CELEX: 51988PC0496
Language: pt
Date: 1988-10-21
Title: Proposta de DIRECTIVA DO CONSELHO relativa à protecção jurídica das invenções biotecnológicas (Apresentada pela Comissão)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (88) 496
Vol. 1988/0178
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Conformément au règlement (CEE, Euratom) n° 354/83 du Conseil du 1er février 1983 concernant
l'ouverture au public des archives historiques de la Communauté économique européenne et de
la Communauté européenne de l'énergie atomique (JO L 43 du 15.2.1983, p. 1) modifié en dernier
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In accordance with Council Regulation (EEC, Euratom) No 354/83 of 1 February 1983 concerning
the opening to the public of the historical archives of the European Economic Community and the
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In Übereinstimmung mit der Verordnung (EWG, Euratom) Nr. 354/83 des Rates vom 1. Februar
1983 über die Freigabe der historischen Archive der Europäischen Wirtschaftsgemeinschaft und
der Europäischen Atomgemeinschaft (ABI. L 43 vom 15.2.1983, S. 1), zuletzt geändert durch die
Verordnung (EU) Nr. 2015/496 vom 17. März 2015 (ABI. L 79 vom 25.3.2015, S. 1), ist dieser Akt
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2015/444 vom      13.   März 2015     über die   Sicherheitsvorschriften für den Schutz von  EU-
Verschlusssachen als herabgestuft angesehen.
 ---pagebreak--- COMISSÃO DAS COMUNIDADES EUROPEIAS
                                COM(88 ) 496 final - SYN 159
                                Bruxelas , 28 de Outubro de 1988
                    Proposta de
               DIRECTIVA DO CONSELHO
       relativa à protecção jurídica das
             invenções biotecnológicas
           ( Apresentada pela Comissão )
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 ---pagebreak---                               EXPLANATORY KEii3RAf«DU"
                                 PART ONE : GENERAL
                                  Contents
Introduction
Purpose and Scope of the Proposed Directive
Subject Matter of Biotechnology
Main Areas of Inventive Work and Their Economic Importance
Categories of Biotechnological Inventions
The Need for Approximation of Laws
    Ci )    Existing Legal Framework in the Member States
    ( ii )  Efforts to Improve Legal Protection for Biotechnological
            Inventions
    ( iii ) Protection of Biotechnological Inventions under the European
            Patent Convention
    ( iv )  Effects of the European Patent Convention upon the Protection
            of Biotechnological Inventions under National Patent Laws
    (v)     Effects of the Community Patent Draft Convention upon the
            Protection of Biotechnological Inventions under the European
            Patent Convention and under National Patent Laws
    ( vi )  Protection of Biotechnological Inventions by the Courts
    ( Vii ) Necessity fcr the Community to Act
 ---pagebreak---                                        - 2 -
Relationship between the proposed Directive and the European Patent Convention
Relationship between the Patent Protection under the Proposed Directive and
the Protection of Plant Breeders' Rights under the UPOV Convention and
National Plant Variety L^ws
Legal Basis
Part II : Particular Provisions
Chapter  1: Patentability of Living Matter
Chapter  2: Scope of Protection
Chapter  3: Dependency License for Plant Varieties
Chapter  4: Deposit , Access and Re-deposit
Chapter 5 : Reversal of the Burden of Proof
Chapter 6 : Definitions and Final Provisions
 ---pagebreak---                                         - 3 -
                              EXPLANATORY MEMORANDUM
                                 PART ONE : GENERAL
                                    INTRODUCTION
1 . In a 1983 Communication to the Council entitled "Biotechnology in the
Community", the Commission emphasised the increasing importance for medicine,
industry and agriculture of applications of modern biotechnology . The
Commission noted that European lack of strength in this field results
principally from the fragmentation of its efforts in research and from the
absence at Community level of a favourable environment for innovation . To
remedy the situation , the Commission undertook several initiatives covering
the problems posed by the recent evolution of modern biotechnology .
In the field of research , the Commission included biotechnology and the
various areas covered by the exploitation and promotion of biological
 resources among the eight priorities of the Framework Programme for 1987-1991 .
The present Action Programme "Biotechnology" (BAP : 75M Ecu for thu period
1985-1989 ) includes research activities , training and collective action to
promote the creation of new processes for better mastery and exploitation by
man of the properties and structures of living matter . BAP , based entirely on
 European cooperation, controls and directs some 350 research contracts grouped
 into 90 transnational projects and assures each year , for about 100 young
 researchers , specialised training indispensable for the development of
 biotechnology ; it also includes numerous scientific projects , notably in the
 fields of plant molecular genetics , of industrial microbiology and of protein
 genetics , which contribute significantly to the innovatory potential of
 agriculture and of Community industry . Several programmes will be initiated
 shortly to permit an increase in ongoing activities and to extend them to
 solving Community problems arising at the interface between industry and
 agriculture .   This concerns , on the one hand, the BRIDGE Programme
 ( Biotechnology Research for Innovation , Development and Growth i r. Europe , with
 a proposed budget of 100M Ecu covering the period 1990-1994 ), which is in
 preparation by the Commission services and which will be taken over in 1990
 ^ C0M(83) 672 final/2 - Annex of October 1983 .
 ---pagebreak---                                         - 4 -
with BAP ; and , on the other hand , two new programmes , ECLAIR and FLAIR ,
presented by the Commission to the Council in 1987 and 1988 , which are aimed
at promoting the development in the Community of agro-industrial and
agro-alimentary technologies . , ECLAIR ( European Collaborative Linkage of
Agriculture and Industry through Research ) has a proposed budget of 80M Ecu
covering the period 1989-1993; FLAIR ( Food-Linked Agro-Industrial Research )
has a proposed budget for mid-1989 to mid-1993 of 25M Ecu . Commission
initiatives in favour of research and development in the field of
biotechnology would remain incomplete if they were not accompanied by
appropriate industrial property legislation which offers to Community science
and industry legal protection indispensable for their inventions . The legal
situation in the Community was identified in the 1983 Communication to the
Council as suffering from deficiencies and discrepancies in statute law and a
general shortage of case law . The problem raised by the absence of a
harmonised system of laws was said to be particularly harmful and dangerous to
an entity like the European Communities in view of the impact on Community
industry and on the functioning of the common market . Specific action at
Community level was envisaged on the basis of the major unresolved legal
issues presented under biotechnology . It was therefore advocated that the
Commission should work out proposals to the Council , inter alia , for a
European approach to intellectual property rights in biotechnology .
2 . Following a " guidelines discussion " at the Research Council of the
European Communities of 28 February 1984 on the Communication from the
Commission and as to suggested Community action , the Council concluded that it
was advisable to take measures as proposed by the Commission to improve the
regulatory environment , including the system of intellectual property rights ,
with a view to facilitating the production , marketing and use of
                                               2
biotechnological products in the Community .
3 . Subsequently , in its White Paper on " Completing the Internal Market "
approved by the Community Heads of State and Government at the European
Council meeting in Milan on 28 / 29 June 1985 , the Commission announced its
intention to propose measures concerning patent protection of biotechnological
inventions . 3
2 SI(84) 144, Annex IV .
3COM(85)310 of 14 June 1985, p.37 .
 ---pagebreak---                                          - 5 -
  4.    The Single European Act , adopted by the Conference of the Representatives
of the Governments of the Member States on 28 February 1986 in The Hague ,
established a new Article 8A of the EEC Treaty providing for the Community " to
adopt measures with the aim of progressively establishing the internal market
over a period expiring on 31 December 1992".
5 . At the time of signing the text of the Single European Act , the Conference
adopted the following declaration on Article 8A :
      . i           ■                                         \
        The Conference wishes by means of the provision in Article 8A to express
        its firm political will to take before 1 January 1993 the decisions
       necessary to complete the internal market defined in those provisions ,
        and more particularly the decisions necessary to implement the
        Commission 's programme described in the White Paper on the Internal
        Market .
 6 . This proposal is one of the measures aimed at providing industry with the
 ability to treat the common market as a single environment for their economic
  activities and to create the conditions necessary for the proper functioning
 of the common market .
  Differences in industrial property laws have a direct and negative impact on
  Community trade and there is no other field of technology where national
  patent laws vary on so many points as they do in biotechnology . To create the
 environment for companies to treat the common market as a single market , it
  is essential to reduce to a minimum the existing differences in the legal
  protection of biotechnological inventions and to prevent others from arising .
  7.    The proposal is necessary to provide authoritative guidance for most of
  the questions and problems presented in national patent law which arise in
  connection with biotechnological inventions and which are not directly
  addressed by such laws . Without such a proposal , the existing lack of
  uniformity of approach makes it impossible for companies to treat the
  Community as a single market . Moreover , without approximation of national
   legislation , tne possibility exists for an even greater variation of national
  approaches in light of the independence of national patent systems and each
  national judiciary .
 ---pagebreak---                                      - 6 -
Purpose and Scope of the Proposed Directive
8.   The main purpose of this proposal for a Directive is to establish
harmonised , clear and improved standards for protecting biotechnological
inventions in order to foster the overall innovatory potential and
competitiveness of Community science and industry in this important field of
modern technology . The provisions of the Directive systematically adapt
existing patent law principles to the field of biotechnology with the aim of
securing the application of patent laws in this important area as effective
as possible .
9 . By providing improved possibilities to protect biotechnological
inventions and greater certainty regarding the scope of protection available ,
the Directive should allow inventors and investors in the Member States to
benefit from patent protection as effective as that in the competitive
markets of Japan and the United States of America ( USA ). This will result in
a greater wi llingness to invest labour and capital in research and
development and in exploiting the results thereof in spite of the high risks
involved .
10 . Establishing a harmonised system of patent law in this area will
facilitate the development of Community industry in biotechnology , trade in
biotechnological products and the establishment of a common market in this
field . Moreover , it will enable Community industry to keep pace with leading
nations in biotechnology and to close or narrow existing gaps .
11 .  The primary purpose of the modern patent system is to promote technical
innovation as the major factor of economic growth by encouraging inventive
activity through rewarding inventors for their creative efforts . The patent
system thus secures costly investment in research and development and
industrial exploitation of research results . Simultaneously , the patent
system encourages an early and beneficial dissemination of knowledge in the
field of activity involved which , without such protection , might be kept
secret . The patent system also offers the necessary incentives for exploiting
the results oi publicly funded research . Such exploitation itself requires
costly investment .
 ---pagebreak---                                          7
12 . Biotechnological research and development and industry making use of
developments in this field are rapidly evolving and expanding on the
international level . Biotechnology is likely to influence and modify the
lives of many people through its ultimate impact on human and animal health
care , agriculture , the food and chemical industries , energy resources and the
environment . It has evolved dramatically through the advance of various
genetic engineering techniques in recent years , particularly so in the USA
and Japan . It is , therefore , of particular urgency for patent protection to
play its important part in these fields in the European Communities .
13 . The patent system , when applied to biotechnology , encounters a number of
particular problems . A reason for this is that biotechnology , as the name
says , is related to living matter , which poses problems in relation to ethics
as well as in relation to the traditional patent law concepts of patentable
subject matter , discovery , novelty , sufficient written disclosure , industrial
applicability and the extent and exhaustion of patent protection .
14 . These particular problems have been handled in some respects in a
different manner in different Member States and , even where Member States
have unilaterally introduced into their laws provisions similar to those of
the European Patent Convention , these provisions do not provide for specific
rules which relate to and are necessary for resolving the particular problems
of biotechnological inventions . In fact , the legal situation suffers from
deficiencies as well as discrepancies in statutory law , regulations and their
interpretation and a general shortage of case law .
15 .  The problem is particularly acute in the European Communities , where the
existence of a harmonised and adequate body of law, rules and practices is of
major importance to the proper functioning of the internal market and the
competitive vigour of industry .
Subject Matter of Biotechnology
16 .  Biotechnology is understood to comprise all the techniques that use or
cause organic changes in any biological material ( such as animal and plant
cells or cell lines , enzymes , plasmids and viruses ), microorganisms , plants
and animals ; or that cause changes in inorganic material by biological means .
 ---pagebreak---                                       - 8 -
In its modern appearance , biotechnology includes the techniques of
recombinant ONA ( deoxyribonucleic acid ), gene transfer , embryo manipulation
and transfer , plant regeneration , cell tollure , monoclonal antibodies , and
bioprocess engineering . This understanding of biotechnology covers the areas
in which inventive work is most active and promising , and in which the
results of that work have particular economic and social importance .
Main Areas of Inventive Work and Their Economic Importance
17 . Biotechnology is rapidly gaining ground . It is playing an increasingly
important role in the future of industry . Inventive work concerns many
sectors , such as pharmaceuticals ( e.g. , the production of human insulin ,
human hormones , interferons , blood products , vaccines and antibiotics ,
monoclonal antibodies , genetically engineered heart attack drugs , etc .);
specialty chemicals and food additives ( e.g. , amino acids , enzymes , single
cell proteins ); commodity chemicals and energy production ( e.g. , biomass
resources ); and environmental applications ( e.g. , pollution control , toxic
waste treatment , microbial enhanced oil recovery ). Agriculture is another
area of biotechnological activities holding the key to innovation crucial for
creating new products and for enhancing environmental acceptability in crop
production ( e.g. , improvement of specific plant characteristics , like insect ,
disease , pesticide , stress or herbicide resistence , use of microorganisms for
crop improvements , etc .), and animal agriculture ( e.g. , diagnosis , prevention
and control of animal diseases , animal nutrition and growth promotion ,
genetic improvement of animal breeds ), as well as new bioprocessing
opportunities ( e.g. , alternative fuels , alternative feed and food sources ,
and other, products ).
18 . Patent documentation gives evidence of an overall increasing patent
activity in biotechnology . The most impressive increase took place in the
field of "mutation / genetic engineering” , i.e. , in the core-region of the new
biotechnological developments . Genetic engineering is composed of newly
emerging methods for inserting , changing or deleting genetic information
within a host organism , L>e it microorga . . . -t,., plant or animal , to give it new
characteristics . The development and use of these new techniques provide the
ability to manipulate the genetic character of organisms while overcoming
complications and limitations of natural gene exchange . The patent file of
 ---pagebreak---                                       - 9 -
the European Patent Office reveals that , in the field of genetic engineering ,
the number of patent applications filed rose approximately 600% fro ,., 1 9 S 1 to
1985 . About 50% of the applications originated from the USA ; Japan
contributed more than 20% ; some 25% of applications came from the Member
States ( United Kingdom 12.1 ; Germany 5.2 ; France 5.0; the Netherlands 2.3 ;
                            4
Denmark 0.5 ; Belgium 0.2 )
19 . The modern genetic engineering techniques complement , rather than
replace , the methods of traditional biotechnology , which will continue to        i
yield new inventions as well . However , the new techniques do, due to their
speed , precision , reliability and scope , offer enormous economic potential .
Market forecasts for modern biotechnological products vary considerably .
However , in no estimate are these markets valued at less than US $ 40 billion
by the year 2000^. It is believed that modern biotechnology has its strongest
research base in the USA; and its strongest commercial base in Japan^, with
Europe remaining below its real potential . Member States , with annual
government funding of biotechnology of approximately US $ 350 million^
should , therefore , strive such as the Commission has already begun ( see
paragraph 1 above ) to improve future prospects for Community industry , in
order to secure an appropriate stake in the world markets for such industry .
Patent protection , adapted to the needs of modern biotechnology , is one
important measure serving this goal .
Categories of Biotechnological Inventions
20 . Inventions resulting from modern biotechnological techniques can be
grouped according to the usual patent law distinction made between product ,
process , and use or application inventions .
Inventions relating to products concern living entities of natural or
artificial origin , such as plants , animals and microorganisms , biological
material , such as plasmids , viruses and replicons , and parts thereof ( e.g. .
 Knuth et al ., Characterization of Genetic Engineering Inventions in
 Patent Claims , 1987 World Patent Information 229 , at 230 .
 Hacking , Economic Aspects of Biotechnology , Cambridge etc ., 1986 , 256 , 257 .
 Hacking , op cit ., 254 .
 Dibner , 232 Science 1367 ( 1986) at 1369 .
 ---pagebreak---                                         10 -
organs , tissues , cells and organelles ). They may also relate to naturally
occurring substances from living entities , biological material and parts
thereof . The invention itself may be the plant , animal , microorganism or a
specific biological material ( e.g. , a plasmid ) per se or the plant , animal ,
etc ., produced by a particular process .
The second category ( process inventions ) concerns processes for the creation
of plants , animals , microorganisms or any biological material and parts
thereof . It includes also such processes as cultivation , isolation , and
purification , and also of bioconversion .
The third category of biotechnological inventions ( application inventions )
comprises specific uses of plants , animals , microorganisms or biological
material .
The Need for Approximation of Laws
(i ) Existing Legal Framework in the Member States
?1 .  The existing legal framework for protecting biotechnological . inn >vat ion
in the Member States has been strongly influenced by two international
conventions , conceived in the late fifties and early sixties on the basis of
the-then state of the art in biological sciences : The " International
Convention for the Protection of New Varieties of Plants ", established in
1961 in Paris ( the UPOV Convention ), and the " Convention on the Unification
of Certain Points of Substantive Law on Patents for Invention ", signed in
1963 ( the Strasbourg Convention ).
22 . The current patent laws of most of the Member States were adopted and
introduced in the late seventies and early eighties as a direct result of the
more recent 1973 " Convention on the Grant of European Patents " ( the European
Patent Convention - EPC ) and the " Convention for the European Patent for the
Common Market " ( Community Patent Convention - CPC ), signed in Luxembourg in
1975 , but net yet in force . With regard to biotechnological innovation , they
follow the basic principles of the UPOV and Strasbourg Conventions , which
were introduced into the EPC without seriously reconsidering developments
which in the meantime had taken place in various areas of biotechnology .
