COMMISSION OF THE EUROPEAN COMMUNITIES 
Brussels, 05.10.1995 
COM(95) 456 final 
94/0285 (COD) 
Amended proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EC) 
concerning the creation of a supplementary protection certificate 
for plant protection products 
(presented by the Commission pursuant to Article 189 a (2) 
of the EC-Treaty) 

EXPLANATORY MEMORANDUM 
GENERAL PRESENTATION 
In December 1994 the Commission presented to Parliament and to the Council a 
proposal for a Regulation concerning the creation of a supplementary protection 
certificate for plant protection products.1 
The Economic and Social Committee adopted its opinion on 27 April 1995.2 
Parliament discussed the proposal in detail in its various committees and during its 
plenary session in June 1995.3 
The purpose of the amended proposal is to take account of these opinions and to clarify, 
where necessary, the wording of a number of provisions. In particular, the amended 
proposal allows for the amendments to Directive 91/414/EEC, made after the 
Commission had presented its proposal. 
Parliament examined the economic conditions in which the plant protection industry 
operates within the Community and set out the specific characteristics of this sector in 
relation to its objectives and in view of its international competitors. 
The Commission is willing to accept the four amendments adopted by Parliament, all of 
which aim to clarify the economic and legal conditions under which the plant protection 
sector in the Community operates. 
1 OJNoC39(), 31.12.1994, p. 21. 
2 OJ No C 
3 OJNoC 
CD 
EXAMINATION OF THE RECITALS 
RECITAL NO 1 
The purpose of this new recital, which adopts in full Amendment 1 adopted by 
Parliament, is to make clear that plant protection research contributes to improvements in 
production and procurement of good-quality food. 
RECITAL NO 3 
This recital has been amended to include the full text of Amendment 2 adopted by 
Parliament. It states that plant protection products will continue to be developed if there 
is adequate protection in the Community to encourage research. 
RECITAL NO 4 
This new recital, which adopts almost the same wording as Amendment 3 adopted by 
Parliament, states that the plant protection sector is in a situation similar to that of the 
pharmaceuticals industry when an equivalent measure to restore the effective duration of 
patent protection was proposed and adopted.4 
RECITAL NO 7 
This new recital, which adopts almost the same wording as Amendment 4 adopted by 
Parliament, states that one of the proposal's objectives is to place European industry on 
the same competitive footing as its international competitors. 
RECITALS NOS 13 AND 14 
These two new recitals set out the scope of protection conferred by the supplementary 
certificate and clarify the links between the basic patent covering a plant protection 
product and the supplementary certificate for the same product. They also state the 
conditions under which a supplementary certificate may be obtained for the derivatives 
of a plant protection product already covered by a supplementary certificate. 
Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary 
protection certificate for medicinal products; OJ No L 182, 2.7.1992, p. 1. 
-2-
EXPLANATION OF THE PROVISIONS 
ARTICLE 2 
The slightly revised wording takes account of any problems that could arise in the 
Member States which were not able to transpose Directive 91/414/EEC concerning the 
placing of plant protection products on the market by the required deadline, and in the 
new Member States which have transitional periods in which to transpose Community 
directives. 
ARTICLE 3 (2) 
This new paragraph states that, as a rule, the holder of a number of patents for the same 
plant protection product may not be granted a number of certificates for that product, and 
sets out the specific circumstances (where two or more applications are pending) in 
which two or more certificates may be issued for the same product. 
ARTICLE 8 (1) 
Since the Commission presented its proposal, Directive 91/414/EEC concerning the 
placing of plant protection products on the market has been amended by Directive 
94/37/EEC of 22 July 1994. Annex II to Directive 91/414/EEC has also been amended. 
The new wording of Article 8(l)(b) takes account of this amendment. 
In addition, the new Article 8(c)(1) allows for the situation in Member States in which 
the authorization to place plant protection products on the market is not published in an 
Official Journal or another official publication. In those Member States, the application 
for a certificate must be accompanied by any other document proving that the 
authorization has been issued, the date on which it was issued and the identity of the 
product authorized. 
