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




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




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




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




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




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




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




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



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



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




    1. 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. 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




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




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

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



      1. a distinction preceded by foreign legislation ..48

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




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




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




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



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




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




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




      1. 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. 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. 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




    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


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




    1. 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. 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. 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







  • 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 biotechnologies1. 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 techniques3. 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. Crick4, 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 animals5; 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 pigs6. 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 biotechnologies7. 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 hydrocarbons8. 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 itself9. 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 201010. 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 199011. 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 Europe12. 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 companies13. 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 process14. 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 debates15. 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 Munich16. 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 protection17. 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, 200018. However, in 2002, only six Member States had implemented it and had integrated it into their national legal systems19. 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 issue20. 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 specificities21. 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.
As previously stated, important divergences appeared in the implementation of the 1998 Biotechnological Directive. The interest here is to explain the reasons of such differing implementations. On which grounds do the various divergences of implementations stand? Are such differences due to differing ethical politics, to differing legal systems or mentalities, or to any other cause? Could the European community have foreseen these difficulties of implementation, when drafting the directive? What are the consequences of these disparities for the harmonisation of the protection of biotechnological inventions?
Indeed, the Biotechnology Directive, which was long awaited by all professionals concerned, has shown lots of difficulties to be drafted. Actually, despite the necessity to set down a legal protection for biological inventions, ten years have been necessary to reach a consensus. Moreover, even after its final draft, its legal validity has been questioned at various levels, and it even appeared necessary to assert its authority (chapter I). However, this tumultuous genesis of the Biotechnology Directive did not stop it from having differing implementations, in French and UK law. Two main issues appeared to be especially sensitive. First of all, the patentability of living organisms, which is the central point of the directive, raised some ambiguities. It even reached a real opposition when implementing the distinction between inventions and discoveries (Chapter II). These disparities went even further when the rights given to a biotechnological invention patentee were considered. At this point, two legal approaches emerged facing the French limitation to the UK protection of such rights (Chapter III). However, these disparities can be explained through a number of factors. In an atmosphere of conflicting legal cultures23, the Biotechnology Directive was, both, needed to get a reconciliation between legislations, and too wide to get a real harmonisation. In its directive, the European Community tried to lay down the basis of a uniform set of rules. However, the directive, allowed France and the UK to integrate their own public policy. Consequently, this study will lead us to determine the different factors which have prevented a uniform implementation of the Directive. Furthermore, we will have to examine, with such factors, if a complete harmonisation was possible and which alternatives existed, at that time, to avoid such difficulties (Chapter 4).

CHAPTER I

THE DIRECTIVE ON THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS: A LONG AWAITED LEGISLATION
Through the course of nearly half a century, biotechnology has gradually become a key field of the economy24. Consequently, and because of the lack of legal harmonisation within the European Community, a piece of legislation was required to give an answer to the fear of investors. It was necessary to create a harmonised and safe legal context in Europe, to attract biotechnological companies25. However, the directive has caused various conflicts. Consequently, ten years have been necessary to reach a consensus among Member States. This tumultuous genesis of the Directive shows how sensitive the issue is, not only legally, but also politically, and economically. Nevertheless, this consensus did not please anyone in particular. Some Member States even tried to challenge the legality and the authority of the said legislation. The assertion of the ECJ but also of some constitutional courts, such as the French Constitutional Court, has, thus, been essential to give some legal legitimacy to the directive.


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

To understand the necessity of drafting a European text able to protect biotechnological inventions within the EC, it is necessary to consider three important factors. It appears that the International context played an important role in the draft of the said directive. Indeed, it has already led the EPO, through its case law, to protect some biotechnological inventions. This first step of the EC towards the protection of biotechnological inventions has been seen as one of the most important signs in Europe, of the necessity to have a harmonised legislation among Member States. But it is mainly because of the economic pressures carried out by biotechnological businesses and investors that the draft of the Biotechnology Directive did not become only necessary but also imperative.





    1. The international context of the protection of biotechnological inventions.

The Biotechnology Directive is not the first piece of legislation dealing with the protection of biotechnological inventions26. At an international level, several agreements could be mentioned27. Moreover, the international context is not only about international legislation but also about foreign case law28.





