Source: EURLEX
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Format: md

No C 44 / 36 Official Journal of the European Communities 16 . 2 . 93

Amended proposal for a Council Directive on the legal protection of biotechnological
inventions (*)

( 93 / C 44 / 03

COM(92 ) 589 final — SYN 159

( Submitted by the Commission on 16 December 1992 pursuant to Article 149 ( 3 ) of the EEC

Treaty )

(') OJ No C 10, 13 . 1 . 1989, p. 3 .

ORIGINAL PROPOSAL AMENDED PROPOSAI

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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

Having regard to the proposal from the Commission,

In cooperation with the European Parliament,

Having regard to the opinion of the Economic and Social
Committee,

Whereas differences exist in the legal protection of
biotechnological inventions offered by the laws and
practices of the Member States and such differences could
create barriers to trade and to the internal market ;

Whereas such differences in legal protection could well
become greater as Member States adopt new and different
legislation and administrative practices or as national
jurisprudence interpreting such legislation and practices
develops differently ;

Whereas biotechnology and genetic engineering are playing
an increasingly important role in a broad range of
industries and the protection of biotechnological
inventions can be considered of fundamental importance
for the Community 's industrial development ;

Whereas the patent system must adapt to new
technological developments which may involve living
matter but which also fulfil the requirements for
patentability ;

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Unchanged

Having regard to the proposal from the Commission ('),

Unchanged

Having regard to the opinion of the Economic and Social
Committee ( 2 ),

Unchanged

Unchanged

Unchanged

Whereas the legal protection of biotechnological
inventions does not necessitate the creation of a separate
body of law in place of the rules of national patent law ;

Whereas the rules of national patent law remain the
essential basis as far as the legal protection of
biotechnological inventions is concerned ; whereas,
however, they must be adapted or supplemented in certain
specific respects in order to take fully into account new
technological developments which may involve biological
material but which also fulfil the requirements for
patentability ;

(') OJ No C 10, 13 . 1 . 1989, p . 3 .

( 2 ) OJ No C 151, 26 . 6 . 1989, p . 10 .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 37

ORIGINAL PROPOSAL AMENDED PROPOSAL

Wheras no prohibition or exclusion exists in national or Unchanged
international patent laws which precludes the patentability
of living matter as such ;

Whereas in implementing the Directive regard should be
had to existing national patent laws, as amended by the
Directive ; whereas those laws contain provisions on the
criteria for patentability or exclusion from patentability,
including provisions to the effect that a patent may not be
granted in respect of inventions the publication or
exploitation of which would be contrary to public policy
(' ordre public ') or morality ;

Whereas it is desirable to include in the body of the
Directive such a reference to public policy and morality in
order to highlight the fact that some applications of
biotechnological inventions, by dint of their consequences
or effects, are capable of offending against them ;

Whereas it is important also to set out in the body of the
Directive a list of inventions excluded from patentability
so as to provide national courts and patent offices with an
essential guide to interpreting the reference to public policy
or morality ;

Whereas, in the light of the general principle that the
ownership of human beings is prohibited, the human body
or parts of the human body per se must be excluded from
patentability ;

Whereas processes for modifying the genetic identity of
human beings for a non-therapeutic purpose which is
contrary to the dignity of man must also be excluded from
patentability ;

Whereas processes for modifying the genetic identity of
animals which are likely to inflict suffering or physical
handicaps without any benefit to man or animal must
likewise be excluded from patentability in so far as the
suffering or physical handicaps inflicted on the animals
concerned are out of all proportion to the objective
pursued ;

Whereas this Directive is without prejudice to national and
Community laws on the monitoring of the applications of
research and of the use or commercialization of its results,
notably from the point of view of the requirements of
public health, safety, the protection of the environment,
the protection of animals, the preservation of genetic
diversity and compliance with certain ethical standards ;

Whereas national patent systems have in the past Unchanged
successfully adapted to technical developments and
scientific breakthroughs in according patent protection to
such developments where appropriate ;

No C 44 / 38 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

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

Whereas without effective and approximated protection Unchanged
throughout the Member States of the Community such
investments might well never be made ;

Whereas some inventions developed through Unchanged
biotechnology and genetic engineering are at present not
clearly protected in all Member States by existing
legislation, administrative practice and court
jurisprudence ; and such protection, where it exists, is not
the same or has different attributes ;