ARTICLE 13 (3) 
This new paragraph takes account of the special features of the authorization procedure 
for placing plant protection products on the market. For the purposes of calculating the 
duration of the supplementary protection certificate, provisional authorization is taken 
into account only if it is subsequently followed by a definitive authorization concerning 
the same product. This provision applies equally to the system under Directive 
91/414/EEC and, where appropriate, to equivalent provisions of national law. 
-3 
ARTICLE 18 
There has been a Community Regulation concerning the creation of a supplementary 
protection certificate for medicinal products since 1992; under that Regulation, a number 
of Member States have adopted special procedural provisions concerning the issue of 
those supplementary certificates. The amendment to Article 18 allows the Member States 
which already have special provisions for supplementary protection certificates for 
medicinal products to apply them, mutatis mutandis, to supplementary protection 
certificates for plant protection products. 
ARTICLE 20 
This new Article takes account of the specific situation of Member States which have 
recently introduced into national law the principle of patentability of plant protection 
products. Under Regulation (EEC) No 1768/92 concerning the creation of a 
supplementary protection certificate for medicinal products, it was decided that the 
Member States whose laws introduced the patentability of pharmaceutical products only 
very recently would be able to implement the Regulation five years later than the other 
Member States. This deferral means that an application for a supplementary protection 
certificate for a medicinal product will be acceptable in the Member States concerned 
only from 2 January 1998. Under this Regulation, account should be taken of the similar 
situation existing in a number of Member States with regard to the patentability of plant 
protection products; for those Member States, the date of application of this Regulation 
should coincide with that of Regulation No 1768/92 for medicinal products. 
ARTICLE 21 
This amendment takes account of the situation in Member States in which the national 
parliament must adopt implementing rules for this Regulation (statutory regulations 
allowing taxes to be levied, etc.) and which need time to do so. In order to allow for this 
difficulty, the Article states that the Regulation is to enter into force six months after its 
publication in the Official Journal of the European Communities. 
4-
Amended proposal for a 
EUROPEAN PARLIAMENT AND COUNCIL REGULATION (EO 
concerning the creation of a supplementary protection 
certificate for plant protection products 
(presented by the Commission under Article 189a(2) of the EC Treaty) 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
THE EUROPEAN PARLIAMENT 
AND THE COUNCIL OF THE 
EUROPEAN UNION, 
Having regard to the Treaty establishing 
the European Economic Community, 
and in particular Article 100a thereof, 
Having regard to the proposal from the 
Commission,1 
Having regard to the opinion of the 
Economic and Social Committee,2 THE EUROPEAN PARLIAMENT 
AND THE COUNCIL OF THE 
EUROPEAN UNION, 
Unchanged 
Having regard to the proposal from the 
Commission,1 
Unchanged 
(1 ) Whereas research into plant 
protection products contributes to 
the continuing improvement in the 
production and procurement of 
plentiful food of good quality at 
affordable prices; 
1 OJNoC 
2 OJ No C 1 OJ No C 390, 31.12.1994, p. 21. 
OJNoC 
<> 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
(1) Whereas plant protection research 
contributes to the continuing 
improvement in crop production; 
(2) Whereas plant protection products, 
especially those that are the result 
of long, costly research, will not 
continue to be developed in the 
Community and in Europe unless 
they are covered by favourable 
rules that provide for sufficient 
protection to encourage such 
research; 
(3) Whereas at the moment the period 
that elapses between the filing of 
an application for a patent for a 
new plant protection product and 
authorization to place the product 
on the market makes the period of 
effective protection under the 
patent insufficient to cover the 
investment put into the research 
and to generate the resources 
needed to maintain a high level of 
research; (2) Unchanged 
(3) Whereas plant protection products, 
especially those that are the result 
of long, costly research, will 
continue to be developed in the 
Community and in Europe if they 
are covered by favourable rules 
that provide for sufficient 
protection to encourage such 
research; 
(4) Whereas, by its very nature, the 
competitiveness of the plant 
protection sector calls for the same 
protection to be afforded to 
innovation as that granted to 
medicinal products by Regulation 
(EEC) No 1768/92 concerning the 
creation of a supplementary 
protection certificate for medicinal 
products; 
(5) Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
(4) Whereas this situation leads to a 
