Source: EURLEX
Language: en
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**COMMISSION OF THE EUROPEAN COMMUNITIES**

**Brussels, 29.08.1997**
**COM(97)** **446 final**

95/ 0350 (COD)

**Amended proposal for a**

**EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE**

**on the legal protection of biotechnological inventions**

**(presented by the Commission pursuant to Article 189 a (2)**
**of** **the EC-Treaty)**

#### **EXPLANATORY MEMORANDUM**

##### **GENERAL COMMENTS**

In February 1996, the Commission presented to European Parliament and the Council a
new proposal for a Directive on the legal protection of biotechnological inventions. [1 ]

The Economic and Social Committee adopted its opinion regarding this proposal on
11 July 1996. [2 ]

European Parliament adopted 66 amendments at its first reading of the proposal during
its plenary part-session of 14-18 July 1997. [3 ]

These amendments reflect European Parliament's concerns regarding the need (a) to
clarify the difference between discoveries and inventions where the patentability of
elements of human origin is concerned and (b) to introduce an ethical dimension into the
proposal for a Directive.

In this respect, this amended proposal takes account of all of European Parliament's
amendments.

There is only one amendment, amendment 76, which the Commission is unable to accept.
This proposed the introduction of an Article 8a. The first paragraph of this amendment
required a patent application for an invention consisting of biological material of animal
or plant origin to indicate the geographical place of origin of the material in question and
to provide evidence that the material had been used in accordance with the legal access
and export provisions in force in the place of origin. The second paragraph required that,
if the biological material was of human origin, the patent application should publish the
name and address of the person of origin or his or her legal representative and also
provide evidence that the material had been used and the patent applied for with the
agreement of the person of origin or of his or her legal representative.

The first paragraph of this amendment goes beyond the international commitments which
the Community and its Member States have entered into in approving and ratifying the
Convention on Biological Diversity of 5 June 1992. [4] Moreover, the second paragraph
does not meet the requirements governing the protection of personal data. [5 ]

1 OJ No C 296, 8.10.1996, p. 4.

2 OJ NO C 295, 7.10.1996, p. 11.

3 Not yet published.

4 Council Decision of 25 October 1993 concerning the conclusion of the Convention on Biological
Diversity, OJNo L 309, 13.12.1993, p. 1.

5 Directive 95/46/EC of the European Parliament and of the Council of 24 October 1995 on the
protection of individuals with regard to the processing of personal data and on the free movement of
such data, OJ No L 281, 23.11.1995.

###### **COMMENTS ON THE RECITALS**

From **a general** point **of view**

The table below indicates the numbers of the recitals into which the amendments adopted
by Parliament have been incorporated.

```
Recitals Amendments

  3 2

  4 3

 8a 5

 9a 6

 9b 7

```

```
 9c

 11

 13

 14

14a

14b

 15

 16

16a-e

 16f

16g

 17

17a

17b

 17c

 18

 19

19a

19b-c

 20

 22

 23

 24

24a

24b

 25

 30

 32

 33

 34

 35

 36

 37

 38

```

```
   2

   3

   5

   6

   7

   8

   9

   11

   12

   13

    1

   14

   15

   16

   17

  99 and 79

   18

   19

   20

   21

   22

   23

   24

   26

   27

   80

   30

   31

   new

  10 and 33

   34

   35

   new

   36

   37

   38

   39

40,41,42,43,68,77

   44

```

**From an individual point of view**

All the amendments to the recitals have been incorporated in full, except as far as the
following aspects are concerned:

**Recital 13** incorporates amendment 11. Its middle section has been slightly reworded in
order to align it on the wording of Article 5(1).

**Recital 14a** incorporates amendment 13. The beginning has been slightly reworded in
order to take better account of the need to finance research against rare or so-called
orphan diseases.

**Recital 15** incorporates amendment 14. It has been slightly reworded at the end because
it is the rights conferred by a patent and not the patent itself which are concerned.

**Recital 16b** incorporates amendment 16b. It has been slightly reworded in order to make
it clearer that it is a DNA sequence's lack of biological function which makes it
unpatentable.

**Recital 16f** incorporates amendment 17. It has been slightly reworded in order to align it
on point 2.4. of Opinion No 8 of the Group of Advisers on the Ethical Implications of
Biotechnology.

**Recital 16g** summarises amendments 79 and 99 in the light of the consequences of
Article 28(1 )(a) of the TRIPs Agreement.

**Recital 17** incorporates amendment 18, with one slight change: the word "practicability"
has been replaced by "application".

**Recital 19** incorporates amendment 23. Its wording has been amended to make it legally
more certain.

**Recital 19c** incorporates the second part of amendment 26. The final clause has been left
out because there is nothing to prevent the patent on a product, e.g. a medicinal product,
whose commercial exploitation has been authorised from being annulled if a judge finds
that one of the conditions for its patentability is not met. Annulment of the patent does
not involve withdrawal of the authorisation to exploit the product commercially. The
two procedures are independent of each other.

**Recital 22** incorporates amendment 80. The end has been slightly reworded in order to
avoid any incorrect scientific interpretation which would be inconsistent with the
amendment's purpose.

**Recital 23** incorporates amendment 30. The wording has been amended following the
deletion of recital 21 by amendment 28 because recital 23 is linked to it.

**Recital 24a** is new. It refers to the definition of human reproductive cloning contained in
Opinion No 9 of the Group of Advisers on the Ethical Implications of Biotechnology. At
the same time, it incorporates what was intended by amendment 55, paragraph 2(bb).
This subparagraph better explains why the patentability of human reproductive cloning is
to be ruled out. In view of the need for proper drafting, any redundant information
should be avoided in the operative part of the Directive and the explanation should be
incorporated into the recitals.

**Recital 24b** is a summary of amendments 10 and 33.

**Recital 32** has been given a new wording. It is aligned on the wording of Article 31(l)(i)
of the TRIPs Agreement in view of the fact that amendment 67 expressly introduces a
reference to the rights and obligations arising out of that agreement, _inter alia,_ in Article
1 (2) of the proposal for a Directive.

**Recital 35** incorporates amendment 38. The words "because otherwise patenting would
be precluded on the grounds of lack of novelty of the invention" have been left out for the
sake of clarity and in order to avoid any incorrect technical interpretation.