Whereas the uncoordinated development in the Unchanged
Community of the legal protection of biotechnological
inventions in the Member States could result in the

creation of new disincentives to trade to the detriment of

further industrial development in such inventions and of
the completion of the internal market ;

Whereas existing differences having such effects need to be Unchanged
removed and new ones having a negative impact on the
functioning of the common market and the development
of trade in biotechnological goods and services prevented
from arising ;

Whereas international developments in the field of legal Unchanged
protection of the results of biotechnology and genetic
engineering demonstrate the advantages to be gained from
approximation of national legislation ;

Whereas scientific and technological developments are Unchanged
often a result of international collaboration on research

and, in consequence, need exists to ensure that
biotechnological inventions may benefit from comparable
protection on an international level ;

Whereas although international instruments exist or are Unchanged
under consideration to harmonize various aspects of the
legal protection of biotechnological inventions, they are
not sufficient for Community purposes which must take
account of the needs of Community science and industry
and a Community market ;

Whereas the patent laws applicable at present in the Unchanged
Member States contain disparities which hinder the
development of trade in biotechnological goods and
services, distort competition within the common market
and therefore directly affect the establishment and
functioning of that market ; whereas it is particularly

16 . 2 . 93 Official Journal of the European Communities No C 44 / 39

ORIGINAL PROPOSAL AMENDED PROPOSAL

important to remove these disparities because, at the stage
reached at present in establishing the common market,
there would appear to be an urgent need to ensure that
undertakings will be offered the possibility of obtaining
effective and equivalent legal protection in all Member
States for the results of their research activities in any part
of the Community ;

Whereas an approximation of the legislation of the Unchanged
Member States is also necessitated by existing language in
national laws originating in certain international patent
and plant variety conventions which have given rise to
considerable uncertainty as to the possibility of protecting
biotechnological inventions concerning plant matter and
microbiological inventions, language such as the exclusion
from patentability of plant and animal varieties and of
essentially biological processes for the production of plants
and animals ;

Whereas it is necessary to encourage potential innovation

in the full range of human endeavours by recognizing that
human intervention which consists of more than the

selection of biological material and allowing such material
to perform inherently biological functions under natural
conditions should be considered patentable subject-matter
and should not be regarded essentially biological ;

Whereas it is necessary to encourage potential innovation
in the full range of human endeavours by recognizing that
human intervention and its impact on the result achieved
must be taken into account in determining whether the
exclusion from patentability of essentially biological
processes applies, it being understood that a process
which, taken as a whole, does not exist in nature and is
more than a mere production process is patentable ;

Whereas it is seemly that the legislation of the Member Unchanged
States should be harmonized in such a way so as not to
conflict with the existing international conventions on
which many Member States ' patent and plant variety laws
are based ;

Whereas the Community 's legal framework on the
protection of biotechnological inventions can be limited to
laying down certain principles as they apply to the
patentability of living matter as such ; to the ability to use
a deposit mechanism in lieu of written descriptions to
satisfy the enabling disclosure requirements for patent
application procedures ; to a reversal of the burden of
proof where release of self-replicable matter has occurred
and to the right to a non-exclusive dependency licence for
plant and animal varieties ;

Whereas the Community 's legal framework on the
protection of biotechnological inventions can be limited to
laying down certain principles as they apply to the
patentability of biological material as such ; to the ability
to use a deposit mechanism in lieu of written descriptions
to satisfy the enabling disclosure requirements for patent
application procedures ; to a reversal of the burden of
proof ; and to the right to a non-exclusive compulsory
licence for plant varieties ;

Whereas, in view of the fact that the function of a patent Unchanged
is to reward the inventor with an exclusive but time-bound

right for his creative efforts and thereby encourage
inventive activities, the right holder should be entitled to
prohibit the use of patented self-replicable material in
situations analogous to those where it would be permitted
to prohibit such use of patented, non-self-replicable
products, i.e. in respect of the production of the patented
product itself ;

No G 44 / 40 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

Whereas, in the area of agricultural exploitation of new Deleted
plant characteristics resulting from genetic engineering,
guaranteed remunerated access in the form of licences of
right must be provided for as an exception to the general
principles of patent law,

Whereas complementary measures of Community law can
be adopted later, if necessary, in order to ensure
consistency between patent law and the plant varieties
protection regime,

HAS ADOPTED THIS DIRECTIVE : HAS ADOPTED THIS DIRECTIVE :

CHAPTER 1

Patentability of living matter

Article 1

Member States shall ensure that their national patent laws
comply with the provisions of this Directive .