      1. The International Regulation on the protection of Biotechnological Inventions the incentive for harmonisation.

Since the 1970s, Intellectual Property Rights (IPRs) have become increasingly important29. Maybe the most important and well-known international agreement dealing with the protection of inventions is the TRIPs agreement, drafted in 1994, and administered by the World Trade Organisation (WTO)30. It sets down minimum standards of protection Members need to follow, concerning all the main IPRs31. This international agreement was particularly expected by industrialists and, nowadays, it has a substantial authority in International Intellectual Property Law32. Section 27.333 is particularly interesting as it has been not only the most controversial section, but also the section which dealt with the patentability of living organisms, and the exceptions to such patentability34. This section is often called the “biotechnological clause”35. It shows, first of all, the concern States had and still have in setting down a protection for biotechnological inventions. Furthermore, the conflict it arose, especially with the Biodiversity Convention, shows the legal differences existing between countries and the sensitivity of this legal issue. The Convention on Biological Diversity was signed by 150 government leaders at the 1992 Rio Earth Summit36 and is dedicated to promoting sustainable development. Indeed, its objectives are to promote conservation of biodiversity and equitable benefit sharing37. The convention sets down mechanisms to encourage transfer of technologies between contracting parties38. While the CBD uses intellectual property rights (IPRs) to protect biodiversity, and allow developing countries to access technologies, the TRIPS agreement strengthens IPRs to protect private investors39. This conflict proves the economic importance of biotechnological inventions, not only as to the investments done by companies from developed countries, but also as to the genetic material, or knowledge, incorporated into these inventions, and which come, most of the time, from developing countries40.

Another essential agreement is the UPOV Convention41. Adopted in 1961, it entered into force in 1968 and has been regularly revised since then. The UPOV Convention sets up the International Union for the Protection of New Varieties of Plants, as well as a sui generis system to protect plant varieties42. One of the main provisions, especially important, is the one dealing with farmers’ privilege43. This section is particularly close to section 11 of the European Directive on the protection of biotechnological inventions where similar rights are granted44.

None of these conventions can be considered separately. They are all dependent on each other. For instance, the UPOV Convention sets down the sui generis system stated in section 27.3 of the TRIPS Convention. Such Conventions do not only have effects at an international level, but also at the national level. Doing so, these conventions tried to weaken all the differences existing between national laws45. However, despite this minimum standard of protection, many disparities sill existed between countries before 1998. They were particularly significant within the European Union despite the creation of the European Patent Office.


Faced with the growing importance of biotechnologies, and the multiplication of international agreements, members of the EU had, not only, to implement the latter, but also to harmonise their legislation46. This need became particularly obvious when facing case law.


      1. The modern case law calling for a European harmonisation as to the protection of biotechnological inventions.

Many case law in the 1980s and 1990s allowed a protection for inventions concerning living organisms. It is this case law and the proliferation of international agreements, which led to the necessity of drafting a harmonised regulation within the European Union, to face both competition and attract investments.

For instance, from the end of the 19th century till the mid 1930s, the patentability on some biological materials, such as some yeast, has been seen as a normal extension of patent law47. Furthermore, in the Diamond v. Chakrabarty48 case in 1980, the U.S Supreme Court, for the first time, accepted a patent on living organisms. However, this evolution in patent law was limited to micro organisms. It is only at the end of the 1980s that patents on biologically modified animals appeared. The patent granted to Harvard University in 1988 for their oncomouse is an example of this evolution49. Finally, patents have been granted on human materials50. As a consequence, patents on living organisms started to spread out, not only in the U.S case law, but also in the EPO decisions, and many other jurisdictions.
However, this case law used to evolve without a uniform legislation in the EU, which weakened its position as one of the technological leaders. The reaction of the EPO compared to national laws show even better the necessity of a harmonisation.


    1. The European Patent Office decisions as the first sign of the necessity of the protection of biotechnological inventions in the European Community.

