The Implementation of the Biotechnology Directive (98/44/Ec) in France and in England

UNIVERSITY OF KENT AT CANTERBURY

KENT LAW SCHOOL

THE IMPLEMENTATION OF THE BIOTECHNOLOGY DIRECTIVE (98/44/EC) IN FRANCE AND IN THE UK: A COMPARATIVE STUDY WHICH SHOWS SERIOUS DISPARITIES DESPITE ITS EFFORT OF HARMONISATION

Supervisor: Alan Story

Words: 20 000

Céline MARQUES

LLM in International Commercial Law

September 2006

Abstract

Biotechnology is defined as the use of micro-organisms, such as bacteria or yeasts, or biological substances, to perform specific industrial or manufacturing processes. Biotechnological inventions have recently become a really important field of investments and, thus a worldwide competitive market. The applications of biotechnologies concern, not only, pharmaceuticals, but also the food industry, health and agriculture. To attract investments and encourage innovations on this field, a harmonised regulation was necessary in European law to protect such inventions. This paper concerns the implementation of the European directive on the protection of biotechnological inventions, in France, and in the United Kingdom. After reaching an arduous consensus, Member States appeared to have difficulties to implement the directive. When studying its implementation in French and UK law, it comes into sight that the patentability of living organisms, and especially genes, is at the heart of the difficulties. Furthermore, the monopoly right granted to a patent holder adds further obstacles in the implementation of the 98/44/EC directive. The aim of this paper is to explain why, despite an effort of harmonisation, only a step towards the reconciliation of legislations has been achieved. The purpose is also to find in which way conflicting interests, but also cultures and legal mentalities of both countries have influenced the implementation of the directive. It appears that, biotechnology is not only a legal issue but also a political, economic, moral and cultural issue and it is the accumulation of these elements which gives all its interest to this comparative study.

DISSERTATION

OUTLINE

LIST OF ABBREVIATIONS…………………………………………………..................................8

ACKNOWLEDGEMENTS………………………………………………………….………………9

INTRODUCTION………………………………………………………..........................................10

- The definition of biotechnologies…………………………………................................10

- The reasons of the draft of the Directive 98/44/EC………………….............................12

- Problematic………………………………………………………………..…………....15

- structure ………………………………………………………………………………………….16

CHAPTER I – THE DIRECTIVE ON THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS: A LONG AWAITED LEGISLATION…………….17

1. The need for a harmonisation concerning the legal status and protection of biotechnological inventions……………………….........................................................17

1.1 The International Context of the protection of biotechnological inventions…………………………....................................................18

1.1.1 The international regulation on the protection of Biotechnological Inventions, the incentive for harmonisation..................................................19

1.1.2 The modern case law calling for a European harmonisation…………..................................22

1.2 The EPO decisions as a first sign of the necessity of the protection of biotechnological inventions in the EC……………............................24

1.3. The pressures from businesses and foreign investors waiting for an efficient protection in Europe………………………………..............25

2. An awaited directive which has been the course of conflicts during its creation………27

2.1 The tumultuous genesis of the directive……………………………..27

2.2 The creation of the directive 98/44/EC which shows divergent opinions from the start………..…………..........................................29

3. The validity of the directive, which can not be questioned any longer, despite the hostility of some Member states……………..................................................................31

3.1 The ECJ decision (ECJ, October 9th, 2000, C-377/98) or the assertion of its validity……………………………...........................................31

3.2 A directive which can not be challenged at a national level either and, which has to be implemented……...………………………………...33

CHAPTER II – THE PATENTABILITY OF LIVING ORGANISMS: A DIFFICULT DISTINCTION BETWEEN INVENTIONS AND DISCOVERIES……………………..............36

1. Patent law applied to living organisms: a regime to study..............................................36

1.1 The choice of the directive: patent law………………………….......37

1.2. The conditions of patentability applied to living organisms……...38

1.2.1 A patentable subject matter……......................39

1.2.2 An industrial application……..........................41

1.2.3 Novelty………...……………..........................43

1.2.4 An inventive step…………………………….44

2. The shy implementation of the distinction between inventions and discoveries in French law…………………………………………………………………………………...…46