Article 2

A subject-matter of an invention shall not be considered
unpatentable for the reason only that it is composed of
living matter .

CHAPTER I

Patentability of biological material

Article 1

Member States shall ensure that legal protection for
biotechnological inventions on the basis of their national
patent laws complies with the provisions of this
Directive .

Article 2

1 . A subject-matter of an invention shall not be
considered unpatentable for the reason only that it is
composed of, uses or is applied to biological material .

2 . ' Biological material ' within the meaning of this
Directive means any self-replicating living matter and any
matter capable of being replicated through a biological
system or by any indirect means .

3 . Inventions shall be considered unpatentable where
publication or exploitation thereof would be contrary to
public policy or morality, provided that the exploitation
shall not be deemed to be so contrary merely because it is
prohibited by law or regulation in some or all of the
Member States .

On this basis, the following inter alia shall be
unpatentable :

( a ) the human body or parts of the human body

per se ;

( b ) processes for modifying the genetic identity of the

human body for a non-therapeutic purpose which is
contrary to the dignity of man ;

( c ) processes for modifying the genetic identity of animals
which are likely to inflict suffering or physical
handicaps upon them without any benefit to man or
animal .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 41

ORIGINAL PROPOSAL AMENDED PROPOSAL

4 . This Directive shall not affect national and

Community laws on the monitoring of the applications of
research and of the use or commercialization of its

results .

Article 3

1 . Micro-organisms, biological classifications other
than plant or animal varieties as well as parts of plant and
animal varieties other than propagating material thereof of
the kind protectable under plant variety protection law
shall be considered patentable subject-matter . Claims for
classifications higher than varieties shall not be affected by
any rights granted in respect of plant and animal
varieties .

2 . Notwithstanding the provisions of paragraph 1,
plants and plant material shall be considered patentable
subject-matter unless such material is produced by the
non-patentable use of a previously known biotechnological

process .

Article 4

Uses of plant or animal varieties and processes for the
production thereof shall be considered patentable
subject-matter .

Article 5

Microbiological processes shall be considered patentable
subject-matter . For purposes of this Directive, this term
shall be taken to mean and to include a process ( or
processes ) carried out with the use of or performed upon
or resulting in a micro-organism .

Article 3

Biological material, including plants and animals, as well
as parts of plants and animals, except plant and animal
varieties, shall be patentable .

Deleted

Article 4

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

Article 5

1 . Microbiological processes shall be patentable . For
the purposes of this Directive, ' microbiological process '
means a process involving or performed upon or resulting
in microbiological material .

2 . A process consisting of a succession of steps shall be
treated as a microbiological process if at least one essential
step of the process is microbiological .

Article 6 Deleted

A process consisting of a succession of steps shall be
regarded a microbiological process, if the essence of the
invention is incorporated in one or more microbiological
steps of the process .

Article 7

Article 6

A process in which human intervention consists in more
than selecting an available biological material and letting it
perform an inherent biological function under natural
conditions shall be considered patentable subject-matter .

Essentially biological processes shall not be patentable . In
determining whether this exclusion applies, human
intervention and its impact on the result achieved shall be
taken into account . A process which, taken as a whole,
does not exist in nature and is more than a mere

production process shall be patentable .

No C 44 / 42 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

Article 8

A subject-matter of an invention, including a mixture,
which formed an unseparated part of a pre-existing
material, shall not be considered unpatentable for the
reason only that it formed part of said natural material .

Article 7

An invention concerning a biological material shall not be
considered a discovery or lacking in novelty for the reason
only that, although not known, it formed part of an
existing material .

Article 9 Deleted

A subject-matter of an invention, including a mixture,
which formed an unseparated part of a pre-existing
material, shall not be considered as an unpatentable
discovery or as lacking novelty for the reason only that it
formed part of said natural material .