**Recital** 37 summarises amendments 40, 41, 42, 43, 68 and 77. Some of these
amendments proposed introducing complete quotations of articles from the Convention
on Biological Diversity. It would appear more appropriate, in view of the fact that recital
40 states that this Directive does not affect the rights and obligations of Member States
arising from international agreements, and that amendment 67, cited above, also refers to
this Convention, to refer globally to the Council Decision of 25 October 1993 concerning
the conclusion of the Convention on Biological Diversity.

###### **COMMENTS ON THE INDIVIDUAL ARTICLES**

**Article 1(2)** incorporates amendment 67.

**Article 2** incorporates amendment 48, paragraphs 2, 4, 5 and 6.

**Article 3** incorporates amendment 48, paragraphs 1 and 3.

Amendment 48 has been divided into two articles for the sake of clarity.

**Article 4** incorporates amendment 47. Paragraph 2 of this Article has been amended in
the same way as recital 17, amended by amendment 18. The word _"practicability"_ is
**replaced by** _**"application".**_

Article 5 incorporates amendments 100 and 49. It corresponds to the former Article 3

Articles 4, 5, 6, 7 and 8 have been deleted in accordance with amendments 50. 51. 52. 5"*
and 54 respectively. This is basically because they have been incorporated into Article 2,
3 and 4 of the amended proposal.

Article 6 incorporates amendment 55. It corresponds to the former Article 9.

It should be noted that the word _"publication"_ bus not been included in paragraph 1. The
paragraph is thus consistent with Article 27(2) of the TRIPs Agreement.

Paragraph 2(bb) of the amendment is not incorporated as such into Article 6. See the
explanation given regarding the new recital 24a.

Article 7 incorporates amendment 78. As the Commission announced during the plenary
debate, it considers that, in the context of the request for proposals to be formulated on
the composition and terms of reference of an ethics committee before the Directive enters
into force, its Group of Advisers on the Ethical Implications of Biotechnology should be
made competent. In so doing, the Commission will take account of Parliaments
Resolution B4-0484/97 of 13 June 1997 on the terms of reference of the Group of
Advisers on the Ethical Implications of Biotechnology.

Article 8(1) is unchanged. It corresponds to the former Article 10.

Article 8(2) incorporates amendment 57.

Article 9 is inspired by amendment 58. It corresponds to the former Article 11.
However, the reference in this amendment to Article 2a(l) (i.e. Article 4(1) of the
amended proposal) is technically and legally incomprehensible in the light of Article 11
of the proposal, which introduces a derogation for farmers, and Article 12, which
provides for a system of compulsory cross-licensing where a patent dominates a plant
variety. It would therefore not be appropriate to include this reference because, in
practice, this would limit the scope of protection conferred by a patent in such a way as to
go against current practice under patent law.

Article 10 is unchanged. It corresponds to the former Article 12.

Article 11 incorporates amendment 59. It corresponds to the former Article 13.

It should be noted that amendment 95, which aimed to amend paragraph 2 of this Article,
gives rise to a number of practical difficulties. The reference to Article 14(1) and (3) of
Regulation No 2100/94 is incomplete. Those two paragraphs cannot function without
paragraph 2 because it that would render meaningless the idea that the derogation
provided for in Article 11 is in accordance with the provisions on plant varieties.
Moreover, farmers might be confronted with different legal situations. This would not be
desirable.

The final sentence of amendment 95 repeats the final sentence of amendment 59.
However, this applies to plants what is specifically laid down for animals, which would
not be appropriate.

Article 12(1) and (2) remain unchanged. They correspond to the former Article 14.

Article 12(3)(b) incorporates amendment 60, _in_ accordance with Article 31(l)(i) of the
TRIPs Agreement.

Article 12(4) incorporates amendment 61.

Article 13 is unchanged. It corresponds to the former Article Î5.

Article 14 is unchanged. It corresponds to the former Article 16.

Article 17 of the initial proposal is deleted in accordance with amendment 62.

Article 15(1) incorporates amendment 63. It corresponds to the former Article 18.

Article 16 is new. It corresponds to amendment 64.

**Articles 17 and 18** are unchanged. They correspond to the former Articles 19 and 20
respectively.

Amended proposal for a
**EUROPEAN PARLIAMENT AND COUNCIL DIRECTIVE**

on the legal protection of biotcchnological inventions
**THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN**

**UNION,**

**Initial proposal**

**Amended proposal**

Having regard to the Treaty establishing Unchanged
the European Community, and in particular
Article 100a thereof,

Having regard to the proposal from the Unchanged
Commission, [1 ]

Having regard to the Opinion of the Unchanged
Economic and Social Committee, [2 ]

Acting in accordance with the procedure Unchanged
laid down in Article 189b of the Treaty, [3 ]

(1) Whereas biotechnology and genetic
engineering arc playing an
increasingly important role in a
broad range of industries and the
protection of biotechnological
inventions will certainly be of
fundamental importance for the
Community's industrial
development;

(2) Whereas the investments required
in research and development,
particularly for genetic engineering,
are especially high and especially
risky and the possibility of
recouping that investment can only
be guaranteed effectively through
adequate legal protection;

(1) Unchanged

(2) Unchanged

(3) Whereas without effective and (3)
harmonised protection throughout
the Member States such

investments might well not be
made;

1 OJ No C 296, 8.10.1996, p. 4.
2 OJ No C 295, 7.10.1996, p. 11.
3 European Parliament Opinion of

Whereas effective and harmonised

protection throughout the Member
States is essential in order to

maintain and encourage investment
in the field of biotechnology;

**Initial proposal** Amended proposal

(4) Whereas following the European (4.)
Parliament's rejection of the joint
text, approved by the Conciliation
Committee, for a European
Parliament and Council Directive

on the legal protection of
biotechnological inventions, [1] the
European Parliament and the
Council have determined that the

legal protection of biotechnological
inventions cannot be left as _it_

currently stands;

Whereas following the European
Parliament's rejection of the joint
text, approved by the Conciliation
Committee, for a European
Parliament and Council Directive on
the Êegai protection of
biotechnological inventions, the
European Parliament and the
Council have determined that the

legal protection of biotechnological
inventions requires clarification:

(5) Whereas differences exist in the
legal protection of biotechnological
inventions offered by the laws and
practices of the Member States;
whereas such differences could

create barriers to trade and to the

creation and proper functioning of
the internal market;

(6) Whereas such differences in legal
protection could well become
greater as Member States adopt new
and different legislation and
administrative practices, or as
national case-law interpreting such
legislation develops differently;

(5) Unchanged

(6) Unchanged

(7) Whereas the uncoordinated (7) Unchanged
development of national laws on
the legal protection of
biotechnological inventions in the
Community could result in the
creation of new disincentives to

trade, to the detriment of the
industrial development of such
inventions and of the smooth

operation of the internal market;

OJ No C 68, 20.3.1995, p. 26.

