CELEX: 51997PC0446
Language: en
Date: 1997-08-29
Title: Amended proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions

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)
 ---pagebreak---  ---pagebreak---                       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.
 ---pagebreak--- 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                    8
                                11                   9
                                13                   11
                                14                   12
                               14a                   13
                               14b                    1
                                15                   14
                                16                   15
                              16a-e                  16
                               16f                   17
                               16g              99 and 79
                                17                   18
                               17a                   19
                               17b                   20
                               17c                   21
                                18                   22
                                19                   23
                               19a                   24
                              19b-c                  26
                                20                   27
                                22                   80
                                23                   30
                                24                   31
                               24a                  new
                               24b              10 and 33
                                25                   34
                                30                   35
                                32                  new
                                33                   36
                                34                   37
                                35                   38
                                36                   39
                                37          40,41,42,43,68,77
                                38                   44
 ---pagebreak--- 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.
 ---pagebreak--- 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".
 ---pagebreak--- 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.
 ---pagebreak---  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.
 ---pagebreak---                                        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 (1)           Unchanged
          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 (2)             Unchanged
         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;
(3)      Whereas without effective and (3)                Whereas effective and harmonised
         harmonised protection throughout                protection throughout the Member
         the        Member States           such         States is essential in order to
         investments might well not be                   maintain and encourage investment
         made;                                           in the field of biotechnology;
 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
 ---pagebreak---              Initial proposal                         Amended proposal
(4)   Whereas following the European (4.)        Whereas following the European
      Parliament's rejection of the joint        Parliament's rejection of the joint
      text, approved by the Conciliation         text, approved by the Conciliation
      Committee,        for     a    European    Committee,      for    a     European
      Parliament and Council Directive           Parliament and Council Directive on
      on the legal protection of                 the      Êegai      protection     of
      biotechnological inventions,1 the          biotechnological inventions, the
      European Parliament          and    the    European Parliament and the
      Council have determined that the           Council have determined that the
      legal protection of biotechnological       legal protection of biotechnological
      inventions cannot be left as it            inventions requires clarification:
      currently stands;
(5)   Whereas differences exist in the (5)       Unchanged
      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 (6)      Unchanged
      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;
(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.
 ---pagebreak---           Initial proposal                         Amended proposal
(8) Whereas the legal protection of (8)        Unchanged
    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;
                                          (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;
 ---pagebreak---               Initial proposai                            Amended proposal
(9)     Whereas harmonisation of the laws (9)         Deleted
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;
                                                (9a) 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;
                                              10
 ---pagebreak--- 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
 ---pagebreak---             Initial proposal                        Amended proposal
(10) Whereas the Community's legal (10)         Unchanged
     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 (11)  Whereas a patent for invention does
     not authorise the holder to               not authorise the holder to
     implement that invention, but             implement that invention, but
     merely entitles him to prohibit third     merely entities him to prohibit third
     parties from exploiting it for            parties from exploiting it for
     industrial      and       commercial      industrial      and      commercial
     purposes; whereas, consequently,          puiposes; whereas, consequently,
     substantive patent law cannot serve       substantive patent law cannot serve
     to call into question national and        to replace or render superfluous
     Community law on the monitoring           nationals European or international
     of research and of the use or             law which may impose restrictions
     commercialisation of its results,         or prohibitions or which concerns
     notably from the point of view of         the monitoring of research and of
     the requirements of public health,        the use or commercialisation of its
     safety, environmental protection,         results, notably from the point of
     animal welfare, the preservation of       view of the requirements of public
     genetic diversity and compliance          health, safety, animal welfare, the
     with certain ethical standards;           preservation of genetic diversity
                                               and compliance with certain ethical
                                               standards;
                                            12
 ---pagebreak---              Initial proposal                          Amended proposal
(12)  Whereas       no    prohibition    or (12) Unchanged
      exclusion exists in national or
      European patent law (Munich
      Convention)       which     precludes
      a priori     the patentability     of
      biological matter;
(13)  Whereas it should be specified that (13)   Whereas patent law must respect
      knowledge relating to the human            the       fundamental       principles
      body and to its elements in their          safeguarding the dignity and
      natural state falls within the realm       integrity of the person; whereas it is
      of scientific discovery and may not,       important to assert the principle that
      therefore, be regarded as patentable       the human body, at any stage in its
