IP/N/1/EU/P/4  
 
15 April 2013  
(13-1970)  Page: 1/8  
Council for Trade-Related Aspects 
of Intellectual Property Rights  Original: English/anglais/inglés  
 
MAIN DEDICATED INTELLECTUAL PROPERTY LAWS AND 
REGULATIONS NOTIFIED UNDER ARTICLE 63.2 
OF THE AGREEMENT 
EUROPEAN UNION 
This document reproduces the text1 of Regulation (EC) No 1610/96 of the European Parliament 
and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products, as notified by the European Union on 20 March 2013 under Article 63.2 of the Agreement (see document IP/N/1/EU/1). 
 
Conseil des aspects des droits de propriété 
intellectuelle qui touchent au commerce 
  
PRINCIPALES LOIS ET RÉGLEMENTATIONS CONSACRÉES À 
LA PROPRIÉTÉ INTELLECTUELLE NOTIFIÉES AU TITRE 
DE L'ARTICLE 63:2 DE L'ACCORD 
U
NION EUROPÉENNE  
Le présent document contient le texte1 du Règlement (CE) n° 1610/96 du Parlement européen et 
du Conseil du 23 juillet 1996 concernant la création d'un certificat complémentaire de protection pour les produits phytopharmaceutiques, notifié par l'Union européenne le 20 mars 2013 au titre 
de l'article 63:2 de l'Accord (voir le document IP/N/1/EU/1).  
Consejo de los Aspectos de los Derechos de Propiedad Intelectual relacionados con el Comercio 
  
PRINCIPALES LEYES Y REGLAMENTOS DEDICADOS A LA 
PROPIEDAD INTELECTUAL NOTIFICADOS EN VIRTUD 
DEL PÁRRAFO 2 DEL ARTÍCULO 63 DEL ACUERDO 
U
NIÓN EUROPEA  
En el presente documento se reproduce el texto1 del Reglamento (CE) Nº 1610/96 del Parlamento 
Europeo y del Consejo, de 23 de julio de 1996, por el que se crea un certificado complementario de protección para los productos fitosanitarios, notificado por la Unión Europea el 20 de marzo 
de 2013 en virtud de lo dispuesto en el párrafo 2 del artículo 63 del Acuerdo (véase el 
documento IP/N/1/EU/1).  
                                               
1 In English only./En anglais seulement./En inglés solamente. IP/N/1/EU/P/4 
 
- 2 - 
 
  PP 3-8 - Offset (Pdf file attached) 
PP 3 à 8 - Offset (fichier Pdf joint) PP 3-8 - Offset (fichero Pdf adjunto) No L 198/30 Official Journal of the European Communities 8. 8. 96 
REGULATION (EC) No 1610/96 OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL 
of 23 July 1996 
concerning the creation of a supplementary protection certificate for plant 
protection products 
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 
THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European 
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 (l), 
Acting in accordance with the procedure referred to In 
Article 189b of the Treaty (3), 
(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; 
(2) Whereas plant protection research contributes to the 
continuing improvement in crop production; 
(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 the competitiveness of the plant protection 
sector, by the very nature of the industry, requires a 
level of protection for innovation which is equivalent 
to that granted to medicinal products by Council 
Regulation (EEC) No 1768/92 of 18 June 1992 
concerning the creation of a supplementary protec­
tion certificate for medicinal products (4); 
(5) 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 
(') OJ C 390, 31. 12. 1994, p. 21 and OJ C 335, 13. 12. 1995, p. 
15. 
(2) OJ No C 155, 21. 6. 1995, p. 14. 
C) Opinion of the European Parliament of 15 June 1995 (OJ C 
166, 3. 7. 1995, p. 89), common position of the Council of 27 
November 1995 (OJ C 353, 30. 12. 1995, p. 36) and decision 
of the European Parliament of 12 March 1996 (OJ C 96, 1. 4. 
1996, p. 30). 
