Manual of Patent Practice

Regulation (EC) No 1610/96 of the European Parliament and of the council (Plant Protection Products)

Section (SPP0.01 - SPP21.01) last updated: April 2016.

Recitals to the regulation

 
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 (OJ No C 390, 31.12.1994, p 21 and OJ No C 335, 13.12.1995, p 15)
Having regard to the opinion of the Economic and Social Committee (OJ No C 155, 21.6.1995, p 14),
Acting in accordance with the procedure referred to in Article 189b of the Treaty (Opinion of the European Parliament of 15 June 1995 (OJ No C 166, 3.7.1995, p 89), common position of the Council of 27 November 1995 (OJ No C 353, 30.12.1995, p 36) and decision of the European Parliament of 12 March 1996 (OJ No C 96, 1.4.1996, p 30)),
(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 (OJ No L 182, 2.7.1992, p. 1.);
(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 penalises 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 (OJ No C 138, 17.5.1993, p. 1.) 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 struck with regard to the determination of the transitional arrangements; whereas such arrangements should enable the Community plant protection industry to catch up to some extent with its main competitors, while making sure that the arrangements do not compromise the achievement of other legitimate objectives concerning the agricultural 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

SPP 0.01

Council Regulation (EEC) No 1768/92 has subsequently been codified under Regulation (EC) No 469/2009 of the European Parliament and of the Council according to Article 22 of which, with reference to an annexed correlation table, all references to Regulation No 1768/92 are to be construed as references to Regulation (EC) No 469/2009 (see SP0.01, SPM0.04 and Annex II to Regulation (EC) No 469/2009).Articles 3(1)(a) and (c), 5, 6, 8(1)(a)(i) to (iv), 8(2), 9 to 12, 13(1) and (2), 14(a) to (c), 15, 16, 17(1) and 18(2) of Regulation (EC) 1610/96 for plant protection products are identical in wording to Articles 3(a) to (c), 5, 6, 8(1)(a)(i) to (iv), 8(4), 9 to 12, 13(1) and (2), 14(a) to (c), 15, 17, 18 and 19(2) respectively, of Regulation (EC) 469/2009 for medicinal products. For commentary on the said Articles in the Plant Protection Regulation reference should be made to the corresponding paragraphs in SPM3.01 to 19.11 relating to the Medicinal Regulation. For commentary on the Recitals and the remaining Articles of the Plant Protection Regulation the following paragraphs should be consulted as well as the equivalent paragraphs in SPM 0.01 to 20.02.

 
Article 1:Definitions
For the purposes of this Regulation, the following definitions shall apply:
1. “plant protection products”: active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:
(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 Council or Commission 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 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.

Product and Plant Protection Product

SPP 1.01

Article 1 distinguishes between the terms “plant protection product” and “product”. Although the EC Plant Protection Regulation creates a certificate for plant protection products, it is the product - defined by Article 1(8) as the active substance or combination of active substances - which is the subject of the certificate pursuant to Article 2. The meaning of “product” was clarified by the European Court of Justice in BASF AG v Bureau Voor de Industriële Eigendom [2002] RPC 9. It was held that a “product” as defined by Article 1(8) includes, along with the active substance, any impurity which inevitably results from the manufacturing process of that substance. However, two products which differ only in the proportion of active substance to impurity they contain (one being more pure than the other) are considered to be one and same “product” within the definition of Article 1(8) - the court holding that a product “cannot change solely because of an alteration in the unit quantity of impurities where both the chemical compound it contains and that compound’s action on its targets remain unchanged”. The fact that, in the case in question, the two products of differing purity required separate marketing authorisations was not relevant in determining whether they amounted to the same “product” within the definition of Article 1. See also SPP3.01 Clarification of the meaning of the term “product” has also been sought in Bayer CropScience AG v Bundespatentgericht, C-11/13, it was determined that “product” is to be interpreted as covering a “safener”, a substance added to plant protection product to eliminate or reduce phytotoxic effects of the protection product on certain plants.