CHAPTER 2

Scope of protection

Article 10 Deleted

The use of a product protected by a patent comprising or
consisting of genetic information to develop another such
product or the use of a patented process to obtain such a
product shall not be regarded as experimental for purposes
of establishing patent infringement, if the developed
product obtained from the experiments or its progeny in
identical or differentiated form, is used for other than
private or experimental purposes .

Article 1 1 Deleted

If a product enjoying patent protection and put on the
market by the patentee or with his consent is
self-replicable, the rights conferred by the national patent
shall not extend to acts of multiplication and propagation
only where such acts are unavoidable for commercial uses
other than multiplication and propagation .

Article 8

Methods for treatment of the human or animal body by
surgery or therapy and diagnostic methods practised on
the human or animal body shall not be patentable . This
provision shall not apply to products, in particular
substances or compositions, for use in any of these
methods .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 43

ORIGINAL PROPOSAL AMENDED PROPOSAL

Article 9

A process comprising a succession of steps shall not be
excluded from patentability for the reason only that one or
more of the steps involve a surgical, therapeutic or
diagnostic method practised on the animal body . The
treatment or diagnostic method shall not, however, be
protected per se .

CHAPTER II

Scope of protection

Article 12

1 . If the subject-matter of a patent is a process for the
production of living matter or other matter containing
genetic information permitting its multiplication in
identical or differentiated form, the rights conferred by the
patent shall not only extend to the product initially
obtained by the patented process but also the identical or
differentiated products of the first or subsequent
generations obtained therefrom, said products being
deemed also directly obtained by the patented process .

2 . Any extension of the protection conferred by the
patent to a process as indicated under paragraph 1 to a
product obtained thereby shall not be affected by an
exclusion of plant or animal varieties from patentability .

Article 13

The protection for a product consisting of or containing
particular genetic information as an essential characteristic
of the invention shall extend to any products in which said
genetic information has been incorporated and is of
essential importance for its industrial applicability or
utility .

Article 10

1 . The protection conferred by a patent on a biological
material possessing, as a result of the invention, specific
characteristics shall extend to all biological materials
derived from that biological material through
multiplication or propagation and possessing the same
characteristics .

2 . The protection conferred by a patent on a process
that enables the production of a biological material
possessing, as a result of the invention, specific
characteristics shall extend to biological material directly
obtained using that process and to any other biological
material derived from such biological material through
multiplication or propagation and possessing the same
characteristics . This extension of protection shall not be
affected by the exclusion from patentability of plant and
animal varieties provided for in Article 3 of this
Directive .

Article 11

The protection referred to in Article 10 shall not extend to
biological material derived from biological material that
has been marketed by the patent holder or with his
consent if the multiplication or propagation result from
the application for which the material was marketed .

Article 12

The protection conferred by a patent on a product
containing or consisting of genetic information shall
extend to all material in which the product is incorporated
and in which the genetic information is contained and
expressed .

No C 44 / 44 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

Article 13

1 . By way of derogation from Chapter II of this
Directive, farmers may use for purposes of multiplication
or propagation on their own farms the seeds obtained
from crops cultivated on their own farms using seeds
protected by patent . Only multiplication or propagation
with a view to producing crops for the farmers concerned
can be authorized .

2 . By way of derogation from Chapter II of this
Directive, farmers rearing livestock protected by patent
may use it for multiplication purposes on their own farms
to renew their stock .

CHAPTER 3

Dependency licence for plant varieties

CHAPTER III

Compulsory licence

Article 14 Article 14

1 . If the holder of a plant breeders ' right or a variety
certificate can exploit or exercise his exclusive rights only
by infringement of the rights attached to a prior national
patent, a non-exclusive licence of right shall be accorded
to the breeders ' right holder to the extent necessary for the
exploitation of such breeders ' right where the variety
protected represents significant technical progress, upon
payment of reasonable royalties having regard to the
nature of the patented invention and consistent with giving
the proprietor of such patent due reward for the
investment leading to and developing the invention .

2 . A licence under paragraph 1 shall not be available
prior to the expiration of three years from the date of the
grant of the patent or four years from the date on which
the application for a patent was filed, whichever period
last expires .

3 . If a licence according to paragraph 1 has been
granted, and if a variety protected by a plant breeders '
right or variety certificate can be exploited by the patentee
only by infringement of the rights attached to such variety,
a non-exclusive licence shall be accorded to the original
patentee to the extent necessary for the exploitation of the
breeders ' right or variety certificate, upon payment of
reasonable royalties having regard to the nature of the
improvement and consistent with giving the proprietor of
the breeders ' right due reward for the investment leading
to and developing the new variety .

