CELEX: 51988PC0496
Language: en
Date: 1988-10-21
Title: PROPOSAL FOR A COUNCIL DIRECTIVE ON THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS

13. 1. 89                             Official Journal of the European Communities                              No C 10/3
                                                             II
                                                     (Preparatory Acts)
                                                COMMISSION
                   Proposal for a Council Directive on the legal protection of biotechnological inventions
                                              COM(88) 496 final — SYN 159
                                    (Submitted by the Commission on 20 October 1988)
                                                       (89/C 10/03)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                         scientific breakthroughs in according patent protection
                                                                 to such developments where appropriate;
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100A               Whereas the investments required in research and devel-
thereof,                                                         opment particularly for genetic engineering are especially
                                                                 high and especially risky and the possibility for
                                                                 recouping that investment can only effectively be
Having regard to the proposal from the Commission,
                                                                 guaranteed through adequate legal protection;
In cooperation with the European Parliament,
                                                                 Whereas without effective and approximated protection
                                                                 throughout the Member States of the Community, such
Having regard to the opinion of the Economic and                 investments might well never be made;
Social Committee,
                                                                 Whereas some inventions developed through biotech-
Whereas differences exist in the legal protection of             nology and genetic engineering are at present not clearly
biotechnological inventions offered by the laws and              protected in all Member States by existing legislation,
practices of the Member States and such differences              administrative practice, and court jurisprudence, and
could create barriers to trade and to the creation and           such protection, where it exists, is not the same or has
proper functioning of the internal market;                       different attributes;
Whereas    such differences in legal protection could well       Whereas the uncoordinated development in the
become     greater as Member States adopt new and                Community of the legal protection for biotechnological
different   legislation and administrative practices or as       inventions in the Member States could result in the
national  jurisprudence interpreting such legislation and        creation of new disincentives to trade to the detriment of
practices  develops differently;                                 further industrial development in such inventions and of
                                                                 the completion of the internal market;
Whereas biotechnology and genetic engineering are
playing an increasingly important role in a broad range          Whereas existing differences having such effects need to
of industries and the protection of biotechnological             be removed and new ones having a negative impact on
inventions can be considered of fundamental importance           the functioning of the common market and the devel-
for the Community's industrial development;                      opment of trade in biotechnological goods and services
                                                                 prevented from arising;
Whereas the patent system must adapt to new techno-
logical developments which may involve living matter but         Whereas international developments in the field of legal
which also fulfil the requirements for patentability;            protection of the results of biotechnology and genetic
                                                                  engineering demonstrate the advantages to be gained
                                                                  from approximation of national legislation;
Whereas no prohibition or exclusion exists in national or
international patent laws which precludes the patenta-
bility of living matter as such;                                 Whereas scientific and technological developments are
                                                                  often a result of international collaboration on research
                                                                  and, in consequence, need exists to ensure that biotech-
Whereas national patent systems have in the past                  nological inventions may benefit from comparable
successfully adapted to technical developments and                protection on an international level;
 ---pagebreak---  No C 10/4                             Official Journal of the European Communities                                   13. 1. 89
 Whereas international instruments exist or are under             patentability of living matter as such; to the ability to use
 consideration to harmonize various aspects of the legal          a deposit mechanism in lieu of written descriptions to
 protection of biotechnological inventions, they are not          satisfy the enabling disclosure requirements for patent
 sufficient for Community purposes which must take                application procedures; to a reversal of the burden of
 account of the needs of Community science and industry           proof where release of self-replicable matter has
 and a Community market;                                          occurred and to the right to a non-exclusive dependency
                                                                  license for plant and animal varieties;
                                                                 Whereas, in view of the fact that the function of a patent
Whereas the patent laws applicable at present in the              is to reward the inventor with an exclusive but
 Member States contain disparities which hinder the               time-bound right for his creative efforts and thereby
 development of trade in biotechnological goods and               encourage inventive activities, the rightholder should be
 services, distort competition within the common market           entitled to prohibit the use of patented self-replicable
 and therefore directly affect the establishment and func-        material in situations analogous to those where it would
 tioning of that market; whereas it is particularly               be permitted to prohibit such use of patented,
 important to remove these disparities because at the stage       non-self-replicable products, i. e. in respect of the
reached at present in establishing the common market,             production of the patented product itself;
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           Whereas, in the area of agricultural exploitation of new
 States for the results of their research activities in any       plant characteristics resulting from genetic engineering,
part of the Community;                                            guaranteed remunerated access in the form of licenses of
                                                                  right must be provided for as an exception to the general
                                                                  principles of patent law,
Whereas an approximation of the legislation of the                HAS ADOPTED THIS DIRECTIVE:
 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                                 CHAPTER 1
protecting biotechnological inventions concerning plant
matter and microbiological inventions, language such as                          Patentability of living matter
the exclusion from patentability of plant and animal
varieties and of essentially biological processes for the
production of plants and animals;                                                           Article 1
                                                                  Member States shall ensure that their national patent
                                                                 laws comply with the provisions of this Directive.
