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TITLE:  Legal protection of biotechnological inventions:
        Commission discusses progress with Member States and establishes
        expert group
SOURCE: European Commission
DATE:   Jan 28, 2003

------------------ archive: ------------------

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

DN: IP/03/127

Date: 28/01/2003



Brussels, 28th 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

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

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:

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

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

- 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)

- Ms Ann Mc Laren (Welcome CRC Institute University of Cambridge UK),
- Ms Siobhan Yates (Director Biotechnology Directorate European Patent
- 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).

Implementation of Directive 98/44/CE on the legal protection of
biotechnological inventions

Member State
a) Implementation : State of play as per 24/01/03
b) Implementation Date

a) A draft law had been submitted to Parliament but due to the general
election, the AT authorities are obliged to submit a new one.
b) Delayed

a) 14-6-2001: Draft law adopted by the Government and submitted to
Parliament on 21 June 2002. Debates taking place in Parliament
b) Not clear but expected before the General election (May 18 2003)

a) 18-10-2000 : Draft law adopted by Government and submitted to
Parliament; Debates were taking place in Parliament, but due to the
general election (last September); DE authorities are obliged to re-
submit a new draft
b) Delayed

a) -
b) May 2000

a) -
b) 30 April 2002

a) -
b) 30 June 2000

a) Draft law adopted by the Government on 31-10-2001 and currently under
discussion in the Senate.
b) Delayed

a) Decree on 15-10-2001
b) 22 October 2001 : Communication to the Commission

a) -
b) 30 July 2000 : Regulations; Notification to the Commission done

a) 19-10-1999: Draft law submitted to Parliament; 26-9-2002: adoption of
the draft law by the first Chamber
b) Not clear

a) Bill submitted to Parliament in June 2000; Parliamentary Committee on
Ethics has been dealing with the issue (meeting on 23 January 2001 with
experts from EPO). The situation seems to be blocked.
b) Delayed

a) Report of the 2nd Chamber (7-6-2000) providing for several amendments
to the draft law submitted on 28-05-1999, Debate in plenary on 02-10-2000.
b) Not clear

a) Draft law has been adopted by Parliament. The Minister Council has
definitively adopted the law. It will enter into force 6 months after
this adoption
b) Expected for 1 July 2003

a) A law should be passed in spring 2003 (debates in Parliament scheduled
during spring session) 
b) Not clear

United Kingdom 
a) -
b) 28 July  2000: Implementation on time for articles 1-11
    6 July  2001: Implementation of Articles 13 and 14
    1 March 2002: implementation of Article 12