CELEX: 51992PC0589
Language: en
Date: 1992-12-16
Title: Amended proposal for a COUNCIL DIRECTIVE on the legal protection of biotechnological inventions

No C 44 / 36                                Official Journal of the European Communities                                   16 . 2 . 93
                Amended proposal for a Council Directive on the legal protection of biotechnological
                                                               inventions (*)
                                                              ( 93 / C 44 / 03
                                                      COM(92) 589 final — SYN 159
                (Submitted by the Commission on 16 December 1992 pursuant to Article 149 (3) of the EEC
                                                                   Treaty)
                (') OJ No C 10 , 13 . 1 . 1989 , p. 3 .
                        ORIGINAL PROPOSAL                                                          AMENDED PROPOSAI
 THE COUNCIL OF THE EUROPEAN COMMUNITIES ,                                 THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European                      Unchanged
Economic Community , and in particular Article 100a
thereof,
Having regard to the proposal from the Commission ,                        Having regard to the proposal from the Commission ('),
In cooperation with the European Parliament ,                              Unchanged
Having regard to the opinion of the Economic and Social                    Having regard to the opinion of the Economic and Social
Committee ,                                                                Committee ( 2 ),
Whereas differences exist in the legal protection of                       Unchanged
biotechnological inventions offered by the laws and
practices of the Member States and such differences could
create barriers to trade and to the internal market ;
Whereas such differences in legal protection could well                    Unchanged
become greater as Member States adopt new and different
legislation and administrative practices or as national
jurisprudence interpreting such legislation and practices
develops differently ;
Whereas biotechnology and genetic engineering are playing                 Unchanged
an increasingly important role in a broad range of
industries and the protection of biotechnological
inventions can be considered of fundamental importance
for the Community's industrial development ;
Whereas the patent system must adapt to new                               Whereas the legal protection of biotechnological
technological developments which may involve living                       inventions does not necessitate the creation of a separate
matter but which also fulfil the requirements for                         body of law in place of the rules of national patent law ;
patentability ;
                                                                          Whereas the rules of national patent law remain the
                                                                          essential basis as far as the legal protection of
                                                                          biotechnological inventions is concerned ; whereas ,
                                                                          however , they must be adapted or supplemented in certain
                                                                          specific respects in order to take fully into account new
                                                                          technological developments which may involve biological
                                                                          material but which also fulfil the requirements for
                                                                          patentability ;
                                                                          (') OJ No C 10 , 13 . 1 . 1989 , p . 3 .
                                                                          ( 2 ) OJ No C 151 , 26 . 6 . 1989 , p . 10 .
 ---pagebreak---  16 . 2 . 93                            Official Journal of the European Communities                                No C 44 / 37
                      ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
 Wheras no prohibition or exclusion exists in national or          Unchanged
international patent laws which precludes the patentability
of living matter as such ;
                                                                   Whereas in implementing the Directive regard should be
                                                                   had to existing national patent laws , as amended by the
                                                                   Directive; whereas those laws contain provisions on the
                                                                   criteria for patentability or exclusion from patentability ,
                                                                   including provisions to the effect that a patent may not be
                                                                   granted in respect of inventions the publication or
                                                                   exploitation of which would be contrary to public policy
                                                                   ('ordre public ') or morality ;
                                                                   Whereas it is desirable to include in the body of the
                                                                   Directive such a reference to public policy and morality in
                                                                   order to highlight the fact that some applications of
                                                                   biotechnological inventions , by dint of their consequences
                                                                   or effects , are capable of offending against them ;
                                                                   Whereas it is important also to set out in the body of the
                                                                   Directive a list of inventions excluded from patentability
                                                                   so as to provide national courts and patent offices with an
                                                                   essential guide to interpreting the reference to public policy
                                                                   or morality ;
                                                                  Whereas , in the light of the general principle that the
                                                                  ownership of human beings is prohibited , the human body
                                                                  or parts of the human body per se must be excluded from
                                                                  patentability ;
                                                                  Whereas processes for modifying the genetic identity of
                                                                  human beings for a non-therapeutic purpose which is
                                                                  contrary to the dignity of man must also be excluded from
                                                                  patentability ;