(4) OJ No L 182, 2. 7. 1992, p. 1. place the said plant protection 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; 
(6) Whereas this situation leads to a lack of protection 
which penalizes plant protection research and the 
competitiveness of the sector; 
(7) Whereas one of the main objectives of the supple­
mentary protection certificate is to place European 
industry on the same competitive footing as its 
North American and Japanese counterparts; 
(8) Whereas, in its Resolution of 1 February 1993 (5) on a 
Community programme of policy and action in rela­
tion to the environment and sustainable develop­
ment, 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 economic competitiveness of 
industry; whereas, accordingly, the issue of a supple­
mentary protection certificate can be regarded as a 
positive measure in favour of environmental protec­
tion; 
(9) 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 hinder 
the free movement of plant protection products 
within the Community and thus directly affect the 
functioning of the internal market; whereas this is in 
accordance with the principle of subsidiarity as 
defined by Article 3b of the Treaty; 
(10) Whereas, therefore, there is a need to create a supple­
mentary 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 
(5) OJ No C 138, 17. 5. 1993, p. 1. No L 198/30 Official Journal of the European Communities 8. 8. 96 
REGULATION (EC) No 1610/96 OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL 
of 23 July 1996 
concerning the creation of a supplementary protection certificate for plant 
protection products 
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 
THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European 
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 (l), 
Acting in accordance with the procedure referred to In 
Article 189b of the Treaty (3), 
(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; 
(2) Whereas plant protection research contributes to the 
continuing improvement in crop production; 
(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 the competitiveness of the plant protection 
sector, by the very nature of the industry, requires a 
level of protection for innovation which is equivalent 
to that granted to medicinal products by Council 
Regulation (EEC) No 1768/92 of 18 June 1992 
concerning the creation of a supplementary protec­
tion certificate for medicinal products (4); 
(5) 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 
(') OJ C 390, 31. 12. 1994, p. 21 and OJ C 335, 13. 12. 1995, p. 
15. 
(2) OJ No C 155, 21. 6. 1995, p. 14. 
C) Opinion of the European Parliament of 15 June 1995 (OJ C 
166, 3. 7. 1995, p. 89), common position of the Council of 27 
November 1995 (OJ C 353, 30. 12. 1995, p. 36) and decision 
of the European Parliament of 12 March 1996 (OJ C 96, 1. 4. 
1996, p. 30). 
(4) OJ No L 182, 2. 7. 1992, p. 1. place the said plant protection 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; 
(6) Whereas this situation leads to a lack of protection 
which penalizes plant protection research and the 
competitiveness of the sector; 
(7) Whereas one of the main objectives of the supple­
mentary protection certificate is to place European 
industry on the same competitive footing as its 
North American and Japanese counterparts; 
(8) Whereas, in its Resolution of 1 February 1993 (5) on a 
Community programme of policy and action in rela­
tion to the environment and sustainable develop­
ment, 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 economic competitiveness of 
industry; whereas, accordingly, the issue of a supple­
mentary protection certificate can be regarded as a 
positive measure in favour of environmental protec­
tion; 
(9) 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 hinder 
the free movement of plant protection products 
within the Community and thus directly affect the 
functioning of the internal market; whereas this is in 
accordance with the principle of subsidiarity as 
defined by Article 3b of the Treaty; 
(10) Whereas, therefore, there is a need to create a supple­
mentary 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 
(5) OJ No C 138, 17. 5. 1993, p. 1. No L 198/30 Official Journal of the European Communities 8. 8. 96 
REGULATION (EC) No 1610/96 OF THE EUROPEAN PARLIAMENT AND OF 
THE COUNCIL 
of 23 July 1996 
concerning the creation of a supplementary protection certificate for plant 
protection products 
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF 
THE EUROPEAN UNION, 
Having regard to the Treaty establishing the European 
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 (l), 
Acting in accordance with the procedure referred to In 
Article 189b of the Treaty (3), 
(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; 
(2) Whereas plant protection research contributes to the 
continuing improvement in crop production; 
(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 the competitiveness of the plant protection 
sector, by the very nature of the industry, requires a 
level of protection for innovation which is equivalent 
to that granted to medicinal products by Council 
Regulation (EEC) No 1768/92 of 18 June 1992 
concerning the creation of a supplementary protec­
tion certificate for medicinal products (4); 
(5) 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 
(') OJ C 390, 31. 12. 1994, p. 21 and OJ C 335, 13. 12. 1995, p. 
15. 
(2) OJ No C 155, 21. 6. 1995, p. 14. 