SPP 1.02

The definitions of the terms “plant protection products” to “product” in Article 1(1) to 1(8) are based on those specified in Article 2 of Council Directive 91/414/EEC of 15 July 1991, now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011, concerning the placing of plant protection products on the market. However, these definitions do not always correspond to the terminology used in UK Marketing Authorizations, or the details published in official Gazettes, because Articles 2 and 3(1)(b) of the Plant Protection Regulation allow for the authorization on which the SPC application is based to be either in accordance with Article 4 of Directive 91/414/EEC (now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011) or an equivalent provision of national (e.g. United Kingdom) law. Thus, the product specified in the Marketing Authorization is generally broadly equivalent to the “plant protection product” as defined in article 1(1), and the “active constituent(s)” or “active ingredient(s)” are generally broadly equivalent to the “product” as defined by Article 1(8).

SPP 1.03

The term “active substance” in the Plant Protection Regulation is identical in effect to “active ingredient” in the Medicinal Regulation. In accordance with recital (13) the term “active substance” in Article 1(8) is interpreted as including any closely related derivative, in particular a salt or ester, which has obtained authorization to be placed on the market and is protected by the claims of the basic patent.

SPP 1.04

If the derivative in question can be regarded as a new and inventive active substance which is protected by a patent which specifically relates to it, e.g. a selection patent, recital (14) allows for the new derivative to be protected by its own certificate in spite of the fact that the non-derivatised form of the active substance and its non-inventive derivatives are the subject of a different certificate.

Basic Patent

SPP 1.05

The basic patent may be either a UK patent or a European patent (UK) (see SPM1.05).

 
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 (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).), 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.

SPP 2.01

A certificate can be granted in the UK for a product which has received an authorization to be placed on the market in accordance with Directive 91/414/EEC or 95/36/EEC, now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011, or with an equivalent provision of national law. The authorization may be granted for the UK only, whereupon it takes the form of an approval issued under the Control of Pesticides Regulations (COPR) 1986 (as amended), or an authorization issued under the UK Plant Protection Product Regulations (UKPPPR) 1995 (as amended), by the Pesticides Safety Directorate of the Ministry of Agriculture, Fisheries and Food. The UKPPPR 1995 implement Directive 91/414/EEC in the UK. COPR is an equivalent provision of national law for the purposes of Article 2. Those plant protection products whose active substances(s) are already on the market in the EC continue to be regulated under UK national legislation under COPR 1986 whose continuation is permitted by virtue of the transitional provisions of EC Directive 91/414/EEC. Those plant protection products that contain active substances new to the Community fall to be regulated under UKPPPR 1995 (which implements EC Directive 91/414/EEC in the UK). Those with a combination of “old” and “new” active substances fall to be regulated under COPR.

SPP 2.02

Recital 4 of the EC Plant Protection SPC Regulation states that the level of protection for innovation for plant protection products is to be equivalent to that granted to medicinal products under Regulation 1768/92, a purpose which is reflected in the similarity of wording of the two Regulations. A medicinal product which had obtained a market authorization and/or was marketed prior to 1 January 1985 would not have been granted a supplementary protection certificate because Articles 3(d) and 19 of Regulation (EEC) No 1768/92 effectively dictated that the first authorization had to be after 1 January 1985. It is therefore the view of the Office that a parallel situation must apply to plant protection products so that any marketing authorization or marketing prior to 1 January 1985 will prevent the grant of a certificate. Whereas the marketing of medicinal products has been regulated by statutory authorization schemes throughout the lifetime of all patents likely to give rise to certificates, this is not the case for plant protection products. Prior to 6 October 1986, when the statutory authorization scheme under the COPR entered into force in the UK, it was theoretically possible for applicant to have marketed a plant protection product without authorization under any provision of national law (even though he may voluntarily have delayed marketing to await authorization under the COPR). In practice, the marketing of plant protection products before this date was regulated under voluntary schemes, particularly the Pesticides Safety Precautions Scheme (PSPS). This consisted of a formal agreement between trade associations (eg the British Agrochemicals Association and the British Pest Control Association) and the UK government departments and agencies responsible for agriculture, health and safety. An agrochemical company who was a member of a trade association party to the agreement was required to apply for clearance of any new pesticide that it intended to market; in practice this was automatic, since it appears there was little likelihood of commercial acceptance of a pesticide without PSPS approval. Approval was subject to an administrative procedure involving inspection by government authorities and marketing of the new product was inevitably delayed. It therefore appears that such products fall within the spirit, if not the strict scope, of Article 2 (see SPP19.01 as to their acceptability under Art 19(1)). In consequence, before deciding whether a certificate may be granted for a plant protection product where the basic patent has a filing date between 9 February 1977 (the earliest date allowable under Art 3(1)(a)) and 6 October 1986, the Office may request the following information in addition to the details given on the application Form SP1:

  • whether any authorization under PSPS for the product was obtained, details of the authorization number and date of issue and a copy of the grant document being required;

  • whether the product was marketed in the UK prior to 1986 with or without authorization, details of the date of marketing being required;

  • whether the applicant was a member of a trade association bound by the PSPS agreement throughout the period from the filing date of the basic patent until 6 October 1986. (See also SPP19.01).

Insofar as the patents relating to products protected by the PSPS have expired there is no further relevance of this scheme to new SPC applications (See also SPP19.01.

 
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; for the purposes of this subparagraph and the Articles which refer to it, an authorization to place the product on the market granted in accordance with the national legislation of the EFTA State shall be treated as an authorization granted in accordance with Directive 91/414/EEC or an equivalent provision of national law of an EC Member State.
(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.
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.

SPP 3.01

The conditions of Article 3 must be satisfied at the date of making an application. Thus, at that date:

  • the basic patent protecting the product must be in force;
  • the product must not previously have been the subject of a certificate in the UK;
  • a valid authorization or approval to place the product on the market in the United Kingdom as a plant protection product must have been granted in accordance with Directive 91/414/EEC (now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011) or a provision of UK law i.e. the Control of Pesticides Regulations (COPR) 1986 or the UK Plant Protection Product Regulations 1995 (see SPP2.01):
  • this authorization must be the first authorization to place the product on the market as a plant protection product in the United Kingdom (although there may have been an earlier first authorization elsewhere in the EC).

For example, in BASF AG v Bureau Voor de Industriële Eigendom [2002] RPC 9 see SPP1.01, the product in question was a plant protection product manufactured according to a patented process, which resulted in a product of higher purity than previously achieved. A marketing authorisation for this higher purity product was granted in 1987, but marketing authorisation for a lower purity product was granted in 1967. The ECJ held that the higher purity product amounted to the same “product” within the meaning of Article 3 as the lower purity product and so held that in such circumstances the conditions of Article 3(1)(d) were not satisfied. Clarification of the meaning of the term “product” has also been sought in Bayer CropScience AG v Bundespatentgericht, C-11/13 it was determined that “product” is to be interpreted as covering a “safener”, a substance added to plant protection product to eliminate or reduce phytotoxic effects of the protection product on certain plants.

SPP 3.02

Under the Control of Pesticides Regulations 1986 marketing approvals are issued at three progressive levels of approval:

  • experimental permit for supply, storage and use only, for a limited period
  • provisional approval for sale, supply, storage, use and advertisement for a limited period whilst outstanding data are obtained
  • full (unlimited) approval for sale, supply, storage, use and advertisement, where there are no outstanding data requirements

Experimental permits only allow experimental work on new substances or new uses to be carried out over a limited area to produce data in support of a future application for approval for commercial use. Such permits are not acceptable as a basis for making an SPC application under Article 2 or 3(1)(b) as they do not allow marketing to take place. (see also SPM3.03.1) Provisional and full authorizations under COPR both allow marketing of the product from the date of grant thereof and are granted under a relevant provision of national (UK) law equivalent to the administrative authorization procedure as laid down in Article 4 of Directive 91/414/EEC (now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011). Consequently both provisional and full UK authorizations are acceptable under Article 3(1)(b). In Hogan Lovells International (C-229/09), the Court of Justice of the European Union confirmed that Article 3(1)(b) of Regulation No 1610/96 is interpreted as meaning that a supplementary protection certificate can be issued for a product in respect of which a provisional MA has been granted under Article 8(1) of Directive 91/414 (Article 30 of Regulation (EC) No 1107/2009).