2.1. The purpose of the distinction in the directive……........................46

2.1.1. the directive…………………............................46

2.1.2. a distinction preceded by foreign legislation ..48

2.2 The strong opposition of French law to article 5 of the biotechnology directive……………………………………..…………....50

2.2.1 The patentability of some specific biological elements: discovery or invention?...................51

2.2.2 The patentability of human elements: a source of uncertainties in French law which could lead to its non-conformity with the biotechnology directive……………………………………...52

2.2.3 The French arguments in favour of a non compliance with article 5 of the directive……53

3. A clear implementation as to the patentability of living organisms in UK law which did not call for a debate………………………………..........................................................................56

3.1 A large discussion on the morality clause despite its clear implementation………………………………………………………56

3.1.1. A proper implementation of article 6 of the directive with however a restrictive interpretation…………57

3.1.2. The criticisms attached to the nature of the provision………………………………………….58

3.2 Criticisms and alternatives expressed on its content…………………59

CHAPTER III – THE RIGHTS GRANTED BY PATENTS: ONE DIRECTIVE BUT TWO DIFFERING IMPLEMENTATIONS…………………………………….......................................64

1. The regular rights granted to a patentee. ………………………………………………...64

1.1. A limited right to exclude others from using, selling or exploiting the patented inventions…….....................................................................65

1.2. The fear of possible abuses of such rights…………………………...66

1.2.1. The Myriad genetics case………………….......67

1.2.2. The large debate on the merits of such monopoly……… ……………………………67

2. The limitations granted by the directive to secure the protection of the incentive to invent and their implementations…………………………………………...……..69

2.1. The need of new defences for biotechnological inventions……………………………………………………………70

2.1.1. The very specific nature of biotechnological inventions led to the necessity of including further limitations…………………….......................................70

2.1.2. Further new limitations motivated by the expending reproducing nature of living organisms……71

2.2. The additional limitations of French Law and its consequences, an imperfect implementation which restrict patentee’s rights………….71

2.3. The English implementation of the directive: a faithful reproduction of the European text but some difficulties with its article 12……….73

3. The exemptions granted to farmers: difficulties of implementation put in relation with international agreements……………………………………………………...75

3.1. The exemptions granted to farmers: a limitation to patent rights essential for agriculture. …………………………………………………76

3.1.1. The economic situation of farmers as to patents…………………………………………………76

3.1.2. The farmer’s privilege: a well-accepted consensus………………………………………...……77

3.2. The implementation of the directive in France and in the UK: an appearance of harmonisation…………………………..…………………78

3.3. The farmer’s privilege: a practice which is likely to be different from the implementation ……………................................................................80

CHAPTER IV – THE DIVERGENT LEGAL MENTALITIES: A POSSIBLE REASON TO THE LACK OF HARMONISATION…..........................................................................................84

1. Is there anything else than the implementations and national provisions to compare in comparative law……………………....................................................................84

1.1. The modern concept of comparative law and its consequences on our study………………………………………..………………………..85

1.1.1. P. Legrand and the concept of legal mentality………….........................................................85

1.1.2. The reasons and interests of taking into account the legal mentality..........................................................86

1.2. What other factors should be compared as regard to the implementation of the biotechnology directive to understand the reasons of its partial success………………………………………...87

2. The use of legal gaps in the Directive to introduce national politics created by mere national interests…………………….......................................................................89

2.1. Ethical issues and commercial interests: two indivisible elements of biotechnological issues leading to different national politics…………………………………………………………………....89

2.2. The uncertainties of the directive used by each legislator to encourage its politics………………………………………………………………...91

3. The unavoidable function of the “legal mentality” in a climate of “conflicting cultures” and the alternatives to a partial and dissatisfactory harmonisation……...93

3.1. A divergence as to the legal mentalities: an important but neglected factor……………………………………..…….........................................94

3.2. The alternatives or what could have been done to have a satisfactory harmonisation: the absence of a simple and perfect answer………………………… …………………………………………95