      inventions; whereas it follows from        formation        or      development,
      this that substantive patent law is        including germ cells, and the simple
      not capable of prejudicing the basic       discovery of one of its elements or
      ethical principle excluding all            one of its products, including the
      ownership of human beings;                  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;
 (14)  Whereas significant progress in the (14)   Whereas significant progress in the
       treatment of diseases has already          treatment of diseases has already
       been made thanks to medicinal              been made thanks to medicinal
       products derived or otherwise              products derived and/or otherwise
       produced from elements isolated            produced from elements isolated
       from the human body, and                   from the human body, and
       medicinal products resulting from a        medicinal products resulting from
       technical     process    aimed     at      technical processes aimed at
       obtaining elements similar in              obtaining elements similar in
       structure to those existing naturally       structure to those existing naturally
       in the human body and whereas,              in the human body and whereas,
       consequently, the patent system             consequently, the patent system
       should promote research aimed at            should promote research aimed at
       obtaining such elements;                    obtaining and isolating such
                                                   elements valuable to medicinal
                                                   production;
                                             13
 ---pagebreak---            Initial proposal                         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 (15)      Whereas, therefore, it should be
     made clear that an invention               made clear that an invention based
     capable of industrial application          on an element isolated from the
     and based on an element isolated           human body or otherwise produced
     from the human body or otherwise           by means of a technical process,
     produced by means of a technical           which is capable of industrial
     process is patentable, even where          application, is not excluded from
     the structure of that element is           patentability, even where the
     identical to that of a natural             structure of that element is identical
     element, since no patent may be            to that of a natural element, while
     interpreted as covering an element         the rights conferred by the patent do
     of the human body in its natural           not extend to the human body and
     environment forming the basic              its elements in their natural
     subject of the invention.                  environment;
                                        14
 ---pagebreak---              Initial proposal                             Amended proposal
(16) Whereas such an element isolated (16)           Whereas such an element isolated
     from the human body or otherwise                from the human body or otherwise
     produced may not be regarded as                 produced is not excluded from
     unpatentable in the same way as an              patentability as it is, for example,
     element of the human body in its                the result of the technical process
     natural state, that is to say, may not.         used to identify, purify and classify
     be equated with a discovery, since              it and to reproduce it outside the
     the element isolated is the result of           human body, techniques which
     the technical processes used to                 human beings alone are capable of
     identify, purify and classify it and            putting into practice and which
     to reproduce it outside the human               Nature        is     incapable       of
     body, techniques which human                    accomplishing by itself;
     beings alone are capable of putting
     into practice and which Nature is
     incapable of accomplishing by
     itself;
                                              (16a) 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;
                                               (16b) 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;
                                               (16c) 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
 ---pagebreak--- 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
 ---pagebreak---               Initial proposal                             Amended proposal
(17) Whereas, in order to determine the (17)          Whereas this Directive shall be
     extent to which piant and animr.1                without prejudice to the exclusion
     varieties are to be excluded from                of plant and animal varieties from
     patentability, it should be specified            patentability; whereas on the other
     that the exclusion concerns those                hand inventions which concern
     varieties     as   such    and     that,         plants or animals are in general
     consequently, it does not prejudice the          patentable ppovided that the
     patentability of plants or animals               application of the invention is not
     obtained by means of a process at                technically confined to a single
     least one stage of which is essentially          plant or animal variety;
     microbiological, irrespective of the
     basic biological material to which that
     process is applied;
                                                (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
 ---pagebreak---               Initial proposa!                             Amended proposal
                                                (17c) 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;
(18) Whereas, for the purposes of (18)                Whereas a procedure for the
     determining whether or not it is                 breeding of plants and animals is
     possible     to    patent    essentially         essentially biological if it is based
     biological processes for obtaining               on crossing whole genomes (with
     plants or animals, human intervention            subsequent selection and perhaps
     and the effects of that intervention on          further crossing of whole genomes);
     the result obtained must be taken into
     account;
(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
 ---pagebreak---              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 (20)           W7hereas the principle whereby
     policy and morality should be                     inventions must be excluded from
     included in the operative part of this            patentability         where     their
     Directive in order to bring out the fact          commercial exploitation offends
     that     some       applications      of          against public policy or morality
     biotechnological inventions, by virtue            must also be stressed in this
     of some of their consequences or                  Directive;
     effects, are capable of offending
     against them;
                                              19
 ---pagebreak---             Initial proposai                      Amended proposal
(21) Whereas it must be determined (21)      Deleted
     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 (22) Whereas the operative part of this
     Directive should also include an        Directive should also include an
     illustrative list of inventions         illustrative list of inventions
     excluded from patentability so as to    excluded from patentability so as to
     provide national courts and patent      provide national courts and patent