lack of protection which penalizes 
plant protection research and the 
competitiveness of the sector; 
(5) Whereas, in its Resolution of 
1 February 1993^ on a Community 
programme of policy and action in 
relation to the environment and 
sustainable development, the 
Council adopted the general 
approach and strategy of the 
programme presented by the 
Commission, which stressed the 
interdependence of economic 
growth and environmental quality; 
whereas improving protection of 
the environment means 
maintaining the competitiveness of 
industry; whereas, accordingly, the 
issue of a supplementary 
protection certificate can be 
regarded as a positive measure in 
favour of envi ronmental 
protection; (6) Unchanged 
(7) Whereas one of the main 
objectives of the supplementary 
protection certificate is to place 
European industry on the same 
competitive footing as its 
American and Japanese 
counterparts; 
(8) Unchanged 
OJNoC 138, 17.5.1993, p. 1. OJNoC138, 17.5.1993, p. 1. 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
(6) Whereas a uniform solution at 
Community level should be 
provided for, thereby preventing 
the heterogeneous development of 
national laws leading to further 
disparities which would be likely 
to create obstacles to the free 
movement of plant protection 
products within the Community 
and thus directly affect the 
establishment and the functioning 
of the internal market; whereas 
this is in accordance with the 
principle of subsidiarity as defined 
by Article 3b of the Treaty 
establishing the European 
Community; 
(7) Whereas, therefore, the creation of 
a supplementary protection 
certificate granted, under the same 
conditions, by each of the Member 
States at the request of the holder 
of a national or European patent 
relating to a plant protection 
product for which marketing 
authorization has been granted is 
necessary; whereas a Regulation is 
therefore the most appropriate 
legal instrument; (9) Unchanged 
(10) Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
(8) Whereas the duration of the 
protection granted by the 
certificate should be such as to 
provide adequate, effective 
protection; whereas, for this 
purpose, the holder of both a 
patent and a certificate should be 
able to enjoy an overall maximum 
of fifteen years of exclusivity from 
the time the plant protection 
product in question first obtains 
authorization to be placed on the 
market in the Community; 
(9) Whereas all the interests at stake in 
a sector as complex and sensitive 
as plant protection must 
nevertheless be taken into account; 
whereas, for this purpose, the 
certificate cannot be granted for a 
period exceeding five years; 
whereas the protection granted 
should furthermore be strictly 
confined to the product which 
obtained authorization to be placed 
on the market as a plant protection 
product; (11) Unchanged 
(12) Whereas all the interests at stake in 
a sector as complex and sensitive 
as plant protection must 
nevertheless be taken into account; 
whereas, for this purpose, the 
certificate cannot be granted for a 
period exceeding five years; 
(13) Whereas the certificate grants the 
same rights as those conferred by 
the basic patent; whereas, 
consequently, where the basic 
patent covers an active substance 
and its various derivatives (salts 
and esters), the certificate grants 
the same protection; 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
(10) Whereas a fair balance should also 
be struck with regard to the 
determination of the transitional 
arrangements; whereas such 
arrangements should enable the 
Community plant protection 
industry to catch up to some extent 
with its main competitors, while 
making sure that the arrangements 
do not compromise the 
achievement of other legitimate 
objectives concerning the 
agricultural and environment 
policies pursued both at national 
and Community level; 
(11) Whereas only action at 
Community level can be effective 
in attaining the objective, which 
consists in ensuring adequate 
protection for innovation in the 
field of plant protection, while 
guaranteeing the proper 
functioning of the internal market 
for plant protection products; 
HAVE ADOPTED THIS 
REGULATION: (14) Whereas the issue of a certificate 
for a product consisting of an 
active substance does not prejudge 
the issue of other certificates for 
derivatives (salts and esters) of the 
product, provided that the 
derivatives are the subject of 
patents specifically covering them; 
(15) Unchanged 
(16) Unchanged 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 1 
Definitions 
For the purposes of this Regulation, the 
following definitions shall apply: 
1. "plant protection products" : active 
substances and preparations 
containing one or more active 
substances, put up in the form in 
which they are supplied to the 
user, intended to: 
1.1. protect plants or plant 
products against all harmful 
organisms or prevent the 
action of such organisms, in 
so far as such substances or 
preparations are not 
otherwise defined below; 
1.2. influence the life processes 
