
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,
Having regard to the opinion of the Economic and Social Committee,
Acting in accordance with the procedure referred to in Article 189b of the Treaty,

(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 protection certificate for medicinal products;

(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 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 supplementary 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 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 economic competitiveness of industry; whereas, accordingly, the issue of a supplementary protection certificate can be regarded as a positive measure in favour of environmental protection;

(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 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;

(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, consequently, 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 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 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 protection, 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:

Definitions
Article 1 
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:

((a)) 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;
((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 ... provisions on preservatives;
((d)) destroy undesirable plants; or
((e)) destroy parts of plants, check or prevent undesirable growth of plants;
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:

((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;
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 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 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;
11.. ‘comptroller’ means the Comptroller-General of Patents, Designs and Trade Marks;
12.. ‘court’ means—

(a) as respects England and Wales, the High Court;
(b) as respects Scotland, the Court of Session;
(c) as respects Northern Ireland, the High Court in Northern Ireland;
13.. ‘EEA authorization’ means an authorization to place a plant protection product on the market which has effect in an EEA state in accordance with Regulation(EC) No 1107/2009;
14.. ‘patent’ means a patent which has effect in the United Kingdom;
15.. “GB authorisation” means an authorisation, to place a plant protection product on the market in England and Wales and Scotland, granted or having effect as if granted under Regulation (EC) 1107/2009;
16.. “NI authorisation” means an authorisation, to place a plant protection product on the market in Northern Ireland, granted or having effect as if granted in accordance with Regulation (EC) 1107/2009 as it has effect by virtue of the Protocol on Ireland/Northern Ireland in the EU withdrawal agreement;
17.. “prescribed” means prescribed by rules under section 123 of the Patents Act 1977.
Scope
Article 2 
A plant protection product may, under the terms and conditions provided for in this Regulation, be the subject of a certificate if it is—
(a)) protected by a patent; and
(b)) the subject of a  GB or NI  authorization prior to being placed on the market as a plant protection product.
Conditions for obtaining a certificate
Article 3 

1. Where an application is submitted under Article 7, a certificate shall be granted if at the date of submission of the application—
(a) the product is protected by a basic patent in force;
(b) there is a valid  GB or NI  authorization to place the product on the market;
(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 in the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.
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 certificate for this product may be issued to each of these holders.
Subject-matter of protection
Article 4 
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  GB or NI authorisation or both GB and NI authorisations  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 in the United Kingdom  before the expiry of the certificate.
Effects of the certificate
Article 5 

(1.) Subject to Article 4 and paragraphs 2 and 3, 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.
(2.) The protection conferred by a certificate in accordance with paragraph 1 shall extend only to the territory in respect of which a valid GB or NI authorisation has been issued and the authorisation—
(a) is the first authorisation for the product in the territory in accordance with Article 3(1)(b) and (d), and
(b) has been issued before the certificate takes effect in accordance with Article 13(1).
(3.) Where after the submission of an application for a certificate in accordance with Article 7 and before the certificate takes effect in accordance with Article 13(1), a GB or NI authorisation is granted in respect of the same product and the authorisation would have met the requirements of Article 3(b) and (d) had it been granted on the date of submission of the application, the protection conferred by a certificate in accordance with paragraph 1 shall extend to the territory of England and Wales and Scotland or the territory of Northern Ireland as the case may be.
Entitlement to the certificate
Article 6 
The certificate shall be granted to the holder of the basic patent or his successor in title.
Application for a certificate
Article 7 

1. The application for a certificate shall be lodged within six months of the date on which the  GB or NI authorization referred to in Article 3 (1) (b) and (d)  to place the product on the market as a plant protection product was granted.Where more than one such authorisation is granted before the application for a certificate is lodged, the application shall be lodged within six months of the date of grant of the earliest of such authorisations.
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.
Content of the application for a certificate
Article 8 