Whereas it is necessary to encourage potential inno-
                                                                                            Article 2
vation in the full range of human endeavours by recog-
nizing that human intervention which consists of more            A subject matter of an invention shall not be considered
then the selection of biological material and allowing           unpatentable for the reason only that it is composed of
such material to perform inherently biological functions         living matter.
under natural conditions should be considered patentable
subject matter and should not be regarded essentially
biological;                                                                                 Article 3
                                                                  1.    Micro-organisms, biological classifications other
                                                                 than plant or animal varieties as well as parts of plant
                                                                 and animal varieties other than propagating material
Whereas it is seemly that the legislation of the Member          thereof of the kind protectable under plant variety
States should be harmonized in such a way so as not to           protection law shall be considered patentable subject
conflict with the existing international conventions on          matter. Claims for classifications higher than varieties
which many Member States' patent and plant variety               shall not be affected by any rights granted in respect of
laws are based;                                                  plant and animal varieties.
                                                                 2.     Notwithstanding the provisions of paragraph 1,
                                                                 plants and plant material shall be considered patentable
Whereas the Community's legal framework on the                   subject matter unless such material is produced by the
protection of biotechnological inventions can be limited         non-patentable use of a previously known biotechno-
to laying down certain principles as they apply to the           logical process.
 ---pagebreak--- 13. 1. 89                              Official Journal of the European Communities                                No C 10/5
                          Article 4                               developed product obtained from the experiments or its
                                                                  progeny in identical or differentiated form, is used for
Uses of plant or animal varieties and processes for the           other than private or experimental purposes.
production thereof shall be considered patentable subject
matter.
                                                                                            Article 11
                          Article 5                               If a product enjoying patent protection and put on the
                                                                  market by the patentee or with his consent is self-
Microbiological processes shall be considered patentable
                                                                  replicable, the rights conferred by the national patent
subject matter. For purposes of this Directive, this term
                                                                  shall not extend to acts of multiplication and propa-
shall be taken to mean and to include a process (or
                                                                  gation only where such acts are unavoidable for
processes) carried out with the use of or perfomed upon
                                                                  commercial uses other than multiplication and propa-
or resulting in a micro-organism.
                                                                  gation.
                          Article 6
                                                                                            Article 12
A process consisting of a succession of steps shall be
regarded a microbiological process, if the essence of the          1.    If the subject matter of a patent is a process for the
invention is incorporated in one or more microbiological          production of living matter or other matter containing
steps of the process.                                             genetic information permitting its multiplication in
                                                                  identical or differentiated form, the rights conferred by
                                                                  the patent shall not only extend to the product initially
                                                                  obtained by the patented process but also to the identical
                          Article 7                                or differentiated products of the first or subsequent
                                                                   generations obtained therefrom, said products being
A process in which human intervention consists in more             deemed also directly obtained by the patented process.
than selecting an available biological material and letting
 it perform an inherent biological function under natural
 conditions shall be considered patentable subject matter.