**Initial proposal** **Amended proposal**

(8) Whereas the legal protection of
biotechnological inventions does
not necessitate the creation of a

separate body of law in place of the
rules of national patent law;
whereas the rules of national patent
law remain the essential basis for

the legal protection of
biotechnological inventions;
whereas, however, they must be
adapted or added to in certain
specific respects in order to take
full account of technological
developments involving biological
material which also fulfil the

requirements for patentability;

(8) Unchanged

(8a) Whereas in such cases as the
exclusion from patentability of
plant and animal varieties and of
essentially biological processes for
the production of plants and
animals, certain concepts in
national laws based upon
international patent and plant
variety conventions have created
uncertainty regarding the protection
of biotechnological and certain
microbiological inventions;
whereas harmonisation is necessary
to clarify the said uncertainty;

**Initial proposai**

(9) Whereas harmonisation of the laws
of the Member States is necessary to clarify
certain concepts in national laws
originating in certain international patent
and plant variety conventions which have
led to some uncertainty as to the possibility
of protecting biotechnological inventions
concerning plant matter and certain
microbiological inventions, concepts such
as the exclusion from patentability of plant
and animal varieties and of essentially
biological processes for the production of
plants and animals;

**(9)**

(9a)

**10**

Amended proposal

Deleted

Having regard to the potential of
the development of biotechnology
for the environment and in

particular the utility of this
technology for the development of
methods of cultivation which are

less polluting and more economical
in their use of land; whereas the
patent system should be used to
encourage research into, and the
application of, such procedures;

**Initial proposal** **Amended proposal**

(9b) Having regard to the importance of
the development of biotechnology
to developing countries, both in the
field of health and combating major
epidemics and endemic diseases
and in that of combating hunger in
the world; whereas the patent
system should likewise be used to
encourage research in these fields;
whereas international procedures
for the dissemination of such

technology in the Third World and
to the benefit of the population
groups concerned should be
promoted;

(9c) Whereas the TRIPs Agreement
signed by the European Community
and the Member States has entered

into force and provides that patent
protection shall be guaranteed for
products and processes in all areas
of technology;

**11**

**Initial** **proposal** Amended **proposal**

(10) Whereas the Community's legal
framework for the protection of
biotechnological inventions can be
limited to laying down certain
principles as they apply to the
patentability of biological material
as such - such principles being
intended, in particular, to determine
the difference between inventions

and discoveries with regard to the
patentability of certain elements of
human origin - and can be further
limited to defining the scope of the
protection accorded by a patent on a
biotechnological invention, to the
right to use a deposit mechanism in
addition to written descriptions, to a
reversal of the burden of proof and
to the option of obtaining
non-exclusive compulsory licences
in respect of interdependence
between plant varieties and
inventions;

(11) Whereas a patent for invention does
not authorise the holder to

implement that invention, but
merely entitles him to prohibit third
parties from exploiting it for
industrial and commercial

purposes; whereas, consequently,
substantive patent law cannot serve
to call into question national and
Community law on the monitoring
of research and of the use or

commercialisation of its results,
notably from the point of view of
the requirements of public health,
safety, environmental protection,
animal welfare, the preservation of
genetic diversity and compliance
with certain ethical standards;

(10) Unchanged

(11) Whereas a patent for invention does
not authorise the holder to

implement that invention, but
merely entities him to prohibit third
parties from exploiting it for
industrial and commercial

puiposes; whereas, consequently,
substantive patent law cannot serve
to replace or render superfluous
nationals European or international
law which may impose restrictions
or prohibitions or which concerns
the monitoring of research and of
the use or commercialisation of its

results, notably from the point of
view of the requirements of public
health, safety, animal welfare, the
preservation of genetic diversity
and compliance with certain ethical
standards;

**12**

(12)

(13)

(14)

**13**

**(12)**

**(13)**

**(14)**

**Initial proposal**

Whereas no prohibition or
exclusion exists in national or

European patent law (Munich
Convention) which precludes
_a priori_ the patentability of
biological matter;

Whereas it should be specified that
knowledge relating to the human
body and to its elements in their
natural state falls within the realm

of scientific discovery and may not,
therefore, be regarded as patentable
inventions; whereas it follows from
this that substantive patent law is
not capable of prejudicing the basic
ethical principle excluding all
ownership of human beings;

Whereas significant progress in the
treatment of diseases has already
been made thanks to medicinal

products derived or otherwise
produced from elements isolated
from the human body, and
medicinal products resulting from a
technical process aimed at
obtaining elements similar in
structure to those existing naturally
in the human body and whereas,
consequently, the patent system
should promote research aimed at
obtaining such elements;

**Amended** **proposal**

Unchanged

Whereas patent law must respect
the fundamental principles
safeguarding the dignity and
integrity of the person; whereas it is
important to assert the principle that
the human body, at any stage in its
formation or development,
including germ cells, and the simple
discovery of one of its elements or
one of its products, including the
sequence or partial sequence of a
human gene, cannot be patented:
whereas these principles are in line
with the criteria of patentability
proper to patent law, whereby a
mere discovery cannot be patented;

Whereas significant progress in the
treatment of diseases has already
been made thanks to medicinal

products derived and/or otherwise
produced from elements isolated
from the human body, and
medicinal products resulting from
technical processes aimed at
obtaining elements similar in
structure to those existing naturally
in the human body and whereas,
consequently, the patent system
should promote research aimed at
obtaining and isolating such
elements valuable to medicinal

production;

**Initial proposal**

(15) Whereas, therefore, it should be
made clear that an invention

capable of industrial application
and based on an element isolated

from the human body or otherwise
produced by means of a technical
process is patentable, even where
the structure of that element is

identical to that of a natural

element, since no patent may be
interpreted as covering an element
of the human body in its natural
environment forming the basic
subject of the invention.