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  GB or NI authorisation or both GB and NI authorisations  as referred to in Article 3(1)(b) and (d); and
((v)) the number and date of the earliest EEA authorization, the granting of which predates the granting of the  GB or NI  authorization as referred to in Article 3(1)(b) and (d);
(b) a copy of the  GB or NI authorisation or both GB and NI authorisations  to place the product on the market, as referred to in Article 3(1)(b) and (d), 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 Commission Regulation 283/2013,  Part A section 1, points 1.1 to 1.7 or Part B, Section 1 points 1.1 to 1.4.3;
(c) where the product is the subject of one or more EEA authorizations granted prior to the  GB or NI  authorization referred to in Article 3(1)(b) and (d), the applicant must provide in relation to the earliest of any such EEA authorizations—
(i) information regarding the identity of the product thus authorised;
(ii) information regarding the legal provision under which the authorization procedure took place; and
(iii) a copy of the notice publishing the authorization in the appropriate 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.
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Lodging of an application for a certificate
Article 9 

1. An application for a certificate shall be lodged with the comptroller.
2. Notification of the application for a certificate shall be published by the  comptroller. 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 GB or NI authorisation or both a GB and a NI authorisation provided under Article 8(1)(b), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;
(e) where there are EEA authorizations granted before  any GB or NI authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorization.
Grant of the certificate or rejection of the application
Article 10 

1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation,  the comptroller  shall grant the certificate.
2. The comptroller  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 or any prescribed fee is not paid.
3. Where the application for a certificate does not meet the conditions laid down in Article 8 or the prescribed fee relating to the application has not been paid,  the comptroller  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.
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Publication
Article 11 

1. Notification of the fact that a certificate has been granted shall be published by  the comptroller. 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 UK, GB or NI authorisation or, where there is more than one such authorisation, of each authorisation provided under Article 8(1)(b) or Article 13A(1), the product identified in the authorisation and the territory in respect of which the authorisation has been granted or has effect as if granted;
(e) where there are EEA authorizations granted before  any authorisation provided under Article 8(1)(b), the number and date of the earliest EEA authorization;
(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 comptroller. The notification shall contain at least the information listed in Article 9 (2).
Annual fees
Article 12 
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Duration of the certificate
Article 13 

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 area comprising the European Economic Area and the United Kingdom, 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.
Authorisation granted after submission of an application for a certificate
Article 13A 

(1.) Where after the submission of an application under Article 7(1), but before the grant of a certificate under Article 10(1) in relation to a GB authorisation, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a plant protection product in the territory of Northern Ireland, the applicant shall notify the comptroller of the grant of the NI authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.
(2.) Where after the submission of an application under Article 7(1), but before the grant of a certificate under Article 10(1) in relation to a NI authorisation, a valid GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a plant protection product in the territory of England and Wales and Scotland, the applicant shall notify the comptroller of the grant of the GB authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.
(3.) Where after the grant of a certificate under Article 10(1) in relation to a GB authorisation, but before expiry of the basic patent, a valid NI authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a plant protection product in the territory of Northern Ireland, the certificate holder shall notify the comptroller of the NI authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.
(4.) Where after the grant of a certificate under Article 10(1) in relation to a NI authorisation, but before expiry of the basic patent, a valid GB authorisation is granted which, at its date of grant, is the first authorisation to place the product on the market as a plant protection product in the territory of England and Wales and Scotland, the certificate holder shall notify the comptroller of the grant of the GB authorisation, within six months of its date of grant and before the certificate takes effect under Article 13(1), and provide the details set out in Article 8(1)(a)(iv) and (b) on the prescribed form.
(5.) If the applicant or certificate holder fails to notify the comptroller of the grant of an authorisation in accordance with any of paragraphs 1 to 4, the protection conferred by a certificate granted under Article 10(1) shall not extend to any additional territory covered by that authorisation.
(6.) On receipt of a notification under any of paragraphs 1 to 4, the comptroller shall publish:
(a) the number and date of the authorisation,
(b) the product identified in that authorisation, and
(c) the relevant territory in respect of which the authorisation has been granted or has effect as if granted.
Expiry of the certificate
Article 14 

