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.