CONCLUSION………………………………………………………………...................................99

ANNEX 1: glossary………………………………………………………………………..………..103

BIBLIOGRAPHY……………………………………………………………………………….....107

List of abbreviations

- CBD ► Convention on Biological Diversity

- DNA ► Deoxyribonucleic Acid

- EC ► European Community

- ECJ ► European Court of Justice

- EPC ► European Patent Convention

- EPO ► European Patent Office

- EU ► European Union

- IPC ► Intellectual Property Code

- IPRs ► Intellectual Property Rights

- GATT ► General Agreement on Tariffs and Trade

- GMO s ► Genetically Modified Organisms

- IPRs ► Intellectual Property Rights

- TRIPs Agreement ► Agreement on Trade-related Aspects of Intellectual

Property Right

- UK ► United Kingdom

- UNCTAD ► United Nations Conference on Trade and

Development

- The UPOV convention ► The International Convention for the Protection

of Varieties of Plants

- WIPO ► World Intellectual Property Organisation

- WTO ► World Trade Organisation

ACKNOWLEDGEMENTS

During the writing of this dissertation, it has been a real pleasure to benefit from the knowledge and advice of various persons.

I would like to acknowledge in particular my supervisor, Mr Alan Story, for his helpful experience in intellectual property law, our useful conversations and his answers to my enquiries. I would also like to thank him for his academic advice which helped me to carry out this project till the end.

I would also like to thank my parents and Nathalie for their constant financial and emotional support throughout the year. I would like to acknowledge their consideration and patience.

I also thank my closest friends in Canterbury, Véronique Govet and Emilie Braive for their persistent moral support. To all the persons I have met in Canterbury as well, and especially in Tyler Court, for what they have taught me during this year, which means tolerance, compassion and patience.

Last but not least, I am extremely grateful to Christian Krause for his continuous encouragement, enthusiasm and most importantly for his unlimited understanding.

THE IMPLEMENTATION OF THE BIOTECHNOLOGY DIRECTIVE (98/44/EC) IN FRANCE AND IN THE UNITED KINGDOM: A COMPARATIVE STUDY WHICH SHOWS SERIOUS DISPARITIES DESPITE ITS EFFORT OF HARMONISATION

Introduction:

Biotechnology has become one of the most mediatised legal and political issues during the last decades. Its extremely fast-evolving innovations, which concern the scientific, as well as the technological and industrial fields, has raised many questions as to the legal framing of biotechnologies[1]. Biotechnology is defined as “the use of living organisms, (eg bacteria), or the enzymes produced by them, in the industrial manufacture of useful products, or the development of useful processes, eg in energy production, processing of waste, manufacture of drugs and hormones”[2]. Biotechnologies concern a very broad field of processes and techniques[3]. With the discovery of the deoxyribonucleic acid (DNA), and its subsequent isolation in 1869 by Friedrich Miescher, and the discovery of its structure and function, in 1953 by J. Watson and F. Crick[4], biotechnology became a far more important issue than what it used to be, and opened the door to new kinds of innovations, as well as new kinds of concerns. By then, biotechnologies were not only about traditional techniques, such as fermentation processes for the production of bread or beer, or other techniques, such as the selective breeding of plants or animals[5]; but it also turned out to be a new era for biotechnologies. Today, biotechnology concerns especially pharmaceuticals, where micro-organisms are used to produce medicine. For instance, genetic engineering allowed the production of insulin, using human cells, instead of cells of pigs[6]. This innovation, due to biotechnological research, reduces possible rejections of the insulin by the body, and increases its efficiency. Thereby nowadays, more than half of the new medicines are related to biotechnologies[7]. It also concerns cloning, diagnostics and testing of some genetic diseases such as breast cancer, gene therapy, xenotransplantation, genetically modified seeds and foods and some new environmental techniques, such as the creation of micro-organisms which can degrade hydrocarbons[8]. Modern biotechnology gathers many expectations and hopes, mainly in public health and in the food industry. However, it also raises questions and fears as to the use of genetic information, biodiversity, the limits and the merit of biotechnology itself[9]. Furthermore, they also have an important effect on economy. According to the European Commission, biotechnologies will represent a market of 2 000 billions euros in 2010[10]. Furthermore, the field of “human biotechnologies”, which concerns mainly genetic therapies, diagnostic and testing processes, and some pharmaceutical products, is especially active. Its worldwide market is considered to be of about $ 35 billions, and it has known a constant increase of 20 per cent each year, since the start of 1990[11]. Consequently, biotechnology has become the new field of substantial investments and competitiveness.