 ---pagebreak---                                      - 11
23 . The key assumptions of the UPON/ and the Strasbourg Conventions , which
were taken over into the EPC and the harmonised national patent laws of all
                                                8
the Member states , except Ireland and Portugal , are , firstly , the belief
that the traditional concept of " technical invention" renders biological
inventions only in rare cases capable of complying with the usual
requirements of patentability ; and, secondly , that inventions in the field of
living matter could be divided into those of microbiology and those of
( macro -) biology .
Based on these premises and taking into account certain known needs of
traditional plant breeders , the 1961 UPOV Convention established a
tailor-made type of protection for new varieties of plants .
Subsequently , the Strasbourg Convention , in view of the long history of
patenting microbiological processes and their products in several States
party to it , made it mandatory as early as 1963 to protect microbiological
processes and their resulting products , but left the signatory States a free
hand as regards the protection of new plant or animal varieties and
essentially biological processes employed in their production .
The EPC , when adopted in 1973 , expressly excluded from patent protection
plant and animal varieties and essentially biological processes for the
production of plants and animals but allowed patenting of microbiological
processes and their products ( Article 53b ).
24 . It should also be mentioned that in 1977 , under the auspices of WIPO ,
the Budapest " Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure " was concluded to which
                                9
twenty-one States have adhered . The States party to this Treaty , which allow
or require the deposit of microorganisms for the purposes of patent
procedure , are obliged to recognise , for such purposes , the deposit of a
microorganism with any recognised international depository authority .
  These Member States have not yet brought their national patent laws into
  line with EPC .
  As of April 1987 . From the Community Member States Greece , Ireland ,
   Luxembourg , and Portugal are not yet party to this Treaty .
 ---pagebreak---                                            12 -
Although this Treaty facilitates applications for patent protection of
biotechnological inventions abroad , it does not influence the substantive
patent law of the " Contracting States ". Its influence on patent laws of the
Contracting States is limited to purely technical provisions regarding the
depositing and redepositing of microorganisms , as demonstrated by Rule 28a
EPC , which was inserted into the EPC Regulations as a result of the
conclusion of the Budapest Treaty .
25 .   Achievements in biotechnology reached during the period of time
necessary to bring into force this international legal framework at the
national level demonstrate that the distinction between micro - and
macrobiology , which serves as the dividing line between patentable and
non-patentable inventions , is artificial and no longer tenable . Developments
originating in microbiology , either as processes or products , are likely to
have a direct effect on the macrobiological sector , giving rise similarly to
visible changes in the plant or animal world . They should , therefore , enjoy
legal treatment according to the same principles as other inventions in
microbiology .
26 . One major consequence of micro- and biotechnological developments is
that " Agriculture has moved from a resource-based to a science-based industry
                                                                        10
as science and technology have been substituted for land and labor " . A
greatly improved understanding and mastery of basic biological mechanisms
have given rise to a change in the concept of what may be considered
" technical " for purposes of patent law . Beginning in the late sixties , the
courts of at least one Member State have held that the general field of
                                                                   11
biology may be included in the notion of what is " technical ".       This changed
appreciation from that represented bythe existing international legal
 framework , however , has only partially been incorporated into statutuory law
and into patent practice , at both the national and the international level .
   Committee on a National Strategy for Biotechnology in Agriculture
   - Board on Agriculture - National Research Council , Agricultural
   Biotechnology - Strategies for National Competitiveness , Washington ,
    D.C. , 1987 , 1 , 2 . According to the Executive Summary of thic rpcrt ,
    it is true even for USA that " Yet current political and econ'-ric policies
   governing agriculture neither fully recognize nor take these changes into
    account ".
    Decision of March 27 1969, Federal Supreme Court , Federal Republic of
    Germany , 1 IIC 136 ( 1970) " Red Dove ".
 ---pagebreak---                                            13 -
27 . Due to its underlying assumptions , outdated by scientific and
technological developments , the present legal framework for protecting
biotechnological inventions in the Member States is unable to satisfy either
the needs of science and industry in this field or the needs of patent
granting authorities and courts . Apart from the now rather questionable
explicit exclusions from patentability , only in part resulting from the
prohibition of double protection established in Art . 2 ( 1 ) UPOV Convention ,
the main and decisive deficiency of the system is to be seen in its almost
complete lack of any reliable legislative guidance on such essential
questions as :
Patentability of Living Matter , that is , what are the criteria to patent
natural material in view of the existing exclusion of discoveries from patent
protection and also in view of the novelty requirement ; what is to be
understood by the terms " microbiological " and " essentially biological
process "; can a microorganism per se be regarded as a product of a
"microbiological process ";
What are the effects of the exclusion from patentability of plant and animal
varieties upon the patenting of microorganisms or taxonomic units different
from plant or animal varieties or upon the patenting of parts of plant c .
animal varieties or their uses ?;
What is the Scope of Patent Protection for Living Matter , in view of the fact
that living matter is self-replicable and , this therefore , causes particular
problems in respect of further generations ;
Sufficient Disclosure , which in spite of the advances in natural sciences
remains a problem of major concern, for example , whether and under what
conditions the written description of an invention may be completed by a
deposit of a microorganism or other self-replicable matter , and what are the
duties of and safeguards for the depositor .
 ( ii ) Ef forts t o Improve Lega l Protection for Biotec hnological Inventions
 28 . OECD . Since the emergence of modern biotechnology , the ability of patent
 laws to offer effective protection for new biotechnological processes and
products has been uncertain . The Organization for Economic Cooperation and
 ---pagebreak---                                            - 14 -
 Development ( OECD ) first initiated an international review on biotechnoloqy
 and patent protection in 1981 . Based on replies to a questionnaire from
                                      12                                   „     .1 7
 governments of nineteen members         ( out of twenty-four ), the Final Report
 detected a great number of deficiencies in patent laws of most of the member
 countries regarding especially the patentability of microorganisms per se ,
 naturally occurring materials , disclosure , deposit and release conditions and
 infringement . Moreover , it was observed in this report inter alia :
       " In no other field of technology , old or new , do national laws vary on
         so many points or diverge so widely as they do in biotechnology . The
         answers to the OECD Questionnaire have brought a wide spectrum of
         varying legal opinions and practices to light which concern almost
         every important aspect of patent protection in biotechnology ."
The replies from the Member States of the Community reflected no less a
divergence either in respect of varying legal opinions and practices or as to
existing deficiencies of national laws . It was felt that only US and Japanese
laws were on the whole adaptive and flexible in respect of new developments in
biotechnology . To improve the present legal situation in the OECD countries ,
the report submitted a number of recommendations .
29 . mPO . At its fourteenth series of meetings ( of September / October 1983 ),
the Assembly of the International ( Paris ) Union for the Protection of
Industrial Property instructed the International Bureau of the World
Intellectual Property Organization ( WIPO ) to
      " study the existing situation concerning the protection , by patents or
        by other means , of inventions in the field of biotechnology ( including
        'genetic engineering' ) and possible means of providing for industrial
        property protection for such inventions , both at the national and
                                   14
        international level "
    Among those countries which answered the Questionnaire were the
   following Member States : Belgium, Denmark , Germany , France , irecariu ,
   Italy , the Netherlands , Portugal and the United Kingdom .
    Biotechnology and Patent Protection - an International Review , OECD,
    Paris 1985 .
14
    WIPO Doc . BI0T / CE / I / 2 .
 ---pagebreak---                                                  15
A Committee of Experts on Biotechnological Inventions and Industrial Property
was established and first convened in 1984 . Subsequently the International
Burc-iu of WIPO prepared an Analysis of Certain Basic Issues in Industrial
                                                             15
Property Protection of Biotechnological Inventions              and then , based on
                                          16
replies to two Questionnaires , submitted nineteen suggestions for solutions
                                                                                    17
concerning industrial property protection of biotechnological inventions
These solutions seem to complete and supplement the recommendations of the
OECD Report .
In three meetings , the Committee of Experts discussed the work done by the
International Bureau and its consultants , particularly the " Suggested
             18
Solutions " . It might initially have been envisaged that the ongoing work of
WIPO could have produced the necessary level of harmonisation for the European
context . This will unlikely be the case in anything but the very long term in
light of the general observation of the Director General of WIPO in the third
session of the Committee of Experts , according to which
      " At present , WIPO did not intend to provoke changes in national
        legislations ; it only wanted to make governments more aware of what was
        happening in this field in the various countries and of what were the
        problems that the legislator might have to solve , so th~t the patent
        system could be fully responsive to the need for protection in this
        exceedingly important technological field ."
Moreover , from the remarks made by a number of delegations , especially , but
not exclusively from the developing countries , it may be concluded that an
agreement on this topic at the universal level either in the form of a special
convention or within the current work of the International Bureau of WIPO on
the Draft Treaty on the Harmonisation of certain provisions in laws for the
                                  19
protection of inventions              cannot be expected for at least several more years .
   WIPO Doc . BIG 281 and WIPO Doc . BIOT / CE / II / 2 .
   WIPO Doc . BI0T / Q / 1 , 2 .
   WIPO Doc . BIOT / CE / III / 2 .
   The work of the Committee is reported in WIPO Docs . BIOT / CE / I / 3 ;
   B10T / CE / II / 3 ; BIOT / CE / III / 3 .
   WIPO Doc . HL / CE / III / 2 .
 ---pagebreak---                                          - 16 -
30 . Thus , the efforts of WIPO in this area will most likely end in no more
than a recommendation addressed to the Member States of WIPO by its Director
General . In view of the complexity of the issues and the interests involved ,
it is only realistic to note that such a recommendation could result in
changes in national legislation , at best , in several years . Notwithstanding
well founded and balanced Suggested Solutions , the WIPO initiative is unlikely
to bring about a prompt , positive and harmonised response at the world or even
the European level . Experience with the revision work on the Paris " Convention
for the Protection of Industrial Property " confirms this appreciation .
 C i i i ) Protection of Biotechnological Inventions under the European Patent
           Convention
31 . The legal basis for granting European patents for biotechnological
inventions is the previously mentioned Article 53 ( b ) EPC , which has served as
a model for national patent law provisions of nine Member States of the
Community . As noted earlier , this article expressly excludes from patent
protection plant and animal varieties and essentially biological processes for
producing plants and animals but allows patenting of microbiological processes
and the products thereof . Article 53 ( b ), however , is not the only provision
of the EPC explicitly dealing with biotechnological inventions . Because
inventions concerning microbiological processes and their products incur
particular difficulties with regard to the usual requirement of sufficient
disclosure , the EPC from the outset introduced special provisions for
compliance with this patent law requirement .
In Rule 28 of the Regulations , if an invention concerns a microbiological
process or the product thereof and involves the use of a microorganism which
is not available to the public and which cannot be described in such a manner
as to enable the invention to be carried out by a person skilled in the art ,
the disclosure requirement may be satisfied by a deposit of a culture of the
microorganism in a culture collection not later than the European patent
application date , including with the application identifying details of the
deposit . The deposited microorganism must be made available from the culture
collection to any person from the date of first publication of the
application . Moreover , this provision lays down detailed rules as to the
release conditions of the deposited material . Rule 28 was subsequently amended
 ---pagebreak---                                             17 -
to introduce the so-called " expert solution " which allows the applicant the
possibility to limit the availability of the deposited material to an
 independent expert until the grant of the furopean patent .
32 . To cope with problems emerging from patent applications in the field of
modern biotechnology , additional guiding measures proved necessary under
Article 53 ( b ) EPC . The European Patent Office ( EPO ) in its " Guidelines for
Examination " therefore addressed a number of particular problems , such as , the
patentability of naturally occurring substances , the demarcation between
" essentially biological " and " essentially non-biological " processes and the
interpretation of the terms " microbiological process ", " microorganism ", and
" product of a microbiological process ".
As to other questions , such as the effects of the exclusion from patentability
of plant and animal varieties upon the patenting of taxonomic units different
from plant or animal varieties or upon the patenting of parts of plant or
animal varieties or their uses , the guidelines are silent .
33 .   Although the solutions provided for in the Examination Guidelines of the
EPO offer valuable guidance for the examining organs of the EPO , and seem to
meet many of the needs of applicants in an appropriate manner , they are
handicapped by the fact that they are neither binding on the Board of Appeals
of the EPO , deciding in final instance on patentability , nor on national
courts competent in nullity procedures regarding European patents . There is no
mechanism in the EPC , such as by Examination Guidelines , to provide for
mandatory guidance on the questions arising in respect of patenting
biotechnological inventions . The Boards of Appeals of the EPO and the national
courts enjoy complete discretion whether to follow the practice of the EPO
when interpreting the EPC . As regards the scope of protection of
biotechnological inventions and the interrelation between the effects of
patents and plant breeders' rights , the EPC does not regulate these issues and
thus no competence of the European Patent Office exists .
34 .   Difficult to predict are future developments as regards the EPC . For the
time- being the EPO is solving problems related tc the application of Article
53 ( b ) EPC on a case - by - case basis in addition to periodic amendment of the
Guidelines for Examination . The practical effects of these Guidelines should
not be underestimated . In view of their limited legal effects , however , the
 ---pagebreak---                                          18
EPO Guidelines cannot be viewed as a suitable means to cure the deficiencies
caused by the lack of legislative guidance with regard to the most essential
problems of patenting biotechnological inventions under Article 53 ( o ) EPC .
While in theory it may be possible to introduce rules related to the
interpretation of substantive patent law provisions of the EPC into the
" Implementing Regulations to the Convention " ( the amendment of which falls
within the competence of the Administrative Council of the European Patent
Organization ), these Regulations so far have no binding effect on the views to
be taken by the courts of the Contracting States when interpreting the EPC .
The same is true even for the Boards of Appeals of the EPO :     under Article 164
( 2 ) EPC , the Implementing Regulations may be deemed to be in conflict with the
wording of the Convention and the Convention may be interpreted in a different
way .
Legislative guidance needed under Article 53 ( b ) EPC could of course be
provided by a revision of the EPC . In light of the difficulties presented by
the revision mechanism of Article 172 EPC , however, it appears unlikely that
the EPC Contracting States would consider any revision at the present time .
( iv )    Effects of the European Patent Convention upon the Protoctirn of
          Biotechnological Inventions under National Patent Laws
35 . When considering the possibilities of the EPC to affect the national
patent laws of the Community Member States , the special legal concept of the
EPC must be taken into account . Although the EPC provides for a system of law
for granting European patents , these patents , in each of the Contracting
States for which they are granted, have the effect of and are subject to the
same conditions as a national patent granted by that State ( Articles 1 and 2
EPC ). A European patent is granted, defined and revoked in applying rules of
the EPC , and to this extent represents a collection of " European " patents . For
all other purposes , such as the scope of protection, European patents
represent patents with national effects , subject to national laws , although
certain minimum standards are orescribed in Articles 64(2 ) and 67 EPC .
In addition , it results from the design of the EPC that the Contracting Staves
are not obliged automatically to align their national patent laws with the
EPC . This has happened in the past but on a purely voluntary , unilateral ,
 ---pagebreak---                                           19
uncoordinated basis .     An amendment of the EPC would probably , but not
mandatorily , lead to changes in national patent laws of most of the Community
Member States .    Horoever , in order to secure a harmonised judicial practice on
points essential to biotechnological inventions in the Contracting States ,
such changes of the EPC would require highly specific provisions . An
additional difficulty with regard to the EPC results from its membership :
whereas four EPC Contracting States are not Community Member States , Denmark ,
Ireland and Portugal are not yet Contracting Parties to the EPC .
(v)      Effects of the Community Patent Draft Convention upon the Protection of
         Biotechnological Inventions under the European Patent Convention and
         under National Patent Laws
The " Convention for the European Patent for the Common Market " of 1975
(" CPC ") and the 1985 Agreement relating to Community Patents^ do not
themselves address questions as to patentability , but leave these issues to
the EPC . The CPC will not , therefore , improve the ability to protect
biotechnological inventions . It is only to the extent that the EPC provides
for patent protection that the CPC will provide for instruments necessary to
secure that Community patents shall have a unitary character as well as :
         " have equal effects throughout the territories to which this Convention
           applies and may only be granted , transferred , revoked or allowed to
           lapse in respect of the whole of such territories _ " ( Article 2 ( 2 )
           CPC ) .
Thus , the CPC will not provide a solution to the basic issue of appropriately
protecting biotechnological inventions . Even for the positive effects which
the CPC may have on the unitary nature of protection , it is difficult to
predict its entry into force .      This is unlikely to occur before 1993 and may
well come into force for less than all Member States of the Community . The
possibility also exists that the CPC will leave open a permanent option
between a Community patent and a European Patent . Alongside the EPC / CPC
structure , national patent laws will continue to exist . Thus , even the entry
^Cf. "Texts established by the Luxembourg Conference on the Community Patent
   1985 " ( Council of the European Communities , Luxembourg 1986 ).
 ---pagebreak---                                          - 20 -
 into force of the CPC would by no means make superfluous amendments of
national laws providing for legislative guidance as to the protection of
biotechnological inventions under national patent law .
 ( vi )    Protection of Biotechnological Inventions by the Courts
36 .     From past experience with the judicial practice of the courts of the
Member States , it may be observed that courts would prefer , perhaps even need
to have , more legislative guidance when dealing with problems of patentability
in the field of biotechnology . As an example of the difficulties encountered
by the courts in the Member States and of the time needed to find solutions
for questions not specifically answered in the law , the case law of the German
Federal Supreme Court on the repeatability requirement of biotechnological
inventions may be mentioned .
This Court first demonstrated its exceptional understanding of the necessity
to interpret in modern patent law the concept of invention according to the
latest state of scientific knowledge in 1969 and affirmed that a method for
breeding animals is eligible for patent protection , provided the procedure is
repeatable , i.e. it can be readily duplicated by a person skilled in the
    . 21
art
Six years later , when the patentability of a microbiological process and of a
microorganism per se i.e. , a product claim , was at issue , the German Federal
Supreme Court affirmed its position as regards the patentability of living
matter in general . It also accepted the deposit of a microorganism strain in
a publicly accessible depository as a valid support of the written description
as far as the microbiological process was concerned , but not in respect of
claims directed to the microorganism per se .