                                                                   2.     Any extension of the protection conferred by the
                                                                   patent to a process as indicated under paragraph 1 to a
                                                                   product obtained thereby shall not be affected by any
                           Article 8                               exclusion of plant or animal varieties from patentability.
 A subject matter of an invention, including a mixture,
 which formed an unseparated part of a pre-existing
 material, shall not be considered unpatentable for the
                                                                                            Article 13
 reason that it formed part of said natural material.
                                                                   The protection for a product consisting of or containing
                                                                   particular genetic information as an essential charac-
                                                                   teristic of the invention shall extend to any products in
                           Article 9                               which said genetic information has been incorporated
 A subject matter of an invention, including a mixture,            and is of essential importance for its industrial applica-
 which formed an unseparated part of a pre-existing                bility or utility.
  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 3
                                                                               Dependency license for plant varieties
                         CHAPTER 2
                     Scope of protection
                                                                                             Article 14
                                                                    1.    If the holder of a plant breeders' right or a variety
                          Article 10                               certificate can exploit or exercise his exclusive rights only
                                                                   by infringement of the rights attached to a prior national
 The use of a product protected by a patent comprising             patent, a non-exclusive license of right shall be accorded
  or consisting of genetic information to develop another          to the breeders' right holder to the extent necessary for
  such product or the use of a patented process to obtain          the exploitation of such breeders' right where the variety
  such a product shall not be regarded experimental for            protected represents a significant technical progress,
  purposes of establishing patent infringement, if the             upon payment of reasonable royalties having regard to
 ---pagebreak--- No C 10/6                              Official Journal of the European Communities                                   13. 1. 89
the nature of the patented invention and consistent with          (a) within a period of 16 months after the date of filing
giving the proprietor of such patent due reward for the               of the application or, if priority is claimed, after the
investment leading to and developing the invention.                   priority date;
                                                                  (b) up to the date of submission of a request for early
2.    A license under paragraph 1 shall not be available              publication of the application;
prior to the expiration of three years from the date of
the grant of the patent or four years from the date on
                                                                  (c) within one month after the national patent office has
which the application for a patent was filed, whichever
                                                                      communicated to the applicant that a right to
period last expires.
                                                                      inspection of the files exists pursuant to paragraph
                                                                      3 (a) (ii) below.
3.    If a license according to paragraph 1 has been
granted, and if a variety protected by a plant breeders'          The ruling period shall be the one which is the first to
right or variety certificate can be exploited by the              expire. The communication of this information shall be
patentee only by infringement of the rights attached to           considered as constituting the unreserved and irrevocable
such variety, a non-exclusive license shall be accorded to        consent of the applicant to the deposited matter being
the original patentee to the extent necessary for the             made available to the public in accordance with this
exploitation of the breeders' right or variety certificate,       Article.
