The European Biotech Directive: Past as Prologue

Published date01 September 2001
AuthorE. Richard Gold,Alain Gallochat
DOIhttp://doi.org/10.1111/1468-0386.00133
Date01 September 2001
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The European Biotech Directive:
Past as Prologue
E. Richard Gold* and Alain Gallochat**
Abstract: The directive on the legal protection of biotechnological inventions (the
`Biotech Directive') represents the end of a decade-long dialogue on how best to
encourage biotechnology innovation in Europe while addressing ethical concerns. The
Biotech Directive represents an interesting compromise between Parliament, Commis-
sion, and Council based on divergent policy concerns, treaty limitations, and international
trade rules. In this article, the authors explore the meaning and implication of the Biotech
Directive by examining its contentious history, its provisions, and its jurisdictional
foundations. Drawing on this base, the authors examine questions left unanswered by
the Biotech Directive and analyse how the Biotech Directive ®ts in with existing
international law.
I Introduction
With the aim of encouraging a strong biotechnology industry in Europe, the Council
and the European Parliament approved the Directive on the legal protection of
biotechnological inventions
1
(the Biotech Directive) in July 1998. The Biotech
Directive harmonises patent law between the Member States with respect to biotech-
nology and ensures that the products of modern biotechnology are patentable
throughout the Community. It does so by establishing both the rules that apply to
the patenting of biotechnological products and processes (including those involving
materials of human origin) and to the scope of protection oered by those patents.
Nevertheless, debate plagued the Biotech Directive from the beginning, leading not
only to a tortuous legislative history, but diculties in transposing the Directive into
the national laws of some Member States.
The Biotech Directive called for its transposition into national law by 30 July 2000.
That deadline has since passed, with only a few Member States having actually passed
legislation to give it eect. While the failure of Member States to transpose directives is
in no way remarkable,
2
the particular reasons holding them back in this case point to
European Law Journal, Vol. 7, No. 3, September 2001, pp. 331±366.
#Blackwell Publishers Ltd. 2001, 108 Cowley Road, Oxford OX4 1JK, UK
and 350 Main Street, Malden, MA 02148, USA
* Associate Professor, Faculty of Law, McGill University; Senior Fellow, Einstein Institute for Science,
Health & the Courts; Research Associate, Health Law Institute, University of Alberta. Professor Gold
would like to thank Lynn Iding, Erin Rogozinski, Danial Lam, and Florence Dagicour for their research
and editorial assistance.
** Advisor to the Ministry of Research, France, Associate Professor, Universityof Panthe
Âon Assas-Paris II.
1
EC, Directive 98/44 of the European Parliament and of the Council of 6 July 1998 on the Legal
Protection of Biotechnological Inventions, OJ L (1998) No L213 at 13 [Biotech Directive].
2
See, for example, European Commission, `Scoreboard: Member States speed up adoption of Internal
Market rules', IP/00/1356, 24 November 2000.
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continuing ethical concerns relating to the patenting of biological materials, particu-
larly with respect to the appropriateness of patenting animals, plants, and materials of
human origin.
The purpose of the Biotech DirectiveÐto create a vibrant European biotechnology
industry that addresses European health-care, agricultural, and environmental
needsÐcontinues to motivate Community legislators. Only six months after the
approval of the Biotech Directive, Parliament and the Council approved the Fifth
Framework Programme for research, technological development and demonstration
activities.
3
This programme placed biotechnological research and the biotechnology
industry at centre stage in addressing Europe's present and future health-care,
agricultural, and environmental needs.
4
The original impetus for the Biotech Directive was to address competition from the
United States and Japan. In 1988, when the Commission issued the ®rst draft of the
Biotech Directive, both the United States and Japan had decided to grant patents over
biological material, whether of human, animal, plant, or microbiological origin. The
United States had recognised patents in genetically-modi®ed living organisms in 1980
and in higher life forms in 1988. While the European Patent Oce (the EPO) had
issued patents on biological materialsÐincluding those of human origin
5
Ðprior to the
Commission's proposal of the draft Biotech Directive, no one knew whether courts
would ®nd these patents to be valid or what scope the courts would give to
biotechnology patents. Given this uncertainty, the Commission feared that a failure
to address biotechnological inventions would detrimentally aect European research
and development.
While the Commission had originally conceived of the Biotech Directive as
harmonising the technical patent law issues necessary to create a robust European
biotech industry, Parliament was quick to point out that the patenting of biological
materials, in particular those of human origin, also raised important ethical and social
concerns. Thus started a ten-year tug-of-war between Parliament on the one hand, and
the Commission and Council on the other. The legacy of that battle continues as the
Community continues to discuss biotechnological innovation and the role of biotech-
nology in society.