                                                                  Whereas processes for modifying the genetic identity of
                                                                  animals which are likely to inflict suffering or physical
                                                                  handicaps without any benefit to man or animal must
                                                                  likewise be excluded from patentability in so far as the
                                                                  suffering or physical handicaps inflicted on the animals
                                                                  concerned are out of all proportion to the objective
                                                                  pursued ;
                                                                  Whereas this Directive is without prejudice to national and
                                                                  Community laws on the monitoring of the applications of
                                                                  research and of the use or commercialization of its results ,
                                                                  notably from the point of view of the requirements of
                                                                  public health , safety , the protection of the environment ,
                                                                  the protection of animals , the preservation of genetic
                                                                  diversity and compliance with certain ethical standards ;
Whereas national patent systems have in the past                  Unchanged
successfully adapted to technical developments and
scientific breakthroughs in according patent protection to
such developments where appropriate ;
 ---pagebreak---   No C 44 / 38                            Official Journal of the European Communities                  16 . 2 . 93
                       ORIGINAL PROPOSAL                                               AMENDED PROPOSAL
  Whereas the investments required in research and                   Unchanged
  development particularly for genetic engineering are
  especially high and especially risky and the possibility of
  recouping that investment can only effectively be
  guaranteed through adequate legal protection ;
  Whereas without effective and approximated protection             Unchanged
  throughout the Member States of the Community such
  investments might well never be made ;
 Whereas       some     inventions      developed      through      Unchanged
 biotechnology and genetic engineering are at present not
 clearly protected in all Member States by existing
 legislation ,    administrative    practice     and      court
 jurisprudence ; and such protection , where it exists , is not
 the same or has different attributes ;
 Whereas the uncoordinated development in the                       Unchanged
 Community of the legal protection of biotechnological
 inventions in the Member States could result in the
 creation of new disincentives to trade to the detriment of
 further industrial development in such inventions and of
 the completion of the internal market ;
 Whereas existing differences having such effects need to be        Unchanged
 removed and new ones having a negative impact on the
 functioning of the common market and the development
 of trade in biotechnological goods and services prevented
 from arising;
Whereas international developments in the field of legal            Unchanged
protection of the results of biotechnology and genetic
 engineering demonstrate the advantages to be gained from
 approximation of national legislation ;
Whereas scientific and technological developments are               Unchanged
often a result of international collaboration on research
and, in consequence , need exists to ensure that
biotechnological inventions may benefit from comparable
protection on an international level ;
Whereas although international instruments exist or are             Unchanged
under consideration to harmonize various aspects of the
legal protection of biotechnological inventions , they are
not sufficient for Community purposes which must take
account of the needs of Community science and industry
and a Community market ;
Whereas the patent laws applicable at present in the                Unchanged
Member States contain disparities which hinder the
development of trade in biotechnological goods and
services , distort competition within the common market
and therefore directly affect the establishment and
functioning of that market; whereas it is particularly
 ---pagebreak---  16 . 2 . 93                               Official Journal of the European Communities                               No C 44 / 39
                         ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
 important to remove these disparities because , at the stage
 reached at present in establishing the common market ,
 there would appear to be an urgent need to ensure that
 undertakings will be offered the possibility of obtaining
 effective and equivalent legal protection in all Member
 States for the results of their research activities in any part
 of the Community ;
 Whereas an approximation of the legislation of the                   Unchanged
 Member States is also necessitated by existing language in
 national laws originating in certain international patent
 and plant variety conventions which have given rise to
 considerable uncertainty as to the possibility of protecting
 biotechnological inventions concerning plant matter and
 microbiological inventions , language such as the exclusion
 from patentability of plant and animal varieties and of
 essentially biological processes for the production of plants
 and animals ;
Whereas it is necessary to encourage potential innovation            Whereas it is necessary to encourage potential innovation
 in the full range of human endeavours by recognizing that            in the full range of human endeavours by recognizing that
 human intervention which consists of more than the                   human intervention and its impact on the result achieved
 selection of biological material and allowing such material          must be taken into account in determining whether the
to perform inherently biological functions under natural             exclusion from patentability of essentially biological
conditions should be considered patentable subject-matter            processes applies , it being understood that a process
 and should not be regarded essentially biological ;                 which , taken as a whole , does not exist in nature and is
                                                                     more than a mere production process is patentable ;
Whereas it is seemly that the legislation of the Member              Unchanged
States should be harmonized in such a way so as not to
conflict with the existing international conventions on
which many Member States' patent and plant variety laws
are based ;
Whereas the Community's legal framework on the                       Whereas the Community's legal framework on the
protection of biotechnological inventions can be limited to          protection of biotechnological inventions can be limited to
laying down certain principles as they apply to the                  laying down certain principles as they apply to the
patentability of living matter as such ; to the ability to use       patentability of biological material as such ; to the ability