C) Opinion of the European Parliament of 15 June 1995 (OJ C 
166, 3. 7. 1995, p. 89), common position of the Council of 27 
November 1995 (OJ C 353, 30. 12. 1995, p. 36) and decision 
of the European Parliament of 12 March 1996 (OJ C 96, 1. 4. 
1996, p. 30). 
(4) OJ No L 182, 2. 7. 1992, p. 1. place the said plant protection 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; 
(6) Whereas this situation leads to a lack of protection 
which penalizes plant protection research and the 
competitiveness of the sector; 
(7) Whereas one of the main objectives of the supple­
mentary protection certificate is to place European 
industry on the same competitive footing as its 
North American and Japanese counterparts; 
(8) Whereas, in its Resolution of 1 February 1993 (5) on a 
Community programme of policy and action in rela­
tion to the environment and sustainable develop­
ment, 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 economic competitiveness of 
industry; whereas, accordingly, the issue of a supple­
mentary protection certificate can be regarded as a 
positive measure in favour of environmental protec­
tion; 
(9) 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 hinder 
the free movement of plant protection products 
within the Community and thus directly affect the 
functioning of the internal market; whereas this is in 
accordance with the principle of subsidiarity as 
defined by Article 3b of the Treaty; 
(10) Whereas, therefore, there is a need to create a supple­
mentary 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 
(5) OJ No C 138, 17. 5. 1993, p. 1. 
IP/N/1/EU/P/4 
       - 3 -8. 8.96 Official Journal of the European Communities No L 198/31 
which marketing authorization has been granted is 
necessary; whereas a Regulation is therefore the most 
appropriate legal instrument; 
(11) 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; 
(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 confers the same rights as 
those conferred by the basic patent; whereas, conse­
quently, where the basic patent covers an active 
substance and its various derivatives (salts and esters), 
the certificate confers the same protection; 
(14) Whereas the issue of a certificate for a product 
consisting of an active substance does not prejudice 
the issue of other certificates for derivatives (salts and 
esters) of the substance, provided that the derivatives 
are the subject of patents specifically covering them; 
(15) Whereas a fair balance should also be stuck with 
regard to the determination of the transitional arran­
gements; 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 compro­
mise the achievement of other legitimate objectives 
concerning the agricultural policy and environment 
protection policy pursued at both national and 
Community level; 
(16) Whereas only action at Community level will enable 
the objective, which consists in ensuring adequate 
protection for innovation in the field of plant protec­
tion, while guaranteeing the proper functioning of 
the internal market for plant protection products, to 
be attained effectively; 
(17) Whereas the detailed rules in recitals 12, 13 and 14 
and in Articles 3 (2), 4, 8 (1) (c) and 17 (2) of this 
Regulation are also valid, mutatis mutandis, for the 
interpretation in particular of recital 9 and Articles 3, 4, 8 (1) (c) and 17 of Council Regulation (EEC) No 
1768/92, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
Definitions 
For the purposes of this Regulation, the following defini­
tions 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: 
(a) protect plants or plant products against all 
harmful organisms or prevent the action of such 
organisms, in so far as such substances or prepara­
tions are not otherwise defined below; 
(b) influence the life processes of plants, other than 
as a nutrient (e.g. plant growth regulators); 
(c) preserve plant products, in so far as such 
substances or products are not subject to special 
Councilor Commission provisions on preserva­
tives; 
(d) destroy undesirable plants; or 
(e) destroy parts of plants, check or prevent undesi­
rable growth of plants; 
2. 'substances': chemical elements and their compounds, 
as they occur naturally or by manufacture, including 
any impurity inevitably resulting from the manufac­
turing process; 
3. 'active substances': substances or micro-organisms 
including viruses, having general or specific action: 
(a) against harmful organisms; or 
(b) 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 in point 5; 8. 8.96 Official Journal of the European Communities No L 198/31 
which marketing authorization has been granted is 
necessary; whereas a Regulation is therefore the most 
appropriate legal instrument; 
(11) 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; 
(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 confers the same rights as 
those conferred by the basic patent; whereas, conse­
quently, where the basic patent covers an active 
substance and its various derivatives (salts and esters), 
the certificate confers the same protection; 
(14) Whereas the issue of a certificate for a product 
consisting of an active substance does not prejudice 
the issue of other certificates for derivatives (salts and 
esters) of the substance, provided that the derivatives 
are the subject of patents specifically covering them; 
(15) Whereas a fair balance should also be stuck with 
regard to the determination of the transitional arran­
