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4-Patents: EC acts against Member States failing to implementbiotech patent directive

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TITLE:  Industrial property: eight Member States referred to Court for
        failure to implement Directive on legal protection of
        biotechnological inventions
SOURCE: Europeam Commission, Press Release
DATE:   Jul 10, 2003

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

Industrial property: eight Member States referred to Court for failure to
implement Directive on legal protection of biotechnological inventions

DN: IP/03/991
Date: 10/07/2003


Brussels, 10th July 2003

Industrial property: eight Member States referred to Court for failure to
implement Directive on legal protection of biotechnological inventions

 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/

 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/03/127).

 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 potential patenting of Human Stem Cells and cells lines obtained
from them.

 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

 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.



European NGO Network on Genetic Engineering

Hartmut MEYER (Mr)
Kleine Wiese 6
D - 38116 Braunschweig

phone:  +49-531-5168746
fax:    +49-531-5168747
mobile: +49-162-1054755
email:  genetnl(at)