a deposit mechanism in lieu of written descriptions to               to use a deposit mechanism in lieu of written descriptions
satisfy the enabling disclosure requirements for patent              to satisfy the enabling disclosure requirements for patent
application procedures ; to a reversal of the burden of              application procedures ; to a reversal of the burden of
proof where release of self-replicable matter has occurred           proof; and to the right to a non-exclusive compulsory
and to the right to a non-exclusive dependency licence for           licence for plant varieties ;
plant and animal varieties ;
Whereas , in view of the fact that the function of a patent          Unchanged
is to reward the inventor with an exclusive but time-bound
right for his creative efforts and thereby encourage
inventive activities , the right holder should be entitled to
prohibit the use of patented self-replicable material in
situations analogous to those where it would be permitted
to prohibit such use of patented , non-self-replicable
products , i.e. in respect of the production of the patented
product itself;
 ---pagebreak---   No G 44 / 40                            Official Journal of the European Communities                                  16 . 2 . 93
                        ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
  Whereas , in the area of agricultural exploitation of new           Deleted
  plant characteristics resulting from genetic engineering,
  guaranteed remunerated access in the form of licences of
  right must be provided for as an exception to the general
  principles of patent law ,
                                                                     Whereas complementary measures of Community law can
                                                                     be adopted later , if necessary , in order to ensure
                                                                     consistency between patent law and the plant varieties
                                                                     protection regime ,
 HAS ADOPTED THIS DIRECTIVE :                                        HAS ADOPTED THIS DIRECTIVE :
                          CHAPTER 1                                                            CHAPTER I
                 Patentability of living matter                                   Patentability of biological material
                            Article 1                                                           Article 1
 Member States shall ensure that their national patent laws          Member States shall ensure that legal protection for
 comply with the provisions of this Directive .                      biotechnological inventions on the basis of their national
                                                                     patent laws complies with the provisions of this
                                                                     Directive .
                           Article 2                                                            Article 2
A subject-matter of an invention shall not be considered             1.    A subject-matter of an invention shall not be
unpatentable for the reason only that it is composed of             considered unpatentable for the reason only that it is
living matter .                                                     composed of, uses or is applied to biological material .
                                                                    2.     'Biological material' within the meaning of this
                                                                    Directive means any self-replicating living matter and any
                                                                    matter capable of being replicated through a biological
                                                                    system or by any indirect means .
                                                                    3.     Inventions shall be considered unpatentable where
                                                                    publication or exploitation thereof would be contrary to
                                                                    public policy or morality , provided that the exploitation
                                                                    shall not be deemed to be so contrary merely because it is
                                                                   prohibited by law or regulation in some or all of the
                                                                   Member States .
                                                                    On this basis ,      the following inter alia shall be
                                                                   unpatentable :
                                                                   ( a ) the human body or parts of the human body
                                                                         per se;
                                                                   ( b ) processes for modifying the genetic identity of the
                                                                         human body for a non-therapeutic purpose which is
                                                                         contrary to the dignity of man ;
                                                                   ( c) processes for modifying the genetic identity of animals
                                                                         which are likely to inflict suffering or physical
                                                                         handicaps upon them without any benefit to man or
                                                                         animal .
 ---pagebreak---   16 . 2 . 93                             Official Journal of the European Communities                                No C 44 / 41
                        ORIGINAL PROPOSAL                                                     AMENDED PROPOSAL
                                                                      4.     This    Directive   shall   not affect national   and
                                                                      Community laws on the monitoring of the applications of
                                                                      research and of the use or commercialization of its
                                                                      results .
                            Article 3                                                             Article 3
  1.     Micro-organisms , biological classifications other           Biological material , including plants and animals , as well
  than plant or animal varieties as well as parts of plant and        as parts of plants and animals , except plant and animal
  animal varieties other than propagating material thereof of         varieties , shall be patentable .
 the kind protectable under plant variety protection law
  shall be considered patentable subject-matter . Claims for
 classifications higher than varieties shall not be affected by
 any rights granted in respect of plant and animal
 varieties .
 2.      Notwithstanding the provisions of paragraph 1 ,             Deleted
 plants and plant material shall be considered patentable
 subject-matter unless such material is produced by the
 non-patentable use of a previously known biotechnological
 process .