gements; 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 compro­
mise the achievement of other legitimate objectives 
concerning the agricultural policy and environment 
protection policy pursued at both national and 
Community level; 
(16) Whereas only action at Community level will enable 
the objective, which consists in ensuring adequate 
protection for innovation in the field of plant protec­
tion, while guaranteeing the proper functioning of 
the internal market for plant protection products, to 
be attained effectively; 
(17) Whereas the detailed rules in recitals 12, 13 and 14 
and in Articles 3 (2), 4, 8 (1) (c) and 17 (2) of this 
Regulation are also valid, mutatis mutandis, for the 
interpretation in particular of recital 9 and Articles 3, 4, 8 (1) (c) and 17 of Council Regulation (EEC) No 
1768/92, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
Definitions 
For the purposes of this Regulation, the following defini­
tions 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: 
(a) protect plants or plant products against all 
harmful organisms or prevent the action of such 
organisms, in so far as such substances or prepara­
tions are not otherwise defined below; 
(b) influence the life processes of plants, other than 
as a nutrient (e.g. plant growth regulators); 
(c) preserve plant products, in so far as such 
substances or products are not subject to special 
Councilor Commission provisions on preserva­
tives; 
(d) destroy undesirable plants; or 
(e) destroy parts of plants, check or prevent undesi­
rable growth of plants; 
2. 'substances': chemical elements and their compounds, 
as they occur naturally or by manufacture, including 
any impurity inevitably resulting from the manufac­
turing process; 
3. 'active substances': substances or micro-organisms 
including viruses, having general or specific action: 
(a) against harmful organisms; or 
(b) 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 in point 5; 8. 8.96 Official Journal of the European Communities No L 198/31 
which marketing authorization has been granted is 
necessary; whereas a Regulation is therefore the most 
appropriate legal instrument; 
(11) 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; 
(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 confers the same rights as 
those conferred by the basic patent; whereas, conse­
quently, where the basic patent covers an active 
substance and its various derivatives (salts and esters), 
the certificate confers the same protection; 
(14) Whereas the issue of a certificate for a product 
consisting of an active substance does not prejudice 
the issue of other certificates for derivatives (salts and 
esters) of the substance, provided that the derivatives 
are the subject of patents specifically covering them; 
(15) Whereas a fair balance should also be stuck with 
regard to the determination of the transitional arran­
gements; 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 compro­
mise the achievement of other legitimate objectives 
concerning the agricultural policy and environment 
protection policy pursued at both national and 
Community level; 
(16) Whereas only action at Community level will enable 
the objective, which consists in ensuring adequate 
protection for innovation in the field of plant protec­
tion, while guaranteeing the proper functioning of 
the internal market for plant protection products, to 
be attained effectively; 
(17) Whereas the detailed rules in recitals 12, 13 and 14 
and in Articles 3 (2), 4, 8 (1) (c) and 17 (2) of this 
Regulation are also valid, mutatis mutandis, for the 
interpretation in particular of recital 9 and Articles 3, 4, 8 (1) (c) and 17 of Council Regulation (EEC) No 
1768/92, 
HAVE ADOPTED THIS REGULATION: 
Article 1 
Definitions 
For the purposes of this Regulation, the following defini­
tions 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: 
(a) protect plants or plant products against all 
harmful organisms or prevent the action of such 
organisms, in so far as such substances or prepara­
tions are not otherwise defined below; 
(b) influence the life processes of plants, other than 
as a nutrient (e.g. plant growth regulators); 
(c) preserve plant products, in so far as such 
substances or products are not subject to special 
Councilor Commission provisions on preserva­
tives; 
(d) destroy undesirable plants; or 
(e) destroy parts of plants, check or prevent undesi­
rable growth of plants; 
2. 'substances': chemical elements and their compounds, 
as they occur naturally or by manufacture, including 
any impurity inevitably resulting from the manufac­
turing process; 
3. 'active substances': substances or micro-organisms 
including viruses, having general or specific action: 
(a) against harmful organisms; or 
(b) 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 in point 5; 
IP/N/1/EU/P/4 
       - 4 -No L 198/32 Official Journal of the European Communities 8. 8. 96 
7. 'harmful organisms': pests of plants or plant products 
belonging to the animal or plant kingdom, and also 
viruses, bacteria and mycoplasmas and other patho­
gens; 
8. 'product': the active substance as defined in point 3 or 
combination of active substances of a plant protection 
product; 
9. 'basic patent': a patent which protects a product as 
defined in point 8 as such, a preparation as defined in 
point 4, a process to obtain a product or an applica­
tion 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. 