     offices with a general guide to         offices with a general guide to
     inteqsreting the reference to public    interpreting the reference to public
     policy or morality;                     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
 ---pagebreak---            Initial proposal                       Amended proposal
(23) Whereas such moral considerations (23)  Whereas morality represents the
     must be given greater weight in         ethical or moral principles generally
     appraising the patentability of         observed in a Member State or
     biotechnological inventions, both       accepted by the scientific or
     on account of the subject-matter of     professional circles concerned;
     this branch of science, namely          whereas it is particularly important
     living matter, and because of the       that these principles be respected in
     often far-reaching implications of      the field of biotechnology in view
     the inventions to be examined;          of the potential scope of inventions
     whereas these considerations do         in this field and their inherent
     not, however, change the nature of      relationship to living matter;
     patent law as a primarily technical     whereas such ethical or moral
     body of law and are no substitute       principles supplement the standard
     for the other legal checks which        legal checks of patent law
     biotechnological inventions are         regardless of the technical field of
     required to undergo from the start      the invention;
     of their development or at the
     marketing stage, particularly with
     regard to safety;
(24) Whereas, in view of the importance (24) Whereas in the European Union
     and the controversial nature of the     there    is a consensus          that
     unprecedented questions raised by       interventions in the human germ
     germ line gene therapy, it is           line and the cloning of human
     important to exclude unequivocally      beings offends against public policy
     from patentability methods of           and morality; whereas it is therefore
     treatment of human beings based on      important to exclude unequivocally
     it;                                     from patentability methods for
                                             intervention in the germ line of
                                             human beings and processes for
                                             cloning human beings;
                                         21
 ---pagebreak--- 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
 ---pagebreak---             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 (25)        Whereas processes for modifying
     the genetic identity of animals             the genetic identity of animals
     which are likely to cause them              which are likely to cause them
     suffering or physical handicaps             suffering without any substantial
     without any substantial benefit to          medical (diagnostic or therapeutic)
     man or animal, and also animals             benefit to man or animal, and also
     resulting from such processes must          animals resulting from such
     be excluded from patentability              processes, must be excluded from
     insofar as the suffering or physical        patentability;
     handicaps inflicted on the animals
     concerned are out of proportion to
     the objective pursued;
                                          23
 ---pagebreak---              Initial proposal                       Amended proposal
(26)  Whereas, in view of the fact that the (26) Unchanged
      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 (27)    Unchanged
      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 (28)        Unchanged
      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.
                                             24
 ---pagebreak---             Initial proposal                          Amended proposal
(29) Whereas, however, the holder of the (29)    Unchanged
     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)       Whereas a second derogation from
     the rights of the holder of the patent      the rights of the holder of the patent
     must authorise the farmer to use the        must authorise the farmer to use the
     protected livestock for breeding            protected livestock for agricultural
     purposes on his own farm, in order          purposes;
     to replenish their numbers;
(31) Whereas the extent and the (31 )             Unchanged
     conditions      of     that      second
     derogation may be determined by
     national laws, regulations and
     practices, since there is no
     Community legislation on animal
     variety rights;
(32) Whereas, in the field of exploitation (32)  Whereas, in the field of exploitation
     of new plant            characteristics     of new plant           characteristics
     resulting from genetic engineering,         resulting from genetic engineering,
     guaranteed      access must, on             guaranteed      access    must,     on
     payment of a fee, be granted in a           payment of a fee, be granted in the
     Member State in the form of a               form of a compulsory licence
     compulsory licence where, in                where, in relation to the genus or
     relation to the genus or species            species concerned, the plant variety
     concerned, public interest demands          represents significant technical
     the exploitation of the plant variety       progress of considerable economic
     for which the licence is requested          interest compared to the invention
     and the plant variety represents            claimed in the patent;
     significant technical progress;
                                              25
 ---pagebreak---             Initial proposal                          Amended proposal
(33) Whereas, in the field of the use of (33)    Whereas, in the field of the use of
     new plant characteristics resulting         new plant characteristics resulting
     from new plant varieties in genetic         from new plant varieties in genetic
     engineering, guaranteed access              engineering, guaranteed access
     against a fee must be granted in the        against a fee must be granted in the
     form of a compulsory licence where          form of a compulsory licence where
     public interest demands the                 the invention represents significant
     exploitation of the invention for           technical progress of considerable
     which the licence is requested and          economic interest;
     where the invention represents
     significant technical progress,
                                            (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
 ---pagebreak---           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
 ---pagebreak--- 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
 ---pagebreak---               Initial proposal                                Amended proposal
HAVE ADOPTED THIS DIRECTIVE:                    HAVE ADOPTED THIS DIRECTIVE:
                CHAPTER I                                        CHAPTER I
                Patentability                                    Patentability
                   Article 1                                        Article 1
1. Member States           shall       protect 1. Unchanged
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      2. This Directive shall be without prejudice
to national and Community laws on the             to the obligations of the Member States
monitoring of research and of the use or          pursuant to international agreements, and
commercialisation of its results.                 in particular the Convention on Biological
                                                  Diversity and the TRIPs Agreement.