                            Article 4                                                            Article 4
 Uses of plant or animal varieties and processes for the             Uses of plant or animal varieties or of processes for their
 production thereof shall be considered patentable                   production , other than essentially biological processes ,
 subject-matter .                                                    shall be patentable .
                           Article 5                                                             Article 5
 Microbiological processes shall be considered patentable            1.     Microbiological processes shall be patentable . For
 subject-matter. For purposes of this Directive, this term          the purposes of this Directive , 'microbiological process'
 shall be taken to mean and to include a process ( or               means a process involving or performed upon or resulting
processes ) carried out with the use of or performed upon            in microbiological material .
or resulting in a micro-organism .
                                                                    2.      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 .
                           Article 6                                Deleted
A process consisting of a succession of steps shall be
regarded a microbiological process , if the essence of the
invention is incorporated in one or more microbiological
steps of the process .
                           Article 7                                                             Article 6
A process in which human intervention consists in more              Essentially biological processes shall not be patentable . In
than selecting an available biological material and letting it      determining whether this exclusion applies , human
perform an inherent biological function under natural               intervention and its impact on the result achieved shall be
conditions shall be considered patentable subject-matter .          taken into account . A process which , taken as a whole ,
                                                                    does not exist in nature and is more than a mere
                                                                    production process shall be patentable .
 ---pagebreak---  No C 44 / 42                             Official Journal of the European Communities                                  16 . 2 . 93
                        ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
                            Article 8                                                         Article 7
 A subject-matter of an invention , including a mixture,             An invention concerning a biological material shall not be
 which formed an unseparated part of a pre-existing                  considered a discovery or lacking in novelty for the reason
 material , shall not be considered unpatentable for the             only that , although not known , it formed part of an
 reason only that it formed part of said natural material .          existing material .
                            Article 9                                Deleted
 A subject-matter of an invention , including a mixture ,
 which formed an unseparated part of a pre-existing
 material , shall not be considered as an unpatentable
 discovery or as lacking novelty for the reason only that it
 formed part of said natural material .
                          CHAPTER 2
                      Scope of protection
                           Article 10                                Deleted
The use of a product protected by a patent comprising or
consisting of genetic information to develop another such
product or the use of a patented process to obtain such a
product shall not be regarded as experimental for purposes
of establishing patent infringement, if the developed
product obtained from the experiments or its progeny in
identical or differentiated form , is used for other than
private or experimental purposes .
                           Article 1 1                              Deleted
If a product enjoying patent protection and put on the
market by the patentee or with his consent is
self-replicable, the rights conferred by the national patent
shall not extend to acts of multiplication and propagation
only where such acts are unavoidable for commercial uses
other than multiplication and propagation .
                                                                                            Article 8
                                                                    Methods for treatment of the human or animal body by
                                                                    surgery or therapy and diagnostic methods practised on
                                                                    the human or animal body shall not be patentable . This
                                                                    provision shall not apply to products , in particular
                                                                    substances or compositions , for use in any of these
                                                                   methods .
 ---pagebreak---  16 . 2 . 93                                Official Journal of the European Communities                              No C 44 / 43
                          ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
                                                                                                 Article 9
                                                                       A process comprising a succession of steps shall not be
                                                                       excluded from patentability for the reason only that one or
                                                                       more of the steps involve a surgical , therapeutic or
                                                                       diagnostic method practised on the animal body . The
                                                                       treatment or diagnostic method shall not , however , be
                                                                       protected per se.
                                                                                               CHAPTER II
                                                                                            Scope of protection
                             Article 12                                                         Article 10
 1.       If the subject-matter of a patent is a process for the       1.    The protection conferred by a patent on a biological
 production of living matter or other matter containing                material possessing, as a result of the invention , specific
genetic information permitting its multiplication in                   characteristics shall extend to all biological materials
identical or differentiated form , the rights conferred by the         derived from that biological material through
patent shall not only extend to the product initially                 multiplication or propagation and possessing the same
obtained by the patented process but also the identical or            characteristics .
differentiated products of the first or subsequent
generations obtained therefrom , said products being
deemed also directly obtained by the patented process .