of plants, other than as a 
nutrient (e.g. plant growth 
regulators); 
1.3. preserve plant products, in 
so far as such substances or 
products are not subject to 
special Council or 
Commission provisions on 
preservatives; 
1.4. destroy undesired plants; or 
1.5. destroy parts of plants, 
check or prevent undesired 
growth of plants; Article 1 
Definitions 
Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. "substances": chemical elements 
and their compounds, as they 
occur naturally or by manufacture, 
including any impurity inevitably 
resulting from the manufacturing 
process; 
3. "active substances": substances or 
micro-organisms including viruses, 
having general or specific action: 
3.1. against harmful organisms; 
or 
3.2. on plants, parts of plants or 
plant products; 
4. "preparations": mixtures or 
solutions composed of two or 
more substances, of which at least 
one is an active substance, 
intended for use as plant protection 
products; 
5. "plants": live plants and live parts 
of plants, including fresh fruit and 
seeds; 
6. "plant products": products in the 
unprocessed state or having 
undergone only simple preparation 
such as milling, drying or pressing, 
derived from plants, but excluding 
plants themselves as defined at 
point 5; 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
7. "harmful organisms": pests of 
plants or plant products belonging 
to the animal or plant kingdom, 
and also viruses, bacteria and 
mycoplasmas and other pathogens; 
8. "product": the active substance is 
defined at point 3 or combination 
of active substances of a plant 
protection product; 
9. "basic patent": a patent which 
protects a product as defined at 
point 8 as such, a preparation as 
defined at point 4, a process to 
obtain a product or an application 
of a product, and which is 
designated by its holder for the 
purpose of the procedure for grant 
of a certificate; 
10. "certificate" : the supplementary 
protection certificate. 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 2 
Scope 
Any product protected by a patent in 
the territory of a Member State and 
subject, prior to being placed on the 
market as a plant protection product, to 
an administrative authorization 
procedure as laid down in Article 4 of 
Council Directive 91/414/EEC,4 or 
pursuant to an equivalent provision of 
national law if it is a plant protection 
product in respect of which the 
application for authorization was 
lodged before the entry into force of 
Directive 91/414/EEC for the Member 
State concerned, may, under the terms 
and conditions provided for in this 
Regulation, be the subject of a 
certificate. 
Article 3 
Conditions for obtaining a certificate 
A certificate shall be granted if, in the 
Member State in which the application 
referred to in Article 7 is submitted, at 
the date of that application: 
a) the product is protected by a basic 
patent in force; Article 2 
Scope 
Any product protected by a patent in the 
territory of a Member State and subject, 
prior to being placed on the market as a 
plant protection product, to an 
administrative authorization procedure 
as laid down in Article 4 of Council 
Directive 91/414/EEC,4 or pursuant to 
an equivalent provision of national law 
if it is a plant protection product in 
respect of which the application for 
authorization was lodged before 
Directive 91/414/EEC was 
implemented by the Member State 
concerned, may, under the terms and 
conditions provided for in this 
Regulation, be the subject of a 
certificate. 
Article 3 
Conditions for obtaining a certificate 
1 Unchanged 
OJ No L 230, 19.8.1991, p. 1. OJ No L 230, 19.8.1991, p. 1. 
\S 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
b) a valid authorization to place the 
product on the market as a plant 
protection product has been 
granted in accordance with 
Article 4 of Directive 91/414/EEC 
or an equivalent provision of 
national law; 
c) the product has not already been 
the subject of a certificate; 
d) the authorization referred to in (b) 
is the first authorization to place 
the product on the market as a 
plant protection product. 
The holder of a number of patents 
for the same product may not be 
granted a number of certificates 
for that product. However, where 
two or more applications are 
pending, two or more certificates 
may be issued for the same 
product to two or more holders of 
different patents for the same 
product. 
\<> 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 4 
Subject-matter of protection 
Within the limits of the protection 
conferred by the basic patent, the 
protection conferred by a certificate 
shall extend only to the product covered 
by the authorizations to place the 
corresponding plant protection product 
on the market and for any use of the 
product as a plant protection product 
that has been authorized before the 
expiry of the certificate. 
Article 5 
Effects of the certificate 
Subject to the provisions of Article 4, 
the certificate shall confer the same 
rights as conferred by the basic patent 
and shall be subject to the same 
limitations and the same obligations. 
