UNIVERSITY OF KENT AT CANTERBURY

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Oct 23, 2013 (3 years and 9 months ago)

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1

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






Superviso
r:

Alan Story






Words:

20 000














Céline MARQUES



LLM in International Commercial Law

September 2006


2



Abstract






Biotechnology is defined as
t
he use of micro
-
organisms, such as bacteria or yeasts,
or biolog
ical substances
, to perf
orm specific industr
ial 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, b
ut 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 dire
ctive 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 o
f
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 interes
t
to this comparative study.









3



























DISSERTATION


OUTLINE

































4




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


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


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



-

The definition of biote
chnologies…………………………………................................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 an
d 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…………...
...............................2
2


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 (EC
J, October 9
th
, 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


5


1.1

The choice of the direc
tive: 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
bi
otechnology directive……………………………………..…………....50


2.2.1

The pa
tentability of some specific biological
eleme
nts: 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 arti
cle 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 interpretati
on…………57


3.1.2.

The criticisms

attached to the na
ture 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



6

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 impleme
ntation which restri
ct patentee’s rights………….71


2.3.

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


3.

The exemptions granted to farmers: difficulties of implementatio
n 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 wel
l
-
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 w
hich 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 con
cept of legal
mentality…………..
...................
....................................85

1.1.2. The reasons and interests of taking into

account
the le
gal 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



7

2.1. Ethical issues and commercial interests: two indivisibl
e elements of
biotechnological issues leading to differen
t national
politics…………………………………………………………………....89


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


3.

The unavoidable functio
n 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 simpl
e and perfect
answer………………………… …………………………………………95




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



ANNEX 1:

glossary……………………………………………………………
…………..………..103


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






































8



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


-

T
he UPOV convention ►

The International Convention for the Protection






of Varieties of Plants



-

WIPO ►



World Intellectual Property Organisation


-

WTO ►




World Trade Organisation







9



ACKNOWLEDGEMENTS














During the writing of this dissertation, it has been a real pl
ea
sure to benefit from

the
knowledge and advice of various p
ersons.

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 close
st 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, compas
sion 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.



10


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. I
ts extremely fa
st
-
evolving

innovations
,

which concern the
scientific
,

as well as the technological

and industrial
fi
elds,
has
raised

many
questions

as to the legal framing of biotechnologies
1
.
Biotechnology is defined as
“the use of living organisms, (eg bacteria), or th
e 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 broa
d field of processes

and
technique
s
3
. With the discovery of
the deoxyribo
nucleic 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

import
ant issue

than

what it used to be
, and opened the d
oor to

new kind
s

of innovations
,

as well as

new kind
s

of
concerns
.

By then, biotechnologies were not
only about traditional techniques
,

such as fermentation proces
ses for the production



1

Bauer M. W. and
Gaskell G.,
Biotechnology, the making of a Global Controversy
, (Cambridge
University Press; 2002)


2
Chambers 21st century
dictionary
, chambers reference
online available on
http://www.chambersharrap.co.uk/chambers/chref/chref.py/main?query=biotechnology&title=21st


3

Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques

: analyse de la
directive européenne et propositions, (
SOLAGRAL collection réseaux biotechnologiques, 1992)


4

University of Delaware, DNA History, november 2004, available on
http://www.ocean.udel.edu/extreme2004/genomics/dnahistor
y.html



11

of bread or bee
r
,

o
r other techniques
,

such as the selective breeding of plant
s

or
animals
5
; but it also turned out to be

a new era for biotechnologies.
Today
,
biotechnology concerns

especially

pharmaceuti
cals, 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
b
iotechnological research, reduces

possible rejections of the insulin

by the body
, and
increases its efficiency.

Thereby n
owadays
, more than half of the new medicines are
related to biotechnologies
7
.
It also concerns cloning, diagnostics and testing of some
genetic disease
s

such as breast cancer
, gene therapy
,

xenotransplantation,

genetically modified
seeds and foods

and some new en
vironmental techniques
, such
as the creation of micro
-
organisms which can degrade hydrocarbons
8
.

Modern
biotechnology

gather
s

many expectations

and hopes, mainly

in public health and in
the food industry. However,
it also raises questions and fear
s

as to t
he use of genetic
information,
biodiversity,

the limits and the merit of biotechnology itself
9
.
Furthermore, t
hey also have an important effect on economy. According to the
European Commission, biotechnologies

will

represent a market of 2 000

billions
euro
s in 20
10
10
.
Furthermore, the field

of

“human biotechnologies”
, which concern
s




5

Schley C., 2001, Biotechnology/
Gene Patenting, University of Kent at Canterbury, UL3 shelved in
Thesis Collection 4906


6

Ilbert H. & Tubiana L., Protection juridique des inventions biotechnologiques

: analyse de la
directive européenne et propo
sitions, (SOLAGRAL collection réseaux biotechnologiques, 1992)


7

Gaumont
-
Prat H., Brevetabilité du vivant

: animal et humain


Inventions biotechnologiques et
contexte socio
-
juridique, (2004), JurisClasseur Brevets, fasc. 4240


8

Bauer M. W. and Gas kell G
.,
Biotechnology, the making of a Global Controversy
, (Cambridge
University Press; 2002)

1


9

Bauer M. W. and Gaskell G.,
Biotechnology, the making of a Global Controversy
, (Cambridge
University Press; 2002)

1


10

Report of the European Commis s ion to the Co
uncil and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30
-
32 available on


12

mainly ge
netic therapies,

diagnostic and testing processes
,

and some pharmaceutical
products,
is especially active. I
ts worldwide market is considered to be of about $ 35
billion
s
,

and it has know
n 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 c
ompeting for the access
to primary materials, such as genes, as w
ell as for their protection,

and
for the
protection of the innovations

coming from the research
,

based on these materials.
On October 21
st
, 1988, the
Council

of the European Community (EC)

pr
oposed a
European directive on the protection of biot
echnological inventions

to assert a
payback in the investments carried ou
t 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
.