                   Article 2                                        Article 2
For the purposes of this Directive,               1. For the purposes of this Directive,
        Biological material means any (a)                 Biological material means any
        material       containing      genetic            material      containing       genetic
        information      and     capable    of            information     and     capable     of
        self-reproduction or of being                     reproducing      itself   or    being
        reproduced in a biological system;                reproduced in a biological system;
        Microbiological process means any (b)             Microbiological process means any
       process involving or performed                     process involving or performed
       upon or resulting in microbiological               upon or resulting in microbiological
       material; a process consisting of a                material.
       succession of steps shall be treated
       as a microbiological process if at
       least one essential step of the
       process is microbiological;
                                               29
 ---pagebreak---       Initial proposai                              Amended proposa!
Essentially biological process for     2. A procedure for the breeding of plants or
the production of plants or animals    animals shall be defined as essentially
means any process which, taken as      biological if it is based on crossing and
a whole, exists in nature or is not     selection.
more than a natural plant-breeding
or animal-breeding process.
                                       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
 ---pagebreak--- 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
 ---pagebreak---                Initial proposal                               Amended proposal
                   Article 3                                        Article 5
 I. The human body and its elements in 1. The human body, at the various stages of
their natural state shall not be considered its formation and development, and the
patentable inventions.                            simple discovery of one of its elements
                                                  including the sequence or partial sequence
                                                  of a gene, cannot constitute patentable
                                                  inventions.
2. Notwithstanding paragraph 1, the subject       2. An element isolated from the human
of an invention capable of industrial             body or otherwise produced by means of a
application which relates to an element           technical process including the sequence or
isolated from the human body or otherwise         partial sequence of a gene may constitute a
produced by means of a technical process          patentable invention, even if the structure
shall be patentable, even if the structure of     of that element is identical to that of a
that element is identical to that of a natural    natural                             element
element.
                                                  3. The function of a sequence or a partial
                                                  sequence of a gene must be disclosed in the
                                                  patent application.
                   Article 4                      Deleted
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                      Deleted
Microbiological processes and products
obtained by means of such processes shall
be patentable.
                                               32
 ---pagebreak---                Initial proposal                             Amended 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                                     Article 6
 1. Inventions     shall     be   considered    1. Inventions    shall     be  considered
unpatentable where exploitation would be       unpatentable where their commercial
contrary to public policy or morality;         exploitation would be contrary to public
however, exploitation shall not be deemed      policy or morality; however, exploitation
contrary merely because it is prohibited by    shall not be deemed to be so contrary
law or regulation.                             merely because it is prohibited by law or
                                               regulation.
2. On the basis of paragraph 1, the 2. On the basis of paragraph 1, the
following shall be considered unpatentable: following shall be considered unpatentable:
(a)      methods of human treatment (a)                 procedures for human reproductive
         involving germ line gene therapy;              cloning;
                                             33
 ---pagebreak---              Initial proposal                            Amended proposal
(b) processes for modifying the genetic (b)          processes for modifying the germ
    identity of animals which arc likely to          line genetic identity of human
    cause them suffering or physical                 beings;
    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.
                                              (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
 ---pagebreak---               Initial proposal                              Amended proposal
               CHAPTER II                                      CHAPTER II
            Scope of protection                             Scope of protection
                 Article 10                                       Article 8
1. The protection conferred by a patent on a 1. Unchanged
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    2. The protection conferred by a patent on a
process that enables a biological material to   process that enables a biological material to
be     produced       possessing     specific   be     produced      possessing      specific
characteristics as a result of the invention    characteristics as a result of the invention
shall extend to biological material directly    shall extend to biological material directly
obtained using that process and to any          obtained through that process and to any
other biological material derived from the      other biological material derived from the
biological material directly obtained           biological material directly obtained
through multiplication or propagation in an     through multiplication or propagation in an
identical or divergent form and possessing      identical or divergent form and possessing
those same characteristics. That protection     those same characteristics.
shall not affect the exclusion from
patentability of plant and animal varieties
as such, pursuant to Article 4(2).
                  Article 11                                      Article 9
The protection conferred by a patent on a       The protection conferred by a patent on a
product containing or consisting of genetic     product containing or consisting of genetic
information shall extend to all material,       information shall extend to all material,
save as provided in Article 3(1), in which      save as provided in Article 5(1), in which
the product is incorporated and in which        the product is incorporated and in which
the genetic information is contained and        the genetic information is contained and
expressed.                                      expressed.