SPP 3.02.1

In Sumitomo Chemical (C-210/12), questions relating to whether or not emergency marketing authorisations for plant protection products (under Art 8(4) of Directive 91/414/EEC, now superseded by Regulation EC/1107/2009) can be used for the purposes of Article 3(1)(b) of the Regulation, and whether such authorisations still need to be in force at the time of an application, were referred to the CJEU for a preliminary ruling. The Court confirmed that Article 3(1)(b) of the Regulation should be interpreted as precluding the issue of a SPC for a plant protection product in respect of which an emergency MA has been issued under Article 8(4) of Directive 91/414/EEC, and that Articles 3(1)(b) and 7(1) of the Regulation must be interpreted as precluding an application for a SPC being lodged before the date on which the plant protection product has obtained the MA referred to in Article 3(1)(b) of that Regulation see SPP7.01.

SPP 3.03

Article 3(2) precludes the granting of more than one certificate for a single product to the holder of a portfolio of related patents all covering the said product, even when the SPC applications are all pending together and meet the requirements of Article 3(1)(c). When the product is protected by several patents held by an applicant e.g. by a patent for the product per se, a patent for a process for making the product and a patent for a plant protection formulation comprising the product, it is for the holder of the patents concerned to chose one of them as the basic patent, bearing in mind that the subject-matter protected by the certificate is constrained by the protection conferred by the patent.

 
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.

SPP 4.01

A certificate extends the protection conferred by the basic patent beyond the term of that patent but only in respect of the product covered by the authorization or approval to place the corresponding plant protection product on the market and any use of the product as a plant protection product that has been authorized or approved before expiry of the certificate. It does not, however, extend the term of the patent itself.

 
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 fora 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 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.

SPP 7.01

The requirements to be met with respect to the period for filing an application under the Plant Protection Regulation are identical to those under the Medicinal Regulation (see SPM7.01 to SPM7.03). In Sumitomo C-210/12 the CJEU has confirmed that Article 7(1) is to be interpreted as precluding an application for a SPC being lodged before the date on which the plant protection product has obtained the MA referred to in Article 3(1)(b) see SPP3.02.1.

 
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 place the product on the market, as referred to in Article 3(1)(b) and, if this authorization is not the first authorization to place the product on the market in the Community, the number and date of that authorization;
(b) a copy of the authorization to place the product on the market, as referred to in Article 3(1)(b), in which the product is identified, containing in particular the number and date of the authorization and the summary of the product characteristics listed in Part A.I (points 1 - 7) or B.I (points 1 - 7) of Annex II to Directive 91/414/EEC or in equivalent national laws of the Member State in which the application was lodged;
(c) if the authorization referred to in (b) is not the first authorization to place the product on the market as a plant protection product in the Community, information regarding the identity of the product thus authorized and the legal provision under which the authorization procedure took place, together with a copy of the notice publishing the authorization in the appropriate official 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.

SPP 8.01

The request for grant of a certificate should specify:

  • the name and address of the applicant (Section 3 of Form SP1);
  • the name of the applicant’s agent (if any) and address for service in the European Economic Area or Channel Islands (Section 4);
  • the EC Regulation (469/2009, formally 1768/92; or 1610/96) under which the application is made Section 5);
  • the product in respect of which the certificate is sought (i.e. the active substance or combination of active substances of the plant protection product) (Section 6);
  • the number, title, expiry date and (if later than the first UK authorization or approval) the date of grant of the basic patent (Section 7);
  • the number and date of the first UK authorization or approval (Section 8);
  • (where different from the first UK authorization or approval) the State, number and date of the first authorization in the EC, plus the identity of the authorized product and the legal provision under which the authorization took place (Section 9).

The wording of Articles 8(1)(a)(iv) and 8(1)(c) does not appear to require such a first authorization to have been granted in accordance with Directive 91/414/EEC (now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011). For applications lodged on or after 1 August 1997, the relevant authorization for the purposes of Articles 8(1)(a)(iv) and 8(1)(c) includes the first authorization in a State which is a Contracting Party to the European Economic Area Agreement (see SP0.09-10).