S
ince 1988, the European
directive
proposal
had

chose
n

to





http://europa.eu/eur
-
lex/en/com/rpt/2002/com2002_0545en01.pdf




11

Beverly
-
Itas s e E., la cons olidation du s ecteur mondial des biotechnologies humaines, report
publis hed in october 2004,
available

on

http://www.eurostaf.fr/fr/catalogue/etudes/sectorielles/pharmaciesante/conso_sect_mondial_biotech/r
esume.html


12

Ilbert H. & Tub
iana L.,
Protection juridique des inventions biotechnologiques

: analyse de la
directive européenne et propositions
, (SOLAGRAL collection réseaux biotechnologiques, 1992
)


13

Gaumont
-
Prat, les tribualtions en France de la directive n° 98
-
44 du 6 juillet 199
8 relative à la
protection juridique des inventions biotechnologiques, (2001),
Rec. Dalloz du 11 octobre 2001, 2993
-
2884



13

protect biotechnological inventions t
hrough 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 inventio
ns had

been reached
on
July 6
th
, 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 di
rective is defined
as a legal text drafted

by the European Community which
links the Member States as to the results to achieve
,

and let
s

them free to implemen
t
it in the way they chose

to.
The European directive, which was expected by the
scientific and l
egal communities, should have been implemented by all
Member

S
tates by
July

30
th
,
2000
18
.
However, in 2002, only six Member Stat
es had



14

Davis J.,
Intellectual property law,
(Butterworths, Core text Series, 2001)


15

European Directive 98/44/CE on the protection of biot
echnological inventions of July 6
th
, 1998,
[1998] OJEC L213/13


16

European Patent Convention

of 5 O
ctober 1973
, available on:


http://www.european
-
patent
-
office.org/legal/epc/e/ma1.
html


17

Gaumont
-
Prat H., Brevetabilité du vivant

: animal et humain


Inventions biotechnologiques et
contexte socio
-
juridique, (2004), JurisClasseur Brevets, fasc. 4240


18

European Directive 98/44/CE on the protection of biotechnological inventions of Ju
ly 6
th
, 1998,
[1998] OJEC L213/13


14

implemented it

and had integrated it into their national legal systems
19
. The United

Kingdom

(UK)

had

mainly implemented th
e 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,

complet
ed the implementation

with

the Patents Rules
2001 (SI 2001/1412)
,

and the Patents and Plant Variety Rights
(Compulsory
Licensing) Regulations 2002 (SI 2002/247).
C
ontrary to the quick implementation

of the UK, France
implemented the Biotechnology

Directive

with 53 months delay
.
The transposit
ion 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 6
th

2004 (statute n° 2004
-
800). A second,
implementing the other se
ctions of the directive, had

been drafted on December 8
th,
2004 (statu
te 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 implementat
ions, 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 D
irective
,

or
to explain in every detail its content. The purpose of this paper is not to
describe the

implementing
statutes

from th
e 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 particular
ly
complex issue
20
.

Indeed,
Biotechnology does no
t only involve patent law,

but also



19

Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brusse
ls 7.10.2002, COM (2002) 545 final, 6
-
7 available on

http://europa.eu/eur
-
lex/en/com/rpt/2002/com2002_0545en01.pdf



20

Bauer M. W. and Gaskell G.,
Biotechnology, the making of

a Global Controversy
, (Cambridge
University Press; 2002)



15

political and ethical issues.

Furthermore, Fr
ench 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.

It
s 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 th
e 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 e
xtent

a
harmonisation
,

on such a complex issue
,

is possible, and
how it
can actually be
handle
d

between two legal systems
,

which are apparentl
y 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 o
f
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 bio
technol
ogical inventions?


Indeed, the Biotechnology D
irective, which was long awaited by all

professionals
concerned, has shown lots of difficulties to be drafted.
Actually, despite the



21

Slapper G. and Kelly D.,
The English legal system, (
London, Cavendish, 6
th

ed., 2003) 3
-
4



22

Slapper G. and Kelly D.,
The English legal system, (
London, Cavendish, 6
th

ed., 2003) 3
-
4


16

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 question
ed at various levels
, and it even appeared necessary to
assert its authority

(
chapter I
). However,
this tumultuous

genesis of the
Biotechnology D
irective 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,
rais
ed some ambiguities
. It even reached

a real opposition when implementing the
distinction between invention
s 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 emerge
d

facing the
French limitation
to the UK

protection of such rights
(Chapter III)
.