1 . If the holder of a patent on a biotechnological
invention refuses to allow another party who is the holder
of a plant variety right to use the invention in return for an
appropriate royalty, a non-exclusive compulsory licence
may be sought from the competent authority and it shall
be granted upon payment of an appropriate royalty if this
is in the public interest .

2 . Each Member State shall designate the authority
competent to grant licences and shall inform the
Commission of each licence granted .

3 . If the holder of a plant variety right refuses to allow
another party who is the holder of a patent to engage in
activities requiring his consent on reasonable terms, a
non-exclusive compulsory licence may be sought from the
competent authority and it shall be granted upon payment
of an appropriate royalty if this is in the public interest .

4 . Where disagreements arise with regard to the 4 . An appeal shall lie from decisions of the competent
significance of the technical progress and as to the level of authority to the courts .
royalties, Member States shall provide for a court of
competent jurisdiction to resolve the dispute .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 45

ORIGINAL PROPOSAL AMENDED PROPOSAL

CHAPTER 4

Deposit, access and re-deposit

Article 15

1 . If an invention involves the use of a micro-organism
or other self-replicable matter which is not available to the
public and which cannot be described in a patent
application in such a manner as to enable the invention to
be carried out by a person skilled in the art, or if it
concerns such matter per se, the invention shall only be
regarded as being disclosed for purposes of national patent
law if :

( a ) the micro-organism or other self-replicable matter has
been deposited with a recognized depositary
institution not later than the date of filing of the
application ;

( b ) the application as filed gives such relevant
information as is available to the applicant on the
characteristics of the micro-organism or other
self-replicable matter ;

( c ) the depositary institution and the file number of the
deposit are stated in the application .

2 . The information referred to in paragraph 1(c ) may
be submitted :

( a ) within a period of 16 months after the date of filing
of the application or, if priority is claimed, after the
priority date ;

( b ) up to the date of submission of a request for early
publication of the application ;

( c ) within one month after the national patent office has
communicated to the applicant that a right to
inspection of the files exists pursuant to paragraph 3
( a ) ( ii ) below .

The ruling period shall be the one which is the first to
expire . The communication of this information shall be
considered as constituting the unreserved and irrevocable
consent of the applicant to the deposited matter being
available to the public in accordance with this Article .

3 . ( a ) Unless the application has been refused or
withdrawn or is deemed to be withdrawn, the
deposited matter shall be available upon request :

( i ) to any person from the date of publication of
the patent application ; and

CHAPTER IV

Deposit, access and re-deposit

Article 15

1 . Where an invention involves the use of or concerns a

biological material which is not available to the public and
which cannot be described in a patent application in such
a manner as to enable the invention to be carried out by a
person skilled in the art, the description shall be considerd
inadequate for the purposes of patent law unless :

( a ) the biological material has been deposited, no later
than the date on which the patent application was
filed, at least with an authorized institution in
accordance with the provisions of the Budapest
Treaty on the international recognition of the deposit
of micro-organisms for the purposes of patent
procedure of 28 April 1977 ;

( b ) the application as filed contains such relevant
information as is available to the depositor on the
characteristics of the biological material deposited ;

( c ) the patent application states the name of the
authorized depositary institution and the accession
number identifying the deposited biological material .

Deleted

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

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

No C 44 / 46 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

( b ) between the first publication of the application and

the granting of the patent, to anyone requesting it or,
if the depositor so requests, only to an independent

expert ;

( ii ) to any person having a right to inspect the ( c ) after the patent has been granted, to anyone
files under the provisions of national patent requesting it .
law relating to applications under which
rights are invoked against such a party, prior
to the date of publication .