 
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 information:
(a) the name and address of the applicant;
(b) the number of the basic patent;
(c) the title of the invention;
(d) the number and date of the authorization to place the product on the market, referred to in Article 3(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 application
1. Where the application for a certificate and the product to which it relates meet the conditions laid down in this Regulation, the authority referred to in Article 9(1) shall grant the certificate.
2. The authority referred to in Article 9(1) shall, subject to paragraph 3, reject the application for a certificate if the application or the product to which it relates does not meet the conditions laid down in this Regulation.
3. Where the application for a certificate does not meet the conditions laid down in Article 8, the authority referred to in Article 9(1) shall ask the applicant to rectify the irregularity, or to settle the fee, within a stated time.
4. If the irregularity is not rectified or the fee is not settled under paragraph 3 within the stated time, the 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;
(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;
(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.
 
Article13: 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.

Provisional first authorization

SPP 13.01

During the substantive examination of the application the applicant will generally be requested to provide details of any full authorizations which have followed an acknowledged first provisional authorization so that the provisions of Article 13(3) can be given effect. However, it is considered that Article 13(3) does not prevent the grant of a certificate on the basis of provisional authorizations which allow marketing of the product see SPP3.02.

 
Article 14: expiry of certificate
The certificate shall lapse:
(a) at the end of the period provided for in Article 13;
(b) if the certificate-holder surrenders it;
(c) if the annual fee laid down in accordance with Article 12 is not paid in time;
(d) if and as long as the product covered by the certificate may no longer be placed on the market following the withdrawal of the appropriate authorization or authorizations to place it on the market in accordance with Article 4 of Directive 91/414/EEC or equivalent provisions of national law. The authority referred to in Article 9(1) may decide on the lapse of the certificate either on its own initiative or at the request of a third party.

Declaration of lapse under Article 14(d)

SPP 14.01

Article 14(d) of the Plant Protection Regulation is equivalent to Article 14(d) of the Medicinal Regulation but refers, naturally, to the relevant Directive 91/414/EEC (now repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011) or equivalent provisions of national (UK) law (see SPM14.02 to SPM14.08).

 
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 justified such revocation or limitation.
2. Any person may submit an application or bring an action for a declaration of invalidity of the certificate before the body responsible under national law for the revocation of the corresponding basic patent.
 
Article 16: Notification of lapse or invalidity
If the certificate lapses in accordance with Article 14(b), (c) or (d) or is invalid in accordance with Article 15, notification thereof shall be published by the authority referred to in Article 9(1).
 
Article 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 decisions 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 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.

SPP 17.01

A decision to grant a certificate is open to appeals seeking to correct the duration of a certificate where the date of the first authorization to place the product on the market in the Community contained in an application is wrong. See also SPM13.06.

 
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, 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.

SPP 18.01

In the UK procedural and fees provisions are laid down in the 2007 Rules and 2007 Fees Rules. See SPM19.01-19.03.

 
Article 19: Transitional Provisions
1. Any product which, on the date on which this Regulation enters into force, is protected by a valid basic patent and for which the first authorization to place it on the market as a plant protection product in the Community was obtained after 1 January 1985 under Article 4 of Directive 91/414/EEC or an equivalent national provision may be granted a certificate.
2. An application made under paragraph 1 for a certificate shall be submitted within six months of the date on which this Regulation enters into force.
 
Article 19A: Provisions relating to the enlargement of the community
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 asa 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 asa 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.

SPP 19.01

In contrast to Article 2, Article 19(1) refers to “an equivalent national provision” rather than “an equivalent provision of national law”. Consequently it appears that marketing authorizations obtained under voluntary as well as statutory procedures in the UK are acceptable as first authorizations under the transitional provisions of Article 19. The Office therefore takes the view that voluntary authorizations granted under the Pesticides Safety Precautions Scheme (PSPS) from 1 January 1985 until 5 October 1986 satisfy the requirements of Article 19(1). Insofar as the patents relating to products protected by the PSPS have expired there is no further relevance of this scheme to new SPC applications (see also SPP2.02).

 
Article 20
1. 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
2. This Regulation shall apply to supplementary protection certificates granted in accordance with the national legislation of the Czech Republic, Estonia, Croatia, Cyprus, Latvia, Lithuania, Malta, Poland, Romania, Slovenia and Slovakia prior to the date of accession.
 
Article 21: Entry into force
This Regulation shall enter into force six months after its publication in the Official Journal of the European Communities.

SPP 21.01

The Plant Protection Regulation was published in the Official Journal of the European Communities on 8 August 1996. It therefore entered into force on 8 February 1997.