However, these disparities can be
explained through a number of factors.
I
n a
n atmosphere

of conflicting legal
cultures
23
,
the Biotechn
ology D
irective was
,

both
,

needed to get a reconci
liation
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

prevent
ed

a uniform implementation of the

D
irective
. Furthermore, we will have to
examine, with such factors, if a complet
e harmonisation was possible and which
alternatives existed, at that time, to avoid such difficulties

(Chapter 4).






23

Beyleveld

D., Brownsword R. and Llewelyn M. “The morality clauses of the Directive on the
Legal Protection of Biotechnological Inventions: conflict, compromise and the patent community” in
Goldberg R. & Lonbay J.
Pharmaceutical Medicine, Biotechnology and European
Law,
(Cambridge
University Press, 2000)


17

CHAPTER I

THE DIRECTIVE ON THE LEGAL PROTECTION OF
BIOTECHNOLOGIC
AL INVENTIONS: A LONG AWAITED

LEGISLATION


Through the course of

nearly ha
lf a century
, biotechnology

has

gradually
become
a
key

field of the economy
24
.
Consequently
,

and
because of
the lack of legal
harmonisation within the European Community,
a piece of
leg
islation 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 companies
25
. However,
the

directive has caused

var
ious conflicts. Consequently, ten

years have been
necessary to

reach a consensus among Member

States. This tumu
ltuous

genesis of
the Directive shows how sensitive the issue i
s
, 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 au
thority 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.




24

Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and genetic engineering”, commission of the
European Communities,
Brussels 7.10.2002, COM (2002) 545 final, 30
-
32 available on

http://europa.eu/eur
-
lex/en/com/rpt/2002/com2002_0545en01.pdf


Life science and biotechnology are widely recognised

as one of the most promising frontier
technologies in the new knowledge
-
based economy” 31



25

Gaumont
-
Prat H., Brevetabilité du vivant

: animal et humain


Inventions biotechnologiques et
contexte socio
-
juridique, (2004), JurisClasseur Brevets, fasc. 424
0


18


To understand

the necess
ity of drafting a European text

able to protect
biotechnologic
al inventions

within the EC
, it is necessary to consider three
i
mportant factors. I
t appears that
t
he International context played an impor
tant role
in the draft of the said

directive.
Indeed, it

has

already

led

the EPO
, through its case
law,

to protect som
e biotechnological inventions. This firs
t step of the EC

towards
the protection of biotechnologica
l inventions

has been seen as one of the most
important sign
s

in Europe
,

of the necessity to have a harmo
nised 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 B
iotechnology
Directive did not become only necess
ary but also
imperative
.



1.1.

The international context of the protection of biotechnological
inventions.


The Biotechno
logy Directive is not

the first

piece of

legislation dealing with the
protection of biotechnological inventions
26
. At an

international

level, several
agreements could

be
mentioned
27
.
Moreover, the international context is not only
about international legislation but also about foreign case law
28
.




26

Bellmann C., Dutfield G., Meléndez
-
Ortiz R.,
Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability,
(Earthscan Publication ltd, London, Sterling VA, 2003) 4
“The
architecture of the global intellectual property regulatory sy
stem includes an increasing and, to
some, bewildering diversity of multilateral agreements, regional conventions and instruments, and
bilateral arrangements.”


27

s uch as the TRIPs agreement, the Convention on Biological Divers ity, the Convention on the Gra
nt
of European Patents (the European Patent Convention), the UPOV Convention and the Budapes t
Treaty on the International Recognition of the Depos it of Micro
-
organis ms for the Purpos es of Patent
Procedure, and many others


28

Dutfield G.,
Intellectual Prope
rty Rights and the Life Science Industries

: a twentieth century
history,
(Ashgate, 2002) 1
-
13. This paper does not allow us to talk about all the international or
regional agreements which have been drafted concerning the protection of biotechnological

19




1.1.1

The I
nternational
Regulation

on the protection of
Biotechnological Inventi
ons the incentive

for
harmonisation.



S
ince the 1970s,

Intellectual Property Right
s

(IPRs)

have become increasingly
important
29
.
Maybe

the most important and well
-
known international agreement

dealing wi
th the
protection of inventions

is the TRIPs agreement
, drafted in 1994
,

and adminis
tered by the World Trade Organis
ation (WTO)
30
.
It

sets down mi
nimum
standards of protection

Members

need to follow, concerning all the mai
n
IPRs
31
.
T
his international agreement was
particularly

expected by industrialists

and
,
nowadays,

it
has a substant
ial authority in International I
ntellectual Property L
aw
32
.





in
ventions. However, others, such as the Bangui Agreement Establishing an African Intellectual
Property Organisation, or the Andean Community Common Regime on Industrial Property are
important as well.


29

Dutfield G.,
Intellectual Property Rights and the L
ife Science Industries

: a twentieth century
history,
(Ashgate, 2002) 1
-
13 As previously stated, it was mainly due to the recent and significant
progress in life industries, including biotechnologies


30

THE WTO IN BRIEF: PART 1 The multilateral trading sys
tem

past, present and future
,

available on


http://www.wto.org/english/thewto_e/whatis_e/inbrief_e/inbr01_e.htm

"
The World Trade Organization came into being in 1995. One
of the youngest of the international
organizations, the WTO is the successor to the General Agreement on Tariffs and Trade (GATT)
established in the wake of the Second World War".