(1.) 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 prescribed annual fee is not paid in time; or
((d)) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of  all  authorizations to place on the market in accordance with Article 28 of Regulation 1107/2009. The comptroller may decide on the lapse of the certificate either of the comptroller's own motion or at the request of a third party.
(2.) Where a UK authorisation is withdrawn and replaced simultaneously with a GB authorisation and a NI authorisation, the certificate granted in respect of the UK authorisation shall not lapse.
(3.) Where a UK, GB or NI authorisation is withdrawn, but one or more such authorisations remain valid, the protection conferred by the certificate shall, as from the date of withdrawal, no longer extend to the territory covered by the authorisation withdrawn but shall continue in respect of the territory covered by any remaining authorisation.
(4.) For the purposes of paragraphs 2 and 3, “UK authorisation” means an authorisation to place a plant protection product on the market in the United Kingdom, granted or having effect as if granted, prior to IP completion day, under Regulation (EC) 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market.
Invalidity of the certificate
Article 15 

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 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 comptroller or the court.
Notification of lapse or invalidity
Article 16 
If the certificate lapses in accordance with Article 14  (1) (b), (c) or (d) or is invalid in accordance with Article 15, or if the territorial extent of the certificate is limited in accordance with Article 14(3),  notification thereof shall be published by  the comptroller.
Appeals
Article 17 

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2. The decision to grant the certificate shall be open to an appeal aimed at rectifying the duration of the certificate 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.
Procedure
Article 18 

1. In the absence of procedural provisions in this Regulation, the procedural provisions applicable to the corresponding basic patent (as modified by section 128B of, and Schedule 4A to, the Patents Act 1977) shall apply to the certificate.
2. Notwithstanding paragraph 1, the procedure for opposition to the granting of a certificate shall be excluded.
TRANSITIONAL PROVISIONS
Article 19 
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Provisions relating to the enlargement of the Community
               
Article 19a 
Without prejudice to the other provisions of this Regulation, the following shall apply:

((a)) 
((i)) any plant protection product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a plant protection product was obtained in the Czech Republic after 10 November 1999 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained,
((ii)) any plant protection product protected by a valid basic patent in the Czech Republic and for which the first authorisation to place it on the market as a plant protection product was obtained in the Community not earlier than six months prior to the date of accession may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained;
((b)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Estonia prior to the date of accession may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or, in the case of those patents granted prior to 1 January 2000, within the six month period provided for in the Patents Act of October 1999;
((c)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Cyprus prior to the date of accession may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained; notwithstanding the above, where the market authorisation was obtained before the grant of the basic patent, the application for a certificate must be lodged within six months of the date on which the patent was granted;
((d)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Latvia prior to the date of accession may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than the date of accession;
((e)) any plant protection product protected by a valid basic patent applied for after 1 February 1994 and for which the first authorisation to place it on the market as a plant protection product was obtained in Lithuania prior to the date of accession may be granted a certificate, provided that the application for a certificate is lodged within six months of the date of accession;
((f)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained after 1 January 2000 may be granted a certificate in Hungary, provided that the application for a certificate is lodged within six months of the date of accession;
((g)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Malta prior to the date of accession may be granted a certificate. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than the date of accession;
((h)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained after 1 January 2000 may be granted a certificate in Poland, provided that the application for a certificate is lodged within six months starting no later than the date of accession;
((i)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Slovenia prior to the date of accession may be granted a certificate, provided that the application for a certificate is lodged within six months of the date of accession, including in cases where the period provided for in Article 7(1) has expired;
((j)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained in Slovakia after 1 January 2000 may be granted a certificate, provided that the application for a certificate was lodged within six months of the date on which the first market authorisation was obtained or within six months of 1 July 2002 if the market authorisation was obtained before that date;
((k)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained after 1 January 2000 may be granted a certificate in Bulgaria, provided that the application for a certificate is lodged within six months of the date of accession;
((l)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained after 1 January 2000 may be granted a certificate in Romania. In cases where the period provided for in Article 7(1) has expired, the possibility of applying for a certificate shall be open for a period of six months starting no later than the date of accession;
((m)) any plant protection product protected by a valid basic patent and for which the first authorisation to place it on the market as a plant protection product was obtained after 1 January 2003 may be granted a certificate in Croatia, provided that the application for a certificate is lodged within six months from the date of accession.
Article 20 
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FINAL PROVISION
Entry into force
Article 21 
This Regulation shall enter into force six months after its publication in the Official Journal of the European Communities.
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