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 
Directive 91/414/EEC ('), 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. 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; 
(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 certi­
ficate; 
(1) OJ L 230, 19. 8. 1991, p. 1. Directive as last amended by 
Directive 95/36/EC (OJ L 172, 22. 7. 1995, p. 8). (d) the authorization referred to in (b) is the first authori­
zation to place the product on the market as a plant 
protection product. 
2. The holder of more than one patent for the same 
product shall not be granted more than one certificate for 
that product. However, where two or more applications 
concerning the same product and emanating from two or 
more holders of different patents are pending, one certifi­
cate for this product may be issued to each of these 
holders. 
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 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 (1) (b) to place the product on the 
market as a plant protection product was granted. 
2. Notwithstanding paragraph 1, where the authoriza­
tion 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. No L 198/32 Official Journal of the European Communities 8. 8. 96 
7. 'harmful organisms': pests of plants or plant products 
belonging to the animal or plant kingdom, and also 
viruses, bacteria and mycoplasmas and other patho­
gens; 
8. 'product': the active substance as defined in point 3 or 
combination of active substances of a plant protection 
product; 
9. 'basic patent': a patent which protects a product as 
defined in point 8 as such, a preparation as defined in 
point 4, a process to obtain a product or an applica­
tion 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. 
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 
Directive 91/414/EEC ('), 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. 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; 
(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 certi­
ficate; 
(1) OJ L 230, 19. 8. 1991, p. 1. Directive as last amended by 
Directive 95/36/EC (OJ L 172, 22. 7. 1995, p. 8). (d) the authorization referred to in (b) is the first authori­
zation to place the product on the market as a plant 
protection product. 
2. The holder of more than one patent for the same 
product shall not be granted more than one certificate for 
that product. However, where two or more applications 
concerning the same product and emanating from two or 
more holders of different patents are pending, one certifi­
cate for this product may be issued to each of these 
holders. 
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 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 (1) (b) to place the product on the 
market as a plant protection product was granted. 
2. Notwithstanding paragraph 1, where the authoriza­
tion 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. No L 198/32 Official Journal of the European Communities 8. 8. 96 
7. 'harmful organisms': pests of plants or plant products 
belonging to the animal or plant kingdom, and also 
viruses, bacteria and mycoplasmas and other patho­
gens; 
8. 'product': the active substance as defined in point 3 or 
combination of active substances of a plant protection 
product; 
9. 'basic patent': a patent which protects a product as 
defined in point 8 as such, a preparation as defined in 
point 4, a process to obtain a product or an applica­
tion 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. 
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 
Directive 91/414/EEC ('), 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. 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; 
(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 certi­
ficate; 
(1) OJ L 230, 19. 8. 1991, p. 1. Directive as last amended by 
Directive 95/36/EC (OJ L 172, 22. 7. 1995, p. 8). (d) the authorization referred to in (b) is the first authori­
zation to place the product on the market as a plant 
protection product. 
2. The holder of more than one patent for the same 
product shall not be granted more than one certificate for 
that product. However, where two or more applications 
concerning the same product and emanating from two or 
more holders of different patents are pending, one certifi­
cate for this product may be issued to each of these 
holders. 
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 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 (1) (b) to place the product on the 
market as a plant protection product was granted. 
2. Notwithstanding paragraph 1, where the authoriza­
tion 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. 
IP/N/1/EU/P/4 
       - 5 -8. 8. 96 Official Journal of the European Communities No L 198/33 
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) the name and address of the representative, if any; 
(iii) the number of the basic patent and the title of 
the invention; 
(iv) the number and date of the first authorization to 
pbce 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; 
(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, informa­
tion regarding the identity of the product thus autho­
rized and the legal provision under which the authori­
zation procedure took place, together with a copy of 
the notice publishing the authorization in the appro­
priate official publication or, failing such a notice, 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. Member States may require a fee to be payable upon 
application for a certificate. 