31

Bellmann C., Dutfield G., Meléndez
-
Ortiz R.,
Trading in knowledge: develo
pment perspectives on
TRIPS, Trade and sustainability,
(Earthscan Publication ltd, London, Sterling VA, 2003) 4


32

Martin Khor,
Intellectual Property, Biodiversity and Sustainable Development: resolving the
difficult issues,

Zed Books, Third World Network,

2002
.

It is important to state that from 1986, which means from the start of the Uruguay Round, the issue of
the protection of intellectual property rights was a

concern for a majority of industrials and
members, even if, this issue had been integrated in

the agenda of the Uruguay Round at the last
minute. Moreover, according to Martin Khor, the agreement has been greatly influenced by
developed countries, to protect their financial investments on biotechnologies and to promote private
monopoly rights


20

Section

27
.3
33

is particularly inte
resting as it has been not only

the most
controversial

section
,

b
ut also

the section which
dealt

with the patentability of

living
organisms
,

and the exceptions to such patentability
34
.

This section is often called the
“biotechnological clause”
35
.
It

shows
,

first of all
,

the concern

S
tates

had and still
have

in

set
ting

down

a protection for biotech
nological inventions. Furthe
rmore, 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

s
igned by 150
government leaders at t
he
1992 Rio Earth Summit
36

and

is dedicated to promoting sustainable development
.

Indeed, its objectives are to promote conse
rvation of biodiversity and

equitable
benefit sharing
37
.
The convention

set
s

down

mechanism
s

to encourage tran
sfer of
techn
ologies between contracting par
t
i
es
38
.
While the CBD uses intellectual
property rights

(IPRs)

to protect biodiversity
,

and allow developing countries to
access technologies, the TRIPS agreement strength
ens IPRs

to protect private



33

TR
IPs agreement, section 27.3
,

“Members may also exclude from patentability: plants and
animals other than micro
-
organisms, and essentially biological processes for the production of
plants or animals other than non
-
biological and microbiological processes.
However, Members shall
provide for the protection of plant varieties either by patents or by an effective sui generis system or
by any combination thereof.(…) “


34

Bellmann C., Dutfield G., Meléndez
-
Ortiz R.,
Trading in knowledge: development perspectives
on
TRIPS, Trade and sustainability,
(Earthscan Publication ltd, London, Sterling VA, 2003) 33


35

UNCTAD
-
ICTSD Project on IPRs and Sus tainable Development,
Resource Book on TRIPS and
Development
, (Cambridge University Press, 2005) 388

This section describe
s the inventions
Member States
may

exclude from patentability but, at the same time, obliges them to protect
microorganisms and some biological processes.


36

United Nations Environment program,
How the con
vention on biological diversity promotes nature
and

human well
-
being
available on
http://www.biodiv.org/doc/publications/guide.asp


37

CBD, s ection 1 The objectives of the CBD
“are the conservation of biological diversity, the
sustainable use

of its components and the fair and equitable sharing of the benefits arising out of the
utilization of genetic resources, including by appropriate access to genetic resources and by
appropriate transfer of relevant technologies, taking into account all ri
ghts over those resources and
to technologies…”


38

The convention on biological divers ity, s ection 16
“Each Contracting Party, recognizing that
technology includes biotechnology, and that both access to and transfer of technology among
Contracting Parties
are essential elements for the attainment of the objectives of this Convention




21

investors
39
.
Th
is 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 ge
netic material
,

or knowledge
,

incorporate
d into these
inventions
, and which come
, mos
t of the time, from developing countries
40
.


Anoth
er essential

agreement is
the UPOV Convention
41
. Adopted in 1961, it entered
into force in 1968 and has been regularly
revised since

then
. The UPOV Convention
set
s

up the International Union for the Protectio
n of New Varieties of Plants
,

as well
as a
sui generis
system to protect plant varieties
42
.
One of the main provisions,
especially

important,

is the

one dealing with

farmers’ privilege
43
.

This section is
particularly close to section 11 of the European Direc
tive on the protection of
biotechnological

inventions where similar rights

are granted
44
.




39

Bellmann C., Dutfield G., Meléndez
-
Ortiz R.,
Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability,
(Earthscan Publication ltd, London, Sterling
VA, 2003) 85


40

Bellmann C., Dutfield G., Meléndez
-
Ortiz R.,
Trading in knowledge: development perspectives on
TRIPS, Trade and sustainability,
(Earthscan Publication ltd, London, Sterling VA, 2003) 85

The TRIPS agreement and the Convention on Biological D
iversity are often said to be conflicting.
This conflict is essentially due to the different interests at stake. While the former tries to secure the
protection of most of the inventions, including biotechnological inventions, to assure benefits to
compa
nies, most of the time located in developed countries, which made large investments; the latter
tries to balance IPRs to encourage the development of countries, where biological elements are
located.