**Amended proposal**

(14a) Whereas, since the patent system
provides insufficient incentive for
financing research into and
production of biotechnological
medicines which are needed to

combat rare or 'orphan' diseases, the
Community and the Member States
have a duty to respond adequately
to this problem;

(14b) Having regard to Opinion No 8 by
the Group of Advisers on the
Ethical Implications of
Biotechnology to the European
Commission;

(15) Whereas, therefore, it should be
made clear that an invention based

on an element isolated from the

human body or otherwise produced
by means of a technical process,
which is capable of industrial
application, is not excluded from
patentability, even where the
structure of that element is identical

to that of a natural element, while
the rights conferred by the patent do
not extend to the human body and
its elements in their natural

environment;

**14**

**Initial proposal** **Amended proposal**

(16) Whereas such an element isolated
from the human body or otherwise
produced may not be regarded as
unpatentable in the same way as an
element of the human body in its
natural state, that is to say, may not.
be equated with a discovery, since
the element isolated is the result of

the technical processes used to
identify, purify and classify it and
to reproduce it outside the human
body, techniques which human
beings alone are capable of putting
into practice and which Nature is
incapable of accomplishing by
itself;

(16)

(16a)

(16b)

(16c)

Whereas such an element isolated

from the human body or otherwise
produced is not excluded from
patentability as it is, for example,
the result of the technical process
used to identify, purify and classify
it and to reproduce it outside the
human body, techniques which
human beings alone are capable of
putting into practice and which
Nature is incapable of
accomplishing by itself;

Whereas the discussion on the

patentability of sequences or partial
sequences of genes is controversial;
whereas, according to this
Directive, the granting of a patent
for inventions which concern such

sequences or partial sequences
require the same criteria to be
applied as in all other areas of
technology;

Whereas a mere sequence of DNA
segments without indication of a
biological function does not contain
a technical teaching and is therefore
not a patentable invention;

Whereas a sequence or partial
sequence can be the subject of a
patentable invention when all the
necessary conditions for a patent
are satisfied: novelty, level of
invention and industrial application;

**15**

**Initial proposal** **Amended** **proposal**

(16d) Whereas for the criterion of
industrial application to be
complied with, the genetic sequence
or partial sequence and thus also the
protein for which a DNA sequence
codes must be determined; whereas
for sequences which overlap, each
sequence will be considered as an
independent sequence in patent law

terms;

(16e) Whereas the requirements for
disclosure of the industrial

application of the sequences or
partial sequences do not differ from
those in other areas of technology;
whereas at least an industrial

application must be actually
disclosed in the patent application;

(16f) Whereas the free and informed
consent of the person from whose
body material is taken is required in
order for an application to be made
for a patent in respect of the use of
that material;

(16g) Whereas this Directive in no way
affects the basis of current patent
law, according to which a patent
may be granted for any new
application of a patented product;

**16**

**Initial** **proposal**

(17) Whereas, in order to determine the
extent to which piant and animr.1
varieties are to be excluded from

patentability, it should be specified
that the exclusion concerns those

varieties as such and that,
consequently, it does not prejudice the
patentability of plants or animals
obtained by means of a process at
least one stage of which is essentially
microbiological, irrespective of the
basic biological material to which that
process is applied;

**Amended proposal**

(17) Whereas this Directive shall be
without prejudice to the exclusion
of plant and animal varieties from
patentability; whereas on the other
hand inventions which concern

plants or animals are in general
patentable p [p] ovided that the
application of the invention is not
technically confined to a single
plant or animal variety;

(17a) Whereas the concept 'plant variety'
is defined by the law protecting
new varieties, pursuant to which a
variety is defined by its whole
genome and therefore possesses
individuality; whereas it is clearly
distinguishable from other varieties;

(17b) Whereas a plant totality which is
characterised by a particular gene
(and not its whole genome) is not
covered by the protection of new
varieties and is therefore not

excluded from patentability even if
it comprises plant varieties;

**17**

**Initial** **proposa!** **Amended proposal**

Whereas, however, if an invention
consists only in genetically
modifying a particular plant variety,
it shall be excluded from

patentability even if the genetic
modification is the result not of

breeding but of a genetic
engineering procedure;

Whereas a procedure for the
breeding of plants and animals is
essentially biological if it is based
on crossing whole genomes (with
subsequent selection and perhaps
further crossing of whole genomes);

(18) Whereas, for the purposes of
determining whether or not it is
possible to patent essentially
biological processes for obtaining
plants or animals, human intervention
and the effects of that intervention on

the result obtained must be taken into

account;

(17c)

(18)

(19) Whereas national patent laws for (19) Whereas this Directive shall be
inventions contain provisions as to the without prejudice to concepts of
criteria for allowing or excluding invention and discovery, as
patentability, including provisions to developed by national, European or
the effect that a patent may not be international patent laws;
granted in respect of inventions
whose publication or exploitation
would be contrary to public policy or
morality;

(19a) Whereas this Directive shall be
without prejudice to the provisions
of national patent law whereby
surgical or therapeutic treatment
procedures applicable to the human
body or the bodies of animals and
diagnostic procedures which are
carried out on the human body or
the bodies of animals are excluded

from patentability;

**18**

**Initial proposal** **Amended proposal**

(19b) Whereas the TRIPs Agreement
provides for the possibility that
members of the World Trade

Organisation may exclude from
patentability inventions whose
commercial exploitation within
their territory must be prevented in
order to protect public policy or
morality, including to protect
human or animal life or health, to
preserve plants or to prevent serious
harm to the environment, provided
that such an exclusion is not

undertaken solely because
exploitation is prohibited by their
legislation;

(19c) Whereas other prohibitions on
exploitation under national law are
not sufficient to exclude

patentability; whereas such an
exclusion presupposes that the
commercial exploitation of the
invention is prohibited in the
Member State in question;

(20) Whereas such a reference to public
policy and morality should be
included in the operative part of this
Directive in order to bring out the fact
that some applications of
biotechnological inventions, by virtue
of some of their consequences or
effects, are capable of offending
against them;

