Source: EURLEX
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13. 1. 89 Official Journal of the European Communities No C 10/3

## II

_(Preparatory Acts)_

# COMMISSION

Proposal for a Council Directive on the legal protection of biotechnological inventions

_COM(88) 496 final_ — _SYN 159_

_(Submitted by the Commission on 20 October 1988)_

(89/C 10/03)

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

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 creation and

proper functioning of 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;

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

Whereas national patent systems have in the past
successfully adapted to technical developments and

scientific breakthroughs in according patent protection
to such developments where appropriate;

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

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

Whereas some inventions developed through 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
Community of the legal protection for 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 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
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
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;

No C 10/4 Official Journal of the European Communities 13. 1. 89

Whereas international instruments exist or are 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
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
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
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
then 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 seemly that the legislation of the Member
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
license for plant and animal varieties;

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

time-bound right for his creative efforts and thereby
encourage inventive activities, the rightholder 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;

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

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.

_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.

13. 1. 89 Official Journal of the European Communities No C 10/5

_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 perfomed upon
or resulting in a micro-organism.

_Article 6_

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_

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.

_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 that it formed part of said natural material.

_Article 9_

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_

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 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 11_

If a product enjoying patent protection and put on the
market by the patentee or with his consent is selfreplicable, 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 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 to 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 any
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.

CHAPTER 3

Dependency license for plant varieties

_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 license 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 a significant technical progress,
upon payment of reasonable royalties having regard to

No C 10/6 Official Journal of the European Communities 13. 1. 89

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 license 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 license 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 license 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.

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

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 selfreplicable 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
made 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

(ii) to any person having a right to inspect the
files under the provisions of national patent
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 license. The term
'compulsory license' shall be construed as
including _ex officio_ licenses and the right to
use patented inventions in the public interest.

4. Until the date on which the technical preparations
for publication of the application are deemed to have

13. 1. 89 Official Journal of the European Communities No C 10/7

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:

(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-d-vis_ the applicant; paragraph 3 (b) (i) and (ii)
shall apply, the requester being regarded as a third
party.

6. For the purposes of paragraph 3 (b), any matter
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
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 microorganism 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
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 institutions for purposes of this Article.

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

_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
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
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 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 selfreplicable 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 microorganisms 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
statement signed by the depositor alleging that the newly
deposited micro-organism or other self-replicable matter
is the same as that originally deposited.

5. If the new deposit provided for in the present
Article has been made under the Budapest Treaty on the
International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28
April 1977, the provisions of that Treaty shall prevail in
case of conflict.

No C 10/8 Official Journal of the European Communities 13. 1. 89

6. If a deposit is not accepted or if the deposited
material is no longer available from the depository
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
sample 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.

7. If a patent is deemed invalid because the patentee
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

_Article 18_

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:
(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 words '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.

_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 the field covered by this
Directive.

_Article 21_

This Directive is addressed to the Member States.