41

The International Convention for the Protec
tion of N
ew Varieties of Plants,

adopted on December
2, 1961, by a Diplomatic Conference held in Paris, available on
http://www.upov.int/en/about/upov_convention.htm


42

UNCTAD
-
ICTSD Project on IPRs a
nd Sus tainable Development,
Resource Book on TRIPS and
Development
, (Cambridge University Press, 2005) 400

«

in order to be eligible for protection, a
plant variety must meet the following requirements

: novelty (…) dinstinctness (…) uniformity (…)
stabili
ty (…) Denomination (…)”


43

Under this section, farmers, even if they’re not allowed to sell protected seeds, can re
-
use them for
propagating purposes on their own land

44

A similar exemption can be found in the European directive on the protection of biote
chnological
inventions in its section 11. The European Directive on the Protection of biotechnological inventions,
section 11

By way of derogation from Articles 8 and 9, the sale or other form of commercialisation
of plant propagating material to a farmer

by the holder of the patent or with his consent for
agricultural use implies authorisation for the farmer to use the product of his harvest for
propagation or multiplication by him on his own farm, the extent and conditions of this derogation
correspondin
g to those under Article 14 of Regulation (EC) No 2100/94.
2.
By way of derogation
from Articles 8 and 9, the sale or any other form of commercialisation of breeding stock or other

22

None of these conventions can be considered separately. They

are all dependent on
each other
.

F
or instance, the UPOV C
onvention
sets down the
sui generis
system
state
d in section 27.3 of the TRIPS Convention. Such Conventions d
o

not only have
effects at an

international level, but also

at the national level. Doing so
, t
hese
conventions tried

to weaken all the differences existing
betwee
n national laws
45
.

However,

despit
e

this minimum standard of protection, man
y disparities sill existed
between

countries

before 1998. They

were par
ticularly significant within the
European Union despite the creation of the European Patent Office.


Faced with the growing importance of biot
echnologies, and the multiplication of
international ag
reements, members of

the EU

had, not

only, to implement the latter
,
but also
to harmonise their legislation
46
. This need became particularly obvious
when facing case law.


1.1.2

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


Many case law in the 1980s and 1990s allowed a p
rotection f
o
r

inventions
concerning

living organisms. It is this case law and the proliferation of in
ternational





animal reproductive material to a farmer by the holder of the patent or with

his consent implies
authorisation for the farmer to use the protected livestock for an agricultural purpose.
This includes
making the animal or other animal reproductive material available for the purposes of pursuing his
agricultural activity but not sal
e within the framework or for the purpose of a commercial
reproduction activity.”

45

UNCTAD
-
ICTSD Project on IPRs and Sustainable Development,
Resource Book on TRIPS and
Development
, (Cambridge University Press, 2005) 400 For instance, many countries create
d in their
national laws a sui generis system such as the one states in the UPOV convention to implement
article 27.3 of the TRIPS agreement.


46
Report of the European Commission to the Council and European Parliament, “development and
implications of pat
ent law in the field of biotechnology and genetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30
-
32 available on

http://europa
.eu/eur
-
lex/en/com/rpt/2002/com2002_0545en01.pdf


23

agreements
,

wh
ich le
d to the necessity of drafting a harmonised regulation within
the European Union
,

to face

both

competition and attract inves
tments
.

For instance, from the end of the 19
th

century till the mid 1930s, the patentability on
some biological materials, suc
h as
some yeast, has been seen as a normal extension
of patent law
47
. Furthermore
, in the
Diamond v. Chakrabarty
48

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 limit
ed to micro organisms. It is on
ly at the end of
the 1980s that

patents on biologic
ally modified animals appeared. T
he patent
granted to

Harvard University
in 1988
for their oncomouse

is an example

of this
evolution
49
.

Finally, patents have been granted on h
uman materials
50
.

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 uni
form legislation in the EU
,
which weakened its position as one of the technological l
eaders.

The reaction of the
EPO

compared to national laws show
even better the necessity of

a

harmonisation.





47

Gaumont
-
Prat H., Loi de bioéthique et droit des brevets: alliance
féconde ou liaison difficile? L
a
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005),
Les Petites Affiches, 18
fév
rier 2005, n°

35, p. 51.
A patent has been granted to Louis Pasteur in 1873 by the U.
S

Patent
Office

for yeast which proves

to be exempted of any disease.


48

U.S Supreme Court,
Diamond v. Chakrabarty
, 447 U.S 303 (1980)

It recognised the patentability
of a

genetically modified oyster. The court held that a patent could be granted for any non
-
human
multicellular organisms non pre existing in the environment, including animals which are due to
men’s interventions.

In this case, the defendant required a patent

for the development of genetically engineered bacteria
with a unique trait.
These living organisms could not be found in nature and was clearly due to
human scientific research and interventions.


49

U.S Patent n° 4 736 866
. In this cas e, a cancer
-
caus ing
genes was ins erted into a mous e


50

Patent EP n° 041
-
313 (1990)


24

1.2

The

European Patent Office decisions

as the first sign of the necessity of
the protecti
on of biote
chnological inventions in the European Community
.


In Europe, the patentability of micro or
ganisms has not been a real issue. Section
53b of the European Patent Convention has recognised the patentability of
biotechnological processes and of the
ir products
51
. Patentability

has

also

been

recognised for

micro
-
organisms isolated from their natural environment.
Another
issue is the patentability of animals. I
n Europe, the patent for the oncomouse of
Harvard University

was

first refu
sed. However, a sec
ond decision hel
d in 1990
stated that the non
-
patentability

of animal
s as a specie

did not apply to the
oncomouse
52
. 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 haemophilia
53
. Finally, some questions arose as to the patentability
of genes in the 1990s. The issue became even more important with the cre
ati
on of
the

Human Genome

Organisation

which aimed at sequencing the DNA
54
. It thus
appears that the patentability of human genes
and the one of human cells are
considered in the same way
55
.