Article 6 
Entitlement to the certificate 
The certificate shall be granted to the 
holder of the basic patent or his 
successor in title. 
Article 7 
Application for a certificate 
1. The application for a certificate 
shall be lodged within six months 
of the date on which the 
authorization referred to in 
Article 3(b) to place the product 
on the market as a plant protection 
product was granted. Article 4 
Subject-matter of protection 
Unchanged 
Article 5 
Effects of the certificate 
Unchanged 
Article 6 
Entitlement to the certificate 
Unchanged 
Article 7 
Application for a certificate 
1. The application for a certificate 
shall be lodged within six months 
of the date on which the 
authorization referred to in 
Article 3(1 )(b) to place the product 
on the market as a plant protection 
product was granted. 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. Notwithstanding paragraph 1, 
where the authorization to place 
the product on the market is 
granted before the basic patent is 
granted, the application for a 
certificate shall be lodged within 
six months of the date on which 
the patent is granted. 
Article 8 
Content of the application for a 
certificate 
1. The application for a certificate 
shall contain: 
a) a request for the grant of a 
certificate, stating in particular: 
i) the name and address of 
the applicant; 
ii) if he has appointed a 
representative, the name 
and address of the 
representative; 
iii) the number of the basic 
patent and the title of the 
invention; 2. Unchanged 
Article 8 
Content of the application for a 
certificate 
1. Unchanged 
a) Unchanged 
i) Unchanged 
ii) Unchanged 
iii) Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
iv) the number and date of 
the first authorization to 
place the product on the 
market, as referred to in 
Article 3(b) and, if this 
authorization is not the 
first authorization to 
place the product on the 
market in the 
Community, the number 
and date of that 
authorization; 
b) a copy of the authorization to 
place the product on the 
market, as referred to in Article 
3(b), in which the product is 
identified, containing in 
particular the number and date 
of the authorization and the 
summary of the product 
characteristics listed in Part A.I 
or B.I of Annex II to Directive 
91/414/EEC or in equivalent 
national laws of the Member 
State in which the application 
was lodged; iv) the number and date of 
the first authorization to 
place the product on the 
market, as referred to in 
Article 3(1 )(b) and, if 
this authorization is not 
the first authorization to 
place the product on the 
market in the 
Community, the number 
and date of that 
authorization; 
b) a copy of the authorization to 
place the product on the 
market, as referred to in Article 
3(1 )(b), in which the product is 
identified, containing in 
particular the number and date 
of the authorization and the 
summary of the product 
characteristics listed in Part A.I 
(points 1-7) or B.I (points 1-7) 
of Annex II to Directive 
91/414/EEC or in equivalent 
national laws of the Member 
State in which the application 
was lodged; 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
c) if the authorization referred to 
in (b) is not the first 
authorization to place the 
product on the market as a 
plant protection product in the 
Community, information 
regarding the identity of the 
product thus authorized and the 
legal provision under which 
the authorization procedure 
took place, together with a 
copy of the notice publishing 
the authorization in the Official 
Journal or any other document 
including the information 
required. 
2. Member States may provide that a 
fee is payable upon application for 
a certificate. c) if the authorization referred to 
in (b) is not the first 
authorization to place the 
product on the market as a 
plant protection product in the 
Community, information 
regarding the identity of the 
product thus authorized and the 
legal provision under which the 
authorization procedure took 
place, together with a copy of 
the notice publishing the 
authorization in the appropriate 
official gazette or, failing such 
publication, any other 
document proving that the 
authorization has been issued, 
the date on which it was issued 
and the identity of the product 
authorized. 
2. Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 9 
Lodging of an application for a 
certificate 
The application for a certificate 
shall be lodged with the competent 
industrial property office of the 
Member State which granted the 
basic patent or on whose behalf it 
was granted and in which the 
authorization referred to in 
Article 3(b) to place the product 
on the market was obtained, unless 
the Member State designates 
another authority for the purpose. 