In the latter context it stated as follows :
           " It is inconsistent with the Patent Act prerequisite of reproducibility
             of the invention to refer the expert to a product of the inventor
             according to the invention in order to reproduce his invention .
             Protection for a microorganism per se or - what amounts to the same
             thing - for a process of propagating a microorganism in a conventional
21
    Decision of March 27 , 1969, 1 IIC 136 ( 1970 )   " Red Dove ".
 ---pagebreak---                                            - 21
            manner without a teaching to the expert as to how to produce the
            microorganism is so alien to convention.il patent law that it could not
            be obtained via a change in the conventional case law but only by a
      >’        . ■                     22
            change of the Patent Act ."
After the German legislature failed to react for another eleven years , the
Federal Supreme Court in 1987 , in view of criticism expressed and even more so
because of a different view taken on the specific issue by the European Patent
Office , reversed its former case law . Since 1987, under the German Patent Act ,
protection for a new microorganism per se is obtainable , if the possibility of
reproducing the new breed can be substituted by the deposit and release of a
reproducible sample of the microorganism
The German case law thus suggests that advances in protecting biotechnological
inventions by decisions of national courts of the Member States can only be
expected after long delays . Legal uncertainties and deficiencies of
protection could , as a rule , be remedied only after years , perhaps even
decades . Under the present patent law regime in the Community , national
judicial decisions , even those of the Supreme Courts , produce legal effects
only in the territory of that particular state so that favourable adapation in
one Member State results in divergent adaptation in the Community as a whole .
Although case law in one Member State may eventually lead to changes in
legislation or have harmonising effects on the case law of other Member
States , no certainty can be offered with such an approach and much time would
be lost .
( vii )    Necessity for the Community to Act
37 .     It results from this analysis of the existing legal framework at national
and international level ( see ( i ) to ( vi )) that the law for protecting
biotechnological inventions is unsatisfactory and in urgent need of
improvements . As a result of the work performed by OECD and WIPO , the main
deficiencies have been detected and recommendations for how to improve the
situation have been put forward . Particularly the " Suggested Solutions "
elaborated by WIPO accord with most of the needs of inventors in modern
biotechnology .
^Decision of March 11 , 1975, 6 IIC 208 (1975) - "Baker 's Yeast".
^Decision of February 12, 1987, 18 IIC 396 (1987) - "Rabies Virus".
 ---pagebreak---                                        - 22
38 . Having regard to the great importance of biotechnology for the future of
the Community , the negative effects of the divergent adaptation resulting from
the situation described above are unacceptable for the Community . Whereas the
two leading nations in biotechnology , the United States of America and Japan ,
have been able continuously to adapt their patent protection according to the
latest needs of industry , science and consumers , the Member States ,
representing comparable potential of intellectual manpower and capital , are
immobilized by a not yet completed and , in respect of biotechnology , in part
outdated legal framework . In order to preclude any further negative effects
for Community science , industry and consumers arising from the present
situation , it is incumbent upon the Commission to propose the necessary
remedial measures .
39 . The Directive is also a prerequiste to eliminating barriers to the
exchange of knowledge and technology transfer between Member States and to
trade in the Community . By providing the same clear and improved standards of
patenting in the national patent laws of Member States , the readiness to
communicate technical knowledge , which in the past has suffered considerable
setbacks , will grow . In parallel , harmonised protection of biotechnological
inventions will not only give incentives necessary for investments in
biotechnology throughout the Community but will also contribute to trade
between Member States which under present conditions is hampered by the fact
that export of self-reproducible biotechnological products into areas with
uncertain , weak or even non-existent protection is less than attractive for
obvious reasons . Also as a result of the Directive , the Community will offer
investors equal possibilities for protection so that they may treat the
Community as a single market with the possibility of securing reasonable
returns on their investments . Community based industries will be attracted to
repatriate their funds invested overseas in recent years in research and
development in biotechnology . Investors from third countries will be more
inclined to invest in the Member States .
Relationship between the Proposed Directive and the European Patent Convention
40 . The proposed directive is intended to coexist , and not to interfere with ,
the existing international legal network in which the EPC , the UPOV Convention
and the Budapest Treaty are the cornerstones . It is therefore indispensable
that any proposal must be compatible with the provisions of those conventions .
 ---pagebreak---                                        - 23 -
Therefore , the legislative guidance offered by the Directive to the Member
States having in their national patent laws provisions identical or' similar TO
that of Article 53 ( b ) EPC , necessarily takes the form of provisions of a more
detailed nature . This represents the only realistic approach to providing
solutions which meet the needs of modern biotechnology and which establish
legal certainty throughout the Member States .
41 . The proposed Directive does not seek to establish a Community industrial
property right for biotechnological inventions . The proposed Directive has ,
however , methodically made use of existing legal principles in patent laws and
Conventions as well as solutions developed in other fora in order to secure an
application of national patent laws for biotechnological inventions which is
both necessary and appropriate for the Community as a whole . By harmonising
national patent law standards for the patenting of biotechnological inventions
and the scope of their protection , it will enable science and industry to
acquire in the Member States one or more national patents tailored to their
needs and the needs of the consumer . Since the EPC and the CPC do not offer
the necessary legislative protection, and due to their coexistence with the
national patent laws , the Directive will fulfil its tasks even after the CPC
has entered into force in all Member States .
42 . The proposed Directive respects the limitations existing under the
pertinent provisions of the EPC and the national patent laws of the Member
States . It is therefore primarily based on the following assumptions :
        - discoveries as such are not regarded as patentable inventions ;
        - plant and animal varieties as such or essentially biological
          processes for the production of plants or animals are excluded from
          patent protection ;
        - microbiological processes or the products thereof are eligible for
          patent protection ; and
        - methods for treatment of the animal body by surgery or tuerspy anu
          diagnostic methods practised on animal body are not regarded as
          inventions which are susceptible of industrial application if
          practised for a therapeutic purpose .
 ---pagebreak---                                                24
43 . It is clear that the framework of the current rules on the patenting of
living matter now reflects incorrect assumptions . In view of the social and
economic importance which biotechnological inventions have for the Community 's
future , the Directive provides for principles which will ensure that such
rules remain strictly limited to their original aims .
44 .   For this purpose the proposed solutions systematically take advantage of
work performed by international organisations such as WIPO, the European
Patent Organisation and OECD . Particularly the approach found in the
                                       24
Examination Guidelines of the EPO          and the " Suggested Solutions " of the
                               25
International Bureau of WIPO        form the basis of or are even in part
incorporated in the solutions of the proposed Directive .
Since the EPO patent grant practice and the Examination Guidelines are
developing on a case -by - case basis , reflecting the immediate needs of the
Examining Division , they do not address all problems in this area or do not so
in an exhaustive manner . The provisions of the proposed Directive necessarily
go further , though generally in the same direction as that originated in the
EPO Examination Guidelines .
Only in some instances , for example in respect of the availability of
deposited matter after the application has been refused or withdrawn or is
deemed to be withdrawn , the provisions of the Directive differ slightly from
those under Rule 28 of the EPC Implementing Regulations . Moreover , the
Directive specifically addresses problems in respect of issues arising under
national patent law only , such as the scope of protection , rights conferred ,
infringement related questions and the like .
45 . Thus , on the whole the proposed Directive corresponds to the EPC and to
the patent grant practices of the EPO . Although it will not directly or
legally affect either the EPC or the practice under the EPC , the indirect
effects of the proposed Directive should be substantial .
     Guidelines for Examination in the European Patent Office , published
     by the European Patent Office , Munich 1983 , as last amended in July 1987 .
25
     Contained in WIPO Doc . BIOT / CE / III / 2 of April 8 , 1987 .
 ---pagebreak---                                         25
Firstly , as far as the Directive correlates with the existing patent granting
practice basea on the EPO Examination Guidelines , it will in fact lead to a
harmonised interpretation of European and national patents .
Secondly , where provisions of the Directive clarify questions not yet answered
in the Examination Guidelines of the EPO, they do so with the necessary
legislative authority and closely following the solutions suggested by the
International Bureau of WIPO . This will facilitate the task of the EPO in its
constant efforts to improve on firm grounds its Examination Guidelines . For
it is virtually excluded that national administrative or judicial authorities
of the Member States , competent for example in revocation procedures , will
take an approach for European patents different from that for national
patents , although they would have been issued on the basis of different but
analogous provisions .
As regards the differences in respect of the availability of the deposited
biological materials , the proposed Directive does not interfere with the EPC .
It only provides for harmonised solutions in national patent laws of the
Member States , which under the present regime differ among themselves as well
as with regard to EPC Rule 28 .
A possible effect of the proposed provisions of the Directive which differ
from EPC Rule 28 could result in an adaptation of that Rule to the Directive .
Such an amendment could be provided for by agreement between the
Administrative Council of the European Patent Organisation , without revising
the EPC .
46 . From the foregoing it is clear that the proposed Directive will not
interfere with the EPC , nor will it establish any interdependence in a legal
sense between the two bodies of law . The practical interaction of the two
systems is nonetheless likely to be productive . On the one hand , only the
Directive is in a position to secure a harmonised practice under the EPC as
far as the national phase of that practice in the Member States is concerned .
On the other hand , the Directive will offer the EPO firm grounds on which to
develop further its patent granting practice according to the latest needs of
industry and science in biotechnology .
 ---pagebreak---                                            26 -
R elationship between the Patent protection under the Proposed Directiv e and
the Pro tect ion of Plant breeders' Rights u nder the UP OV Convention and
National Plant Varieties Laws
47 .    The proposed Directive will not fetter the principles or the working of
either the plant breeders' system or the UPOV Convention . The principle of the
prohibition of double protection , i.e. protection by plant breeders' rights
and patents for the same botanical genus or species , as established under
Article 2 ( 1 ) UPOV Convention , is no longer uniformly applied in the
                    26    . .                 ,           27
Convention itself      and is also very much in dispute .    Nonetheless , the
Directive leaves that principle untouched .
Notwithstanding extensive criticism of certain UPOV principles by major users
of plant variety protection based on the UPOV system , an approach directing
the Member States to revise the obligations into which they entered under
international conventions outside of the Community legal framework appears
inappropriate for the moment . Moreover , certain positive effects , in part
experienced with plant breeders' rights in the Community Member States which
                               28
are also members of the UPOV , in those areas of plant agriculture in which
                                          29
such rights are effectively available , leads to the conclusion that a
restrictively applied exclusion of patentability of plant varieties as such
will not harm developments in modern plant biotechnology and could be
tolerated .
     Exceptional Rules for protection under Two Forms , Introduced into the
     UPOV Convention by the 1978 Revision ( Article 37 ( 1 ) allow , under
     certain conditions , Member States or adhering States to grant plant
     breeders' rights as well as patents for the same botanical genus or
     species . So far the United States of America has taken advantage of this
     possibility . The US Patent and Trade Mark Office ( PTO) thus grants patents
     for plant varieties regardless of whether they are eligible for special
     plant variety protection established along the lines of the UPOV-Convent ion
     ( Decision of the PTO Board of Appeals and Interferences of September 24 ,
     1985 , 227 USPQ 443 - ex parte " Hibberd").
^ Proposals of International Non-governmental Organisations for Revision
     of the Convention , Document UPOV / IOM/ III / 3 .
28
     Greece , Luxembourg and Portugal are not members of the UPOV .
29
     The UPOV Convention allows its contracting States to limit protection to
     only a minimal number of genera or species of plants , i.e. , States must -
     after eight years of memberhip , protect at least 24 ( Article 4 ( 3 ) (b ) ( i i i ) .
     As a result of this principle , even in the Community Member States
     belonging to the UPOV , extensive areas of plant agriculture are not
     covered by UPOV-type plant breeders' rights .
 ---pagebreak---                                         - 27 -
For it is the modern plant biotechnology which offers the prospects to
eventually overcome problems with which Community agriculture is faced and
which therefore merits the best possible incentives . Farmers throughout the
Community are in great need of new products , commercially desirable as well as
environmentally acceptable , which traditional plant breeding techniques are
not able to produce . Modern plant biotechnological processes , for example for
transferring foreign genes into plant cells or for regenerating transformed
cells into whole plants etc ., as well as products thereof , such as genetically
modified plant cells , plant cell lines , plant tissue culture and transgenic
plants , must be offered the best possible protection in order to provide the
incentives necessary to mobilize intellectual manpower and to induce capital
investment to the extent necessary to maximize the innovatory potential in the
Community 's agricultural sphere .
48 . The UPOV-type protection which is at present available does not offer
appropriate incentives . For example, it does not cover process innovation . In
addition , the scope of protection provided for products encompasses only the
production and commercialization of the reproductive or propagative material ,
as such , of the protected variety , but not whole plants or parts of plants ,
such as cut flpwers , as end products . Lastly , and far more importantly , plant
breeders' rights are governed by the principle of independence : no
authorization is required from and no licence fees are paid to the original
breeder for the use of his protected variety as a starting base for breeding
and commercialising new varieties . Although this rule was designed to
facilitate improvement of plant genetic diversity , it was and remains , in its
broad form , an insufficient incentive to lead to investments in truly new
developments .
Distinctness , a criterion for protection of new varieties , as applied under
the UPOV scheme does not focus on characteristics essential for the working
( functioning ) of a plant variety . The rule of independence seems to have
resulted in investments to achieve minimal variations of existing varieties ,
rather than in research and development of genuine improvements in genetic
diversity . Traditional breeding methods , supported by plant breeders' rights ,
were not able to prevent the present situation in Community agriculture in
which the EEC is unable either to consume or to sell all that it produces .
                                      y
 ---pagebreak---                                        - 28 -
Biotechnological methods for developing new plant products offer genuine
promise for producing commercially desirable and therefore saleable
agricultural materials .
In this connection a recently established " Committee on a National Strategy
for Biotechnology in Agriculture " of the US National Research Council - a body
of the National Academy of Sciences since 1916 - recommends in its 1987 report
on " Agricultural Biotechnology " inter alia :
      " Patenting and licensing play necessary roles in advancing technology
        transfer and assuring the commercialisation of research results ,
        especially in capital intensive fields such as biotechnology . Patenting
        and licensing by universities and government agencies should be
        encouraged as key instruments used to transfer technology . Universities
        and government agencies should provide incentives to their scientists to
        encourage patenting . Public policy should encourage state land-grant
        universities to confer exclusive licences on patents to private
        companies with the resources , marketing , and product interests required
        to translate these discoveries into commercial products .
The Committee in effect is recommending no less than a complete departure fn..,.;
a policy followed for decades in US agricultural economics which generally
opposed exclusive rights in the field of publicly funded agricultural
research .
49 . The principles of the UPOV Convention as applied in the national laws of
the Member States will be unaltered by the proposed Directive . Nonetheless it
is indispensable to secure the undisturbed functioning of the patent system in
areas clearly allocated for patent protection , that principles necessary to
clarify the interrelation of the effects of patents and plant breeder' rights
be adopted . The pertinent provisions of the Directive safeguard the necessary
contents of patent rights , taking account of all the relevant interests
involved , including science , industry , breeders , growers , farmers , taxpayers
and consumers .
30
    Agricultural Biotechnology - Strategies for National Competitiveness
    Washington , D.C. , 1987 , 14 .
 ---pagebreak---                                       - 29 -
Legal Basis
50 .  In the White Paper on completing the Internal Market under " Creation of
Suitable Conditions for Industrial Cooperation " the Commission gave clear
notice of its intention to propose to the Council specific measures to improve
patent protection of biotechnological inventions in light of the negative
impact which differences in national laws have on intra-Community trade and on
the ability of industry to treat the common market as a single environment .
The present proposal therefore forms part of the Commission 's programme for
the completion of the internal market before 31 December 1992 .
For the achievement of the internal market before 31 December 1992 , Article
100A paragraph 1 , sentence 2 provides by way of derogation from Article 100 :
       The Council shall , acting by a qualified majority on a proposal from the
       Commission in cooperation with the European Parliament and the Economic
       and Social Committee , adopt the measures for the approximation of the
       provisions laid down by law , regulation or administrative action in
       Member States which have as their object the establishment and
       functioning of the internal market .
Article 8A paragraph 2 defines the internal market as comprising " an area
without internal frontiers in which the free movement of goods , persons ,
services and capital is ensured in accordance with the provisions of this
Treaty ." Differences in industrial property laws , such as exist in national
patent laws in Member States as regards biotechnological inventions , hamper
the proper functioning of the internal market . The present proposal will
establish equal possibilities for protection of the results of
biotechnological research and will thereby create a legal framework
facilitating cooperation between enterprises . In addition, the Directive will
produce suitable conditions for the exploitation of the results of such
research and will encourage industrial development and greater
intra-Community trade .
Industry in those countries with clear and established practices of
patentability and patent procedure is in a more favourable position than that
in countries where practices have yet to be established and where insufficient
 ---pagebreak---                                       - 30 -
experience has resulted in an uncertain situation for the protectior of
biotechnological inventions . Such differences distort the conditions, of
establishment and of competition in Member States for firms which engage in
activities concerned with biotechnology . The development of a Community
biotechnology industry as a whole is hindered . In consequence , the common
market fails to develop as it should for its proper functioning .
By providing the conditions for the results of research to be legally
protected on a uniform basis in the Member States , innovation and technical
progress on an EEC scale will be encouraged .
The Directive will also foster a greater movement of biotechnological goods
between Member States because the reluctance to engage in inter-State trade
which results from a lack of protection in one or more Member States will be
eliminated or will not arise if legal protection is clearly available on an
equivalent level in all Member States . Without the improvement in protection
and legal certainty anticipated by the Directive , offers for sale of many
future biotechnological products would not be made in some Member States and
the enforcement of national patent rights in a Member State where protection
existed against imports from a Member State where no protection was available
could prevent the creation of the conditions necessary for the proper
functioning of the common market . The free movement of goods could be
adversely affected due to a variable system of national protection in the
Member States .
