Patenting Life [Archived]

The European Union assured the legal protection of innovation in the area of biotechnology with Directive 98/44/EC on the legal protection of biotechnological inventions. The Directive established harmonised standards in order to foster the innovative potential and competitiveness of science and industry in the Union. The Directive sets out which inventions involving plants, animals or the human body may or may not be patented. It requires the Member States to allow the patenting, under certain conditions, of inventions which may have an industrial application. The Commission is currently pursuing infringement proceedings against nine Member States for their failure to transpose the Directive into national law by the 30 July 2000 deadline.

The Directive 98/44/EC on the legal protection of biotechnological inventions entered into force in July 1998. It systematically adapts the rules of the law of patents to the sphere of biotechnology to provide biotechnological inventions with an equal level of protection by patent in all the EU Member States.

It contains a number of definitions and rules on interpretation what can and cannot be patented, and to resolve demarcation problems that arise with the patenting of new plant varieties.

The directive contains provisions intended to harmonise the issuing of patents by different offices and to lead to uniform legislation. It also defines the scope of the protection provided by a patent on a biotechnological invention.

Opponents to the directive say that living things are not inventions and therefore cannot be patented. Many scientific and non-governmental organisations demand a suspension of the directive.

The Directive 98/44/EC on the legal protection of biotechnological inventions has not yet been implemented in all Member States because of strong opposition to patenting human, animal and plant genetic material.

The Commission sent reasoned opinions to nine Member States (Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden) in December 2002, regarding their failure to transpose the Directive into national law. The sending of a reasoned opinion is the second stage of formal infringement proceedings. If the Commission does not receive a satisfactory reply within two months, it may decide to refer the Member States concerned to the Court of Justice.  

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