In this article, we hope to shed light on the debate surrounding the adoption of the
Biotech Directive not only for its own sakeÐit provides a wonderful example of the
relationship between the major European institutionsÐbut also for what it tells us
about the future of biotechnology patents in Europe. There are several aspects of this
debate that we will focus upon.
First, we wish to analyse what the history of the Biotech Directive teaches us about
the jurisdictional basis for Community action in the area of biotechnology patenting.
European Law Journal Volume 7
332 #Blackwell Publishers Ltd. 2001
3
Dec. 99/182, [1999] OJ L 026, 1±33.
4
Annex II of Dec. 99/167 which states, in part as follows:
The programme will capitalise on speci®c scienti®c strengths in knowledge areas and in the productive
sectors with strong growth potential, such as the biotechnology and food industries. Thus, the heart of
this programme, improving the quality of life, promoting life sciences and technologies and decoupling
economic growth from environmental degradation,will contribute in the short and in the longer term to
European competitiveness and employment.Europe must promote start-ups in particular in the areas of
biotechnology and the agro-food industry which have recently shown a consistent growth rate.'
5
Human Interferon (INF), EP 032134, issued 15/08/84; Human Interleukin 2 (IL-2) EP 091539, issued
13/07/88; Human Factor VIII, EP 083483 (US 4,361,509), issued 27/04/88.
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Now that the Community is contemplating moving beyond harmonising national
laws with respect to biotechnology to setting up a European-wide patent, it is
important to understand the jurisdictional competence of the Community in patent
matters.
Second, the Biotech Directive did not completely harmonise patent laws among the
Member States with respect to biotechnology. For example, it did not provide any
de®nition of animal variety although the question of whether a particular animal-
based invention is patentable turns, among other factors, on whether it is a `variety'.
We will, therefore, suggest areas where further harmonisation is required in respect of
biotechnological inventions.
Third, given that much of the concern over the Biotech Directive was voiced by the
public and members of organised civil society, we will examine the role that the public
ought to play in setting policy that aects biotechnology patents. In particular, given
that the public continues to express uncertainty over both scienti®c and intellectual
property questions, we wish to examine the role that the public can properly have in
the biotechnology patent debate. Through this examination, we will ask whether
mechanisms exist that would oer members of the public sucient scienti®c
and intellectual property education to permit them to actively participate in the
establishment of policy in this area.
Fourth, we will look at the interaction between ethics and patent policy. There are
two types of ethical implications to biotechnology patents. The ®rst relates to the
ethics of using the inventions. The Member States have already responded to this
concern by including a clause in their patent legislation providing that inventions
whose commercialisation violates ordre public (public order) or morality, are not
patentable.
6
The second type of implication is less easily addressed. The patent system,
through its reliance on market incentives, has the potential to not only encourage the
creation of socially-bene®cial inventions but to encourage the development of morally
suspect activity. The locus of the ethical concern is not, therefore, simply the patent
system, but also the world market that relies on distributing private property rights
over inventions.
Fifth, we wish to examine the relationship between European patent policy over
biotechnological inventions and international obligations, particularly those related to
trade and to the environment. While the Agreement on Trade Related Aspects of
Intellectual Property Rights
7
(`TRIPs') substantially limits the Community's freedom
to enact patent rules aecting biotechnological innovations, the Rio Convention on
Biological Diversity
8
establishes the obligation to enhance biodiversity, although using
less-constraining language.
We will delve into these issues later in this article. First, in Part II, we examine the
history of the Biotech Directive, from the events that led to its creation, to its
introduction in 1988, its adoption in 1998, and its subsequent transposition into
national law. In Part III, we describe the provisions of the Directive itself. This is
followed up in Part IV with an analysis of the impact of the Biotech Directive on
September 2001 The European Biotech Directive
#Blackwell Publishers Ltd. 2001 333
6
At present, Member States also exclude from patent protection inventions the publication of which would
violate ordre public or morality. This exclusion will be eliminated once amendments to the European Patent
Convention come into force two years after 15 state parties to the Convention ratify or adhere to it.
7
Agreement on Trade Related Aspects of Intellectual Property Rights, 15 April 1994, 33 ILM 1197.
8
Convention on Biological Diversity, done at Rio de Janeiro, 5 June 1992 [the Convention on Biological
Diversity].

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