51

European Patent Convention, article 53b
«

plant or animal varieties or essentially biological
processes for the production of plants or animals; this provision does not apply to microbiologic
al
processes or the products thereof.”

52

Déc. T. 19/90, Regents de l’Université de Harvard

: JOOEB déc 1990, p. 476


53

Patent SCRIPPS EP 83 483



54

The Human Genome Organis ation

(HUGO)

is the international organis ation of s cientis
ts involved
in human genet
ics, e
s tablis hed in 1989
. Further information is available on
http://www.hugo
-
international.org/


55

Gaumont
-
Prat H., Loi de bioéthique et droit des brevets: alliance
féconde ou liais on difficile? L
a
pénul
tième péripétie de la transposition de la directive (CE) 98/44, (2005),
Les Petites Affiches, 18
février 2005, n°

35, p. 51.


25

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
cre
ation of
the Biological Resources Centre
56
. Despite this political will in favour of
biotechnologies,

investors and companies
used to consider any investment

in Europe
as a financial risk. This reluc
tance to invest had

negative consequences on the
European
economy and was a decisive reason to draft a piece of legislation on the
issue.


1.3

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


The market of the biotechnological inven
tions is particularly important

fo
r
several

reasons. First, it gathers significant investments and second
,

the innovations at stake
are particularly val
uable. Health represents the main application of biotechnologies.
In its report, the European Commission evaluates the
total world market po
tential of
biotechnological applications

to more than 2000 billion euros in 2010
57
.
Furt
hermore, the same report

states that
,

even if investments in biotech
nology
within the EU

increase gradually during the last decades, it remain
s

remarkably low
compared t
o investments
in the U.S.





56

Gaumont
-
Prat H., Loi de bioéthique et droit des brevets: alliance
féconde ou liaison difficile? L
a
pénultième péripétie de la tra
nsposition de la directive (CE) 98/44, (2005),
Les Petites Affiches, 18
février 2005, n°

35, p. 51

.

57

Report of the European Commission to the Council and European Parliament, “development and
implications of patent law in the field of biotechnology and g
enetic engineering”, commission of the
European Communities, Brussels 7.10.2002, COM (2002) 545 final, 30
-
32 available on

http://europa.eu/eur
-
lex/en/com/rpt/2002/com2002_0545en0
1.pdf


26

For instance

in France
, it appears
that the number of applications for patents of
French origin hardly increas
ed compared to the total number

of
applicati
ons. Indeed,
it comes into view

that the main increase of applications is d
ue to

foreign

applications
58
. Furthermore, if we consider only applications for patents on
biotech
nologies 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
Commission
60
,
clearly identifies

the lack of an efficient protection of
biotechnological inve
nt
ions as one of the reasons
,

which explain
s

the difference of
investments between the U.S and the European Union
. It

also
represents
one of the

reason
s why

l
ess

patent applications

are registered

in the European Union rather
than in the U.S
61
.
The interest o
f 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 le
gal interest not to let Me
mber

states set

up their own regulation which
would

most probably

increase
legal
disparities among them.





58

Gaumont
-
Prat H., Loi de bioéthique et droit des brevets: alliance
féconde ou liaison difficile? L
a
pénultième péripétie de la transposition de la directive (CE) 98/44, (2005),
Les Petites Affiches, 18
février 2005, n°

35, p. 51.

Between 1995 and 2
002, the number of applications to be granted a patent increased of 5,3% but only
1,4% are due to “French” applications.


59

Noëlle Lenoir, relever le défi des biotechnologies, March 11
th

2002 available on

http://www.genopole.org/media/pdf/fr/communication/defi
-
biotechs
-
noelle
-
lenoir.pdf#search=%22le%20rapport%20lenoir%22


60

Report of the European Commis s ion, (COM (2002), 2
final,
January 14
th
,

2002)


61

Report of the European Commis s ion, (COM (2002), 2 final,
January 14
th
,

2002)


27

Given all these

elements,

a regulation seemed to be necessary to protect
biotechnological
inventions. Biotechnologies represent

an essential

field of
the
economy and the pr
essures created by investors mad
e the draft of a common
regulation even more important. Thus,
the EC

decided to draft the European
directive on the protection of biotechnological in
ventions. The Directive was

adopted
on
July 6
th
, 1998
. However, ten years have been necessary to reach its final
draft.
Indeed, despite its necessity, the Europ
ean Directive has been the course

of
large conflicts.


2.

An awaited

directive which

has been the course

of conflicts during its
creation



Consequentl
y, 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.


2.1

The tumultuous genesis of the directi
ve.