Article 9 
Lodging of an application for a certificate 
1. 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. 
2. 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 infor­
mation: 
(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 (1) (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. 
Article 10 
Grant of the certificate or rejection of the applica­
tion 
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 certifi­
cate if the application or the product to which it relates 
does not meet the conditions laid down in this Regula­
tion. 
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 
application shall be rejected. 
5. 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 
1. 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; 8. 8. 96 Official Journal of the European Communities No L 198/33 
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) the name and address of the representative, if any; 
(iii) the number of the basic patent and the title of 
the invention; 
(iv) the number and date of the first authorization to 
pbce 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; 
(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, informa­
tion regarding the identity of the product thus autho­
rized and the legal provision under which the authori­
zation procedure took place, together with a copy of 
the notice publishing the authorization in the appro­
priate official publication or, failing such a notice, 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. Member States may require a fee to be payable upon 
application for a certificate. 
Article 9 
Lodging of an application for a certificate 
1. 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. 
2. 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 infor­
mation: 
(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 (1) (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. 
Article 10 
Grant of the certificate or rejection of the applica­
tion 
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 certifi­
cate if the application or the product to which it relates 
does not meet the conditions laid down in this Regula­
tion. 
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 
application shall be rejected. 
5. 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 
1. 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; 8. 8. 96 Official Journal of the European Communities No L 198/33 
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) the name and address of the representative, if any; 
(iii) the number of the basic patent and the title of 
the invention; 
(iv) the number and date of the first authorization to 
pbce 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; 
(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, informa­
tion regarding the identity of the product thus autho­
rized and the legal provision under which the authori­
zation procedure took place, together with a copy of 
the notice publishing the authorization in the appro­
priate official publication or, failing such a notice, 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. Member States may require a fee to be payable upon 
application for a certificate. 
Article 9 
Lodging of an application for a certificate 
1. 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. 
2. 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 infor­
mation: 
(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 (1) (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. 
Article 10 
Grant of the certificate or rejection of the applica­
tion 
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 certifi­
cate if the application or the product to which it relates 
does not meet the conditions laid down in this Regula­
tion. 
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 
application shall be rejected. 
5. 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 
1. 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; 
IP/N/1/EU/P/4 
       - 6 -No L 198/34 Official Journal of the European Communities 8. 8.96 
(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 (1) (b) 
and the product identified in that authorization; 
(e) where relevant, the number and date of the first autho­
rization to place the product on the market in the 
Community; 
(f) the duration of the certificate. 
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 the certificate to 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. 
3. For the purposes of calculating the duration of the 
certificate, account shall be taken of a provisional first 
marketing authorization only if it is directly followed by a 
definitive authorization concerning the same product. 
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 authori­
zations to place it on the market in accordance with 
Article 4 of Directive 91/414/EEC or equivalent provi­
sions 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. 
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 to the extent 
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 justi­
fied 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, notifi­
cation thereof shall be published by the authority referred 
to in Article 9 (1). 
Article 17 
Appeals 
1. 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 deci­
sions taken in respect of national patents. 
2. The decision to grant the certificate shall be open to 
an appeal aimed at rectifying the duration of the certifi­
cate where the date of the first authorization to place the 
product on the market in the Community, contained in 
the application for a certificate as provided for in Article 
8, is incorrect. 
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 (EEC) No 1768/92, No L 198/34 Official Journal of the European Communities 8. 8.96 
(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 (1) (b) 
and the product identified in that authorization; 
(e) where relevant, the number and date of the first autho­
rization to place the product on the market in the 
Community; 
(f) the duration of the certificate. 
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 the certificate to 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. 
3. For the purposes of calculating the duration of the 
certificate, account shall be taken of a provisional first 
marketing authorization only if it is directly followed by a 
definitive authorization concerning the same product. 
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 authori­
zations to place it on the market in accordance with 
Article 4 of Directive 91/414/EEC or equivalent provi­
sions 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. 
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 to the extent 
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 justi­
fied 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, notifi­
cation thereof shall be published by the authority referred 
to in Article 9 (1). 
Article 17 
Appeals 
1. 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 deci­
sions taken in respect of national patents. 
2. The decision to grant the certificate shall be open to 
an appeal aimed at rectifying the duration of the certifi­
cate where the date of the first authorization to place the 
product on the market in the Community, contained in 
the application for a certificate as provided for in Article 
8, is incorrect. 