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          (3) (a) Unless the application has been refused or
investment leading to and developing the new variety.                      withdrawn or is deemed to be withdrawn, the
                                                                           deposited matter shall be available upon request:
4.    Where disagreements arise with regard to the                          (i) to any person from the date of publication
significance of the technical progress and as to the level                      of the patent application; and
of royalties, Member States shall provide for a court of                   (ii) to any person having a right to inspect the
competent jurisdiction to resolve the dispute.                                  files under the provisions of national patent
                                                                                law relating to applications under which
                                                                                rights are invoked against such a party, prior
                        CHAPTER 4                                               to the date of publication;
               Deposit, access and re-deposit                         (b) Subject to the provisions of paragraph 4, such
                                                                           availability shall be effected by the issue of a
                                                                           sample of the deposited matter to the person
                         Article 15                                        making the request (hereinafter referred to as the
                                                                           'requester'). Said issue shall be made only if the
1.    If an invention involves the use of a micro-                         requester has undertaken vis-a-vis the applicant
organism or other self-replicable matter which is not                      for or proprietor of the patent:
available to the public and which cannot be described in
a patent application in such a manner as to enable the                      (i) not to make the deposited matter or any
                                                                                matter derived therefrom available to any
invention to be carried out by a person skilled in the art,
                                                                                third party;
or if it concerns such matter per se, the invention shall
only be regarded as being disclosed for purposes of                        (ii) to use the deposited matter or any matter
national patent law if:                                                         derived therefrom in any country only for
                                                                                experimental     purposes    concerning     the
                                                                                invention, with the proviso that this
(a) the micro-organism or other self-replicable matter                          restriction will cease, in the country of the
    has been deposited with a recognized depositary                             patent right on the basis of which the sample
    institution not later than the date of filing of the                        of the deposited matter was obtained, with
    application;                                                                the grant of a patent or other enforceable
                                                                                right in the invention involved. This
(b) the application as filed gives such relevant infor-                         provision shall not apply in the country of
    mation as is available to the applicant on the charac-                      the patent right. on the basis of which the
    teristics of the micro-organism or other self-                              sample of the deposited matter was obtained
    replicable matter;                                                          in so far as the requester is using the matter
                                                                                under a compulsory license. The term
                                                                                'compulsory license' shall be construed as
(c) the depositary institution and the file number of the                       including ex officio licenses and the right to
    deposit are stated in the application.                                      use patented inventions in the public interest.
2.    The information referred to in paragraph 1 (c) may         4.    Until the date on which the technical preparations
be submitted:                                                    for publication of the application are deemed to have
 ---pagebreak--- 13. 1. 89                               Official Journal of the European Communities                              No C 10/7
been completed, the applicant may inform the national              (a) the micro-organism or other self-replicable matter is
patent office that, until the publication of the mention of             no longer viable; or
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.
                                                                   (b) for any other reason the depositary institution is
                                                                        unable to supply samples;
5.    The following may be nominated as an expert:
(a) any natural person provided that the requester                 and if the micro-organism or other self-replicable matter
     furnishes evidence, when filing the request, that the         has not been transferred to another depositary institution
     nomination has the approval of the applicant;                 recognized for the purposes of Article 15, from which it
                                                                   continues to be available, an interruption in availability
(b) any natural person recognized as an expert by the              shall be deemed not to have occurred if a new deposit of
     national patent office. The nomination shall be               the micro-organism or other self-replicable matter orig-
     accompanied by an undertaking from the expert                 inally deposited is made within a period of three months
     vis-d-vis the applicant; paragraph 3 (b) (i) and (ii)         from the date on which the depositor was notified of the
     shall apply, the requester being regarded as a third          interruption by the depositary institution and if a copy of
    party.                                                         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
6.     For the purposes of paragraph 3 (b), any matter             number of the application or of the national patent.
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        2.    In the case provided for in paragraph 1 (a), the new
to or for carrying out the invention. The undertaking              deposit shall be made with the depositary institution with
referred to in paragraph 3 (b) shall not impede a deposit          which the original deposit was made; in the cases
of derived matter, necessary for the purposes of patent            provided for in paragraph 1 (b), it may be made with
procedure.                                                         another depositary institution recognized for the
                                                                   purposes of Article 15 (9).
7.     The request provided for in paragraph 3 shall be
submitted to the national patent office on a form
recognized by that office. The national patent office
                                                                   3.    "Where the institution with which the original
shall certify on the form that a national patent
                                                                   deposit was made ceases to be recognized for the
application referring to the deposit of the micro-
                                                                   purposes of the application of Article 15, whether
organism or other self-replicable matter has been filed,
                                                                   entirely or for the kind of micro-organism or other self-
and that the requester or the expert nominated by him is
                                                                   replicable matter to which the deposited micro-organism
entitled to the issue of a sample of the micro-organism
                                                                   or other self-replicable matter belongs, or where that
or other self-replicable matter.