Notification of the application for 
a certificate shall be published by 
the authority referred to in 
paragraph 1. The notification shall 
contain at least the following 
information: 
a) the name and address of the 
applicant; 
b) the number of the basic patent; 
c) the title of the invention; 
d) the number and date of the 
authorization to place the 
product on the market, referred 
to in Article 3(b), and the 
product identified in that 
authorization; Article 9 
Lodging of an application for a 
certificate 
The application for a certificate 
shall be lodged with the competent 
industrial property office of the 
Member State which granted the 
basic patent or on whose behalf it 
was granted and in which the 
authorization referred to in 
Article 3(1 )(b) to place the product 
on the market was obtained, unless 
the Member State designates 
another authority for the purpose. 
Unchanged 
a) Unchanged 
b) Unchanged 
c) Unchanged 
d) the number and date of the 
authorization to place the 
product on the market, referred 
to in Article 3(1 )(b), and the 
product identified in that 
authorization; 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
e) where relevant, the number and 
date of the first authorization 
to place the product on the 
market in the Community. 
Article 10 
Grant of the certificate or rejection 
of the application 
1. Where the application for a 
certificate and the product to 
which it relates meet the 
conditions laid down in this 
Regulation, the authority referred 
to in Article 9(1) shall grant the 
certificate. 
2. The authority referred to in Article 
9(1) shall, subject to paragraph 3, 
reject the application for a 
certificate if the application or the 
product to which it relates does not 
meet the conditions laid down in 
this Regulation. 
3. Where the application for a 
certificate does not meet the 
conditions laid down in Article 8, 
the authority referred to in 
Article 9(1) shall ask the applicant 
to rectify the irregularity, or to 
settle the fee, within a stated time. 
4. If the irregularity is not rectified or 
the fee is not settled under 
paragraph 3 within the stated time, 
the authority shall reject the 
application. e) Unchanged 
Article 10 
Grant of the certificate or rejection of 
the application 
1. Unchanged 
Unchanged 
Unchanged 
Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
Member States may provide that 
the authority referred to in 
Article 9(1) is to grant certificates 
without verifying that the 
conditions laid down in 
Article 3(c) and (d) are met. 
Article 11 
Publication 
Notification of the fact that a 
certificate has been granted shall 
be published by the authority 
referred to in Article 9(1). The 
notification shall contain at least 
the following information: 
a) the name and address of the 
holder of the certificate; 
b) the number of the basic patent; 
c) the title of the invention; 
d) the number and date of the 
authorization to place the 
product on the market referred 
to in Article 3(b) and the 
product identified in that 
authorization; 
e) where relevant, the number and 
date of the first authorization 
to place the product on the 
market in the Community; 
f) the duration of the certificate. Member States may provide that 
the authority referred to in 
Article 9(1) is to grant certificates 
without verifying that the 
conditions laid down in 
Article 3(1 )(c) and (d) are met. 
Article 11 
Publication 
Unchanged 
a) unchanged 
b) unchanged 
c) unchanged 
d) the number and date of the 
authorization to place the 
product on the market referred 
to in Article 3(1 )(b) and the 
product identified in that 
authorization; 
e) unchanged 
f) unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
2. Notification of the fact that the 
application for a certificate has 
been rejected shall be published by 
the authority referred to in Article 
9(1). The notification shall contain 
at least the information listed in 
Article 9(2). 
Article 12 
Annual fees 
Member States may require that the 
certificate be subject to the payment of 
annual fees. 
Article 13 
Duration of the certificate 
1. The certificate shall take effect at 
the end of the lawful term of the 
basic patent for a period equal to 
the period which elapsed between 
the date on which the application 
for a basic patent was lodged and 
the date of the first authorization 
to place the product on the market 
in the Community, reduced by a 
period of five years. 
2. Notwithstanding paragraph 1, the 
duration of the certificate may not 
exceed five years from the date on 
which it takes effect. Article 12 
Annual fees 
Unchanged 
Article 13 
Duration of the certificate 
1. Unchanged 
Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 14 
Expiry of the certificate 
The certificate shall lapse: 
a) at the end of the period provided 
for in Article 13; 
b) if the certificate-holder surrenders 
it; 
c) if the annual fee laid down in 
accordance with Article 12 is not 
paid in time; 
d) if and as long as the product 
covered by the certificate may no 
longer be placed on the market 
following the withdrawal of the 
appropriate authorization or 
authorizations to place it on the 
market in accordance with 
Article 4 of Directive 91/414/EEC 
or equivalent provisions of 
national law. The authority 
referred to in Article 9(1) may 
decide on the lapse of the 
certificate either on its own 
initiative or at the request of a 
third party. For the purposes of calculating the 
duration of the certificate, account 
is taken of a provisional first 
marketing authorization only if it 
is subsequently followed by a 
definitive authorization concerning 
the same product. 