Given the financial importance of this field, investors are competing for the access to primary materials, such as genes, as well as for their protection, and for the protection of the innovations coming from the research, based on these materials. On October 21st, 1988, the Council of the European Community (EC) proposed a European directive on the protection of biotechnological inventions to assert a payback in the investments carried out by companies, and to encourage research, innovations, and the increase of investments in biotechnologies in Europe[12]. The purpose of this harmonisation was to face the competition coming from the United States and Japan. Indeed, the European hindrance, as to the filing and grant of patents, compared to the United States, started to be substantial. Between 1981 and 1995, 70 per cent of the patents granted by the European Patent Office (EPO) belonged to American or Japanese firms, whereas only 24 per cent were granted to European companies[13]. Since 1988, the European directive proposal had chosen to protect biotechnological inventions through patent law. A patent is usually defined as an official title granted by a patent office to a person or a business, giving the sole right, for a limited period of time, to make and sell a particular product or exploit a particular process[14]. However, the patent is a right to exclude others, which means, first of all, competitors, from using, exploiting, selling or producing the invention. However, it does not give a right to commercialise it.

A consensus on the protection of biotechnological inventions had been reached on July 6th, 1998, through the adoption of the Biotechnology directive, after 10 years of parliamentary debates[15]. The use of a directive to set down a protection for biotechnological inventions could seem, at first, inappropriate, given the existence of the Convention of Munich[16]. However, because of the complexity of the procedure to amend the said convention, the European Community considered that a directive would be the quickest and most efficient way to grant such a protection[17]. A directive is defined as a legal text drafted by the European Community which links the Member States as to the results to achieve, and lets them free to implement it in the way they chose to. The European directive, which was expected by the scientific and legal communities, should have been implemented by all Member States by July 30th, 2000[18]. However, in 2002, only six Member States had implemented it and had integrated it into their national legal systems[19]. The United Kingdom (UK) had mainly implemented the Biotechnology Directive 98/44/EC in the Patents Regulations 2000 (SI 2000/2037) as far as sections 1 to 11 were concerned. They have, then, completed the implementation with the Patents Rules 2001 (SI 2001/1412), and the Patents and Plant Variety Rights (Compulsory Licensing) Regulations 2002 (SI 2002/247). Contrary to the quick implementation of the UK, France implemented the Biotechnology Directive with 53 months delay. The transposition had been made in two parts. A first statute, implementing sections 5 and 6 of the directive, related to the inventions as to the human body and its elements, had been drafted on August 6th 2004 (statute n° 2004-800). A second, implementing the other sections of the directive, had been drafted on December 8th, 2004 (statute n° 2004-1338). However, the difference of time which has been necessary to implement the directive in France and in the UK is not the only disparity. Indeed, comparing both implementations, some important divergences appear, and show a quite differing political will from one country to the other. The interest of this paper is not to challenge the merit of the Biotechnology Directive, or to explain in every detail its content. The purpose of this paper is not to describe the implementing statutes from the UK and France. The point, here, is to make a comparative analysis, between two legal systems, on the implementation of the said directive. Given the various interests at stake, biotechnology is a particularly complex issue[20]. Indeed, Biotechnology does not only involve patent law, but also political and ethical issues. Furthermore, French law has its origin in Civil law, or more particularly in the European continental system of law, which is primarily derived from Roman law, and the Germanic tradition. Its codification of abstract principles and its history are two of its major specificities[21]. However, the UK is a Common Law country. Its legal system is divided into two legal fields, Common Law and Equity. Common law systems have a pragmatic approach to the particular problems which appear, and are, thus, often reluctant in giving abstract principles.[22] These differences of origins imply, therefore, important differences between both legal systems. Consequently, it can be interesting to understand in which extent a harmonisation, on such a complex issue, is possible, and how it can actually be handled between two legal systems, which are apparently very different from one another.