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 (EEC) No 1768/92, No L 198/34 Official Journal of the European Communities 8. 8.96 
(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 (1) (b) 
and the product identified in that authorization; 
(e) where relevant, the number and date of the first autho­
rization to place the product on the market in the 
Community; 
(f) the duration of the certificate. 
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 the certificate to 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. 
3. For the purposes of calculating the duration of the 
certificate, account shall be taken of a provisional first 
marketing authorization only if it is directly followed by a 
definitive authorization concerning the same product. 
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 authori­
zations to place it on the market in accordance with 
Article 4 of Directive 91/414/EEC or equivalent provi­
sions 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. 
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 to the extent 
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 justi­
fied 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, notifi­
cation thereof shall be published by the authority referred 
to in Article 9 (1). 
Article 17 
Appeals 
1. 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 deci­
sions taken in respect of national patents. 
2. The decision to grant the certificate shall be open to 
an appeal aimed at rectifying the duration of the certifi­
cate where the date of the first authorization to place the 
product on the market in the Community, contained in 
the application for a certificate as provided for in Article 
8, is incorrect. 
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 (EEC) No 1768/92, 
IP/N/1/EU/P/4 
       - 7 -8. 8. 96 Official Journal of the European Communities No L 198/35 
shall apply to the certificate, unless national law lays 
down special procedural provisions for certificates as 
referred to in this Regulation. 
2. Notwithstanding paragraph 1, the procedure for 
opposition to the granting of a certificate shall be 
excluded. 
TRANSITIONAL PROVISIONS 
Article 19 
1. Any product which, on the date on which this Regu­
lation 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 Commu­
nity 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 made under paragraph 1 for a certifi­
cate shall be submitted within six months of the date on 
which this Regulation enters into force. 
Article 20 
In those Member States whose national law did not, on 1 
January 1990, provide for the patentability of plant 
protection products, this Regulation shall apply from 2 
January 1998. 
Article 19 shall not apply in those Member States. 
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. 
This Regulation shall be binding in its entirety and directly applicable in all Member 
States. 
Done at Brussels, 23 July 1996. 
For the European Parliament 
The President 
K. HANSCH For the Council 
The President 
M. LOWRY 8. 8. 96 Official Journal of the European Communities No L 198/35 
shall apply to the certificate, unless national law lays 
down special procedural provisions for certificates as 
referred to in this Regulation. 
2. Notwithstanding paragraph 1, the procedure for 
opposition to the granting of a certificate shall be 
excluded. 
TRANSITIONAL PROVISIONS 
Article 19 
1. Any product which, on the date on which this Regu­
lation 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 Commu­
nity 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 made under paragraph 1 for a certifi­
cate shall be submitted within six months of the date on 
which this Regulation enters into force. 
Article 20 
In those Member States whose national law did not, on 1 
January 1990, provide for the patentability of plant 
protection products, this Regulation shall apply from 2 
January 1998. 
Article 19 shall not apply in those Member States. 
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. 
This Regulation shall be binding in its entirety and directly applicable in all Member 
States. 
Done at Brussels, 23 July 1996. 
For the European Parliament 
The President 
K. HANSCH For the Council 
The President 
M. LOWRY 8. 8. 96 Official Journal of the European Communities No L 198/35 
shall apply to the certificate, unless national law lays 
down special procedural provisions for certificates as 
referred to in this Regulation. 
2. Notwithstanding paragraph 1, the procedure for 
opposition to the granting of a certificate shall be 
excluded. 
TRANSITIONAL PROVISIONS 
Article 19 
1. Any product which, on the date on which this Regu­
lation 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 Commu­
nity 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 made under paragraph 1 for a certifi­
cate shall be submitted within six months of the date on 
which this Regulation enters into force. 
Article 20 
In those Member States whose national law did not, on 1 
January 1990, provide for the patentability of plant 
protection products, this Regulation shall apply from 2 
January 1998. 
Article 19 shall not apply in those Member States. 
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. 
This Regulation shall be binding in its entirety and directly applicable in all Member 
States. 
Done at Brussels, 23 July 1996. 
For the European Parliament 
The President 
K. HANSCH For the Council 
The President 
M. LOWRY 
IP/N/1/EU/P/4 
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