Article 14 
Expiry of the certificate 
Unchanged 
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ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 15 
Invalidity of the certificate 
1. The certificate shall be invalid if: 
a) it was granted contrary to the 
provisions of Article 3; 
b) the basic patent has lapsed 
before its lawful term expires; 
c) the basic patent is revoked or 
limited so that the product for 
which the certificate was 
granted would no longer be 
protected by the claims of the 
basic patent or, after the basic 
patent has expired, grounds for 
revocation exist which would 
have justified such revocation 
or limitation. 
2. Any person may submit an 
application or bring an action for a 
declaration of invalidity of the 
certificate before the body 
responsible under national law for 
the revocation of the 
corresponding basic patent. 
Article 16 
Notification of lapse or invalidity 
If the certificate lapses in accordance 
with Article 14(b), (c) or (d), or is 
invalid in accordance with Article 15, 
notification thereof shall be published 
by the authority referred to in Article 
9(1). Article 15 
Invalidity of the certificate 
Unchanged 
Article 16 
Notification of lapse or invalidity 
Unchanged 
?S 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
Article 17 
Appeals 
The decisions of the authority referred 
to in Article 9(1) or of the body referred 
to in Article 15(2) taken under this 
Regulation shall be open to the same 
appeals as those provided for in 
national law against similar decisions 
taken in respect of national patents. 
Article 18 
Procedure 
1. In the absence of procedural 
provisions in this Regulation, the 
procedural provisions applicable 
under national law to the 
corresponding basic patent shall 
apply to the certificate, unless that 
law lays down special procedural 
provisions for certificates. 
Notwithstanding paragraph 1, the 
procedure for opposition to the 
granting of a certificate shall be 
excluded. Article 17 
Appeals 
Unchanged 
Article 18 
Procedure 
1. In the absence of procedural 
provisions in this Regulation, the 
procedural provisions applicable 
under national law to the 
corresponding basic patent and, 
where appropriate, the procedural 
provisions applicable to the 
certificates referred to in 
Regulation 1768/92, shall apply to 
the certificate, unless national law 
lays down special procedural 
provisions for certificates as 
referred to in this Regulation. 
2. Unchanged 
U 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
TRANSITIONAL PROVISIONS 
Article 19 
1. Any product which, on the date on 
which this Regulation enters into 
force, is protected by a valid basic 
patent and for which the first 
authorization to place it on the 
market as a plant protection 
product in the Community was 
obtained after 1 January 1985 
under Article 4 of Directive 
91/414/EEC or an equivalent 
national provision may be granted 
a certificate. 
2. An application for a certificate as 
referred to in paragraph 1 shall be 
submitted within six months of the 
date on which this Regulation 
enters into force. TRANSITIONAL PROVISIONS 
Article 19 
Unchanged 
Article 20 
In those Member States whose national 
law did not, on 1 January 1990, provide 
for the patentability of plant protection 
|it#t«fiff to, llito I'.MgulrtllMit «JIIMII M|i|jlv 
from 2 January 1998. 
Article 19 shall not apply in those 
Member States. 
n 
ORIGINAL PROPOSAL AMENDED PROPOSAL 
FINAL PROVISION 
Article 20 
Entry into force 
This Regulation shall enter into force 
three months after its publication in the 
Official Journal of the European 
Communities. 
This Regulation shall be binding in its 
entirety and directly applicable in all 
Member States. 
Done at Brussels, FINAL PROVISION 
Article 21 
Entry into force 
This Regulation shall enter into force 
six months after its publication in the 
Official Journal of the European 
Communities. 
Unchanged 
Done at Brussels, 
n 

ISSN 0254-1475 
COM(95) 456 final 
DOCUMENTS 
EN 08 15 
Catalogue number : CB-CO-95-501-EN-C 
ISBN 92-77-94028-X 
Office for Official Publications of the European Communities 
L-2985 Luxembourg 
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