( b ) Subject to the provisions of paragraph 4, such

availability shall be effected by the issue of a
sample of the deposited matter to the person
making the request ( hereinafter referred to as the
' requester '). Said issue shall be made only if the
requester has undertaken vis-a-vis the applicant for
or proprietor of the patent :

( i ) not to make the deposited matter or any
matter derived therefrom available to any
third party ;

( ii ) to use the deposited matter or any matter
derived therefrom in any country only for
experimental purposes concerning the
invention, with the proviso that this
restriction will cease, in the country of the
patent right on the basis of which the sample
of the deposited matter was obtained, with
the grant of a patent or other enforceable
right in the invention involved . This provision
shall not apply in the country of the patent
right on the basis of which the sample of the
deposited matter was obtained in so far as the
requester is using the matter under a
compulsory licence . The term ' compulsory
licence ' shall be construed as including ex
officio licences and the right to use patented
inventions in the public interest .

3 . Unless the patent holder or applicant, as applicable,
abandons his rights, the sample can be supplied only if the
person requesting it undertakes, for the duration of the
validity of the patent :

( a ) not to make it or any matter derived therefrom
available to third parties ;

( b ) not to use it or any matter derived therefrom in any

country except for experimental purposes .

4 . Until the date on which the technical preparations Deleted
for publication of the application are deemed to have been
completed, the applicant may inform the national patent
office that, until the publication of the mention of the
grant of the patent, the availability referred to in
paragraph 3 shall be effected only by the issue of a sample
to an expert nominated by the requester .

5 . The following may be nominated as an expert : Deleted

( a ) any natural person provided that the requester
furnishes evidence, when filing the request, that the
nomination has the approval of the applicant ;

( b ) any natural person recognized as an expert by the
national patent office . The nomination shall be
accompanied by an undertaking from the expert
vis-a-vis the applicant ; paragraphs 3 ( b ) ( i ) and ( ii )
shall apply, the requester being regarded as a third

party .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 47

ORIGINAL PROPOSAL AMENDED PROPOSAL

6 . For the purposes of paragraph 3 ( b ), any matter Deleted
derived from the deposited matter shall be deemed to be
any matter derived therefrom by culturing or in any other
way of replication which matter still exhibits those
characteristics of the deposited matter which are essential
to or for carrying out the invention . The undertaking
referred to in paragraph 3 ( b ) shall not impede a deposit of
derived matter, necessary for the purposes of patent
procedure .

7 . The request provided for in paragraph 3 shall be Deleted
submitted to the national patent office on a form
recognized by that office . The national patent office shall
certify on the form that a national patent application
referring to the deposit of the micro-organism or other
self-replicable matter has been filed, and that the requester
or the expert nominated by him is entitled to the issue of a
sample of the micro-organism or other self-replicable

matter .

8 . The national patent office shall transmit a copy of Deleted
the request, with the certification provided for in
paragraph 7 to the depositary institution as well as to the
applicant for, or the proprietor of, the patent .

9 . Member States shall designate recognized depositary Deleted
institutions for purposes of this Article .

10 . If a micro-organism or other self-replicable material Deleted
has been deposited in accordance with paragraphs 1 and 2
and has become available to any person or an expert in
accordance with paragraphs 3 or 4, it shall henceforth be
regarded available to the public in accordance with
paragraph 1 .

4 . At the depositor 's request, where an application is
refused or withdrawn or a patent is revoked or cancelled,
access to the deposited material shall be limited to an
independent expert for 20 years from the date on which
the patent application was filed . In the abovementioned
case, the provisions of paragraph 3 shall apply .

Article 16 Article 16

1 . If a micro-organism or other self-replicable matter
deposited in accordance with Article 15 ceases to be
available from the institution with which it was deposited
because :

( a ) the micro-organism or other self-replicable matter is
no longer viable ; or

( b ) for any other reason the depositary institution is

unable to supply samples,

and if the micro-organism or other self-replicable matter
has not been transferred to another depositary institution
recognized for the purposes of Article 15, from which it
continues to be available, an interruption in availability

If the biological material deposited in accordance with
Article 15 ceases to be available from the authorized

depositary institution, a new deposit of the material shall
be permitted in accordance with the provisions of the
Budapest Treaty on the international recognition of the
deposit of micro-organisms for the purposes of patent
procedure of 28 April 1977 .

No C 44 / 48 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

shall be deemed not to have occurred if a new deposit of
the micro-organism or other self-replicable matter
originally deposited is made within a period of three
months from the date on which the depositor was notified
of the interruption by the depositary institution and if a
copy of the receipt of the deposit issued by the institution
is forwarded to the national patent office within four
months from the date of the new deposit stating the
number of the application or of the national patent .

