Brussels, 10 th July 2003
The European Commission has decided to refer Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands and Sweden to the European Court of Justice, as they have still not implemented Directive 98/44/EC on the legal protection of biotechnological inventions. The Directive should have been written into national law by 30 July 2000. It aims to clarify certain principles of patent law applied to biotechnological inventions whilst ensuring that strict ethical rules are respected. Such clarifications have proved essential in order to fully exploit the medical, environmental and economic potential of biotechnology in line with high ethical standards. Non-implementation of this Directive is putting the European biotechnology sector at a serious disadvantage. Despite the Commission's efforts to co-operate closely with them in order to try and accelerate the implementation procedure, the Member States concerned failed to reply satisfactorily to formal requests in the form of reasoned opinions - sent by the Commission in December 2002 (see IP/02/1928 ).
Directive 98/44 was adopted by the Council and the European Parliament to promote the development of biotechnological inventions at EU level ( MEMO/00/39 ). Before it was adopted, there were numerous discrepancies between the Member States' laws. It also provides the European Union with a means of permitting European companies to compete on level terms with their Japanese and American rivals whilst ensuring strict safeguards against the patenting of unethical inventions.
To date only seven Member States have implemented the Directive. Non-implementation elsewhere has created trade barriers and hampered the Internal Market.
This is despite the Commission's efforts to co-operate with Member States to speed up progress, including through three high-level meetings, the most recent in January 2003. These meetings reviewed the state of play and gave Member States the opportunity to explain any political and technical obstacles (see IP/03/1 ).
In December 2002, the Commission decided to request officially Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden to implement the Directive on pain of being taken to the Court (see IP/02/1928 ). Only Portugal has since done so. The January meeting took place within the framework of that infringement procedure.
The Commission is fully aware of the concerns which the Directive can arouse in public opinion in some Member States, in as much as it concerns the patentability of biological material, which, when the patentability conditions are met, can extend to elements isolated from the human body.
The Directive does, however, contain clear and precise provisions safeguarding the dignity and integrity of the person. The Court of Justice, in its ruling of 9th October 2001 (case C-377/98), confirmed that the Directive fully upheld these essential principles.
In recognition of the fact that the way regulation is conceived and applied needs to take account of the fast-changing nature of the biotechnology sector, the Commission will continue to follow any developments very closely.
The Commission has published several reports required by the Directive. On 14 January 2002 it published "An assessment of the implications for basic genetic engineering research of failure to publish, or late publication of, papers on subjects which could be patentable" and on 7 October 2002, it published the first annual report on "Development and implications of patent law in the field of biotechnology and genetic engineering" ( IP/02/1448 ).
To pursue its review, the Commission has appointed a group of eminent experts to assist it in drawing up future reports. The group is focussing on two particularly sensitive fields identified by the report:
- the scope to be given to patents related to sequences or partial sequences of genes isolated from the human body;
The group's conclusions will be presented to the Commission and taken into account for the preparation of next annual report on the development and implications of patent law in the field of biotechnology and genetic engineering.
The full text of Directive EC 98/44 on the legal protection of biotechnological inventions is at:
The full text of the Commission's 2002 report can be found at:
Information concerning current infringement procedures against all Member States is available on the Europa website:
Directive 98/44 was adopted after a 10-year debate in both the Council and the European Parliament. Given the considerable amount of high-risk investment that is often required in biotechnology, particularly genetic engineering, adequate patent protection is essential to encourage the investment required to create jobs and maintain the European Union's competitiveness in this crucial field.
However, the Directive explicitly excludes from patentability discoveries which extend knowledge without applying it for a new purpose. It is therefore not possible under the Directive to patent, for example, DNA sequences with no clearly identified function, because they are not inventions but discoveries, i.e. they already existed, discovering them extends knowledge but that knowledge has thereafter to be applied to be technically useful. Processes or products using DNA sequences can be patented only if they satisfy the criteria of novelty, inventiveness and industrial applicability.
The Directive also excludes from patenting on ethical grounds certain applications such as processes for cloning human beings or modifying their genetic identity, the use of human embryos for industrial purposes and processes for modifying the genetic identity of animals which may cause them suffering without substantial medical benefits.
Life sciences and biotechnology offer considerable potential in many areas, especially health care, agriculture and environmental protection.
By 2005 the European biotechnology market could be worth over €100 billion. By 2010, global markets, including sectors where life sciences and biotechnology constitute a major portion of new technology applied, could amount to over €2,000 billion, excluding agriculture.
DN: IP/03/991 Date: 10/07/2003
DN: IP/03/991 Date: 10/07/2003