2.       Any extension of the protection conferred by the             2.     The protection conferred by a patent on a process
patent to a process as indicated under paragraph 1 to a               that enables the production of a biological material
product obtained thereby shall not be affected by an                  possessing, as a result of the invention , specific
exclusion of plant or animal varieties from patentability .           characteristics shall extend to biological material directly
                                                                      obtained using that process and to any other biological
                                                                      material derived from such biological material through
                                                                      multiplication or propagation and possessing the same
                                                                      characteristics . This extension of protection shall not be
                                                                      affected by the exclusion from patentability of plant and
                                                                      animal varieties provided for in Article 3 of this
                                                                      Directive .
                                                                                                Article 11
                                                                      The protection referred to in Article 10 shall not extend to
                                                                      biological material derived from biological material that
                                                                      has been marketed by the patent holder or with his
                                                                      consent if the multiplication or propagation result from
                                                                      the application for which the material was marketed .
                             Article 13                                                         Article 12
The protection for a product consisting of or containing              The protection conferred by a patent on a product
particular genetic information as an essential characteristic         containing or consisting of genetic information shall
of the invention shall extend to any products in which said           extend to all material in which the product is incorporated
genetic information has been incorporated and is of                   and in which the genetic information is contained and
essential importance for its industrial applicability or              expressed .
utility .
 ---pagebreak--- No C 44 / 44                              Official Journal of the European Communities                                   16 . 2 . 93
                        ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
                                                                                                Article 13
                                                                     1.     By way of derogation from Chapter II of this
                                                                     Directive , farmers may use for purposes of multiplication
                                                                     or propagation on their own farms the seeds obtained
                                                                     from crops cultivated on their own farms using seeds
                                                                     protected by patent . Only multiplication or propagation
                                                                     with a view to producing crops for the farmers concerned
                                                                     can be authorized .
                                                                     2.    By way of derogation from Chapter II of this
                                                                     Directive , farmers rearing livestock protected by patent
                                                                     may use it for multiplication purposes on their own farms
                                                                     to renew their stock .
                          CHAPTER 3                                                          CHAPTER III
            Dependency licence for plant varieties                                       Compulsory licence
                           Article 14                                                           Article 14
 1.    If the holder of a plant breeders' right or a variety         1.    If the holder of a patent on a biotechnological
certificate can exploit or exercise his exclusive rights only       invention refuses to allow another party who is the holder
by infringement of the rights attached to a prior national          of a plant variety right to use the invention in return for an
patent , a non-exclusive licence of right shall be accorded         appropriate royalty , a non-exclusive compulsory licence
to the breeders' right holder to the extent necessary for the       may be sought from the competent authority and it shall
exploitation of such breeders' right where the variety              be granted upon payment of an appropriate royalty if this
protected represents significant technical progress , upon          is in the public interest .
payment of reasonable royalties having regard to the
nature of the patented invention and consistent with giving
the proprietor of such patent due reward for the
investment leading to and developing the invention .
2.     A licence under paragraph 1 shall not be available           2.     Each Member State shall designate the authority
prior to the expiration of three years from the date of the         competent to grant licences and shall inform the
grant of the patent or four years from the date on which            Commission of each licence granted .
the application for a patent was filed , whichever period
last expires .
3.     If a licence according to paragraph 1 has been               3.     If the holder of a plant variety right refuses to allow
granted , and if a variety protected by a plant breeders'           another party who is the holder of a patent to engage in
right or variety certificate can be exploited by the patentee       activities requiring his consent on reasonable terms , a
only by infringement of the rights attached to such variety ,       non-exclusive compulsory licence may be sought from the
a non-exclusive licence shall be accorded to the original           competent authority and it shall be granted upon payment
patentee to the extent necessary for the exploitation of the        of an appropriate royalty if this is in the public interest .
breeders' right or variety certificate , upon payment of
reasonable royalties having regard to the nature of the
improvement and consistent with giving the proprietor of
the breeders' right due reward for the investment leading
to and developing the new variety .
4.     Where disagreements arise with regard to the                 4.     An appeal shall lie from decisions of the competent
significance of the technical progress and as to the level of       authority to the courts .
royalties , Member States shall provide for a court of
competent jurisdiction to resolve the dispute .