(20) W [7] hereas the principle whereby
inventions must be excluded from

patentability where their
commercial exploitation offends
against public policy or morality
must also be stressed in this

Directive;

**19**

**Initial** **proposai**

(21) Whereas it must be determined
whether applications offend against
public policy and morality in each
specific case, by means of an
appraisal of the values involved,
whereby the benefit to be derived
from the invention, on the one
hand, is weighed and evaluated
against any risks associated
therewith, and any objections based
on fundamental principles of law,
on the other hand;

(22) Whereas the operative part of this
Directive should also include an

illustrative list of inventions

excluded from patentability so as to
provide national courts and patent
offices with a general guide to
inteqsreting the reference to public
policy or morality;

**Amended** proposal

(21) Deleted

(22) Whereas the operative part of this
Directive should also include an

illustrative list of inventions

excluded from patentability so as to
provide national courts and patent
offices with a general guide to
interpreting the reference to public
policy and morality; whereas this
list cannot presume to be
exhaustive; whereas processes the
use of which offend against human
dignity, such as processes to
produce chimeras from a mixture of
human and animal genomes, are
also excluded from patentability;

**20**

**Initial proposal** **Amended proposal**

(23) Whereas such moral considerations (23)
must be given greater weight in
appraising the patentability of
biotechnological inventions, both
on account of the subject-matter of
this branch of science, namely
living matter, and because of the
often far-reaching implications of
the inventions to be examined;
whereas these considerations do

not, however, change the nature of
patent law as a primarily technical
body of law and are no substitute
for the other legal checks which
biotechnological inventions are
required to undergo from the start
of their development or at the
marketing stage, particularly with
regard to safety;

(24) Whereas, in view of the importance (24)
and the controversial nature of the

unprecedented questions raised by
germ line gene therapy, it is
important to exclude unequivocally
from patentability methods of
treatment of human beings based on
**it;**

**21**

Whereas morality represents the
ethical or moral principles generally
observed in a Member State or

accepted by the scientific or
professional circles concerned;
whereas it is particularly important
that these principles be respected in
the field of biotechnology in view
of the potential scope of inventions
in this field and their inherent

relationship to living matter;
whereas such ethical or moral

principles supplement the standard
legal checks of patent law
regardless of the technical field of
the invention;

Whereas in the European Union
there is a consensus that

interventions in the human germ
line and the cloning of human
beings offends against public policy
and morality; whereas it is therefore
important to exclude unequivocally
from patentability methods for
intervention in the germ line of
human beings and processes for
cloning human beings;

**Initial proposal** **Amended** **proposai**

(24a) Whereas in the European Union
there is a consensus that

interventions in the human germ
line and the cloning of human
beings offends against public policy
and morality; whereas it is therefore
important to exclude unequivocally
from patentability methods for
intervention in the germ line of
human beings and processes for
cloning human beings;

**22**

**Initial proposal** **Amended proposal**

(24b) Whereas this Directive does not
affect the application of the
Convention on Human Rights and
Fundamental Freedoms of 4

November 1950, the Convention
for the protection of human rights
and the dignity of the human person
with respect to applications of
biology and medicine: Convention
on human rights and biomedicine of
19 November 1996, or any other
international instrument concerning
the protection of human rights on
which the Member States have

cooperated or to which they have
acceded;

(25) Whereas processes for modifying
the genetic identity of animals
which are likely to cause them
suffering or physical handicaps
without any substantial benefit to
man or animal, and also animals
resulting from such processes must
be excluded from patentability
insofar as the suffering or physical
handicaps inflicted on the animals
concerned are out of proportion to
the objective pursued;

(25) Whereas processes for modifying
the genetic identity of animals
which are likely to cause them
suffering without any substantial
medical (diagnostic or therapeutic)
benefit to man or animal, and also
animals resulting from such
processes, must be excluded from
patentability;

**23**

**Initial proposal**

(26) Whereas, in view of the fact that the
function of a patent is to reward the
inventor for his creative efforts by
granting an exclusive but
time-bound right, and thereby
encourage inventive activities, the
holder of the patent should be
entitled to prohibit the use of
patented self-reproducible material
in situations analogous to those
where it would be permitted to
prohibit such use of patented,
non-self-reproducible products,
namely in respect of the production
of the patented product itself;

(27) Whereas it is necessary to provide
for a first derogation from the rights
of the holder of the patent when the
propagating material incorporating
the protected invention is sold to a
farmer for farming purposes by the
holder of the patent or with his
consent; whereas that initial
derogation must authorise the
farmer to use the product of his
harvest for further multiplication or
propagation on his own farm;
whereas the extent and the

conditions of that derogation must
be limited in accordance with the

extent and conditions set out in

Council Regulation (EC)
No 2100/94;i

(28) Whereas only the fee envisaged
under Community plant variety
rights as a condition for applying
the derogation from Community
plant variety rights can be required
of the farmer;

OJNoL227, 1.9.1994, p. 1.

**Amended proposal**

(26) Unchanged

(27) Unchanged

(28) Unchanged

**24**

**Initial proposal**

(29) Whereas, however, the holder of the (29)
patent may defend his rights against
a farmer abusing the derogation or
against the breeder who has
developed the plant variety
incorporating the protected
invention if the latter fails to adhere

to his commitments;

(30) Whereas a second derogation from (30)
the rights of the holder of the patent
must authorise the farmer to use the

protected livestock for breeding
purposes on his own farm, in order
to replenish their numbers;

**Amended proposal**

Unchanged

Whereas a second derogation from
the rights of the holder of the patent
must authorise the farmer to use the

protected livestock for agricultural

purposes;

(31) Whereas the extent and the
conditions of that second

derogation may be determined by
national laws, regulations and
practices, since there is no
Community legislation on animal
variety rights;

(31 ) Unchanged

(32) Whereas, in the field of exploitation (32)
of new plant characteristics
resulting from genetic engineering,
guaranteed access must, on
payment of a fee, be granted in a
Member State in the form of a

compulsory licence where, in
relation to the genus or species
concerned, public interest demands
the exploitation of the plant variety
for which the licence is requested
and the plant variety represents
significant technical progress;

