Intellectual property/telecommunications: Directive on the protection of biotechnological inventions - a controversial recommendation approved by the European Parliament 1

The European Parliament has approved a controversial recommendation regarding the proposed Directive on the legal protection of biotechnological inventions, in its second reading under the co-decision procedure. The Directive must now be formally adopted by the Member States and transposed into national law before coming into force in two years' time at the earliest.

The approved text takes into account amendments proposed by the Parliament after it rejected the initial proposal for a Directive. The provisions of the Directive systematically adopt the rules of patent law in the biotechnological field in order to ensure that patent legislation is more effectively applied in this area.

The Directive provides that Member States will protect biotechnological inventions under national patent law, which shall be adjusted to take account of the provisions of the Directive. The Directive is stated to be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs agreement and the Convention on Biological Diversity. For the purposes of the Directive, inventions will be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature. However, the Directive provides that plant and animal varieties and essentially biological processes for the production of plants or animals will not be patentable.

Inventions will also be considered unpatentable where their commercial exploitation would be contrary to public order or morality, such as:

• processes for cloning human beings;
• processes for modifying the genetic identity of human beings;
• uses of human embryos for industrial or commercial purposes; or
• processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal (including the animals resulting from such processes).

The Directive further provides that the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. However, an element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. The Directive makes it clear that the industrial application of a sequenced or a partial sequence of a gene must be disclosed in the patent application. The Directive goes on to provide rules on patentability, scope of protection, compulsory cross-licensing and the deposit and access of the biological material when making an application.

Proponents of the Directive believe that it will further the innovative potential and the competitivity of Community science and industry in this field. However, the Directive has been fiercely opposed by many environmentalists, religious groups, and some political parties.