 ---pagebreak---  16 . 2 . 93                                    Official Journal of the European Communities                                 No C 44 / 45
                              ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
                                CHAPTER 4                                                            CHAPTER IV
                       Deposit, access and re-deposit                                      Deposit, access and re-deposit
                                 Article 15                                                           Article 15
 1.       If an invention involves the use of a micro-organism              1.     Where an invention involves the use of or concerns a
or other self-replicable matter which is not available to the              biological material which is not available to the public and
public and which cannot be described in a patent                           which cannot be described in a patent application in such
 application in such a manner as to enable the invention to                a manner as to enable the invention to be carried out by a
be carried out by a person skilled in the art , or if it                   person skilled in the art , the description shall be considerd
concerns such matter per se, the invention shall only be                   inadequate for the purposes of patent law unless :
regarded as being disclosed for purposes of national patent
law if:
( a ) the micro-organism or other self-replicable matter has               ( a ) the biological material has been deposited , no later
       been deposited with a recognized depositary                               than the date on which the patent application was
        institution not later than the date of filing of the                     filed , at least with an authorized institution in
        application ;                                                            accordance with the provisions of the Budapest
                                                                                 Treaty on the international recognition of the deposit
                                                                                 of micro-organisms for the purposes of patent
                                                                                 procedure of 28 April 1977 ;
( b ) the application as filed gives such relevant                         ( b ) the application as filed contains such relevant
       information as is available to the applicant on the                       information as is available to the depositor on the
       characteristics of the micro-organism or other                            characteristics of the biological material deposited ;
       self-replicable matter ;
( c ) the depositary institution and the file number of the                ( c ) the patent application states the name of the
       deposit are stated in the application .                                   authorized depositary institution and the accession
                                                                                 number identifying the deposited biological material .
2.        The information referred to in paragraph 1(c) may               Deleted
be submitted :
( a ) within a period of 16 months after the date of filing
       of the application or , if priority is claimed , after the
       priority date ;
( b ) up to the date of submission of a request for early
       publication of the application ;
( c ) within one month after the national patent office has
       communicated to the applicant that a right to
       inspection of the files exists pursuant to paragraph 3
       ( a ) ( ii ) below .
The ruling period shall be the one which is the first to
expire. The communication of this information shall be
considered as constituting the unreserved and irrevocable
consent of the applicant to the deposited matter being
available to the public in accordance with this Article .
3 . ( a ) Unless the application has been refused or                      2.      Access to the deposited biological material shall be
             withdrawn or is deemed to be withdrawn , the                 provided through the supply of a sample :
             deposited matter shall be available upon request :
              ( i ) to any person from the date of publication of         ( a ) up to the first publication of the patent application , to
                     the patent application ; and                                only those persons who are authorized under national
                                                                                 patent law ;
 ---pagebreak---  No C 44 / 46                                   Official Journal of the European Communities                                   16 . 2 . 93
                              ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
                                                                           ( b ) between the first publication of the application and
                                                                                 the granting of the patent , to anyone requesting it or ,
                                                                                 if the depositor so requests , only to an independent
                                                                                 expert ;
            ( ii ) to any person having a right to inspect the             (c ) after the patent has been granted , to anyone
                     files under the provisions of national patent               requesting it .
                    law relating to applications under which
                     rights are invoked against such a party , prior
                    to the date of publication .
      ( b ) Subject to the provisions of paragraph 4 , such                3.      Unless the patent holder or applicant , as applicable ,
            availability shall be effected by the issue of a               abandons his rights , the sample can be supplied only if the
            sample of the deposited matter to the person                   person requesting it undertakes , for the duration of the
            making the request ( hereinafter referred to as the            validity of the patent :
            'requester'). Said issue shall be made only if the
            requester has undertaken vis-a-vis the applicant for
            or proprietor of the patent :
              ( i ) not to make the deposited matter or any               ( a ) not to make it or any matter derived therefrom
                    matter derived therefrom available to any                    available to third parties ;
                    third party ;
            ( ii ) to use the deposited matter or any matter              ( b ) not to use it or any matter derived therefrom in any
                    derived therefrom in any country only for                    country except for experimental purposes .
                    experimental purposes concerning the
                    invention , with the proviso that this
                    restriction will cease , in the country of the
                    patent right on the basis of which the sample
                    of the deposited matter was obtained , with
                    the grant of a patent or other enforceable
                    right in the invention involved . This provision
                    shall not apply in the country of the patent
                    right on the basis of which the sample of the
                    deposited matter was obtained in so far as the
                    requester is using the matter under a
                    compulsory licence . The term 'compulsory
                    licence' shall be construed as including ex
                    officio licences and the right to use patented
                    inventions in the public interest .