Notwithstanding the benefits to the internal market which would result from
the entry into force of the CPC , unlikely in any event before 1993 , this
Convention will be limited to patents granted under the European Patent
Convention only . In consequence , the national systems of patent law would be
unaffected by the entry into force of the CPC . Thus , there remains a need for
an instrument directed to the national patent systems which encourages
biotechnological research in Europe with a reasonable expectation , if desired ,
of protecting such work via the national patent systems . This in turn will
ensure that both a Community biotechnological industry and Community trade in
biotechnological products develop as necessary for the proper functioning of
the common market .
 ---pagebreak---                                            31
In the preparation of this proposal the Commission has taken into account the
requirements of Article 8c of the Treaty and has concluded that no special
provisions or derogations seem warranted or justified at this stage .
Likewise the Commssion has studied the question of the high level of
health / safety / envi ronmental and consumer protection required by the terms of
Article 100AC3 ) of the Treaty . In the preparation of this proposal , full
account was taken of these considerations which are directly dealt with in
other Community instruments .
 ---pagebreak---                                       - 32
                         PART TWO : PARTICULAR PROVISIONS
                                     CHAPTER 1
                          Patentability of Living Matter
                                     Article 1
This Article defines the aim of the Directive : to ensure that national patent
laws are in compliance and accord with the terms of the directive . The
Directive will have no legal effects vis - a -vis the European Patent Convention
( EPC ) or any provisions thereof .
                                     Article 2
The aim of Article 2 is to establish legislatively that the condition of being
alive or of being living matter would be legally insufficient to render such
material unpatentable . This principle must be explicitly recognised for
biotechnological inventions . The normal criteria for patentability provide no
guidance on how to determine the patentability of living matter . This article
is therefore necessary even though the principle to be established is already
widely recognised . Where the principle is not completely accepted , under
Article 2 , the argument can no longer be raised that all living matter must be
excluded from patent protection on the ground that the mere fact of being
alive disqualifies such inventions from being regarded as patentable , e.g. , on
the basis that they are natural products .
The history of industrial property protection demonstrates that inventions in
newly developing technologies have always encountered difficulties in securing
legal protection . Such an explicit legislative provir^n as is laid down in
Article 2 is necessary to remedy certain difficulties 0 nd to prevent others
from arising when general provisions of patent law are applied to inventions
 ---pagebreak---                                      - 33 -
involving technology that makes use of living entitites such as animals ,
plants and micro-organisms . As all inventive activity involves intervention
by man into the processes or products of nature , there is no reason to exclude
from protection inventive activity relating to living matter , other than the
area of humankind ( but this type of provision is already commonplace in patent
law on public policy grounds as is found in Article 52(4 ) EPC ).
Only a very few national courts of the Member States , after decades of
uncertainty , have managed to develop a coherent doctrine under patent law to
protect living matter .   Article 2 will establish a minimum level of legal
certainty without the delay caused by awaiting judicial resolutions which may
not arise . Such certainty is required to foster economic and technical
progress . This can only be achieved within an acceptable period of delay by
requiring legislative adoption of the rule to recognise the general rule that
living matter as such is no less patentable than non-living matter if the
required extent of novelty , inventive activity and industrial applicability is
present for patent law purposes .
                                    Article 3
Although biotechnology is an old science involving the use of and deliberate
selection by man of organisms which improve agriculture , animal husbandry and
baking and brewing activities , research in the new areas of biotechnology is
producing an even greater ability on the part of man to intervene in natural
biological processes . When attempt is made to determine the extent of patent
protection which might be available to inventions in the field of living
matter , there is the additional complication of a special system which was
devised for the protection of plant varieties . The existence of this special
system has generated uncertainty as to the extent to which plant matter as
such can be patented .
Biological classification begins with the kingdom descending from the phylum
through the genera and species . All members of genera and species possess at
 least some common characteristics but also usually possess other
characteristics which distinguish some members from others . A variety ,
however , for purposes of variety protection , is defined as a group whose
members possess no distinguishing characteristics one from another .
 ---pagebreak---                                          - ЗА -
Exceptions to patentability for the categories of inventions relating to plant
and animal varieties and essentially biological processes for producing plants
and animals were created under certain conventions on the basis that these
inventions lacked industrial applicability . It was considered preferable to
provide special protection for plant varieties some of which were already
patented and patentable in various countries . For animal varieties , the need
for protection was less evident and therefore patent protection was not
seriously considered .
It is clear today that the new biotechnological techniques , which were unknown
to the authors of the relevant exclusions , have come to occupy the territory
of both fields . This is demonstrated by the numerous developments which have
arisen in microbiology which now lead to the development of new plant and
animal characteristics .   No justification appears to exist at present to
continue to treat the results of different forms of research differently as to
the protection which may be obtained . Thus , were patent and plant variety
protection systems being formulated on the basis of current scientific
developments and technology , different provisions for these systems might be
adopted from those chosen thirty years ago .       Nonetheless , until the
international legal framework can be adapted to the new technologies , these
exclusions will remain and must be addressed if greater legal clarity and
certainty are to be achieved .
The exclusion of plant and animal varieties prohibits only the patenting of
animals , plants and plant propagating material in the genetically fixed form
of a plant or animal variety . There is no justification where an invention
concerning plant or animal matter , such as plant or animal cells , cell lines ,
tissue cultures and larger parts , is not covered by the language of the
exclusion to either withhold protection from such an invention or to give the
exclusion a wider interpretation than is justified by the purpose for which it
was developed .   It is perfectly acceptable and appropriate for the exclusion
to be limited , in conformity with its wording , to those cases in which plants
are characterised precisely by their individual phenotype . Article 3 first
sentence therefore provides that it is not plants and animals in general which
are excluded from pai i-ntabi i. 1 ty but only plant and animal varieties as such ,
 ---pagebreak--- i.e. in the genetically fixed and stable form of a variety . Thus , Article
first sentence will establish the principle that patent protection is
available for plant and animal material which is not a variety .
The second sentence of Article 3 is necessary as regards plants in light of
the uncertainty created by Article 2(1 ) of the UPOV Convention which obliges
contracting States to provide only one form of legal protection for the same
genus or species . The principle is clear that if plant variety protection is
available for a variety , patent protection would not . But if patent
protection is available for plant material which is not a variety , as is
required in the first sentence of this Article , the rule must be legislatively
clarified as to how far the patent rights extend . Thus , this sentence
acknowledges the principle that protected plant varieties must co-exist
alongside patents on plants but requires the further principle to be
introduced that the patent rights pertaining to such patent claims must be
enforceable even in respect of finished varieties incorporating such patented
inventions .
Without Article 3 , the patenting of new plant characteristics , such as insect ,
disease and herbicide resistance , might not be given the proper legal effects
which encourage economic progress via the patent system . Article 3 in no way
interferes with the role or the legal effects of the system of breeders’
rights . However , problems of interaction between exclusive rights granted
under the patent and plant breeders' systems may arise where the patentability
of plants , parts of plants such as genetic sequences and classifications other
than varieties is recognised . The legal uncertainty which is thereby created
relating to the extent of the rights which may be enforced between the two
systems must be resolved . Article 3 is therefore necessary to ensure that the
patent system is allowed to produce its proper effects without hindrance from
or to the plant breeders' system . Article 3 is also necessary to respond to
the need to determine the effect of patent rights in any invention relating to
plants which is subsequently incorporated into a variety and which variety is
subsequently protected by a plant breeders' right . Article 3 establishes the
principle that in such a case the patent rights would remain effective as to
the patented invention .
 ---pagebreak---                                      - 36 -
Article 2(1 ) of the UPOV Convention directs the contracting States that they
may accord only one form of protection to any protected genera or species .
This means that both variety protection and patent protection ( double
protection ) cannot be granted to the same plant genera or species . Article .3
ensures that a clear borderline is drawn between protectable subject matter in
each system . One may take as an example a genetic sequence inserted into the
genetic material of a plant which renders the plant resistant to insects . The
genetic sequence is patented and is subsequently incorporated into an existing
variety . The new variety now possesses the new characteristic and is eligible
for variety protection . There is no reason for such a new variety to be free
from the effects of the patent .  This would effectively deny the inventor of
the legitimate scope of the right to his invention .
Such an approach neither jeopardises nor runs contrary to the principle of
Article 2(1 ) UPOV . It is not the genetic sequence which is protected by the
plant breeders' right nor is the variety protected by the patent . There is no
requirement in either patent law or in plant variety law that the patent
rights associated with a patented invention are extinguished simply because a
variety right is also associated with the final product . Nor do any
compelling policy reasons exist for such an interpretation . Quite the
contrary . Future developments in biotechnology are likely to provide a
valuable range of new and enhanced agricultural products incapable of being
produced under traditional breeding techniques which will have a ready market
demand . It is also foreseeable that new agriculture products will be
developed that have new industrial applications , for example , as petrochemical
substitutes and in the field of polymer chemistry .
Notwithstanding the historical context and logical inconsistency of present
plant variety and patent laws , the Commission considers that it would be
harmful neither to the interests of European industry engaged in
biotechnological research nor to the purposes for which the directive is
designed to allow a certain number of cases , likely to have applications as
plant varieties , which would otherwise have been patentable , to be excluded
from patentable subject matter under national patent laws when such plants
have been produced by a known biotechnologial process . The principle of
Article 3(2 ) is necessary to ensure this result .
 ---pagebreak---                                          - 37 -
                                        Artide 4
  Patent Law traditionally recognises three types of protectable inventions :
  process inventions , product inventions and application inventions ( also called
  " uses "). The corresponding categories of patentable biotechnological
  inventions would be identified as :
       Dinventions relating to a process for the creation of a living organism
           or the production of other biological material ;
       2 ) inventions relating to an organism or material as such ; and
       3 ) inventions relating to the use of an organism or other biological
           material .
  As most Member States have explicitly excluded from patent protection plant
' and animal varieties as such , the result is that plant and animal varieties as
  products are not eligible for patent protection . This does not , however , have
  the effect of excluding the other two types of inventions from protection if
  and as these relate to plant varieties , that is , microbiological processes and
  processes which are not " essentially biological " for the production of plant
  varieties and specific uses of plant varieties . Article 4 is needed so that
  these two types of inventions are expressly included in protectable subject
  matter under the patent laws of the Member States .
  Article 4 will thus establish the principle in national patent laws that the
  traditional categories of patentable inventions relating to processes and uses
  are not affected by the exclusion of plant and animal varieties from patent
  protection . In light of the exclusionary provisions of many patent laws along
  with the principle of the prohibition of double protection in Article 2(1 ) of
  the UPOV Convention , Article 4 is necessary to establish clearly that the
  traditional categories of patentable inventions as these relate to
  biotechnological inventions constitute patentable subject matter .
                                        Article 5
  Most Member States' national patent laws mirror the language of Article 5 ( b )
  of the European Patent Convention which states that patents shall not be
  granted in respect of
 ---pagebreak---                                       - 38 -
       plant or animal varieties or essentially biological processes for the
       product ion of plants or animals ; this provision does not apply to
       microbiological processes or the products thereof .
Thus , when the exclusions for plant and animal varieties and essentially
biological processes were drafted , the field of microbiology , which did not
involve traditional breeding processes , was singled out as being appropriate
for patent protection . Microbiological processes and products of such
processes were specifically recognised as eligible for patent protection . The
underlying motivation for this language was to carve out of patent law
protection the results of traditional breeding processes using plants and
animals . The results of such breeding processes would enjoy their own
protection in the form of plant or animal variety rights .
Because inventions relating to living matter specifially resulting from
microbiology are patentable in those Member States with such provisions , it is
therefore of considerable importance for the application of patent law to
establish what is included in the term " microbiological process ". Where the
determination of the patentability of a biotechnological invention rests on
the criterion of whether a process is microbiological , it is vital to a proper
application of patent law that this term be correctly defined . Article 5 of
the Directive addresses this problem and establishes a minimum principle in
this respect .
No attempt was made to specify the borderline between those areas capable of
patent protection - microbiological processes and products - and those areas
excluded from protection - plant and animal varieties and essentially
biological processes - it being assumed that the results of traditional
breeding and microbiological processes would be readily distinguishable . Had
science and biotechnology not made the advances they have in the past thirty
years , these distinctions would continue to be valid and the two types of
protection would have wholly separate fields of application .
 ---pagebreak--- As many inventions in the field of biotechnology concern microorganisms , the
principle of patent law in Article 5 in respect of microbiological processes
corresponds best to the original intentions of the drafters of the exclusions ,
accords with the exclusions which have been adopted and offers an adequate
incentive to potential innovators to pursue high risk and costly research .
Without this Article , it would be possible for widely varying definitions to
be adopted throughout the Community of what is considered microbiological and ,
consequently , for very different decisions to be taken regarding the same
factual patent application - Article 5 is therefore necessary to establish a
minimum uniform principle of patent law and at the same time avoid an
inappropriately narrow principle from being adopted in connection with the
patent law concept of "a microbiological process ". Thus , the rule must be
established that inventions relating to processes which either use or directly
operate upon or result in a microorganism should be considered microbiological
and thus eligible for patent protection . Article 5 prescribes this rule . In
this connection , Article 5 must be read in conjunction with Article 19 of what
should be understood by the term " microorganism ". Thus the principle of
Article 5 would not be limited only to microorganisms as such but would apply
to other microscopic animate matter as well .
                                    Article 6
                       {
Likewise greater certainty and uniformity must be engendered into the
application of the criterion in national patent laws of the patent law concept
of a "microbiological process ". To give optimum effect to developments in
biotechnology , it must be legislatively established that neither the entire
process nor every step in the process need be of a microbiological nature in
order for the process as a whole to be deemed microbiological . If a necessary
and important part of a Complex process is microbiological , while other steps
of the process are merely biological , rejections of patentability on the basis
that the process is essentially biological should be prevented . Article 6 is
necessary to produce this result .
 ---pagebreak--- The Article will make it necessary for the principle to be adopted that a
multi-step process in which the essence of the invention is incorporated into
a microbiological step is not deprived of its microbiological character simply
because the process contains other , non-microbiological , steps . To take an
example , the genetic manipulation of a plant cell may be performed which is a
microbiological process . Thereafter , the entire plant may be regenerated from
the single cell (a process called differentiation ). This latter process may be
said to be essentially biological , but the entire process should be accorded
the character of microbiological because the essence of the process and the
invention is a microbiological step . The process should therefore be
considered patentable despite the presence of an essentially biological step
in the overall inventive process . Without Article 6 , the exclusion from
patentability of essentially biological processes for the production of plants
could result in erroneous rejections to patentability and unsystematic
adaptation of national patent law principles when applied in the same factual
contexts .
                                     Article 7
Because some national patent laws exclude essentially biological processes
from patentability , it is necessary to lay down a principle of patent laws
which establishes the extent to which human intervention is required in order
to ensure that an invention will be considered patentable subject matter . In
this connection , it is important to distinguish between traditional breeding
activities and other forms of human intervention in biological matter . As
essentially biological processes are generally agreed to refer to traditional
breeding processes , it is important that the principle laid down differentiate
between the use of biological material which falls into the category of
essentially biological and that use which may properly be regarded as
patentable subject matter .
 The EPO Examination Guidelines stipulate in this regard that human
 intervention must play a " significant part " in determining or controlling the
 result it is desired to achieve and notes that the question is one of degree
depending on the extent to which there is technical intervention by man in the
 ---pagebreak---                                        - 41
process ( C-IV , 3.4 ). Article 7 of the Directive , by contrast , is intended to
exclude only traditional biological breeding activities based upon • lection
and as such may be regarded as slightly more liberal than the Guide' : nes .
Article   7 will ensure that both an appropriate and a consistent rule is
adopted for national patent systems in situations where it needs to be
determined if sufficient technical human intervention has occurred to render
an invention patentable . Such a rule should reflect a liberal approach in
view of the now artificial nature of the distinction between " essentially
biological " and "not essentially biological " processes . Biotechnological
techniques have effectively rendered this difference of little practical
value . Thus , for purposes of national patent laws , human intervention of a
technical nature into the natural processes of biology need not be at the same
time of a drastic nature in order for a process to fall outside the scope of
being " essentially biological ". Any human intervention aside from selection ,
such as influencing the crossing procedure or the replication process , would
remove the process from the field of "essentially biological " processes . The
invention would , of course , thereafter fall to be considered under the
criteria for patenting .
     < ■
                                      Article 8                   „•
In certain circumstances , patent law recognises the patentability of products
or substances which are of natural origin . Usually this occurs in situations
where a product exists in a naturally occurring mixture of substances without
it having been identified in the mixture . The invention typically consists of
identification of the substance and isolation for useful purposes in a usable
or pure form in which it did not exist in nature .
With the new biotechnological techniques , many substances are now capable of
being selected and adapted for industrial , commercial and medical uses . The
possibility of legally protecting such developments in the field of
biotechnology is important to ensure that the necessary investment r ~d
 research are undertaken .
 ---pagebreak---                                          42
Not all national patent systems have recognised the patentability of naturally
occurring matter which fulfils the criteria for patentability , such as th^t in
a mixture ( either natural or modified ) notwithstanding the fact that the
substance existed in an unidentified form prior to the recognition of its
existence and utility and prior to adapting the matter for use in an
industrial application . Article 8 will establish that , as long as a claimed
product has not been sufficiently disclosed , it should not be considered
unpatentable simply because it was part of a pre-existing natural material .