2 . In the case provided for in paragraph 1 ( a ), the new Deleted
deposit shall be made with the depositary institution with
which the original deposit was made ; in the cases provided
for in paragraph 1 ( b ), it may be made with another
depositary institution recognized for the purposes of
Article 15 ( 9 ).

3 . Where the institution with which the original deposit Deleted
was made ceases to be recognized for the purposes of the
application of Article 15, whether entirely or for the kind
of micro-organism or other self-replicable matter to which
the deposited micro-organism or other self-replicable
matter belongs, or where that institution discontinues,
temporarily or definitively, the performance of its
functions as regards deposited micro-organisms or other
self-replicable matter, and the notification referred to in
paragraph 1 from the depositary institution is not received
within six months from the date of such event, the
three-month period referred to in paragraph 1 shall begin
on the date on which this event is announced in the official

publication of the national patent office .

4 . Any new deposit shall be accompanied by a Deleted
statement signed by the depositor alleging that the newly
deposited micro-orgariism or other self-replicable matter is
the same as that originally deposited .

5 . If the new deposit provided for in the present Article Deleted
has been made under the Budapest Treaty on the
international recognition of the deposit of micro-organisms
for the purposes of patent procedure of 28 April 1977, the
provisions of that Treaty shall prevail in case of conflict .

6 . If a deposit is not accepted or if the deposited Deleted
material is no longer available from the depositary
institution and a re-deposit according to paragraphs 1 to 5
does not or could not remedy the unavailability, such
unavailability shall not affect the patentability of the
invention if the applicant / patentee provides the requesting
party entitled to receive a sample with such same certifying
its identity with the material used in the invention or
obtained as the invention or with the originally deposited
material, as the case may be .

16 . 2 . 93 Official Journal of the European Communities No C 44 / 49

ORIGINAL PROPOSAL AMENDED PROPOSAL

7 . If a patent is deemed invalid because the patentee Deleted
can no longer provide for a sample of the deposited
material in accordance with this Article, such invalidity
shall in no case have retroactive effects .

CHAPTER 5

Reversal of the burden of proof

Article 17

1 . If the subject-matter of a patent is a process for
obtaining a new or known product, the same product
when produced by any other party shall, in the absence of
proof to the contrary, be deemed to have been obtained by
the patented process, if a necessary means to carry out the
process had been deposited in accordance with Article 14
and had been released to a third party .

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

account .

CHAPTER 6

Miscellaneous

CHAPTER V

Reversal of the burden of proof

Article 17

1 . If the subject-matter of a patent is a process for
obtaining a new product, any identical product produced
by any person other than the patent holder shall, in the
absence of proof to the contrary, be deemed to have been
obtained by means of the patented process .

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

account .

CHAPTER VI

Final provisions

Article 18 Deleted

Any exclusion from patentability or from the field of
industrial applicability of surgical or diagnostic methods
practised on an animal body shall apply to such methods
only if practised for a therapeutic purpose .

Article 19

For the purposes of this Directive : Deleted

( a ) the word ' micro-organism ', where used, shall be
interpreted in its broadest sense as including all
microbiological entities capable of replication, e.g. as
comprising, inter alia, bacteria, fungi, viruses,
mycoplasmae, rickettsiae, algae, protozoa, and cells ;
and

( b ) the word ' self-replicable matter ', where used, shall be
interpreted to comprise also matter possessing the
genetic material necessary to direct its own replication
via a . host organism or in any other indirect way, e.g.
as comprising, inter alia, seeds, plasmids, DNA
sequences, protoplasts, replicons and tissue cultures .

No C 44 / 50 Official Journal of the European Communities 16 . 2 . 93

ORIGINAL PROPOSAL AMENDED PROPOSAL

Article 20

1 . Member States shall bring into force the laws
necessary to comply with this Directive not later than
31 December 1990 .

2 . Member States shall communicate to the

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

Article 18

1 . The Member States shall adopt the laws, regulations
and administrative provisions necessary for their
compliance with this Directive not later than

When they adopt such measures the Member States shall
include references to this Directive or shall make such

references when they effect official publication . The
manner in which such references are to be made shall be

laid down by the Member States .

2 . The Member States shall communicate to the

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

Article 21 Article 19

This Directive is addressed to the Member States . Unchanged