In Europe, the patentability of micro organisms has not been a real issue. Section 53b of the European Patent Convention has recognised the patentability of biotechnological processes and of their products51. Patentability has also been recognised for micro-organisms isolated from their natural environment. Another issue is the patentability of animals. In Europe, the patent for the oncomouse of Harvard University was first refused. However, a second decision held in 1990 stated that the non-patentability of animals as a specie did not apply to the oncomouse52. Thus, the invention was patentable if it gathered all the requirements. As for “human material”, the EPO had already granted several patents in the 1980s. For instance, we could state as an example the patents granted on human purified proteins to cure haemophilia53. Finally, some questions arose as to the patentability of genes in the 1990s. The issue became even more important with the creation of the Human Genome Organisation which aimed at sequencing the DNA54. It thus appears that the patentability of human genes and the one of human cells are considered in the same way55.


Despite this case law from the EPO, there was no uniform regulation to protect biotechnological inventions. However, faced with the growing importance of these inventions and the necessity to protect them in order to encourage innovation, some political measures have been taken. These measures are mainly related to the creation of the Biological Resources Centre56. Despite this political will in favour of biotechnologies, investors and companies used to consider any investment in Europe as a financial risk. This reluctance to invest had negative consequences on the European economy and was a decisive reason to draft a piece of legislation on the issue.


    1. The pressures from businesses and foreign investors waiting for an efficient protection in Europe

The market of the biotechnological inventions is particularly important for several reasons. First, it gathers significant investments and second, the innovations at stake are particularly valuable. Health represents the main application of biotechnologies. In its report, the European Commission evaluates the total world market potential of biotechnological applications to more than 2000 billion euros in 201057. Furthermore, the same report states that, even if investments in biotechnology within the EU increase gradually during the last decades, it remains remarkably low compared to investments in the U.S.


For instance in France, it appears that the number of applications for patents of French origin hardly increased compared to the total number of applications. Indeed, it comes into view that the main increase of applications is due to foreign applications58. Furthermore, if we consider only applications for patents on biotechnologies during the last decade, it has doubled. Given these figures, it became clear that investors feared making investments in Europe because of the lack of protection and legal uniformity biotechnological inventions were submitted to. Indeed, some reports, such as the “rapport Lenoir”59 or the report of the European Commission60, clearly identifies the lack of an efficient protection of biotechnological inventions as one of the reasons, which explains the difference of investments between the U.S and the European Union. It also represents one of the reasons why less patent applications are registered in the European Union rather than in the U.S61. The interest of the harmonisation was thus doubled. First, there was an economic interest to avoid the departure of investors in competing countries, where the protection of biotechnological inventions is granted. Moreover, there was also a legal interest not to let Member states set up their own regulation which would most probably increase legal disparities among them.
Given all these elements, a regulation seemed to be necessary to protect biotechnological inventions. Biotechnologies represent an essential field of the economy and the pressures created by investors made the draft of a common regulation even more important. Thus, the EC decided to draft the European directive on the protection of biotechnological inventions. The Directive was adopted on July 6th, 1998. However, ten years have been necessary to reach its final draft. Indeed, despite its necessity, the European Directive has been the course of large conflicts.


  1. An awaited directive which has been the course of conflicts during its creation

Consequently, it is necessary to study the tumultuous genesis of the draft of the directive to understand the different opinions at stake, and why it is such a complex issue to study and why it led to a differing implementation.




    1. The tumultuous genesis of the directive.

The Directive on the protection of biotechnological inventions entered into force in July 30th, 1998. Its genesis has been particularly tumultuous, and its draft difficult. The first proposal for this directive was drafted in October 21st, 1988. Ten years of legal arguments have been necessary to find a compromise62. The purpose of this proposal was to clarify the implementation of patent law on biotechnological inventions in order to encourage the free movement of new biotechnological products, and processes, and investments. Many amendments to the proposal have been recommended, after the first reading by the European Parliament in 199263. The discussions between the Council and the Commission on the amendments submitted by the Parliament led to the procedure of conciliation to find a compromise in September 199464. Divergences of opinions, mainly on three points, remained despite the numerous discussions and readings65. First, the issue of the patentability of animals, and more specifically, the distinction between discoveries and inventions involving living organisms raised many problems. The exclusion of patentability for “processes of modifying the germ line genetic identity of human beings”66, and the introduction of the derogation of farmers, have been two other very important and conflicting issues. The first difficulty, which is mainly the distinction between discoveries and inventions, has been induced by the concern of the patentability of human genes. The draft of this section gave rise to many misunderstandings and discussions. However, the interest of such debate is that it underlined the necessity to integrate a distinction concerning human biological elements able to be patented. The second issue concerned first the germinal genetic therapy and its non-patentability. These issues, which involve mainly economy and ethics, were solved on August 29th, 1997, when the European Commission adopted the modified directive proposal, rejecting however its amendment 76. The latter implemented and even widened the requirements of the CBD, as to the access of biological resources. Doing so, the Parliament was adding conditions of patentability which were not considered either within the TRIPS agreement, or within patent law. Consequently, the final draft made by the European Council, has been adopted by the European Parliament on May 12th, 1998, with 338 votes in favour of the directive and 110 against67.