Although an invention may involve a naturally occurring substance , such as an
alkaloid isolated from a plant root , or a biological factor isolated from an
animal organ , there will be a considerable difference between the product as
it existed in nature and the product in a useful form . As such it is different
from the product as it existed in nature . The so-called natural material has
been changed by human intervention and the form in which it is claimed for
patent purposes is not the same as that in which it exists in nature . Such
products must in any event comply with all the criteria of patentability
 ( novelty , inventive step and industrial applicability ).
The EPO Examination Guidelines also recognise this rule . There , it is said
that if a substance found in nature must first be isolated from its
surroundings and a process for obtaining it is developed , such process is
patentable . Moreover , if the substance can be properly characterised either by
 its structure , by the process by which it is obtained or by any other
parameters , and it is " new" in the sense of having no previously recognised
existence , then the substance per se may be patentable ( C-IV , 2.3 ) unless it
 is specifically excluded , such as plant or animal varieties .
 This Article is different from Article 2 which addresses the question of the
patentabi li Ity of living matter as such , whether microorganisms , plants or
 animals . Here , the products are likely to be other than living organisms
 themselves , for example , plasmids , DNA ( deoxyribonucleic acid ) segments ,
 proteins , peptides , enzymes and the like .
 ---pagebreak---                                          43 -
        <                             Article 9
A basic principle of patent law is that a mere discovery is unpatentable . A
discovery is defined in the Geneva " Treaty on the International
Recognition of Scientific Discoveries " of 1978 as the recognition of
phenomena , properties or laws of the material universe . Objections to
patentability of natural substances - living or non - may be raised on the
basis that such products are discoveries and therefore that they are not
"new". Such objections are usually raised in the biotechnological context , as
noted above , for the sole reason that the products were present in a
pre-existing material which itself may or may not be part of the prior art for
patent law purposes . Article 9 deals with the two related issues of discovery
and lack of novelty .
According to the EPO Examination Guidelines , if a new property of a known
material or article is discerned , it would constitute a discovery and would be
unpatentable . If , however , the new property is put to practical use , the
result may be a patentable invention . If a natural substance is sought to be
patented , the Guidelines note that the line of demarcation between the mere
discovery of a natural substance and its patentability will depend on the
degree of human technical intervention necessary to obtain it ( C-IV , 2.3 ).
Where a substance is claimed in a form which results from human intervention
in the material world , it is more than mere discovery , irrespective of whether
the intervention is simple or complex . Article 9 is necessary to ensure that
this distinction is correctly applied in patent law . As to the argument that
such products are not " new", a product is considered "new" under the patent
laws of most Member States if it does not from part of the " state of the art ".
The state of the art is deemed to be everything which has been made available
to the public by means of a written or' oral disclosure , by use or in any other
way before the patent application was filed ( for example , Article 54 EPC ). The
fact that a product may have existed in a mixture before its identification ,
isolation , purification and usefulness have been established does not render
it part of the state of the art for purposes of patent law because it was
effectively " not available " to the public by any means .
 ---pagebreak---                                        44
The principle required by Article 9 does not prejudge the issue of the novelty
of the product . If information was available as to the existence of the
particular mixture in question , and if the information available could have
made the particular product foreseeable as a separate entity and would have
enabled the person skilled in the art to render it into useful form , such
product may be considered not to be new . In the absence of specific
information , and if a product isolated from a mixture or synthesised is
physically different from the mixture which was available to the public prior
to the invention , novelty should be admitted as a matter of principle .
Article 9 will ensure that an invention is not erroneously considered
unpatentable as a discovery simply because it was once part of a pre-existing
mi xture .
 ---pagebreak---                                       - 45 -
                                     CHAPTER 2
                               Scope of Protection
                                    Article 10
Article 10 is addressed to the issue of experimental use of a patented
         !
invention involving living or self-replicable matter . The issue of
experimental use in patent law is not dealt with in the EPC . Article 31(b ) of
the " Convention on the European Patent for the Common Market " ( CPC ) states
only that the rights conferred by a Community patent shall not extend to :
      acts done for experimental purposes relating to the subject-matter
      of the invention .
Under national patent laws as well , experimental use of a patented invention
does not consitute patent infringement but interpretations vary of what acts
constitute experimental use .
If a patented biotechnological product is employed to produce an improvement
over the previous product , such use may legitimately be regarded as
experimental use . If the improved product is a biotechnological product which
is self-replicating , the patented starting material need only be prepared once
in small quantities . To obtain commercial amounts it would not be necessary
to reuse the product enjoying patent protection or to find a new way of
production, avoiding the direct use of the patented product , as would be the
case , for example , with a patented chemical product unable to reproduce
itself . Replication of the small amount obtained in the first " experiment "
with self reproducing material would suffice .
In order to safeguard the patent rights granted for the first invention and
thereby place the inventor in such a case on ~n equal footing v-!th invent ,' ,'r
in other fields , Article 10 is necessary to qualify the first use of the
patented product to obtain even a small amount of a new or improved product as
 ---pagebreak---   г
                                        - 46 -
  experimental use so long as the improved product is multiplied for other
  experimental purposes . If multiplication were for commercial purposes , then
  such use of the new product would not be covered by the patent law doctrine of
  experimental use .
  It would be irrelevant whether an improved product is obtained from a product
  enjoying patent protection in one or several process steps . What is essential
  is whether any new product obtained by using a patented product is
  manufactured by multiplication of the material obtained from the patented
  product . Article 10 establishes the minimum necessary point beyond which the
  use of patented self-reproducing products will not be considered experimental ,
  that is , at commercialisation .
■ Article 10 is needed in part because of the variety of interpretations of what
  acts constitute experimental use . More importantly , it establishes a rule for
  patented living matter consistent with patent law doctrine applicable in other
  fields of patentable subject matter .
                                   |
                                       Article 11
    ■î                                              t                            ;
  Under traditional patent law doctrine , the purchaser of a patented product may
  use such product in any manner he deems fit . A purchaser may put the product
  to such use as is consistent with its purchase , for example , a patented
  machine may become part of a factory production process ; a patented chemical
  may be used to treat plants or kill insects , etc .
   It is a well-established patent law principle that a purchaser of a patented
  product is not allowed , unless it has been specifically agreed , to manufacture
  the patented product itself . The jurisprudence of the Court of Justice has
   recognised the patentee 's right " to use the invention with a view to
  manufacturing industrial products and putting them into circulation for the
   first time" ( Centrafarm B.V. et al . v. Sterling Drug Inc . 1974 ECR 1147 at
   1162 ) .
   The Treaty 's articles on the free movement of goods should not be confused
  with the patentee 's exclusive rights to produce patented products . The
  principle in the Treaty of Rome in respect of the free movement of goods
 ---pagebreak---                                         47
( Articles 30 to 36 ) has also resulted in the development of an exhaustion
principle as applied to trade between Member States including goods covered by
industrial property . Once a patented product has been placed on the market by
a patentee or with his consent , no control over the further use of the product
in intra-Community trade may be exerted by the patentee or a licensee .
The exhaustion of rights which applies under the Court 's interpretation of
these articles relates to three activities : the use , offer for sale and sale
of a product covered by industrial property rights . Use in such a case
relates to use of the product in commerce in intra-Community trade . It does
not include the manufacture of products covered by industrial property rights .
Patent rights would not be exhausted for the production of the patented
product until the patent term itself expired .
The purpose of Article 11 is to establish this rule for patented living or
self-replicable matter . Thus , the purchaser of , for example , patented barley
may use his barley to make whisky without infringing the patent ; the purchaser
of patented malt or yeast , for example , may use these products to make beer
without infringing the patent . Both uses involve a certain amount of
multiplication ( such as germination ) of the product sold but such uses are
clearly intended by the sale .
Where patented self-replicating material is sold for purposes of propagation ,
for example, seeds , the purchaser usually a farmer will have the right without
patent infringement to use the products for the purpose for which he purchased
such seeds , i.e. to grow a crop for harvesting even though such use
unavoidably involves multiplication of his seeds . The patent rights would
not be exhausted in respect of the use of the crop grown from the patented
seeds as a source for the sale of new propagating material ( seeds ) as this
would involve production for the purposes of selling the patented product
itself . ( Any variety rights inherent in seeds protected by plant breeders'
rights would similarly be unexhausted in respect of the use of the crop grown
from the seeds as a source for the sale of new propagating material ).
Article 11 will ensure that the use which is intended in a - ale of patented
self-reproducing material is not confused with a use which involves patent
infringement . The provisions of Article 11 are needed because the issue of
 ---pagebreak---                                         48 -
the extent of patent rights in respect of patented Living or self-replicating
material has not been dealt with in any national patent system and the
provisions of the EPC do not address this question , save that the rights
conferred by a European patent are said to be the same as would be conferred
by a national patent ( Article 64(1 ) EPC ). Infringement of European patents is
considered under national law principles taking account of EPC requirements
regarding claim interpretation . The issue which is addressed in Article 11
therefore is not regulated by any specific provision of the EPC .
The CPC , of which seven out of the nine original signatories have adopted laws
ratifying this Convention , at Article 32 , provides that the rights conferred
by a Community patent shall not extend to acts concerning a patented product
within the territories of the contracting States after the product has been
put on the market in any State by or with the consent of the proprietor of the
patent unless there are grounds under Community law which would justify the
extension of the patent rights to such acts . Article 81 of the CPC provides
the same principle in respect of national patents .
The intention of the drafters of these provisons was to incorporate into the
provisions of the CPC the prior and future jurisprudence of the Court of
Justice dealing with the interpretation of Articles 30 and 36 of the Treaty of
Rome . These provisions , as has been demonstrated above , relate to different
principles of Community law than those dealt with in Article 11 of the
Directive .
Article 11 is necessary therefore to distinguish between the meaning of " use "
for different purposes of national patent law , the EPC and the CPC .   For
national patent laws , it needs to be legislatively established that use which
involves propagation solely for the purpose of obtaining additional
propagative or self-replicating material does not come within the scope of
intended use which would be exhausted upon the sale of a patented product .
The patent rights inherent in the use of material such as seeds are not
exhausted for a use which consists of multiplying such material solely to
obtain more thereof . Without Article 11 , the relationship of the exhaustion
principle under Articles 30 to 36 of the Treaty of Rome and exh ; ustion of
patent rights for self-replicating material under national patent laws might
have remained unclear .
 ---pagebreak---                                         49
                                    Artide 12
In traditional patent law doctrine , the protection conferred by a patented
process extends to the product produced by the protected process . This
principle exists in the laws of most Member States and is also found in the
EPC ( Article 64(2 )).
Where a patented invention is a process which makes use of living or
self-replicable matter , the scope of the patent rights conferred must be
ascertainable . Putting things differently , both a patentee and third parties
must be apprised of the point at which patents rights in such material are
exhausted .    Article 12 addresses this issue .
The product obtained from the patented process may be either living matter or
other matter which is capable of self-replication, for example , a
microorganism which can be cloned or a plant cell which can be differentiated
to yield the plant itself . It will readily be recognised that matter which is
capable of reproducing itself may be purchased in small quantities and
subsequently made to reproduce under appropriate conditions . The effect of
the patent rights conferred by the process would be completely nullified if
further generations of the microorganism or differentiated plants would no
longer benefit from the patent protection accorded to the process .
Two specific sitations in which a need for the principle of Article 12 may be
envisaged are :
      ( 1 ) where a patented process is carried out in a country where no patent
      protection exists and either the first generation of said product but ,
      more usually ; a second - usually multiplied - generation is imported into
      a country where patent protection has been accorded ; and
      ( 2 ) where the direct product of the process is , for example, a seed or a
      cell which can be regenerated to a plant , the seed or the cell is
      produced in a country where no patent protection exists and the plant or
      plant material produced therefrom is imported into a country where patent
      protection does exist .
 ---pagebreak---                                          50 -
Article 12(1 ) will therefore establish that patent protection will extend not
only to those products initially obtained from the process but also to farther
generations of microoganisms and to plants grown from cell tissue . Such
further generations of microorganisms or regenerated plants are products whose
properties which were initially obtained by the process are still present and
are determinative of their value . Such products should properly be regarded as
"direct " products of patented processes . Thus plants would benefit from the
protection of the direct product of a process for the production of a plant
cell or parts of plants when regenerated from such cells or parts .
There may also be cases where the product of a protected process takes the
form o.f a variety . Article 12(2 ) is necessary to ensure that protection is
nonetheless accorded , even where the patented process produces plant
varieties . Although varieties are excluded in most national patent laws as
such from patent protection , they are not excluded from protection as products
of patented processes .
This view is found in the Report on the 1975 Luxembourg Conference on the
                                            31
Community Patent Convention ( CPC ), 1981 , . During the discussion of Article
29(c ) CPC , it was questioned whether it would be possible to protect a plant
variety or animal variety by means of the principle in Article 29 , that is , as
a " direct product " of the patented process . It was agreed by the Conference to
revise Article 29(c ) following the interventions of two Member States to the
effect that protection of plant and animal varieties as direct products of
patented processes was not excluded even though varieties were excluded per se
in the EPC ( Article 53(b ) EPC ). This was felt to result from the patent law
principle that the protection conferred by a patented process extends to the
products directly obtained by such process ( Article 64(2 ) EPC ).
The European Patent Office ( EPO ) has not yet adopted a definitive position on
this issue . The Commission agrees with the views of the governmental
Conference and has therefore proposed the same rule in Article 12(2 ) in
respect of national patent laws . Article 12(2 ) will therefore legislatively
31
   Minutes of the Conference published in Records of the Luxembourg Conference
   on the Community Patent , 1975 , Luxembourg 1981 , footnote 75 , p.234 .
 ---pagebreak---                                         51
establish the principle for national patent laws that the protection of a
patented process will extend to the products of such processes , even where
these include plant and animal varieties .
Since national patent laws contain the same wording as the CPC in this regard,
it is envisaged that adoption of this principle for national patent systems
will result in a greater degree of harmonisation between the EPC and the CPC
on the one hand and the national patent systems on the other .
                                    Article 13
As a result of the Directive greater possibilities will exist for patenting
products consisting of or containing genetic information , such as a particular
DNA segment . Where such biological products are incorporated into a more
complex product , such as where the DNA is incroporated into a host
microorganism which may be multiplied , the patent protection enjoyed by such
products should extend to all products in which the particular genetic
information which was essential for the invention remains of essential
importance for the products concerned .
Where the patented material is incorporated into a plant or animal variety ,
such variety may legitimately be subject to the rights granted in the patent"1.
Article 13 will establish this principle for national patent rights . Two
arguments have been advanced to suggest that this result would be
inappropriate : first , because manufacturing steps were required to obtain the
variety from the patented product ; and secondly , because plant varieties are
excluded from patentability .
As to the first argument , if the particular industrial applicability or
usefulness of a variety directly results from an invention which has been
patented , then such a variety owes its unique characteristics to the effects
of the invention and should therefore come within the scope of protection
accorded by the patent . Where an invention is of no commercial importance for
the variety , then a different issue would be raised . This situation is not
addressed in the Directive because Article 13 specifically stipulates that the
patented invention must be of essential importance for the utility or
industrial applicability of the final product ..
 ---pagebreak---                                         52 -
As to the second argument , an exclusion of varieties from patentability is not
synonymous with being free from the scope of a relevant patent . In future
there are likely to be inventions capable ol application in many different
plant varieties . For example , resistance to disease or herbicide tolerance may
be genetically incorporated into a broad range of plants covering many
different varieties . Thus , to be excluded from patentability does not mean
that a variety should be free from the effects of a patent granted in a case
where an invention in the field of plants concerns a generic concept which is
characterised by new generic information and which can be realised in a
multitude of different varieties .
Article 13 is necessary so that this important principle of patent law is
explicitly recognised for inventions which do not permit their direct
exploitation but which must become part of another entity in order to be used
effectively . It would be an insufficient incentive for ensuring that necessary
research is undertaken to accord patent protection only to material which on
its own has no commercial value . Patent rights must be legislatively
prescribed for any final product whose utility , commercial value or industrial
applicability depends on a patented invention . The rule must be legislatively
mandated in light of the variety of views on this issue for which existing
patent laws provide no solution . Without Article 13 , it might be considered
that the patent protection of a biological product would be lost if such
product becomes part of a more complex final product even though such
biological product is of essential importance for commercialising the final
product .
                                     CHAPTER 3
                Dependency License for Plant and Animal Varieties
                                    Article 14
It is foreseeable that if patents are granted to genetic material , to products
containing such material and to biological classifications of plants or
animals different from varieties , the situation will arise that new varieties
 ---pagebreak---                                        53 -
will be bred incorporating such material which will fall under the scope of
one or more patents . Commercialisation of such now varieties without
authorisation by the patentee could constitute patent infringement .
The implications for granting such patents require that a balancing of
interests be made as regards the value for society of promoting new
technologies and as regards the public interest in maintaining a reasonable
limitation on exclusive rights in sensitive areas . This is particularly true
in the agricultural sector where the interests of breeders , growers , farmers ,
science-based industry , the environment , tax payers and the consumer must be
taken into account .
Article 14 is necessary to provide for the possibility commercially to exploit
new varieties which represent significant technical progress under a
non-exclusive license as of right , provided the patentee enjoys the right to
receive fair renumeration for the exploitation of his invention . Provision
must also made for the patentee to be granted a non-exclusive royalty-paying
license from the variety rightholder because in some cases the inventor
himself may not be able to exploit his invention in a commercially usable form
unless he can commercialise the results obtained by his licensee .
The basic principle provided for in this article is needed in order to give
effect to the public interest in promoting further developments of
agricultural inventions through breeding activities and to recognise the
interests of the patentee to enjoy his exclusive rights which rights provide
the incentive for engaging in innovatory activities .
                                    v
The patent laws of some Member States already provide for a dependency or
compulsory license in the event that a subsequent patentable invention cannot
be worked without infringement of an earlier patent . This article is similar
in that a variety could not be commercially exploited without a license
granted by the patentee if such variety came within the scope of relevant
patent rights . The provisions of Article 14 differ from existing national
patent law provisions in according a license of right , not to a subsequent
patentee , but to a subsequent rightholder of a variety developed using the
patented invention .