The Directive on the protection of biotechnological inventions entered into force in
July 30
th
, 1998. Its genesis has been particularly tumultuous
,

and its draft

difficult.
The first prop
osal for this directive was

drafted in October 21
st
, 1988.
Ten y
ears of

legal arguments have been necessary to find
a compromise
62
.
The purpose of this
proposal was to clarify the implementation of patent law on biotechnological



62

Gaumont
-
Prat H., La laborieuse transposition de la directive n°98/44/CE du 6 juillet 1998 relative
à la protection des inventions bi
otechnologiques
, suite et fin

?
, (2005),
Propriété Industrielle n° 3,
mars 2005, Etude 5


28

inventions

in order to encourage the free movement of new biotechnological
products
,

and pro
cesses
,

and

investments. Many amendments to the proposal have
been recommended
,

after the first reading by the European Parliament in 1992
63
.
The discussions between the Council and the Commission on the amendments
submitted by the Parliament led to the pro
cedure of conciliation to find a
compromise in September 1994
64
.
Divergences of opinions
, mainly on three points,

remained despite the numerous discussions and
readings
65
. First, the issue of the
patentability of animals, and more specifically, the
distinct
ion between discoveries

and inventions in
volvi
ng living

or
ganisms

raised many problems.
The exclusion of
patentability
for
“processes of modifying the germ line genetic identity of human
beings

66
,

and t
he intro
duction of the derogation of

farmer
s
,

have bee
n 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
mi
sunderstandings and discussions. However, the interest of such debate is that it

underlined

the necessity to integrate

a distinction concerning human biological
elements able t
o be patented. The second issue

concerned first the
germinal gen
et
ic
therapy

and

its non
-
patentability. These issues, which involve

main
ly economy and
ethics, were

solv
ed on A
ugust 29
th
,

1997, when the European Commission adopted
the modified directive proposal, rejecting however its amendment 76. The latter

implemented

and

even widen
ed the requirements of the CBD
,

as to the access of



63

JOCE n° C 305, November 23rd, 1992


64

Common
propos al adopted by the Committee of conciliation on January 23
rd
, 1995 (Doc.
-
PE


COMS 3606/1/95, February 21
st
, 1995


65

Chemtob
-
Con
cé M. C. et Gallochat A.,
Le Brevetabilité des inventions technologiques appliquées
à l’homme.

(Ed. Lavoisier, Tech & Doc, Paris 2
ème

ed., 2004)

48



66

Directive 98/44/EC on the legal protection of biotechnological inventions, s ection 6 (2) b)


29

biological resources. Doing so, the Parliament was adding conditions of
patentability which were not considered
either with
in the TRIPS agreement
,

or
with
in patent law. Consequently,

t
he final draft made
by the European Council, has
been adopted by the European Parliament on May 12
th
, 1998,
with 338 votes in

favour of the directive and

110

against
67
.


However
, g
iven these conflicts and hesitations, we could wonder if this consensus
satisfied all parties an
d all opinions.


2.2

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


The first proposal in 1988 was essenti
ally settling technical principles on

biotechnological inventions, setting down their protection and stati
ng the exclusions
to patentability. It just clarified the application of patent law to biote
chnological
inventions. Faced with

criticisms and pressures of lobbies, amendments were
proposed in order to introduce e
thical 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 element
s

required
,

as well
as
,

technical provisions. The C
ommission h
ad queried the European Group on
Ethics in S
cien
ce and

New T
echnologies about the compatibility of the directive
with the main ethical principles. Twice, the European Group asserted the

said




67

Chemtob
-
Co
ncé M. C. et Gallochat A.,
Le Brevetabilité des inventions technologiques appliquées
à l’homme.

(Ed. Lavoisier, Tech & Doc, Paris 2
ème

ed., 2004)

54



30

compatibility
68
.

However, even if
,

at th
e European level,

the final draft of the
directive

seemed to represent a u
niform

opinion, it appears
,

when looking at national

and ethical committee reports
,

that the situation is more complex.
On June 8
th
, 2000,
the French national advisory committee of ethics
69

advised the French government

to
“start a new discussion about the
terms of the directive
”. D
espite the adoption of
the directive, c
onflicts 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 stre
ngthened by
the opinion of the Parliamentary Agency on the Evaluation of Scientific and
Technological C
hoices
70
. At the judicial level, these diverging opi
nion
s 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 19
th
, 1998
71
.

The most important
point
is maybe the quickness of the
vari
ous reactions.

The criticisms
did

not concern the patent system as such, o
r its
applications to living organisms
. They mostly concern
ed

what could be claimed

saved for the patentability exclusions

of human beings,

plant and animal varieties
72
.

Despite ten y
ears of discussion
s and

apparent agreement
s
, signs of oppositions and
disagreements started to
rise straight afte
r the adoption of the directive.
This paper



68

Opinion n°3 of September 30
th

1993 on the ethical questions raised by the commission proposal of
a direc
tive on the legal protection of biotechnological inventions, and the opinion n° 8 of September
25
th

1996 as to the ethical aspects of the patentability of inventions based on human elements.


69

Opinion n°64 on the

law propos al to implement the E
uropean dir
ective on the legal protection

of
biotechnological inventions


70

Opinion given on december 20th, 2001


71

ECJ, October 9th, 2001, aff.
C
-
377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd.
E., n°42


72

Il
bert H. & Tubiana L.,
Protection juridique des inventions biotechnologiques

: analyse de la
directive européenne et propositions
, (SOLAGRAL collection réseaux biotechnologiques, 1992)

6


31

can not s
tress all the differing opinions

that may have exi
sted after the adoption of
the D
irective
. 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 direct
ive.


3.

The validity of the directive, which can not be questioned any longer,
despite the hostility of some
M
ember

States.


Various Member

States
tried to challenge the d
irective, first before the ECJ
, and
th
en before their national constitutional

court.
Ho
wever, the legality

o
f the directive
was

strengthened and its implementation
became
unavoidable.


3.1

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



We need to keep
in mind that the directive applies

pa
tent law to living organisms
.

