Commission urges remaining Member States to implement biotech invention protection directive
The European Commission met with representatives from Member States to assess efforts made to implement Directive 98/44 on biotech invention protection and to the work of a new expert group. The meeting, which took place on 28 January within the framework of an infringement procedure, was the third opportunity for Member States to explain the political and technical obstacles, which continue to block the implementation of the directive into national laws and regulations. Currently, only six Member States have met the 30 July 2000 deadline and implemented the directive. In December 2002 the Commission officially requested that Germany, Austria, Belgium, France, Italy, Luxembourg, the Netherlands, Portugal and Sweden take steps to implement the directive, and warned that the consequence of not complying could be referral to the European Court of Justice. 'Unless the 1998 Directive is properly implemented, Europe's biotech sector will be working with one hand tied behind its back and will fall further and further behind,' said Internal Market Commissioner Frits Bolkestein. While recognising the difficult nature of the task, Research Commissioner Philippe Busquin also emphasised the necessity for speedy implementation of the directive. 'To ensure Europe excels in biotechnology, we need a robust European system for protecting biotech inventions.' During the meeting, Member States welcomed the guidance given by a Commission report entitled 'Developments and implications of patent law in the field of biotechnology and genetic engineering'. Discussions focused on the key chapters of the report, which cover the patentability of plants and animals, the patentability of isolated elements of the human body and exceptions to patentability. While implementing the Directive quickly is essential, Commissioner Bolkestein reiterated the need to 'keep a close eye on this fast moving field and make sure the European policy framework keeps pace with technical and legal developments'. With this in mind, the Commission brought representatives at the meeting up to date with the outcome of the group of experts' first meeting: The Commission recently established the group to analyse important issues surrounding biotechnological inventions. It will be responsible for advising and assisting the preparation of future annual reports on the development and implications of patent law on biotechnology and genetic engineering. The group brings together renowned experts including representatives from the patent profession, patent practitioners, legal experts, scientists and representatives from the European Patent Office and the World Intellectual Property organisation. The mixed composition of the group should ensure that all relevant aspects are dealt with, taking into account the various related policy areas and the interests of different stakeholders. The Commission stresses that the group will not touch upon ethical issues, which are the mandate of the European Group on Ethics. Instead it will focus on legal and technical aspects and on the mutual impact of the legal framework and the European Research and Innovation Area. The expert group is expected to discuss the level of protection to be given to sequences or partial-sequences of genes isolated from the human body and the patentability of human stem cells and cell lines derived from them in the coming months. Reports on the meetings will be submitted to the Commission for further discussion and will be published at the same time as the Commission's 2003 annual monitoring report, towards the end of the year 'I am confident that the expert group will help us and Member States to ensure that the directive will work for research, innovation and the public interest not against them,' concluded Mr Busquin.