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 techno­
logical 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 patenta­
bility 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 devel­
opment 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 biotech­
nology 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 devel­
opment 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 biotech­
nological 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 func­
tioning 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 inno­
vation in the full range of human endeavours by recog­
nizing 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 biotechno­
logical 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 self-
replicable, the rights conferred by the national patent 
shall not extend to acts of multiplication and propa­
gation only where such acts are unavoidable for 
commercial uses other than multiplication and propa­
gation. 
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 charac­
teristic of the invention shall extend to any products in 
which said genetic information has been incorporated 
and is of essential importance for its industrial applica­
bility 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 infor­
mation as is available to the applicant on the charac­
teristics 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. (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. 
2. The information referred to in paragraph 1 (c) may 
be submitted: 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 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 
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 para­
graphs 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 orig­
inally 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 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 notifi­
cation 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 Micro­
organisms 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 orig­
inally 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, myco-
plasmae, 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 repli­
cation via a host organism or in any other indirect 
way, e.g. as comprising, inter alia, seeds, plasmids, 
DNA sequences, protoplasts, replicons and tissue 
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.