4.        Until the date on which the technical preparations              Deleted
for publication of the application are deemed to have been
completed , the applicant may inform the national patent
office that , until the publication of the mention of the
grant of the patent , the availability referred to in
paragraph 3 shall be effected only by the issue of a sample
to an expert nominated by the requester .
5.        The following may be nominated as an expert :                   Deleted
( a ) any natural person provided that the requester
        furnishes evidence , when filing the request , that the
        nomination has the approval of the applicant ;
( b ) any natural person recognized as an expert by the
        national patent office . The nomination shall be
        accompanied by an undertaking from the expert
        vis-a-vis the applicant ; paragraphs 3 (b ) ( i ) and ( ii )
        shall apply , the requester being regarded as a third
        party .
 ---pagebreak---   16 . 2 . 93                               Official Journal of the European Communities                             No C 44 / 47
                          ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
  6.      For the purposes of paragraph 3 ( b ), any matter            Deleted
  derived from the deposited matter shall be deemed to be
  any matter derived therefrom by culturing or in any other
  way of replication which matter still exhibits those
  characteristics of the deposited matter which are essential
  to or for carrying out the invention . The undertaking
  referred to in paragraph 3 ( b ) shall not impede a deposit of
  derived matter, necessary for the purposes of patent
  procedure .
 7.       The request provided for in paragraph 3 shall be             Deleted
 submitted to the national patent office on a form
 recognized by that office . The national patent office shall
 certify on the form that a national patent application
 referring to the deposit of the micro-organism or other
 self-replicable matter has been filed , and that the requester
 or the expert nominated by him is entitled to the issue of a
 sample of the micro-organism or other self-replicable
 matter .
 8.      The national patent office shall transmit a copy of           Deleted
 the request , with the certification provided for in
 paragraph 7 to the depositary institution as well as to the
 applicant for , or the proprietor of, the patent .
 9.      Member States shall designate recognized depositary          Deleted
 institutions for purposes of this Article .
 10 .      If a micro-organism or other self-replicable material      Deleted
has been deposited in accordance with paragraphs 1 and 2
 and has become available to any person or an expert in
 accordance with paragraphs 3 or 4 , it shall henceforth be
regarded available to the public in accordance with
paragraph 1 .
                                                                      4.     At the depositor's request , where an application is
                                                                      refused or withdrawn or a patent is revoked or cancelled ,
                                                                      access to the deposited material shall be limited to an
                                                                      independent expert for 20 years from the date on which
                                                                      the patent application was filed . In the abovementioned
                                                                      case , the provisions of paragraph 3 shall apply .
                             Article 16                                                         Article 16
1.      If a micro-organism or other self-replicable matter           If the biological material deposited in accordance with
deposited in accordance with Article 15 ceases to be                  Article 15 ceases to be available from the authorized
available from the institution with which it was deposited            depositary institution , a new deposit of the material shall
because :                                                             be permitted in accordance with the provisions of the
                                                                      Budapest Treaty on the international recognition of the
( a ) the micro-organism or other self-replicable matter is           deposit of micro-organisms for the purposes of patent
       no longer viable ; or                                          procedure of 28 April 1977 .
( b ) for any other reason the depositary institution is
       unable to supply samples ,
and if the micro-organism or other self-replicable matter
has not been transferred to another depositary institution
recognized for the purposes of Article 15 , from which it
continues to be available , an interruption in availability
 ---pagebreak---  No C 44 / 48                            Official Journal of the European Communities                  16 . 2 . 93
                       ORIGINAL PROPOSAL                                              AMENDED PROPOSAL
 shall be deemed not to have occurred if a new deposit of
 the micro-organism or other self-replicable matter
 originally deposited is made within a period of three
 months from the date on which the depositor was notified
 of the interruption by the depositary institution and if a
 copy of the receipt of the deposit issued by the institution
 is forwarded to the national patent office within four
 months from the date of the new deposit stating the
 number of the application or of the national patent .
 2.    In the case provided for in paragraph 1 ( a ), the new      Deleted
 deposit shall be made with the depositary institution with
 which the original deposit was made ; in the cases provided
 for in paragraph 1 ( b ), it may be made with another
depositary institution recognized for the purposes of
Article 15 ( 9 ).