**25**

Whereas, in the field of exploitation
of new plant characteristics
resulting from genetic engineering,
guaranteed access must, on
payment of a fee, be granted in the
form of a compulsory licence
where, in relation to the genus or
species concerned, the plant variety
represents significant technical
progress of considerable economic
interest compared to the invention
claimed in the patent;

**Initial proposal**

(33) Whereas, in the field of the use of
new plant characteristics resulting
from new plant varieties in genetic
engineering, guaranteed access
against a fee must be granted in the
form of a compulsory licence where
public interest demands the
exploitation of the invention for
which the licence is requested and
where the invention represents
significant technical progress,

**Amended proposal**

(33) Whereas, in the field of the use of
new plant characteristics resulting
from new plant varieties in genetic
engineering, guaranteed access
against a fee must be granted in the
form of a compulsory licence where
the invention represents significant
technical progress of considerable
economic interest;

(34) Whereas the TRIPs Agreement
contains detailed provisions on the
burden of proof which are binding
on all Member States; whereas,
therefore, a provision in this
Directive is not necessary;

(35) Whereas the Commission will
investigate whether, in the field of
basic genetic engineering research,
free and unimpeded scientific
exchanges are hampered because
publications containing information
which might be patentable are
delayed or not undertaken, as a
result of which patentability would
be excluded because of the lack of

novelty on the part of the inventor;
whereas the Commission will carry
out a comparison with the patent
law of the United States and Japan
in this respect and report to the
European Parliament and the
Council two years after the entry
into force of this Directive;

**26**

**Initial proposal** **Amended proposal**

(36) Whereas the Commission will
report [annually] to the European
Parliament on the development of
patent law in the field of
biotechnology and genetic
engineering;

(37) Whereas the rights and obligations
of the Member States derived from

international agreements,
particularly further to the Council
Decision of 25 October 1993 on the

conclusion of the Convention on
Biological Diversity, [1] and Articles
3, 8(j), 16(2), second sentence, and
16(5) of the Convention on
Biological Diversity of
5 June 1992, are not affected by this
Directive;

**1** **OJ No L** **309,13.12.1993,** **p. 1.**

**27**

**Initial proposal** **Amended proposal**

(38) Whereas the Third Conference of
the Parties of the Biodiversity
Convention, which took place in
November 1996, noted in Decision
HI/17 that 'further work is required
to help develop a common
appreciation of the relationship
between intellectual property rights
and the relevant provisions of the
TRIPs Agreement and the
Convention on Biological
Diversity, in particular on issues
relating to technology transfer and
conservation and sustainable use of

biological diversity and the fair and
equitable sharing of benefits arising
out of the use of genetic resources,
including the protection of
knowledge, innovations and
practices of indigenous and local
communities embodying traditional
lifestyles relevant for the
conservation and sustainable use of

biological diversity';

**28**

**Initial proposal** **Amended proposal**

HAVE ADOPTED THIS DIRECTIVE: HAVE ADOPTED THIS DIRECTIVE:

**CHAPTER I**

**Patentability**

_Article 1_

1. Member States shall protect
biotechnological inventions under national
patent law. Member States shall, if
necessary, adjust their national patent law
to take account of the provisions of this
Directive.

2. This Directive shall be without prejudice
to national and Community laws on the
monitoring of research and of the use or
commercialisation of its results.

_Article 2_

For the purposes of this Directive,

CHAPTER I

Patentability

_Article 1_

1. Unchanged

2. This Directive shall be without prejudice
to the obligations of the Member States
pursuant to international agreements, and
in particular the Convention on Biological
Diversity and the TRIPs Agreement.

_Article 2_

1. For the purposes of this Directive,

_Biological_ _material_ means any (a)
material containing genetic
information and capable of
self-reproduction or of being
reproduced in a biological system;

_Microbiological process_ means any (b)
process involving or performed
upon or resulting in microbiological
material; a process consisting of a
succession of steps shall be treated
as a microbiological process if at
least one essential step of the
process is microbiological;

**29**

_Biological_ _material_ means any
material containing genetic
information and capable of
reproducing itself or being
reproduced in a biological system;

_Microbiological_ _process_ means any
process involving or performed
upon or resulting in microbiological
material.

**Initial** **proposai**

_Essentially biological process for_
_the production of plants or animals_
means any process which, taken as
a whole, exists in nature or is not
more than a natural plant-breeding
or animal-breeding process.

Amended proposa!

2. A procedure for the breeding of plants or
animals shall be defined as essentially
biological if it is based on crossing and
selection.

3. The concept _plant variety_ is defined by
Article 5 of Regulation (EC) No 2100/94.

_Article 3_

1. For the purposes of this Directive,
inventions which are novel, imply
inventive activity and are capable of
industrial application shall be patentable
even if they concern a product consisting of
or containing biological material or a
procedure by means of which biological
material is produced, processed or used.

2. Biological material which is isolated
from its natural environment or processed
by means of a technical process may be the
subject of an invention even if it already
occurred in nature.

_Article 4_

1. The following shall not be patentable:

(a) plant and animal varieties,

(b) essentially biological procedures for
the breeding of plants and animals.

2. Inventions which concern plants or
animals may be patented if the application
of the invention is not technically confined
to a particular plant or animal variety.

**30**

**Initial proposal** **Amended proposal**

3. Paragraph 1(b) shall be without
prejudice to the patentability of inventions
which concern a microbiological or other
technical procedure or a product obtained
by means of such a procedure.

**31**

**Initial proposal**

_Article 3_

_I_ . The human body and its elements in
their natural state shall not be considered

patentable inventions.

2. Notwithstanding paragraph 1, the subject
of an invention capable of industrial
application which relates to an element
isolated from the human body or otherwise
produced by means of a technical process
shall be patentable, even if the structure of
that element is identical to that of a natural

element.

_Article 4_

1. The subject of an invention shall not be
considered unpatentable merely on the
grounds that it is composed of, uses, or is
applied to biological material.

2. Biological material, including plants and
animals, as well as elements of plants and
animals obtained by means of a process not
essentially biological, except plant and
animal varieties as such, shall be
patentable.

_Article 5_

Microbiological processes and products
**obtained by** means of **such** processes shall
**be patentable.**

Amended proposal

_Article 5_

1. The human body, at the various stages of
its formation and development, and the
simple discovery of one of its elements
including the sequence or partial sequence
of a gene, cannot constitute patentable
inventions.

