Brussels, 28^th January 2003

Legal protection of biotechnological inventions: Commission discusses progress with Member States and establishes expert group

The European Commission has met with Member States in order to try to speed up progress in the implementation of Directive 98/44 (see MEMO/00/39) on the legal protection of biotechnological inventions. Despite the 30 July 2000 deadline, the Directive has been implemented in national legislation in only six Member States (DK, FIN, UK, IE, SP, and GR). In December 2002 the Commission decided to request the other nine formally to follow suit, on pain of being taken to the European Court of Justice see (IP/02/1928). The Commission has also set up a group of experts to advise and assist it in preparing future annual reports on the development and implications of patent law on biotechnology and genetic engineering, as required in Article 16c of the Directive ("16c reports"). The first such report was issued by the Commission in October 2002 (see IP/02/1448).

Internal Market Commissioner Frits Bolkestein said: "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. Implementing the Directive quickly is essential but at the same time we 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. So I am delighted we have been able to establish such an impressive group of experts to help us prepare our annual reports on the interface between patent law and the biotech sector."

"Biotechnology is the sector of growth for the coming decades" said European Research Commissioner Philippe Busquin. "To ensure Europe excels in biotechnology, we need a robust European system for protecting biotech inventions. This is what the European Directive will give us, if properly implemented by Member States. 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."

Implementation meeting

The main purpose of the meeting with Member States was to review the precise state of play concerning the implementation of the Directive.

This meeting was the third one to have given Member States (others were held in January 1999 and January 2001) opportunities to explain the political and technical obstacles which continue to block the implementation of the Directive into national laws and/or regulations. Despite the deadline for implementation being 30 July 2000, only six Member States have so far implemented the Directive while the other Member States are currently at varying stages of progress (see annex attached).

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 European Court of Justice (see IP/02/1928). The latest meeting took place within the framework of that infringement procedure.

The meeting also included an exchange of views on the first report under Article 16c of the Directive, issued by the Commission on 7 October 2002, and entitled 'Developments and implications of patent law in the field of biotechnology and genetic engineering' (see IP/02/1448). The meeting concentrated 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. Member States welcomed the guidance given by the report.

Finally, the Commission informed Member States on the first meeting of the expert group it has set up to assist and advise it in drawing up future reports.

Expert group on legal and technical aspects of biotechnological inventions

The group's mandate is to analyse important issues surrounding biotechnological inventions. It will not touch upon ethical issues, which are the mandate of the European Group on Ethics, but instead will focus more on legal and technical aspects and on the mutual impact of the legal framework and the research and innovation area.

The group brings together renowned experts including representatives from the patent profession, patent practitioners (from the private sector, big business and a small biotech company), three legal experts, two scientists and representatives from the European Patent Office and the World Intellectual Property organisation (WIPO). The mixed composition of the group will ensure that all relevant aspects are dealt with, taking into account the various related policy areas and the interests of different stakeholders.

The group is chaired by Mr. Vincenzo Scordamaglia, a legal expert and former director of the Secretariat of the Council. Mr Sven Bostyn from Maastricht University was elected reporter for the first topic which deals with the level of protection to be given to patents of sequences or partial-sequences of genes isolated from the human body. Ms Geertrui van Overwalle of the University of Leuven in Belgium will report on "the patentability of human stem cells and cell lines derived from them".

These topics will be discussed by the group in March and May 2003 respectively, after which reports will be made available to the Commission. The reports will discuss the issues, analyse potential impacts and propose possible options. Reports will be published at the same time as the 2003 annual monitoring report of the Commission is published, towards the end of the year.

The full text of the Commission's 2002 report can be found at:

http://www.europa.eu.int/comm/internal_market/fr/indprop/invent/index.htm

And the full text of Directive EC 98/44 on the legal protection of biotechnological inventions at:

http://europa.eu.int/eur-lex/pri/en/oj/dat/1998/l_213/l_21319980730en00130021.pdf

Composition of the expert group

Chairman:

• Mr Vincenzo Scordamaglia (Honorary Director-General of the EU Council - Consultant in IPRs IT)

Reporters:

• Ms Gertrui Van Overwalle, (Centre for Intellectual Property rights Faculty of Law Leuven BE)
• Mr Sven Bostyn, Assistant Professor of Commercial and Intellectual Property Law (Maastricht University NL)

Members:

• Ms Ann Mc Laren (Welcome CRC Institute University of Cambridge UK),
• Ms Siobhan Yates (Director Biotechnology Directorate European Patent Office),
• Mr Jacques Warcoin (Patent agent Cabinet Regimbeau FR),
• Mr Daniel Alexander (Barrister, London, UK),
• Mr. Bo Hammer Jensen (Director, Senior Patent Counsel Novozymes A/S DK),
• Mr Franciso Bernardo Noriega (Deputy Director, Intellectual Property, PharmaMar S.A. - ES)
• Mr Josef Straus (Professor of law and Head of Department Max Planck-Institute for Foreign and International Patent, Copyright and Competition Law, Munich DE),
• Mr Francis Quétier (Genoscope- Evry, FR),
• Mr Ingwar Koch (Director, Patent Law Directorate - European Patent Office),
• Mr Kjergaard (Senior Counsellor Biotechnology and Genetic Resources, Traditional Knowledge Division World Intellectual Property Organisation).