 ---pagebreak---                                         54
 There is no principle of compulsory licensing between patent and plant variety
 rights which exists in any patent or plant variety law . Article 14 is crucial
 therefore to an effective exploitation of patented biotechnological inventions
 in the plant field . Without Article 14, a plant variety rightholder would have
 to rely on the willingness of the patentee to enter into voluntary bilateral
 agreements for the use of the patented invention , which agreements the
 patentee otherwise may or may not be willing to enter into , on terms the
 breeder may or may not be willing to agree .
 To benefit from the provisions of Article 14(1 ), a variety must represent
 significant technical progress compared with the teaching of the patent . The
 significance of the technical progress required for this purpose is a
 different notion from that of distinctness as currently used in plant variety
 protection law . This provision ensures that licenses of right would only be
 available where the new variety represents a genuine agricultural achievement
 in the first instance, for example , in successfully introducing a genetic
 sequence into an existing variety . This requirement would preclude licenses
 from being issued for only minor improvements to varieties which had been
 initially bred by incorporating   patented inventions .
 Article 14(2 ) provides that an application for compulsory licenses may only be
 made after the expiration of a certain period of time . This period is a
 reasonable measure to ensure that a patent applicant will have a limited
 opportunity to make exclusive use of or even to develop for commercial
 marketing his invention prior to encountering competitors and competition in
^the market place . In normal circumstances , competitors would be required to
 await the expiration of the full patent itself i.e. ,. twenty years from the
 date of filing of the patent application , before being able to use the
 invention as of right ( albeit without the payment of royalties ).
 Article 14(3 ) anticipates the situation where the original patentee would like
 to exploit his invention in the form of a plant variety into which it has been
 developed by a breeder . This provision of the Article would accord the
 patentee the right to obtain a non-exclusive license from the breeder to
 exploit on a commercial basis any variety into which his invention may have
 been incorporated, upon payment of reasonable royalties . This provision is
 ---pagebreak---                                          55 -
necessary , for example , to give an inventor who is not a breeder the
possibility of commercially exploiting his invention in cases where such
exploitation may only be possible in the form of a variety .
Article 14(4 ) allocates to a national tribunal the task of resolving disputes
between patentees and holders of breeders' rights as to the significance of
the technical progress or whether the royalties are reasonable . This is both a
reasonable safeguard and a necessary measure as it may be expected that
disagreements could arise over these issues in the same manner as they may
arise over whether a plant variety development falls within the claims of a
patent , especially in the context of exploiting new and commercially superior
products in the plant field . A neutral adjudicating body having the power to
enforce its judgements will be necessary for the effective implementation of
the principles in Article 14 . Paragraph 4 of Article 14 is therefore
necessary to direct that the resolution of disputes concerning the application
of the principles prescribed in this article should be determined by a court
of competent jurisdiction . This would normally be a court seised of a patent
infringement case .
                                      CHAPTER 4
                          Deposit , Access and Re-deposit
                                     Article 15
Deposit
It is a fundamental requirement of all patent laws that an enabling disclosure
must be made with an application for a patent . All Member States have enacted
a similar standard in this regard . An enabling disclosure is one which enables
a person skilled in the art to carry out the invention . This principle also
appears in the EPC ( Article 83). It is a requirement whose purpose is
justified by the grant of exclusive rights to an inventor in exchange for
disclosure the invention . This in turn contributes to technical progress for
the general public and to an advance in the technical state of the art . Once
 ---pagebreak---                                        56
the patent has expired the enabling disclosure provides a description of how
the invention may be reproduced for those who wish capitalise on the no longer
patented invention .
In the case of biotechnological inventions , the complexity of biological
material generally makes it impossible either to describe in a written fashion
the living material itself or to describe in a written fashion all the steps
and parameters involved to reach the result which is sought to be patented . It
is therefore impossible in many cases for the inventor to state how a person
skilled in the art could successfully- repeat his invention .
The unique aspect of inventions dealing with biological matter is that they
usually self-reproduce themselves under appropriate conditions . In such a
case , reproduction by a person not the inventor of the steps and parameters
originally employed to develop the invention ceases to be important because
the result desired can be obtained much more simply and reliably by
self-replication of the material .
Although the patent laws require an enabling disclosure , there is no
legislative requirement that such disclosure be in written form . The fact that
product inventions in traditional fields of technology could only be disclosed
in the required manner by a complete written description of how to make the
product must not have as a logical consequence that , in a new technological
field , the legal requirement cannot be satisfied in another manner , namely
through a reference to a deposit . It is therefore possible and desirable , in
order to secure the patentability of biotechnological inventions which cannot
be described in a written form , to require that a system of deposit be
established for all national patent systems not unlike that which already
exists for the EPC . Many Member States already , as a practical matter , permit
but do not require deposit while at least one requires that patent
applications for living matter be supplemented by reference to a deposited
sample of the animate material .
Several Member States are already parties to the Budapest " Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of
Patent Procedure of 1977 ". This Treaty establishes accepted procedures for
deposits to be made for patent purposes . It regulates the technical and legal
 ---pagebreak---                                         57 -
aspects of the depository institution and of the deposit and binds the
signatories who require or admit such deposits for patent purposes to accept ,
for purposes of their national patent procedure , a deposit made in accordance
with the Treaty in any depository institution provided by the Treaty . This
Treaty does not oblige the signatories to accept a deposit for purposes of
national patent law procedures .
Article 15 of the Directive requires the principle to be adopted that the
deposit mechanism will be recognised in all national examining offices for
patent application purposes both for process and product patents . Such a
principle is necessary in light of the differences in national practices and
requirements . Without the principle that a deposit may suffice as an enabling
disclosure , the patentability of many important inventions , for example , in
the field of new hybridoma cells for the production of antibodies , vaccines or
other biological factors , or of microorganisms isolated from their environment
which may be valuable agents in the fields of ecology or agriculture or as a
means of producing antibiotics or biological factors , could be jeopardised or
rendered less certain .
The EPC regulations have established rules for deposit of living matter in
connection with applications for European patents . The provisions of
Article 15 of the Directive correspond to these rules ( Rule 28 ) for depositing
living matter in connection with European patent applications with one
exception and three differences . EPC Rule 28 applies to inventions whose
claims relate to microbiological processes or products thereof . The rule in
Article 15 is not limited to inventions involving a microbiological process
but could apply to virtually any invention which involved the use of either a
microorganism or other self-reproducing material , which might be claimed in
any form ( i.e. product , process or use claims ). In practice , the rule of
Article 15(1 ) should provide a clearer , but not substantively different , rule
than that found in Rule 28 EPC .
Unless such a clear statement of the principle of the extent to which a
deposit may complete or replace a traditional written description of the
invention is adopted legislatively , considerable difficulties would be
encountered in patent enforcement procedures in determining the validity of a
patent , such as occurred in the German Federal Supreme Court decision in the
 ---pagebreak---                                            58
" Tol Iwut vi rus " case which endorsed a similar deposit rule for product claims
in Germany but which had to overrule longstanding prior jm i -. luudence to do
so .
Access / Release
  \
The Budapest Treaty does not regulate the question of the release of samples
of deposited material to the public . Issues such as the time at which release
is required , to whom and under what conditions such release should take place
were left to national and international laws - with the exception of the
minimum requirement that , generally , release is only made if the patent
application has been published ( Rule 11 , Regulations of the Budapest Treaty ).
Unlike a traditional written description of an invention which always requires
a third party seeking to work the invention to invest a perhaps substantial
amount of time , effort and expense , access to deposited living matter enables
competitions and would-be users of the invention to obtain instantly and
without cost the results of the applicant 's research . A single sample may ,
under appropriate conditions , be sufficient to begin commercial activities .
In some cases , a microorganism will represent an entire factory . Unless the
issues of the time and conditions of release are satisfactorily resolved ,
inventors will be tempted to refrain from disclosing their inventions to the
detrimment of the public and of technical progress in this field , and at
considerable risk to the inventor whose invention may be re-invented by
another or may lose its confidential nature .
For these reasons a standardized deposit systems with sufficient safeguards
for the applicant as to the time and conditions of release needs to be
established for national patent laws so that equal possibilities will exist
for protecting inventions in this field .
The practice of early publication of a patent application in Europe came about
as a result of the introduction of deferred examination of such applications
because most patent offices had thousands of pending , u^-'aminod , applications
on file at any given moment .      Publication of the patent application alerted
the public of the existence of the claims in pending applications which
 ---pagebreak---                                        59 -
otherwise would have remained unknown for several more years . This avoided
duplication of research and production in fields covered by others . The
adoption of a system of publication and deferred examination was not initially
intended to provide industry with a source of valuable technical information
on the relevant state of the art . Rather , it was more of a practical
necessity . The importance and use of the publication of patent applications
as a source of technical , commercial and industrial information for interested
circles developed subsequently .
Thus , the purpose for which the publication of patent applications was adopted
was to give notice to the interested public of areas likely to be covered by
future exclusive rights . There was no intention or desire to create the
capability of exploiting the invention for commercial purposes although , even
with a written disclosure , such a possibility was not excluded . For this
reason , a system of compensation was devised for the use of an invention prior
to patent grant following publication .
Since a written disclosure in a patent application is open to the public in
Europe at the date of first publication , it has been argued that the same
criterion should apply to a deposit and that deposits should likewise be open
to the public . This problem does not arise in the USA where no publication of
the application is made prior to the grant of a patent . If a patent is not
granted , no release is made of deposited material . An applicant could then
make use of his invention as a trade secret . In Japan , a distinction is made
between the initial publication of the application and third party access to
deposited material , so that samples are only made available to the public
during the period allocated for the opposition procedure after the second
publication indicating the notice of patent grant .
In European countries with an early publication system , a rule imposing public
access rights to deposits from the date of first publication could produce
considerable disadvantages for the inventor of a biotechnological invention .
If release to the public of deposited material is made before patent grant , an
inventor whose application is withdrawn or denied would not have the
possibility of using his invention as a trade secret . Release of sue !,
material to third parties could enable them , in some cases , to begin
commercial activities . While the possibi lity of losing the confidential
 ---pagebreak---                                      - 60 -
nature of an invention exists for all published but subsequently unsuccessful
patent applications , the release of material which greatly facilities the use
of an invention distorts the disclosure rule to the unwarranted advantage of a
competitor because of the greater immediate value of a sample of the deposited
material than that of a written description .
In respect of deposited animate matter , therefore , it is necessary to separate
the desired notice function qf the early publication from the undesirable
effects of  providing the capability for the public to employ the invention for
other than  verification or experimental purposes . Thus , restrictions and
conditions  on access to and transmission of any samples of matter deposited in
connection  with patent application procedures must be established .
                  /
Patent applicants who have considered making or have made deposits in
connection with their applications have expressed dissatisfaction with certain
aspects of the EPC deposit rules ( Rule 28 EPC ) and similar provisions of
national patent systems . Under the EPC rules , where a deposit has been made
pursuant to a patent application , a party requesting a sample must undertake
not to make it available to third parties and to make use of the sample only
for experimental purposes . These undertakings expire if the patent
application is unsuccessful , is withdrawn or is deemed to be withdrawn , or if
the patent has expired in all designated States .
The undertaking to restrict the use of samples of deposited matter to
experimental uses prescribed in EPC Rule 28 expires as soon as the
application is refused or withdrawn and at the moment a patent is granted . In
cases where the patent is granted , the patent rights themselves would prevent
other than experimental use of such samples . In the cases where no patent is
granted , an applicant not only is obliged to allow samples of his material to
be delivered to third parties without any compensation he also loses the
confidential nature of his work and the possibility of exploiting the
invention as a trade secret .
Rule 28 EPC was amended in 1979 following wide-°cale dissatisfaction with
this aspect of the release conditions to conta-'r mainly two improvements :
 ---pagebreak---                                        - 61
     ( 1 ) adoption of the expert solution ; and
     ( 2 ) an extension of the undertaking required from the
           requesting party to include cultures derived from
           the sample .
The expert solution is an option which an applicant may elect which provides
for release of a sample up to the moment of patent grant or refusal thereof or
of withdrawal of the application if a third party requests a sample of the
deposit . Release is made to an independent expert who is himself bound to use
the sample only for experimental purposes and not to transmit it to others
including the third party .     The expert is free , however , to report the
results of his experiments and verification of the sample to the third party .
The expert solution has been introduced into the national patent practices of
Denmark , France and Italy . The Italian practice is a variant of the EPC rule
in that the expert solution is not optional and applies for the entire patent
term .
The expert solution of EPC Rule 28 does not protect the applicant in a
situation where an application is withdrawn , not pursued or refused . In
addition , it has been questioned whether the rule is compatible with the
requirement that an application must disclose an invention in a manner
sufficiently clear and complete for it to be carried out by a person skilled
in the art ( Article 83 EPC ).   There have as yet been no judicial decisions on
this question and thus on the issue of the sufficiency of the disclosure for
purposes of the EPC . Both difficulties need to be addressed in the context of
national patent laws .
The obligation for a patent disclosure to enable the public to carry out an
invention applies to the public in the jurisdiction of the patent right
involved . According to the accepted theory of patent law, whereby the
granting authority and the inventor effectively enter into a contract to the
effect that the inventor is accorded exclusive rights in exchange for
disclosing his invention , there is an .absence of the quid pro quo between the
patentee and the grantor where disclosure in the form of a sample of
self-replicating material is provided to the public of a jurisdiction where no
patent has been granted or applied for .
 ---pagebreak---                                      - 62 -
There is no legal requirement in patent law that an applicant must enable the
public of other countries to exploit his invention nor is there any interest
on the part of a State which has granted exclusive rights in respect of an
invention to make samples available to another jurisdiction where no
protection exists . Transmission of a sample of the deposit to another
jurisdiction where release has been requested , despite the absence of rights
associated with a patent application or a patent , serves no genuine purpose of
the patent system . Such a possibility should be minimised for inventions in
the field of living matter .
It has been suggested that to eliminate the possibility of inappropriate
release of samples , the rule would need to be adopted that samples of the
deposit may only be delivered to parties residing in a country for which or in
which a patent application had been filed or where a patent had been granted .
Such an approach is unlikely to meet with much support in light of the
well-established principle of open disclosure in all patent laws .            A similar
result can be achieved , as is done in Article 1 5(3 ) ( b ) ( i i ) , by imposing an
undertaking on a requesting party that the sample will be used only for
experimental purposes irrespective of the countries to which such samples may
ultimately be brought or transmitted . This restriction , along with the
undertaking not to transmit a sample to any third parties , will enable an
applicant to monitor whether undertakings have been respected as well as to
ensure the effectiveness of the undertakings given .
For some inventions , patent applications will concern biotechnological
inventions starting from living material which was previously deposited in
connection with another patent application by either the same or another
person . If such an earlier deposit had legally become available to the public
not later than the time of the new patent application , it would belong to the
relevant state of the art for all patent law purposes . The patent law concept
of the state of the art comprises everything which has been made available in
some form to the public prior to the filing . of a patent application . The
novelty of an invention , as is its inventive step , and its disclosure are
judged against the standard of the state of the art of the relevant technical
field concerned . If a microorganism had become available to t!.c puLLic and
thus formed part of the state of the art at the time of a subsequent
application , there would be no need for the applicant to re-deposit this
 ---pagebreak---                                         63
material or to maintain such earlier deposit . This result follows from the
fact that the microorganism forms part of the state of the art and would be
the same in any other technical field for purposes of patent application
procedures .
Any restriction on the release of samples of a deposit which was made for
purposes of patent procedures which prevents the public in the country of the
patent right from having access to the deposit after first publication may put
into question the loss of novelty normally accompanying the initial
publication , that is , it may be queried whether or not such material is deemed
to be part of the state of the art . If a microorganism or other deposited
animate matter has become part of the state of the art , which occurs in all
technical fields upon publication of the patent application , such matter
should be regarded as available to the public within the meaning of novelty or
disclosure for national patent law purposes . In consequence , samples could
cease to be available to the public from the depositary institution without
affecting the novelty-destroying or disclosure effect of the published
application .   In as much as the public was provided with access to the
technical details of an invention either directly or through an expert and in
view of the fact that such access will be considered to constitute an adequate
disclosure of the invention , it follows that a published application becomes
part of the prior art independent of the outcome of the application . Article
15(10 ) establishes this principle .
Such a principle needs to be established particularly for those cases
involving living or self-reproducing matter where an application does not
result in the grant of a patent and where the application is published so that
one or more samples could have been released either to the public or to an
expert . The application of such a principle in these cases is analogous to
the situation where a product has been exhibited for a time at a public trade
fair and has consequently become part of the state of the art for all time and
is thus considered as being available to the public . No obligation exists to
provide another enabling disclosure to the public .
The system of early publication and deferred eyemination of patent
applications is unlikely to be changed in Europe in the foreseeable future .
The requirements for disclosure of inventions are closely similar in all
 ---pagebreak---                                        64 -
Member States both for European and national patent applications . In view of
the work already done and the consensus already achieved in respect of I'.PC
Rules 28 and 28a , any harmonisation of th .; provisions of national patent laws
regulating the conditions of access , release and re-deposit should parallel
those of the EPC taking into account the shortcomings from which the EPC rules
are thought to suffer .
Thus , the differences between Article 15 of the Directive and EPC Rule 28 may
be summarised as follows :
1 . The undertaking required in Article 15 paragraph 3(b)(i ) - that a party
requesting a sample of deposited material will not make it available to third
parties - does not expire while the undertaking in EPC Rule 28 expires if " the
application has been refused or withdrawn or is deemed to be withdrawn or , if
a patent is granted , before the expiry of the patent in the designated State
in which it last expires " ( Rule 28(3)(a )).