2. An element isolated from the human

body or otherwise produced by means of a
technical process including the sequence or
partial sequence of a gene may constitute a
patentable invention, even if the structure
of that element is identical to that of a

natural element

3. The function of a sequence or a partial
sequence of a gene must be disclosed in the
patent application.

Deleted

Deleted

**32**

**Initial proposal**

_**Article 6**_ **Deleted**

Essentially biological processes for the
production of plants or animals shall not be
patentable.

_**Article 7**_ **Deleted**

Uses of plant or animal varieties and
processes for their production, other than
essentially biological processes for the
production of plants or animals, shall be
patentable.

_**Article 8**_ **Deleted**

The subject of an invention concerning a
biological material shall not be considered
a discovery or lacking in novelty merely on
the grounds that it already formed part of
the natural world.

_**Article 9**_

**Amended proposal**

_**Article 6**_

1. Inventions shall be considered

unpatentable where exploitation would be
contrary to public policy or morality;
however, exploitation shall not be deemed
contrary merely because it is prohibited by
law or regulation.

2. On the basis of paragraph 1, the
following shall be considered unpatentable:

1. Inventions shall be considered

unpatentable where their commercial
exploitation would be contrary to public
policy or morality; however, exploitation
shall not be deemed to be so contrary
merely because it is prohibited by law or
regulation.

2. On the basis of paragraph 1, the
following shall be considered unpatentable:

(a) methods of human treatment (a)
involving germ line gene therapy;

**33**

procedures for human reproductive
cloning;

**Initial proposal**

(b) processes for modifying the genetic
identity of animals which arc likely to
cause them suffering or physical
handicaps without any substantial
benefit to man or animal, and also
animals resulting from such
processes, whenever the suffering or
physical handicaps inflicted on the
animals concerned are

disproportionate to the objective
pursued.

**Amended** **proposal**

(b) processes for modifying the germ
line genetic identity of human
beings;

(c) methods in which human embryos
are used;

(d) processes for modifying the genetic
identity of animals which are likely
to cause them suffering without any
substantial medical benefit to man

or animal and also animals resulting
from such processes;

_**Article 7**_

The Commission's Group of Advisers on
the Ethical Implications of Biotechnology
shall assess all ethical aspects of
biotechnology.

**34**

**Initial proposal**

**CHAPTER II**

**Scope of protection**

_**Article 10**_

1. The protection conferred by a patent on a
biological material possessing specific
characteristics as a result of the invention

shall extend to any biological material
derived from that biological material
through multiplication or propagation in an
identical or divergent form and possessing
those same characteristics.

2. The protection conferred by a patent on a
process that enables a biological material to
be produced possessing specific
characteristics as a result of the invention

shall extend to biological material directly
obtained using that process and to any
other biological material derived from the
biological material directly obtained
through multiplication or propagation in an
identical or divergent form and possessing
those same characteristics. That protection
shall not affect the exclusion from

patentability of plant and animal varieties
as such, pursuant to Article 4(2).

_**Article**_ _**11**_

The protection conferred by a patent on a
product containing or consisting of genetic
information shall extend to all material,
save as provided in Article 3(1), in which
the product is incorporated and in which
the genetic information is contained and
expressed.

**Amended** **proposal**

**CHAPTER II**

**Scope of protection**

_**Article 8**_

1. Unchanged

2. The protection conferred by a patent on a
process that enables a biological material to
be produced possessing specific
characteristics as a result of the invention

shall extend to biological material directly
obtained through that process and to any
other biological material derived from the
biological material directly obtained
through multiplication or propagation in an
identical or divergent form and possessing
those same characteristics.

_**Article 9**_

The protection conferred by a patent on a
product containing or consisting of genetic
information shall extend to all material,
save as provided in Article 5(1), in which
the product is incorporated and in which
the genetic information is contained and
expressed.

**35**

**Initial proposal**

_**Article 12**_

The protection referred to in Articles 10
and 11 shall not extend to biological
material obtained from the multiplication
or propagation of biological material
marketed in the territory of a Member State
by the holder of the patent or with his
consent, if the multiplication or
propagation necessarily results from the
application for which the biological
material was marketed, provided that the
obtained material is not subsequently used
for other multiplication or propagation.

_**Article 13**_

1. By way of derogation from Articles 10
and 11, the sale of 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 reproduction or
propagation by him on his own farm, the
scope of and procedure for this derogation
corresponding to those under Article 14 of
Regulation (EC) No 2100/94.

2. By way of derogation from Articles 10
and 11, the sale of breeding stock to a
farmer by the holder of the patent or with
his consent implies authorisation for the
farmer to use the protected livestock for
breeding purposes on his own farm, in
order to replenish their numbers.

**Amended proposal**

_**Article**_ _**10**_

The protection referred to in Articles 8 and
9 shall not extend to biological material
obtained from the multiplication or
propagation of biological material
marketed in the territory of a Member State
by the holder of the patent or with his
consent, if the multiplication or
propagation necessarily results from the
application for which the biological
material was marketed, provided that the
obtained material is not subsequently used
for other multiplication or propagation.

_**Article**_ _**11**_

1. By way of derogation from Articles 8
and 9, the sale of 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 reproduction or
propagation by him on his own farm., the
scope of and procedure for this derogation
coiTesponding to those under Article 4 of
Regulation (EC) No 2100/94.

2. By way of derogation from Articles 8
and 9, the sale of breeding stock or other
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 the sate for the
purposes of pursuing agricultural activities
but not the sale within the framework, or for
the purpose of a commercial breeding
activity.

**36**

**Initial proposal** **Amended** **proposal**

3. The extent and the conditions of the 3. Unchanged
derogation provided for in paragraph 2
shall be determined by national laws,
regulations and practices.

**CHAPTER III**

**Compulsory cross-licensing**

_Article 14_

1. Where a breeder cannot acquire or
exploit a plant variety right without
infringing a prior patent, he may apply for
a compulsory licence for non-exclusive use
of the invention protected by the patent
inasmuch as the licence is necessary for the
exploitation of the plant variety to be
protected, subject to payment of an
appropriate royalty. Member States shall
provide that where such a licence is
granted, the holder of the patent will be
entitled to a cross-licence on reasonable

terms to use the protected variety.