                                              35
 ---pagebreak---                Initial proposal                            Amended proposal
                  Article 12                                    Article 10
The protection referred to in Articles 10     The protection referred to in Articles 8 and
and 11 shall not extend to biological         9 shall not extend to biological material
material obtained from the multiplication     obtained from the multiplication or
or propagation of biological material         propagation      of    biological   material
marketed in the territory of a Member State   marketed in the territory of a Member State
by the holder of the patent or with his       by the holder of the patent or with his
consent,     if the       multiplication  or  consent,     if the multiplication         or
propagation necessarily results from the      propagation necessarily results from the
application for which the biological          application for which the biological
material was marketed, provided that the      material was marketed, provided that the
obtained material is not subsequently used    obtained material is not subsequently used
for other multiplication or propagation.      for other multiplication or propagation.
                  Article 13                                    Article 11
1. By way of derogation from Articles 10      1. By way of derogation from Articles 8
and 11, the sale of propagating material to   and 9, the sale of propagating material to a
a farmer by the holder of the patent or with  farmer by the holder of the patent or with
his consent for agricultural use implies      his consent for agricultural use implies
authorisation for the farmer to use the       authorisation for the farmer to use the
product of his harvest for reproduction or    product of his harvest for reproduction or
propagation by him on his own farm, the       propagation by him on his own farm., the
scope of and procedure for this derogation    scope of and procedure for this derogation
corresponding to those under Article 14 of    coiTesponding to those under Article 4 of
Regulation (EC) No 2100/94.                   Regulation (EC) No 2100/94.
2. By way of derogation from Articles 10      2. By way of derogation from Articles 8
and 11, the sale of breeding stock to a       and 9, the sale of breeding stock or other
farmer by the holder of the patent or with     reproductive material to a farmer by the
his consent implies authorisation for the      holder of the patent or with his consent
farmer to use the protected livestock for      implies authorisation for the farmer to use
breeding purposes on his own farm, in          the protected livestock for an agricultural
 order to replenish their numbers.             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
 ---pagebreak---               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                           CHAPTER III
        Compulsory cross-licensing              Compulsory cross-licensing
                  Article 14                           Article 12
 1. Where a breeder cannot acquire or 1. Unchanged
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 2. Unchanged
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.
                                             37
 ---pagebreak---                Initial proposal                              Amended proposal
3. Applicants for the licences referred to in 3. Unchanged
paragraphs 1 and 2 above must
demonstrate that:
(a)     they have applied unsuccessfully to (a) Unchanged
        the holder of the patent or of the
        plant variety right to obtain a
        contractual licence;
(b)     exploitation of the plant variety or (b)        the plant variety or the invention
        the invention for which the licence             constitutes significant technical
        is requested is dictated by the                 progress of considerable economic
        public interest and the plant variety           interest.
        or the invention          constitutes
        significant technical progress.
4. Each Member State shall designate the 4. Each Member State shall designate the
authority or authorities responsible for authority or authorities responsible for
granting the licence. The licence shall be granting the licence.
granted principally for the supply of the
domestic market of the Member State
which has granted the licence.
               CHAPTER IV                                      CHAPTER IV
    Deposit, access and re-deposit of a              Deposit, access and re-deposit of a
            biological material                              biological material
                  Article 15                                      Article 13
1. Where an invention involves the use of        1. Unchanged
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:
                                              38
 ---pagebreak---                Initial proposal                  Amended 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.
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
 ---pagebreak---                Initia! proposal                             Amended proposal
3. The sample shall be supplied only if the 3. Unchanged
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.
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                                   Article 14
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
 ---pagebreak---                Initial proposal                             Amended proposal
2. Any new deposit shall be accompanied             Unchanged
by a statement signed by the applicant
certifying that the newly deposited
biological material is the same as that
originally deposited.
                CHAPTER V                        Deleted
              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                                    CHAPTER VI
               Final provisions                               Final provisions
                   Article 18                                    Article 15
 1. Member States shall bring into force the      1. Member States shall bring into force the
laws, regulations and administrative             laws, regulations and administrative
provisions necessary to comply with this         provisions necessary to comply with this
Directive not later than 1 January 2000.         Directive not later than 1 January 1999.
They shall immediately inform the                They shall immediately inform the
Commission thereof                                Commission thereof.
                                               41
 ---pagebreak---                Initial proposal                            Amended proposal
When      Member States       adopt     these Unchanged
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.
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.
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 ---pagebreak---  ---pagebreak---                                                                  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
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