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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

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(2),

Acting in accordance with the procedure referred to in Article 189b of the Treaty(3),

  1. (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(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 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(5) 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:

Article 1 Definitions

For the purposes of this Regulation, the following definitions shall apply:

  1. ‘plant protection products’: active substances and preparations containing one or more active substances, put up in the form in which they are supplied to the user, intended to:

    1. 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;

    2. influence the life processes of plants, other than as a nutrient (e.g. plant growth regulators);

    3. preserve plant products, in so far as such substances or products are not subject to special Council or Commission provisions on preservatives;

    4. destroy undesirable plants; or

    5. 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:

    1. against harmful organisms; or

    2. on plants, parts of plants or plant products;

  4. ‘preparations’: mixtures or solutions composed of two or more substances, of which at least one is an active substance, intended for use as plant protection products;

  5. ