Mouse patent application -- see our Information Letters N.S. 176 and 178 -- and continues to be a major issue in the oppositions to that patent).

While the Council and the Commission favored adoption of a directive, in the spring of 1994 it failed to secure approval of the European Parliament and, following election of a new Parliament in the summer, the issue was referred to a conciliation committee which is comprised of members of the Council and the Parliament. The key issue was protection of genes and the compromise adopted by the conciliation committee was to permit protection of genes but only "if they are industrially applicable and obtained in a technical manner." Once this compromise was reached, the directive had to be resubmitted to the European Parliament. In fact the wording of the text presented to the European Parliament for approval differed slightly from this and was severely criticized by the European biotechnology industry. In the end, the European Parliament voted to reject the entire proposal for a directive. Although it is open to the Commission to start proceedings for adoption of a new directive, it seems unlikely that this will occur and the development of the law in this area will now be left to the European Patent Office and the Courts.