2 . The undertaking required in paragraph 3(b ) ( ii ) - to use the sample for
experimental purposes only - will expire only in those countries where a
patent right comes into existence . Once a patent right is created , the patent
laws themselves would limit a third party to the use of a patented invention
for experimental purposes . This rule permits those who have received samples
to use the material in other countries for experimental purposes . Under EPC
Rule 28 , if a patent is refused or an application is withdrawn , this
undertaking would expire , enabling third parties to commercialise the
deposited material . This is an undesirable consequence resulting from a
misconstrued application of the system of early publication wherein physical
access to deposited material is equated with the notice function of the
publication .
3.   The sample would no longer be available to the public or to an expert if
the application fails or otherwise does not lead to the grant of a patent
where the application had been published and the deposit was available either
to the public or to an expert .
 ---pagebreak---                                          - 65
                                       Artide 16
^e-Depo :; i t
It may happen that a depositary institution will no longer be able to provide
a sample of a valid deposit to a requesting party entitled to it for reasons
other than those regulated under the Budapest Treaty , for example , because of
the dangerous character of the material or the end of the contractual period
of maintenance . It would be unjust to refuse an application or to declare
invalid a patent right on the basis of such incapacity of the depository
institution , unless the appl i cant / patentee or owner of the right could not
provide the requesting party with a sample of the material , certifying its
identity with the originally deposited material ( similar to the provisions of
Article 4(1)(h)(ii ) of the Budapest Treaty ).
Article 16 is needed to ensure that an applicant or patentee in all national
patent systems will be allowed to re-deposit a microorganism or other animate
matter for patent law purposes if his original deposit ceases to be available
from the institution with which it was deposited , as is provided in EPC Rule
28a and in similar provisions of some Member States' laws . The provisions of
Article 16(1 ) - ( 5 ) are virtually identical to those of EPC Rule 28a except
that the Directive explicitly mentions other self-replicable matter in
addition to microorganisms .
Situations may arise where a re-deposit cannot be effected by the original
depositor / patentee even where the original deposit has given rise to the grant
of a patent . In such a case , the validity of the patent may be questioned as
an enabling disclosure no longer exists relative to the patent . Article 16(7 )
is necessary , therefore , to establish the principle that any ruling declaring
the invalidity of a patent on the basis of the patentee 's inability to
re-deposit a sample of the original material will not retroactively invalidate
the patent . This rule is needed because the original grant of the patent was
based on a deposit which initially complied with all the procedural
requirements for patent grant but which deposit only subsequently became
unavailable to the public .
 ---pagebreak---                                         66 -
EPC Rule 28a does not address the question of validity and nullity . It is all
                                                    I
the more important , therefore , to establish this rule for national patent laws
as it will affect the validity of European patents in that questions of
validity not regulated by provisions of the EPC are subject to national patent
                     I
law principles concerning validity .
                                     CHAPTER 5
                         Reversal of the Burden of Proof
                                    Article 17
After a patent has been granted , uncertainty as to whether the patent is being
worked on an unauthorised basis by one or more third parties may arise . If a
patentee decides to initiate litigation in the belief that his patent claims
are being infringed , he must , in certain situations , bear the burden of
establishing by a preponderance of the evidence that infringement has likely
taken place .
For patents involving new products , produced by new processes , the burden of
proof that the patent has not been infringed in the event of dispute usually
rests with the alleged infringer . This is based on the premise that no method
other than that revealed in the patent application is known to produce the
product in question , it being non-existent theretofore . This principle has
been codified into many patent laws of the Member States and is also found in
the CPC ( Article 75 ) .
In the situation where a patentee of a     process patent suspects patent
infringement is taking place , it is often difficult to establish whether a
particular product , which is identical to another product itself obtainable by
a patented process , has in fact been manufactured or produced using the
patented process . This is particularly the case with biotechnological
inventions where microorganisms may be used in patented processes and where
neither such use nor the nature of the process can easily be detected in the
final product .
 ---pagebreak---                                       - 67 -
In cases where the product is previously known so that a process different
from the one protected in the process patent must have been available , no
legal provisions on the burden of proof in patent disputes exist in the laws
of the Member States or in the EPC or the CPC .   The normal rules of evidence
would apply to the effect that the patentee of a process for producing a known
product would bear the burden of establishing a prima facie case by a
preponderance of the evidence that infringement of his process has probably
occurred .
If a sample of deposited self-reproducing material has been released , it will
be difficult , if not impossible , for a patentee to prove that an alleged
infringer has used the patented process to manufacture the known product , as
it may always be claimed - without need of proof - that the known unpatented
process was used . If the burden of proof remains with the patentee , he is
unlikely to be able effectively to defend his patent . If the alleged
infringer is not using the patented process , it is far easier for him to prove
his non-infringement by , for example , demonstrating how he produced the
products , than it is for the patentee to prove the infringement .
Thus , in connection with the use of the deposit mechanism to complete an
enabling disclosure , where necessary for patent application purposes , Article
17 is necessary to provide that the burden of proof would be reversed if
release of a sample of deposited material has been made which represents a
sufficient mechanism for working the invention . The rule of Article 17 is
limited to the narrow situation where two conditions are satisfied :   a
sufficient means of carrying out the patented invention must have been
deposited in a culture collection and a sample of such deposit must have been
released .
If the rule were limited to only those persons who have physically received a
sample from a depository institution , it would be easy to circumvent the
reversal in the burden of proof by use of an intermediary who requests the
sample and thereafter transmits it to the interested party .   Thus the rule
must be established , and Article 17(1 ) is necessary in order to establish ,
that the reversal of the burden of proof is applicable without restriction if
the conditions have been fulfilled . Nonetheless , sufficient safeguards must
be provided so that alleged infringers are not subjected to abusive use of
 ---pagebreak--- this provision t>y put < nt IMV. wishing to I corn of t In * i r compel itors 1
manul <JC tor ing melhods .  Spi.h a principle ol l lie reversal <>l l he burden of
proof therefore must and does include .1 provision excluding I he nerd tor an
alleged infringer to disclose his confidential business secrets in adducing
his proof even if the burden of proving non-infringement does lie with him .
                                         CHAPTER 6
                            Definitions and Final Provisions
                                        Article 18
New production methods in animal biotechnology may require steps which might
be qualified as " surgical methods ". These include processes for breeding
cattle , for example , by estrous synchronisation , super-ovulation , artificial
insemination and embyro recovery and transfer (a procedure wherein embryos are
removed , frozen and reimplanted in surrogate mothers elsewhere ) and processes
for improving the food conversion ratio in animals , for example , by surgical
implantation of growth stimulating or regulating substances .
Most patent laws and the EPC ( Article 52(4 )) exclude the patenting of surgical
methods for treating human and animal bodies on the basis that such methods
are not industrially applicable . For those methods of treatment which were
developed for or are applied to treating and preventing diseases or physcial
impairments in humans and animals , it is usually the case that such methods do
not have an industrial character , but possess rather a medical or a
therapeutic character . Developments in biotechnology have resulted in logical
inconsistencies not foreseen in the principle as originally drafted . A method
of adding a chemical substance to animal food to improve food conversion is
considered patentable because it is not surgical but an equivalent surgical
procedure to implant slow-release hormones to improve food conversion is not
patentable because it is surgical in nature .
 ---pagebreak---                                        - 69 -
It was not the intention to exclude from patent protection developments which
fulfil the criteria of patentability if they have an industrial character . It
was simply unforeseen that surgical techniques would be developed which would
also be industrially applicable .
For biotechnological techniques for animal production which are of an
industrial or commercial nature and which are not therapeutic , such as those
mentioned above , the rule should be amended so that such methods may be
patentable if practiced for reasons which are other than therapeutic and if
practiced on an animal body . Thus the rule in this regard should be changed
to the extent necessary to encourage research in this field without undoing
the original- intention of the drafters of the exclusion . Without Article 18 ,
an important set of biotechnological inventions would not be eligible for
patent protection .
                                     Article 19
The term " microorganism " is used in two different ways in the Directive .
First , in Articles 3 and 5 , this term relates to substantive criteria for
patentability and establishes rules regarding living matter and certain patent
law exclusions from patentability . Secondly , in Articles 15 and 16 , this term
is used in relation to procedural requirements regarding disclosure for
purposes of patent applications . The Directive must avoid limiting the
application of patent law , both substantively and procedural ly , to only those
inventions which concern living matter literally coming within the biological
classification of microorganisms .
When the Budapest Treaty on microorganism deposit was instituted in 1977, the
problems of accepting deposits of living matter were only partially
appreciated . In light of subsequent developments , this Treaty has quite
sensibly been interpreted to apply to other forms of living matter in addition
to microorganisms . The problems which led to the Budapest Treaty will
continue to be of importance where matter is sought to be patented which
contains genetic information to replicate or to direct its replication . All
such materia ! should     pi inciple be admitted to the deposit system for
purposes of patent procedure . Thus , any usage of the term microorganism for
 ---pagebreak---                                          70 -
patent Law purposes must not be Limited and shouLd be understood to incLude
any living matter which can be deposited in a culture collection of the type'
acknowledged by the Budapest Treaty and its implementing regulations .
The substantive requirements of patent Law should be construed in such a
manner that Living matter may aLways benefit from patent protection .     The
notions of the term " invention " shouLd aLways be sufficiency broad to incLude
a L L new developments in biotechnology .
Thus Article 19 is needed to establish the rule that the term microorganism
shouLd not be too narrowly construed and that future developments in
biotechnology in respect of animate matter which is capable of being deposited
in a culture collection such as fungi , virsuses , mycoplasmae , rickettsiae ,
algae , protozoa and cells can benefit from the principles of the Directive and
fulfil both the substantive and procedural requirements of patentability .
This approach ■ corresponds to the definition of " living material " which was
suggested for use with the kinds of material that should be accepted for
deposit under the Budapest Treaty ( BioT / CE / II / INF / 4 ) .
 ---pagebreak---                               Dlrectlva do Conselho
                               de  .
         relativa à protecção Jurídica das Invenções biotecnológicas
                                          ./ CEE )
0 CONSELHO DAS COMUNIDADES EUROPEIAS ,
Tendo em conta o Tratado que Institui a Comunidade Económica Europeia e ,
nomeadamente , o seu artigo 100O-A ,
Tendo em conta a proposta da Comissão ,
Em cooperação com o Parlamento Europeu ,
Tendo em conta o parecer do Comité Económico e Social ,
Considerando que a existência de certas diferenças na protecção jurídica
das invenções biotecnológicas a nível das legislações e práticas dos
Estados-membros é susceptlvel de criar obstáculos às trocas comerciais e
à Instituição e correcto funcionamento do mercado interno ;
Considerando que tais diferenças de protecção Jurídica podem vir a
aumentar com a introdução pelos Estados-membros de novas e diversas
legislações e práticas administrativas ou com a diferente evolução da
Interpretação     de   tal   legislação   e   práticas    pelas   jurisprudências
nac iona i s ;
Considerando que a biotecnologia e a engenharia genética desempenham um
papel cada vez ma is importante numa vasta gama de indústrias e que a
protecção das invenções biotecnológicas se pode considerar de fundamental
importância para o desenvolvimento Industrial da Comunidade ;
Considerando    que  o   sistema  de  patentes     deve ser  adaptado  aos  novos
desenvolvimentos tecnológicos susceptlveis de envolver matéria viva mas
que preenchem igualmente os requisitos de patenteabi I Idade ;
 ---pagebreak---                                          71
Considerando que a área da investigação e desenvolvimento , sobretudo no
domínio da engenharia genética exige investimentos particularmente
elevados     e    particularmente    arriscados    e  que    a  possibilidade   de
recuperação dos referidos Investimentos apenas pode ser garantida através
de uma protecção jurídica adequada ;
Considerando que na ausência de uma protecção efectlva e semelhante em
todos os Estados-membros da Comunidade tais investimentos podem nunca vir
a ser realizados ;
Considerando que algumas das invenções desenvolvidas com recurso à
biotecnologia e à engenharia genética não beneficiam actualmente de uma
protecção clara em todos os Estados-membros proporcionada pela legislação
em vigor , pela prática administrativa ou pela Jurisprudência dos
tribunais ; que tal protecção , quando existente , não é idêntica ou possui
diferentes atributos ;
Considerando que a evolução descoordenada na Comunidade da protecção
Jurídica das invenções blotecnológicas nos Estados-membros pode criar
novos obstáculos ao comércio em detrimento de um maior             desenvolvimento
industrial das referidas Invenções e da realização do mercado interno ;
Considerando a necessidade de eliminar as diferenças actualmente
existentes que provocam tais efeitos e a de evitar o aparecimento de
novas diferenças com um Impacte negativo no funcionamento do mercado
comum    e     no     desenvolvimento   do   comércio     de   bens   e   serviços
b iotecno lóg i cos ;
Considerando que os desenvolvimentos             internacionais no domínio da
protecção Jurídica dos resultados da            biotecnologia e da engenharia
genética revelam as vantagens a obter com a aproximação das legislações
nacionais ;
 ---pagebreak---                                            72
Considerando que os desenvolvimentos científicos e tecnológicos resultam
 frequentemente da colaboração Internacional no domínio da Investigação e
que ,   por conseguinte , é necessário garantir que as                      Invenções
b iotecnológ Icas possam beneficiar de protecção comparável a nível
 Internacional ;
Considerando     que ,   apesar   de existirem ,   ou   estarem  a   ser  objecto  de
consideração , Instrumentos internacionais relativos à harmonização de
diversos aspectos da protecção Jurídica das invenções blotecnológlcas ,
tais Instrumentos são , no entanto , Insuficientes para realizar os
objectlvos da Comunidade que têm que tomar em consideração as exigências
da ciência e da indústria comunitárias bem como o mercado da Comunidade ;
Considerando que o direito das patentes presentemente aplicável nos
Estados-membros contém disparidades que Impedem o desenvolvimento do
comércio de bens e serviços blotecno lógicos , falseiam a concorrência no
mercado comum e , por conseguinte , afectam directamente a criação e o
funcionamento do referido mercado ;         considerando que é particularmente
 Importante eliminar       tais disparidades ,   uma vez que na actual        fase de
realização do mercado comum , parece existir uma necessidade urgente de
garantir que seja proporcionada às empresas a possibilidade de obterem em
todos os Estados-membros uma protecção jurídica efectlva e semelhante
relativamente aos resultados das suas activ idades de investigação em
qualquer parte da Comunidade ;
Considerando que se torna Igualmente necessário uma aproximação das
legislações dos Estados-membros devido às disposições incluídas nas
legislações      nacionais      tais   como as        relativas    à    exclusão da
patenteabl I Idade     de   variedades  animais    e    vegetais   e  dos   processos
essencialmente biológicos de produção de plantas e animais - que ,
baseadas em determinadas convenções internacionais sobre patentes e
variedades de plantas , deram origem a uma considerável incerteza quanto à
possibilidade de proteger as Invenções microbiológicas e as invenções
blotecnológlcas relativas à matéria vegetal ;
Considerando que é necessário Incentivar as potencialidades de Inovação
em toda a gama da criatividade humana , através do reconhecimento de que a
intervenção humana que ultrapassa a mera selecção de material biológico
permitindo a este o desempenho , em condições naturais , das funções
biológicas que lhe são Inerentes deve ser considerada matéria patenteável
e não entendida como essencialmente biológica ;
 ---pagebreak---                                        - 73 -
Considerando que as          legislações dos Estados-membros devem ser
harmonizadas de modo a não colidirem com as convenções Internacionais em
vigor nas quais se baseia o direito de patentes e a legislação sobre
variedades de plantas dos Estados-membros ;
Considerando que é possível limitar o enquadramento Jurídico comunitário
relativo à protecção das invenções biotecno lógicas à previsão de certos
princípios aplicáveis à patenteabi I Idade da matéria viva enquanto tal , à
possibilidade de utilizar um mecanismo de depósito em vez de descrições
por escrito para satisfazer os requisitos de divulgação necessários aos
procedimentos de aplicação das patentes , à inversão do ónus da prova
aquando da ocorrência da divulgação de matéria auto-rep I I cáve I e ao
direito de licença dependente não exclusiva relativa a variedades
vegetais e animais ;
Considerando que , tendo em conta o facto de a função da patente consistir
na recompensa do esforço criativo do inventor - encorajando deste modo a
actlvidade inventiva - através da concessão de um direito exclusivo mas
 limitado no tempo , o detentor do direito deverá poder proibir o uso do
material auto-rep I I cáve I patenteado em situações análogas àquelas em que
seria permitido proibir tal uso relat I vamente a produtos não
auto-rep I içáveis , ou seja quanto à produção do próprio produto
patenteado ;
Considerando que , no domínio da exploração agrícola das novas
caracter Ist i cas vegetais resultantes de actlvidades de engenharia
genética , deve ser garantido o acesso remunerado sob a forma de licenças ,
enquanto excepção aos princípios gerais do direito de patentes ;
ADOPTOU A PRESENTE Dl RECTIVA :
                                    CAPÍTULO I
                       Patenteabi I Idade da Matéria Viva
                                    Artigo 10
Os Estados-membros devem assegurar a compatibilidade do         seu  direito
nacional de patentes com o disposto na presente dl rectiva .
 ---pagebreak---                                        - 74 -
                                     Artigo 2o
A matéria objecto de ama Invenção não será considerada não patenteável
pelo simples facto de ser composta de matéria viva .
                                     Artigo 3o
1.   Serão considerados matéria patenteável os microrganismos , as unidades
     taxonómicas que não as variedades vegetais ou animais bem como as
     partes das variedades vegetais ou animais que não a matéria da sua
     reprodução do tipo protegido pela lei de protecção das variedades
     vegetais . Os pedidos referentes a unidades taxonómicas superiores às
     variedades não serão afectados por nenhum            direito   concedido
     relativamente às variedades vegetais e animais .