However, given these conflicts and hesitations, we could wonder if this consensus satisfied all parties and all opinions.


    1. The creation of the directive 98/44/EC which shows, from the start, some divergent opinions.

The first proposal in 1988 was essentially settling technical principles on biotechnological inventions, setting down their protection and stating the exclusions to patentability. It just clarified the application of patent law to biotechnological inventions. Faced with criticisms and pressures of lobbies, amendments were proposed in order to introduce ethical elements. After the refusal to adopt the directive proposal in March 1995, the European Commission proposed a new draft in December 1995. This latter proposal gathered ethical elements required, as well as, technical provisions. The Commission had queried the European Group on Ethics in Science and New Technologies about the compatibility of the directive with the main ethical principles. Twice, the European Group asserted the said compatibility68. However, even if, at the European level, the final draft of the directive seemed to represent a uniform opinion, it appears, when looking at national and ethical committee reports, that the situation is more complex. On June 8th, 2000, the French national advisory committee of ethics69 advised the French government to “start a new discussion about the terms of the directive”. Despite the adoption of the directive, conflicts and diverging opinions remained. As far as ethical issues are concerned, the conflict concerned three main points such as the non-commercialisation of the human body, the free access of the knowledge of gene, and the sharing of this knowledge. In France, this opposition has been strengthened by the opinion of the Parliamentary Agency on the Evaluation of Scientific and Technological Choices70. At the judicial level, these diverging opinions and even criticisms have been expressed by the action for cancellation brought by the Netherlands, supported by Italy and Norway, before the European Court of Justice on October 19th, 199871. The most important point is maybe the quickness of the various reactions. The criticisms did not concern the patent system as such, or its applications to living organisms. They mostly concerned what could be claimed saved for the patentability exclusions of human beings, plant and animal varieties72. Despite ten years of discussions and apparent agreements, signs of oppositions and disagreements started to rise straight after the adoption of the directive. This paper can not stress all the differing opinions that may have existed after the adoption of the Directive. However, such differing opinions have been substantial, and prove the dissatisfaction members felt. This dissatisfaction was, indeed, so deep-seated that the intervention of various jurisdictions appeared necessary to give further authority to the directive.




  1. The validity of the directive, which can not be questioned any longer, despite the hostility of some Member States.

Various Member States tried to challenge the directive, first before the ECJ, and then before their national constitutional court. However, the legality of the directive was strengthened and its implementation became unavoidable.




    1. The ECJ decision (ECJ, October 9th, 2000, C-377/98) or the assertion of the validity of the directive.

We need to keep in mind that the directive applies patent law to living organisms. Moreover, article 5 makes genes the legal stand for patentability. This provision has been at the origin of many disputes73. In a sentence, the compromise found in the directive failed to satisfy all Member States. Thus, on October 19th, 1998, less than four months after the adoption of the Biotechnological Directive, the Netherlands brought an action for cancellation before the ECJ under article 173 of the European Convention (now article 230 of the European Convention)74. Some other countries, such as Italy, and Norway, intervened in support of the Netherlands75. The Netherlands brought six pleas76. First, they claimed that the directive was contrary to the principle of subsidiarity77. Then they argued that it infringed the principle of legal certainty that it was incompatible with obligations in International Law that it had not been adopted properly, and finally, they claimed that the directive amounted to the reification of the human material, and thus did not respect the fundamental right of human dignity. In its decision, rendered on October 9th, 2001, the ECJ held that the directive framed patent law in such a rigorous way that the human body remained inalienable, and thus, human dignity was preserved. Consequently, the ECJ dismissed the claim and declared the Directive valid. The ECJ also asked Member States to implement it within the time limit set up to do so. Indeed, on July 10th, 2003, the European Commission decided to take action against the 8 Member States which had not implemented the directive yet.