                                                                   institution discontinues, temporarily or definitively, the
                                                                   performance of its functions as regards deposited micro-
8.     The national patent office shall transmit a copy of         organisms or other self-replicable matter, and the notifi-
the request, with the certification provided for in                cation referred to in paragraph 1 from the depositary
paragraph 7, to the depositary institution as well as to           institution is not received within six months from the
the applicant for, or the proprietor of, the patent.               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
9.     Member      States   shall    designate    recognized       patent office.
depositary institutions for purposes of this Article.
10.      If a micro-organism or other self-replicable
material has been deposited in accordance with para-               4.    Any new deposit shall be accompanied by a
graphs 1 and 2 and has become available to any person              statement signed by the depositor alleging that the newly
or an expert in accordance with paragraph 3 or 4, it shall         deposited micro-organism or other self-replicable matter
henceforth be regarded available to the public in                  is the same as that originally deposited.
accordance with paragraph 1.
                          Article 16                               5.    If the new deposit provided for in the present
                                                                   Article has been made under the Budapest Treaty on the
1.     If a micro-organism or other self-replicable matter         International Recognition of the Deposit of Micro-
deposited in accordance with Article 15 ceases to be               organisms for the Purposes of Patent Procedure of 28
available from the institution with which it was deposited         April 1977, the provisions of that Treaty shall prevail in
because:                                                           case of conflict.
 ---pagebreak--- No C 10/8                              Official Journal of the European Communities                                  13. 1. 89
6.    If a deposit is not accepted or if the deposited                                     CHAPTER 6
material is no longer available from the depository
institution and a re-deposit according to paragraphs 1 to                                 Miscellaneous
5 does not or could not remedy the unavailability, such
                                                                                            Article 18
unavailability shall not affect the patentability of the
invention if the applicant/patentee provides the                  Any exclusion from patentability or from the field of
requesting party entitled to receive a sample with such           industrial applicability of surgical or diagnostic methods
sample certifying its identity with the material used in the      practised on an animal body shall apply to such methods
invention or obtained as the invention or with the orig-          only if practised for a therapeutic purpose.
inally deposited material, as the case may be.
                                                                                            Article 19
                                                                  For the purposes of this Directive:
7.    If a patent is deemed invalid because the patentee
                                                                  (a) the word 'micro-organism', where used, shall be
can no longer provide for a sample of the deposited
material in accordance with this Article, such invalidity             interpreted in its broadest sense as including all
shall in no case have retroactive effects.                            microbiological entities capable of replication, e.g. as
                                                                      comprising, inter alia, bacteria, fungi, viruses, myco-
                                                                      plasmae, rickettsiae, algae, protozoa, and cells; and
                                                                  (b) the words 'self-replicable matter', where used, shall
                        CHAPTER 5
                                                                      be interpreted to comprise also matter possessing the
              Reversal of the burden of proof                         genetic material necessary to direct its own repli-
                                                                      cation via a host organism or in any other indirect
                                                                      way, e.g. as comprising, inter alia, seeds, plasmids,
                                                                      DNA sequences, protoplasts, replicons and tissue
                         Article 17
                                                                      cultures.
1.    If the subject matter of a patent is a process for
obtaining a new or known product, the same product                                          Article 20
when produced by any other party shall, in the absence            1.    Member States shall bring into force the laws
of proof to the contrary, be deemed to have been                  necessary to comply with this Directive not later than 31
obtained by the patented process, if a necessary means to         December 1990.
carry out the process had been deposited in accordance
with Article 14 and had been released to a third party.           2.    Member States shall communicate to the
                                                                  Commission the texts of the main provisions of national
                                                                  law which they adopt in the field covered by this
2.     In the adduction of proof to the contrary, the             Directive.
legitimate interests of the defendant in protecting his                                     Article 21
manufacturing and business secrets shall be taken into
account.                                                          This Directive is addressed to the Member States.