2.   Sem prejuízo do disposto no no 1 , as plantas e o material vegetal
     serão considerados matéria patenteável , salvo se o referido material
     for produzido mediante a utilização não patenteável de um processo
     b lotecno lóg I co prevlamente conhecido .
                                     Artigo 4o
As utilizações das variedades vegetais ou animais bem como os processos
para a sua produção serão considerados matéria patenteável .
                                     Artigo 5o
Os processos mlcroblológlcos serão considerados matéria patenteável . Para
efeitos da aplicação da presente dl rectiva , consl dera-se que a expressão
" processo    mlcroblológlco "     significa    e Inclui  o(s )   processo(s )
executado(s ) mediante a utilização de um microrganismo , o(s ) executado(s )
com base em tal microrganismo e o(s ) nele resul tante(s ) .
                                     Artigo 6o
Um processo consistente numa sequência de fases será considerado um
processo mlcrobiológico no caso de a essência da invenção fazer parte
integrante de uma ou mais fases mlcrobiológicas do processo .
 ---pagebreak---                                     - 75 -
                                 Artigo 7o
Será considerado matéria patenteável o processo em que a Intervenção
humana ultrapasse a mera selecção de material biológico disponível
permitindo a este o desempenho , em condições naturais', das funções
biológicas que lhe são Inerentes .
                                 Ar t i go 80
0 objecto de uma Invenção - Incluindo uma mistura - que tenha constituído
parte Integrante de um material preexistente não será considerado não
patenteável pelo simples facto de ter feito parte do referido material
natura I .
                                 Artigo 9o
0 objecto de uma Invenção - incluindo uma mistura - que tenha constituído
parte integrante de um material preexistente não será considerado como
descoberta patenteável ou como não apresentando carácter inovador pelo
simples facto de ter feito parte do referido material natural .
                               CAPITULO II
                           Ambito de Droteccao
                                Artigo 1 Oo
A utilização de um produto protegido por uma patente que inclua ou
consista em Informações genéticas com vista a desenvolver um produto do
mesmo tipo , ou a utilização de um processo patenteado para obter tal
produto não serão consideradas como experimentais para efeitos da
determinação de violação de patente , no caso de o produto desenvolvido
obtido a partir das experiências ou a sua progénie em formas idênticas ou
diferenciadas serem utilizados para outros fins que não privados ou
exper I menta I s .
 ---pagebreak---                                     - 76 -
                                 Art igo 1 10
Se um produto que beneficia da protecção conferida pela patente e que é
lançado no mercado pelo titular da patente ou com o seu consentimento for
auto-repl Icável , os direitos conferidos pela patente nacional abrangerão
os actos de multiplicação e de propagação apenas na medida em que estes
sejam Inevitáveis para utlizações comerciais diferentes da multiplicação
e da propagação .
                                 Artigo 12o
1 . No caso de o objecto da patente consistir num processo para a produção
de matéria viva ou de qualquer outra matéria contendo Informações
genéticas que permitam a sua multiplicação em formas           idênticas ou
diferenciadas , os direitos conferidos pela patente não deverão abranger
apenas o produto Inlcialmente obtido pelo processo patenteado mas também
os produtos Idênticos ou diferenciados da primeira geração ou de gerações
subsequentes obtidos a partir do primeiro produto , considerando-se também
tais produtos como obtidos dlrectamente pelo processo patenteado .
2 . Nenhuma extensão da protecção conferida por uma patente a um dos
processos referidos no no 1 a um produto obtido com base nesse processo
será afectada por qualquer forma de exclusão da patenteab I I i dade de
variedades vegetais ou animais .
                                 Artigo 13o
A protecção concedida a um produto que consiste em ou contém Informações
genéticas especiais que constituem caracter Ist Icas essenciais da invenção
será alargada a todos os demais produtos em que as referidas Informações
genéticas tenham sido incorporadas e em que constituam um elemento
essencial para a sua aplicabilidade ou utilidade industrial .
                        )
                        I
 ---pagebreak---                                         77
                                  CAPlTULO I I I
                Llcencas dependentes cara variedades veaetals
                                   Artigo 140
1 . Se o titular de um direito de produção de plantas ou de um certificado
de variedade apenas puder explorar ou exercer os seus direitos exclusivos
mediante Infracção de direitos decorrentes de uma patente nacional
anterior , será concedida ao titular do direito de produção de plantas uma
 licença não exclusiva na medida necessária à exploração de tal direito ,
nos casos em que a variedade protegida represente um progresso técnico
significativo , mediante o pagamento de rova I t les razoáveis adequadas à
natureza da invenção pateanteada e compatíveis com a atribuição ao
proprietário    de   tal patente   da  devida    recompensa   pelo   investimento
conducente à Invenção e ao seu desenvolvimento .
2 . Não será possível obter a licença referida no no 1 antes do termo do
prazo de três anos a contar da data de concessão da patente ou quatro
anos a contar da data de apresentação do pedido de patente , prevalecendo
o prazo cujo termo seja posterior .
3.   Se  tiver  sido concedida uma     licença nos    termos do no     1  e se a
variedade    protegida   pelo  direito    de   produção   de   plantas   ou   pelo
certificado    de  variedade  apenas  puder   ser   explorada   pelo  titular   da
patente mediante infracção dos direitos relativos a tal variedade , será
copcedlda ao titular original da patente uma licença não exclusiva na
medida necessária à exploração do direito de produção de plantas ou do
certificado de variedade , mediante o pagamento de rova I t i es razoáveis
adequadas à natureza do melhoramento e compatíveis com a atribuição ao
proprietário do direito de produção da devida recompensa pelo
investimento conducente à nova variedade e ao seu desenvolvimento .
4 . Sempre que surgirem desacordos relativamente à relevância do progresso
técnico e ao montante das rova I t les . os Estados-membros assegurarão a
existência de um tribunal com competência para resolver a disputa .
 ---pagebreak---                                            78
                                      CAPlTULO IV
                         Deoóslto .. acesso e novo depósito
                                      Artigo 15o
1 . Se uma Invenção envolver a utilização de um microrganismo ou de outra
matéria auto-repl icável não disponível ao público e que não possa ser
descrita no pedido de patente de forma a permitir a sua execução por
pessoa qualificada nesse domínio , ou se respeitar a tal matéria per se .
tal Invenção apenas será considerada divulgada , para efeitos do direito
nacional de patentes , se :
     a)  o microrganismo ou a outra matéria auto-repl Icável tiver sido
         depositada Junto de uma Instituição depositária reconhecida o
         mais tardar até à data de apresentação do pedido ;
     b)  o pedido tal como apresentado fornecer as referidas Informações
         relevantes de que dispõe o autor           do pedido relativamente às
         caracter Ist I cas   do  microrganismo    ou  da  outra matéria  auto-
         repl Icável ;
     c)  a   instituição depositária e o número de arquivo do depósito
         constarem do pedido .
2 . Os dados referidos na alínea c ) do no 1 podem ser apresentados :
     a)  num prazo de dezasseis meses após a data de apresentação do
         pedido , ou , se for reivindicada prioridade , após a data de
         pr lor idade ;
     b)  até à data de apresentação de um requerimento para publicação
         antecipada do pedido ;
 ---pagebreak---                                         - 79 -
     c) no prazo de um mês a partir da comunicação do serviço nacional de
        patentes ao autor do pedido da existência do direito de inspecção
        dos arquivos previsto na alínea a ), ponto II ) do no 3 Infra .
0 prazo a respeitar será o que expirar em primeiro lugar . A comunicação
destes   dados    será   considerada     como    constituindo    um   consentimento
Irrevogável e Incondicional do autor do pedido relativamente à colocação
da matéria depositada à disposição do público em conformidade com o
presente artigo .
3.a)    Salvo   o    caso  de    o  pedido    ter   sido   recusado ,   retirado   ou
        considerado retirado , a matéria depositada                 será ,   mediante
        requerimento , colocada à disposição :
         I)       de qualquer pessoa , a partir da data de publicação do
                  pedido de patente ;
         li )     de qualquer pessoa com direito a proceder à inspecção dos
                  arquivos    em   conformidade     com  o   disposto    no   direito
                  nacional de patentes aplicável aos pedidos com base nos
                  quais os direitos são invocados contra tal parte , antes
                  da data de publicação ;
  b)    Sem prejuízo do disposto no no 4 , a colocação à disposição será
        concretizada através da entrega de uma amostra da matéria
        depositada     ao   autor    do   requerimento     (a   seguir     denominado
        " requerente "). Tal entrega apenas será efectuada se o requerente
        se tiver comprometido perante o autor do pedido ou o titular da
        patente :
        I)        a não colocar a matéria depositada ou qualquer matéria
                  dela derivada à disposição de terceiros ;
         li )     a utilizar a matéria depositada ou qualquer matéria dela
                  derivada     em    qualquer     pais   unicamente      para    fins
                  experimentais relativos à Invenção , sob a condição de que
                  esta restrição cessará , no pais onde é válido o direito
                  de patente com base no qual foi obtida a amostra da
                  matéria depositada com a concessão de uma patente ou de
                  qualquer outro direito exequível relativo à invenção em
                  causa . Esta disposição não será aplicável no pais onde é
                  válido o direito de patente com base no qual foi obtida a
                  amostra da matéria depositada enquanto o requerente
                  continuar a utilizar a matéria ao abrigo de uma licença
 ---pagebreak---                                        - 80 -
                  obrigatória .   A   expressão   " licença  obrigatória "  será
                   interpretada como incluindo licenças ÊJL off leio bem como
                  o direito de utilizar , no interesse público ,       invenções
                  patenteadas .
4.   Até   à  data   em  que   se   considera   deverem   estar  terminados   os
preparativos técnicos para a publicação do pedido , o autor do pedido pode
informar o serviço nacional de patentes de que , até à publicação da
referência da concessão da patente , a colocação à disposição referida no
no 3 apenas será concretizada mediante a entrega de uma amostra a um
perito nomeado pelo requerente .
5 . Pode ser nomeada como perito :
     a)  qualquer pessoa singular , desde que o requerente forneça prova ,
         aquando do preenchimento do requerimento , de que a nomeação
         obteve a aprovação do autor do pedido -,
     b)  qualquer pessoa singular reconhecida como perito pelo serviço
         nacional de patentes . A nomeação será acompanhada por um
         compromisso do perito para com o autor do pedido ; serão
         aplicáveis os pontos I ) e il ) da alfnea b ) do no 3 , sendo o
         perito considerado como terceiro .
6 . Para efeitos do disposto na altnea b ) do no 3 , qualquer matéria
derivada da matéria depositada será considerada como tendo sido obtida
através de cultura ou de qualquer outro modo de replicação ,          desde que
continue a apresentar as caracter Ist Icas da matéria depositada     essenciais
à invenção ou à sua execução . 0 compromisso referido na alínea      b ) do no 3
não impedirá o depósito da matéria derivada necessário para          efeitos do
processo de patente .
7 . 0 requerimento previsto no no 3 será apresentado ao serviço nacional
de patentes num formulário por ele reconhecido . 0 serviço nacional de
patentes atestará no referido formulário que Já foi apresentado um pedido
de patente nacional relativo ao microrganismo ou outra matéria auto-
replicável depositada , e que o requerente ou o perito por ele nomeado tem
direito à entrega de uma amostra do microrganismo ou outra matéria auto-
repl Icável .
 ---pagebreak---                                        - 81
8 . 0 serviço nacional de patentes transmitirá uma cópia do requerimento
 com a atestação prevista no no 7 à instituição deposltárla bem como ao
autor do pedido de patente ou ao proprietário desta .
9.    Os     Estados-membros designarão as        Instituições    depositárias
reconhecidas para efeitos do disposto no presente artigo .
10 . Se um microrganismo       ou outra matéria auto-repl Icável tiver sido
depositada nos termos dos     nos 1 e 2 e tiver sido colocada à disposição de
qualquer pessoa ou de um      perito em conformidade com os nos 3 e 4 , será
considerado como estando     a partir desse momento à disposição do público
de acordo com o no 1 .
                                    Artigo 16o
1 . No caso de um microrganismo ou outra matéria auto-repl Icável
depositada em conformidade com o artigo 15o deixar de estar disponível na
 instituição em que foi depositada por :
     a)   o microrganismo ou outra matéria auto-rep I I cáve I ter deixado de
          ser viável , ou
     b)   por qualquer outra razão , a instituição depositária ser incapaz
          de fornecer amostras ,
e se o microrganismo ou outra matéria auto-rep li cáve l não tiver sido
transferida para outra Instituição deposltárla reconhecida para efeitos
do artigo 15o , onde continue disponível , não se considerará ter ocorrido
uma Interrupção da disponibilidade se tiver sido efectuado um novo
depósito      do    microrganismo     ou    outra  matéria     auto-rep I l cáve I
or Iglnar lamente depositada num prazo de três meses a partir da data em
que o depositante tiver sido notificado da interrupção pela Instituição
depositária e se tiver sido enviado ao serviço nacional de patentes , no
prazo de quatro meses a partir da data do novo depósito , um recibo do
depósito emitido pela instituição onde se mencione o número do pedido ou
da patente nac lona I .
 ---pagebreak---                                              - 82 -
2 . No caso previsto na alínea a ) do no 1 , o novo depósito deverá ser
efectuado na Instituição deposltárla na qual foi efectuado o depósito
original ; nos casos previstos na alínea b ) do no 1 , deverá ser feito
noutra Instituição deposltárla reconhecida para efeitos do no 9 do artigo
150 .
3 . Quando a instituição na qual foi efectuado o depósito original deixar
de ser reconhecida para efeitos da aplicação do artigo 15o , quer em
termos    gerais   quer    re I at I vamente   ao   tipo de microrganismo ou outra
matéria auto-repl Icável a que pertence o microrganismo ou matéria
auto-rep I Icáve I depositada , ou quando tal Instituição Interromper ,
temporária ou def Inl t I vamente , o exercício das suas funções no que diz
respeito aos microrganismos ou outra matéria auto-repl icável depositada ,
e a notificação por parte da Instituição deposltárla referida no no 1 não
tiver sido recebida no prazo de seis meses a partir da data de tal facto ,
o prazo de três meses referido no no 1 terá inicio na data em que o facto
em questão for anunciado na publicação oficial do serviço nacional de
patentes .
4 . Qualquer novo depósito será acompanhado de uma declaração assinada
pelo depositante alegando que o microrganismo ou outra matéria
auto-rep I icáve I objecto do novo depósito é             idêntico ao originalmente
depos I tado .
5 . Se o novo depósito previsto no presente artigo tiver sido efectuado ao
abrigo do Tratado de Budapeste sobre o reconhecimento Internacional                do
depósito de microrganismos para               fins de procedimento em matéria de
patentes de 28 de Abril de 1977 , prevalecerá o disposto em tal Tratado em
caso de conf I l to .
6 . Se o depósito não for aceite ou se o material depositado deixar de
estar disponível na Instituição deposltárla e um novo depósito , em
conformidade com os nos 1 a 5 , não remediar ou não puder remediar tal
indlsponibi I Idade , esta não afectará a patenteab i I I dade da invenção se o
autor do ped ido/ t I tul ar da patente fornecer uma amostra ao requerente com
direito a ela     certificando a         sua   Identidade  relat Ivamente ao material
utilizado na Invenção , obtido como invenção ou ao material originalmente
depositado , conforme o caso .
 ---pagebreak---                                      - 83 -
7 . Se uma patente for considerada anulada devido ao facto de o seu
titular deixar de poder fornecer uma amostra do material depositado nos
termos do presente artigo ,     tal  anulabi I Idade não terá nunca efeitos
retroact I vos .
                                  CAPITULO V
                          Inversão do ónus da prova
                                  Artigo 17o
1 . Se a matéria patenteada for um processo para a obtenção de um produto
novo ou Já conhecido , considerar -se-á que , salvo prova em contrário , o
mesmo produto obtido por qualquer outra parte , o foi através do processo
patenteado , desde que um dos elementos necessários à execução do processo
tenha sido depositado em conformidade com o artigo 14o e divulgado a
terce I ros .
2 . Na adução de prova em contrário serão tomados em consideração os
legítimos Interesses do requerido na protecção dos seus segredos
comerciais e de fabricação .
                                 CAPITULO VI
                            Disposições diversas
                                  Artigo 18o
Apenas será possível        uma exclusão de patenteabi I idade ou de
aplicabilidade industrial relativa a métodos cirúrgicos ou de diagnóstico
realizados num corpo animal no caso de tais métodos serem utilizados com
objectivos terapêuticos .
 ---pagebreak---                                           84 -
                                     Artigo 19o
Para efeitos da presente directlva :
a)    o termo " microrganismo " será Interpretado no seu sentido mais amplo
      como abrangendo todas as entidades m I crob lo lóg I cas susceptlveis de
      repllcação , como por exemplo , entre outras , bactérias , fungos , vírus ,
      mlcopl asmas , rickettsias , algas , protozoários e células ;
b)    a expressão " matéria auto-repl Icável " será interpretada de forma a
      abranger Igualmente a matéria possuidora do material genético
      necessário à dlrecção da sua própria repllcação através de um
     organismo hospedeiro ou de qualquer outro modo indirecto , como por
     exemplo ,   entre outros ,    sementes ,   plasmódlos ,  sequências de ADN ,
      protoplastos , repllcons e culturas de tecidos .
                                     Artigo 200
1 . Os Estados-membros porão em vigor , o mais tardar até 31 de Dezembro de
1990 , a legislação necessária para dar cumprimento à presente directlva .
2.   Os Estados-membros comunicarão à Comissão o texto das principais
disposições da legislação nacional por eles adoptada no domínio abrangido
pela presente directlva .
                                     Artigo 210
Os Estados-membros são destinatários da presente dl rectiva .
Feito em Bruxelas , em                    198 .
                                                        Pelo Conselho ,
                                                         0 Présidente