However, despite this assertion and this hardening behaviour of the ECJ, many doubts remained. For instance, in France, political authorities questioned the European Commission twice about the scope of article 578. The aim was to specify the scope and authority of claims on sequence or partial sequence of human genes. Indeed, while taking into account the decision of the ECJ, it appears that the Court analysed the directive first in relation with the state of biotechnological industry in Europe, instead of looking at its role in society79. When characterising the directive, the Court had considered biotechnology primarily as an industrial rather than an ethical or social issue80. Consequently, this approach raised more questions than answers about the content of the directive itself. However, this decision enabled the directive not to be challenged anymore, and to have a complete authority within European law. Nevertheless, some Member States tried to challenge the validity of the directive before their constitutional court, recourse which proved to be useless given the legal force of the directive.


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

We can take the example of France and its refractory reaction against the directive once it was adopted. This example can be interesting and relevant given that during the 10 years of discussions, France had always supported the European Community to draft the directive and had always voted in its favour at the European Council.



However, the implementation of the directive was carried out with fifty three months of delay, after a conviction for breach81, and the threat of financial penalties82 under article 228 of the European Convention. In 2002, fearing the European sanctions, a bill was introduced to the Parliament. Nonetheless, some members tried to challenge the said proposal, asking for a judicial review of the bill implementing the directive. In its decision rendered on July 29th, 2004, the French Constitutional Court asserted the compatibility and legality of the bill83.
Thus, despite an attempt to challenge the directive before the ECJ84, to challenge the implementing bill before the Constitutional Court85, to have another discussion before the European commission86, and even despite petitions87 and negative opinions of national groups of ethics towards some provisions of the directive88, its implementation as well as its legal effects appeared to be unavoidable.
The directive entered into force in July 30th, 1998, and despite its non implementation, started to create national and international effects. At a national level, the directive had some legal effects even if it had not been implemented within the time limit, which means within July 30th, 2000. Moreover, according to the Marleasing case89, national jurisdictions have to construe national legislation with regard to the European directive even if the latter has not been implemented yet. Finally, according to the Région Wallonne case90, Member States have to avoid drafting legislation which could endanger the implementation of the Directive.
Despite all the efforts made either to avoid the implementation of the directive, or to slow down the mechanism of implementation, the European legal text had to be implemented.
Through this paper, we have shown the clear reluctance of Member States to implement the directive. The reasons of such opposition are still obscure; however the approach of the European Commission and of the ECJ, which is to consider the protection of biotechnological inventions as more a technical issue than an ethical or social one, may represent the start of an answer. To know more about this essential point, it is however necessary to enter more deeply into the content of the directive. Two main issues have to be studied more carefully, the patentability of living organisms and the rights granted to the patentee.

CHAPTER II

THE PATENTABILITY OF LIVING ORGANISMS: A DIFFICULT DISTINCTION BETWEEN INVENTIONS AND DISCOVERIES
The directive 98/44/EC of July 6th, 1998, was greatly motivated by the political will of the European Union to encourage investments and research in biotechnologies. Public authorities, whether national or European, considered that patent law represented the best system to protect biotechnological inventions. To be competitive in this field, the directive was deemed to be similar to the legislation of the United States and Japan. Consequently, the European text was drafted to be first a commercial piece of legislation. However, on July 30th, 2000, time limit to implement the directive, only Denmark had respected its commitments. This reluctance was first due to the provisions on the patentability of living organisms. Two main legal issues appeared particularly sensitive. The distinction between discoveries and inventions was the first sign of a differing opinion and, thus, diverging implementation of the directive. Following this sign, the patentability of inventions including human biological material has been at the heart of the conflict.
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