M
oreover
,

article 5 make
s

genes the legal stand for patentability.
This provision has
been at the origin of many disputes
73
.
In a sentence
, the compromise found in the
d
irective failed to satisfy all Member S
tates. Thus, o
n Oct
ober 19
th
, 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



73

Le Gal C., La contestation de la directive relative à la protection

des inventions biotechnologiques,
la fin des espérances françaises? , (2005),
La Semaine Juridique Edition Générale

n°11, 16 mars
2005, I 120



32

Convention (now article 230 of the European Convention)
74
. Some
other countries,
such as Italy
,

and Norway
,

intervened in support of the Netherlands
75
.
The
Netherlands brought six pleas
76
. First, they claimed that the directive was contrary to
the principle of subsidiarity
77
. Then they

argued that it infringed the princip
le of
legal
certainty that

it was incompatible with obligations in International
Law that

it
had not been adopted properly
,

and finally, t
hey claimed t
hat the directive amounted
to the reification of the human material
,

and thus did not respect the fundame
ntal
right of human dignity
.

In its decision
, rendered

on October 9
th
, 200
1, 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
dis
missed the claim and
declared the Di
rective valid. The ECJ also asked
Member S
tates to impleme
nt it within the time limit

set up to do so.

Indeed, on July
10
th
, 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
doubt
s remained. For instance,
in France, political authorities questioned the



74

The Treaty establishing the European Community, article 230.

The Court of Justice shall review
the legality o
f acts adopted jointly by the European Parliament and the Council, of acts of the
Council, of the Commission and of the ECB, other than recommendations and opinions, and of acts
of the European Parliament intended to produce legal effects vis
-
à
-
vis third p
arties.”

Official Journal
C
-
325of 24 December 2002

75

ECJ,October 9th, 2001, aff.
C
-
377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd.
E., n°42



76

ECJ,October 9th, 2001, aff.
C
-
377/98, Kingdom of the N
etherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd.
E., n°42


77

According to this principle, the EU may only act (i.e. make laws ) where member s tates agree that
action of individual countries is ins ufficient. The principle was

es tablis hed in the
1992

Treaty of
Maastricht
.


33

European Commission twice about the scope of article 5
78
. The aim w
as

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 appea
rs that the Court
analysed

the directive first in relation with the state of biotechnological

industry in
Europe
,

instead of looking at its role in society
79
.
When cha
racterising the directive,
the C
ourt h
ad considered biotechnology

primar
il
y

as

an industrial rather than an
ethical or social issue
80
. Consequently, this approach
raised more questions

than
answers

about the content of t
he directive itself
. However, this decision enabled the
directive not to be challenged anymore
,

and
to
have a c
omplete authority within

European law. Nevertheless,
some
Member States
tried to challenge the validity of
th
e directive before the
ir

constitutional court, recourse which proved to be useless
given the legal force of the directive.


3.2


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


We can take the example of Fr
ance and its refractory reaction agains
t 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
.




78

Letters from the French President to the President of the European Commission in June 2000 and
february 2001.


79

MacLaren M., Patently U
ns atis factory

?: community Legis lative competence and the ECJ Biotech
D
ecis ion,
German Law Journal No 18 (01 December 2001) European and international law.


80

MacLaren M., Patently U
nsatisfactory

?: community Legislative competence and the ECJ Biotech
Decision,
German Law Journal No 18 (01 December 2001) European and internat
ional law.

“The
Court held that biotechnological innovations was fit for regulation under a conventional intellectual
property regime, that the Directive’s primary intent was harmonisation for the well
-
functioning of
the internal market and that harmonisat
ion was effected only by clarifying existing national
legislation.”


34

However, the implemen
tation of the directive was

carried out with fifty three
months of delay, after
a conviction for breach
81
,

and the threat of
financial
penalties
82

under article 228 of the European Conventio
n. In 2002, fearing the
European

sanctions, a bill

was

introduced to the Parliament. Nonetheless, some
members tried to chall
enge the said proposal, asking for a judicial review of the bill
implementing the directive
. In its decision rendered on July 29
th
,

2004,
the French
Constitutional Court asserted the compatibility and legality of the bill
83
.


Thus
, despite an attempt to challenge the directive before the ECJ
84
,

to challenge the
implementing bill before the Constitutional Court
85
,

to have another discuss
ion
before the European commission
86
,
and even despite

petitions
87

and negative
opinions of national groups of ethics towards some provisions of the directive
88
,
its
implementation

as well as its legal effects appeared to be

unavoidable
.


Th
e directive enter
ed into force i
n July 30
th
, 1998, and des
pite its non
implementation,

started to create national and
international effects
.
A
t a

national
leve
l, the directive had

s
ome legal effects even if it had

not been implemented



81

ECJ, July 1st, 2004, case C
-
448/03


82

Letter from the European Commis s ion to the French
government on October 5th, 2004


83

Cons. Cons t., July 29th, 2004, dec. N° 2004
-
498 DC, JO

n° 182 o
f augus t 7th, 2004, p.14077


84

ECJ,October 9th, 2001, aff.
C
-
377/98, Kingdom of the Netherlands c/ European Parliament and
Council of the European Union, JCP 2001 éd.
E., n°42


85

Cons. Cons t., July 29th, 2004, dec. N° 2004
-
498 DC, JO

n° 182 of augus t 7th,