3.     Where the institution with which the original deposit       Deleted
was made ceases to be recognized for the purposes of the
application of Article 15 , whether entirely or for the kind
of micro-organism or other self-replicable matter to which
the deposited micro-organism or other self-replicable
matter belongs , or where that institution discontinues ,
temporarily or definitively , the performance of its
functions as regards deposited micro-organisms or other
self-replicable matter , and the notification referred to in
paragraph 1 from the depositary institution is not received
within six months from the date of such event , the
three-month period referred to in paragraph 1 shall begin
on the date on which this event is announced in the official
publication of the national patent office .
4.     Any new deposit shall be accompanied by a                   Deleted
statement signed by the depositor alleging that the newly
deposited micro-orgariism or other self-replicable matter is
the same as that originally deposited .
5.     If the new deposit provided for in the present Article      Deleted
has been made under the Budapest Treaty on the
international recognition of the deposit of micro-organisms
for the purposes of patent procedure of 28 April 1977 , the
provisions of that Treaty shall prevail in case of conflict .
6.     If a deposit is not accepted or if the deposited            Deleted
material is no longer available from the depositary
institution and a re-deposit according to paragraphs 1 to 5
does not or could not remedy the unavailability , such
unavailability shall not affect the patentability of the
invention if the applicant / patentee provides the requesting
party entitled to receive a sample with such same certifying
its identity with the material used in the invention or
obtained as the invention or with the originally deposited
material , as the case may be .
 ---pagebreak---  16 . 2 . 93                              Official Journal of the European Communities                             No C 44 / 49
                        ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
 7.      If a patent is deemed invalid because the patentee          Deleted
 can no longer provide for a sample of the deposited
 material in accordance with this Article , such invalidity
 shall in no case have retroactive effects .
                          CHAPTER 5                                                         CHAPTER V
                Reversal of the burden of proof                                   Reversal of the burden of proof
                           Article 17                                                        Article 17
 1.      If the subject-matter of a patent is a process for          1.    If the subject-matter of a patent is a process for
 obtaining a new or known product , the same product                 obtaining a new product , any identical product produced
when produced by any other party shall , in the absence of           by any person other than the patent holder shall , in the
proof to the contrary , be deemed to have been obtained by           absence of proof to the contrary , be deemed to have been
the patented process , if a necessary means to carry out the         obtained by means of the patented process .
process had been deposited in accordance with Article 14
and had been released to a third party .
2.      In the adduction of proof to the contrary , the              2.    In the adduction of proof to the contrary , the
legitimate interests of the defendant in protecting his             legitimate interests of the defendant in protecting his
manufacturing and business secrets shall be taken into               manufacturing and business secrets shall be taken into
account .                                                            account .
                          CHAPTER 6                                                        CHAPTER VI
                         Miscellaneous                                                    Final provisions
                           Article 18                               Deleted
Any exclusion from patentability or from the field of
industrial applicability of surgical or diagnostic methods
practised on an animal body shall apply to such methods
only if practised for a therapeutic purpose .
                           Article 19
For the purposes of this Directive :                                Deleted
( a ) the word 'micro-organism', where used , shall be
      interpreted in its broadest sense as including all
      microbiological entities capable of replication , e.g. as
      comprising , inter alia, bacteria , fungi , viruses ,
      mycoplasmae , rickettsiae , algae , protozoa , and cells ;
      and
( b ) the word 'self-replicable matter', where used , shall be
      interpreted to comprise also matter possessing the
      genetic material necessary to direct its own replication
      via a. host organism or in any other indirect way , e.g.
      as comprising , inter alia, seeds , plasmids , DNA
      sequences , protoplasts , replicons and tissue cultures .
 ---pagebreak--- No C 44 / 50                            Official Journal of the European Communities                                16 . 2 . 93
                      ORIGINAL PROPOSAL                                                 AMENDED PROPOSAL
                         Article 20                                                        Article 18
 1.   Member States shall bring into force the laws                1.    The Member States shall adopt the laws , regulations
necessary to comply with this Directive not later than             and administrative provisions necessary for their
31 December 1990 .                                                 compliance with this Directive not later than
                                                                  When they adopt such measures the Member States shall
                                                                   include references to this Directive or shall make such
                                                                  references when they effect official publication . The
                                                                   manner in which such references are to be made shall be
                                                                  laid down by the Member States .
2.    Member      States    shall   communicate     to   the      2.     The   Member    States  shall communicate    to    the
Commission the texts of the main provisions of national           Commission the texts of the provisions of national law
law which they adopt in this field covered by this                which they adopt in the field covered by this Directive .
Directive .
                         Article 21                                                        Article 19
This Directive is addressed to the Member States .                Unchanged