2. Where the holder of a patent on a
biotechnological invention cannot exploit it
without infringing a prior plant variety
right, he may apply for a compulsory
licence for non-exclusive use of the plant
variety protected by that right, subject to
payment of an appropriate royalty.
Member States shall provide that where
such a licence is granted, the holder of the
variety right will be entitled to a
cross-licence on reasonable terms to use

the protected invention.

**CHAPTER** **III**

**Compulsory** cross-licensing

_Article_ _12_

1. Unchanged

2. Unchanged

**37**

**Initial proposal**

3. Applicants for the licences referred to in
paragraphs 1 and 2 above must
demonstrate that:

(a) they have applied unsuccessfully to
the holder of the patent or of the
plant variety right to obtain a
contractual licence;

(b) exploitation of the plant variety or
the invention for which the licence

is requested is dictated by the
public interest and the plant variety
or the invention constitutes

significant technical progress.

4. Each Member State shall designate the
authority or authorities responsible for
granting the licence. The licence shall be
granted principally for the supply of the
domestic market of the Member State

which has granted the licence.

**CHAPTER IV**

**Deposit, access and re-deposit of** **a**
**biological material**

_**Article 15**_

1. Where an invention involves the use of

or concerns a biological material which is
not available to the public and which
cannot be described in a patent application
in such a manner as to enable the invention

to be reproduced by a person skilled in the
art, the description shall be considered
inadequate for the purposes of patent law
unless:

**Amended proposal**

3. Unchanged

(a) Unchanged

(b) the plant variety or the invention
constitutes significant technical
progress of considerable economic
interest.

4. Each Member State shall designate the
authority or authorities responsible for
granting the licence.

**CHAPTER IV**

**Deposit, access and re-deposit of a**
**biological material**

_**Article 13**_

1. Unchanged

**38**

**Initial proposal**

(a) the biological material has been
deposited, no later than the date
on which the patent application
was filed, with a recognised
depositary institution. At least
the international depositary
authorities which acquired this
status by virtue of Article 7 of
the Budapest Treaty of
2SAprill977 on the
International Recognition of the
deposit of micro-organisms for
the purposes of patent procedure,
hereinafter referred to as the

"Budapest Treaty", shall be
recognised;

(b) the application as filed contains
such relevant information as is

available to the applicant on the
characteristics of the biological
material deposited;

(c) the patent application states the
name of the depository
institution and the accession

number.

**Amended proposal**

2. Access to the deposited biological 2. Unchanged
material shall be provided through the
supply of a sample:

(a) up to the first publication of the
patent application, only to those
persons who are authorised under
national patent law;

(b) between the first publication of
the application and the granting
of the patent, to anyone
requesting it or, if the applicant
so requests, only to an
independent expert;

(c) after the patent has been granted,
and notwithstanding revocation
or cancellation of the patent, to
anyone requesting it.

**39**

**Initia!** **proposal**

3. The sample shall be supplied only if the
person requesting it undertakes, for the
term during which the patent is in force:

(a) not to make it or any matter
derived from it available to third

parties and

(b) not to use it or any matter
derived from it except for
experimental purposes,

unless the patent holder or
applicant, as applicable, expressly
waives such an undertaking.

Amended proposal

3. Unchanged

4. At the applicant's request, where an 4. Unchanged
application is refused or withdrawn, access
to the deposited material shall be limited to
an independent expert for twenty years
from the date on which the patent
application was filed. In that case,
paragraph 3 shall apply.

5. The applicant's requests referred to in 5. Unchanged
point (b) of paragraph 2 and in paragraph 4
may only be made up to the date on which
the technical preparations for publishing
the patent application are deemed to have
been completed.

_Article_ _16_

1. If the biological material deposited in 1. Unchanged
accordance with Article 15 ceases to be

available from the recognised depositary
institutions, a new deposit of the material
shall be permitted on the same terms as
those laid down in the Budapest Treaty.

**40**

_Article_ _14_

**Initial proposal**

2. Any new deposit shall be accompanied
by a statement signed by the applicant
certifying that the newly deposited
biological material is the same as that
originally deposited.

**CHAPTER V**

**Burden of proof**

_**Article**_ _**17**_

l.If the subject-matter of a patent is a
process for obtaining a new product, then,
when the same product is produced by any
other party, it shall, in the absence of proof
to the contrary, be deemed to have been
obtained by the patented process.

2. In the adduction of proof to the contrary,
the legitimate interests of the defendant in
protecting his manufacturing and business
secrets shall be taken into account.

**CHAPTER VI**

**Final provisions**

_**Article**_ _**18**_

1. Member States shall bring into force the
laws, regulations and administrative
provisions necessary to comply with this
Directive not later than 1 January 2000.
They shall immediately inform the
Commission thereof

**Amended proposal**

Unchanged

Deleted

**CHAPTER VI**

**Final provisions**

_**Article**_ _**15**_

1. Member States shall bring into force the
laws, regulations and administrative
provisions necessary to comply with this
Directive not later than 1 January 1999.
They shall immediately inform the
Commission thereof.

**41**

**Initial proposal**

When Member States adopt these
measures, these shall contain a reference to
this Directive or shall be accompanied by
such reference at the time of their official

publication. The procedure for such
reference shall be adopted by
Member States.

**Amended proposal**

Unchanged

2. Member States shall communicate to the 2. Unchanged
Commission the text of the main

provisions of national law which they
adopt in the field covered by this Directive.

_**Article 16**_

Every five years after the transposition of
this Directive the Commission shall

publish a report on any problems
encountered with regard to the relationship
between this Directive and international

agreements on the protection of human
rights to which the Member States have
acceded or on which they have cooperated.
The report shall be forwarded to European
Parliament and the Council.

_**Article 19**_ _**Article 17**_

This Directive shall enter into force on the Unchanged
20th day following that of its publication in
the Official Journal of the European
Communities.

_**Article 20**_ _**Article 18**_

This Directive is addressed to the Unchanged
Member States.

**42**

###### **ISSN 0254-1475**

### COM(97) 446 final

# **DOCUMENTS**

#### EN 05 06 08 15 Catalogue number : CB-CO-97-455-EN-C ISBN 92-78-24376-0

Office for Official Publications of the European Communities

L-2985 Luxembourg

## **43**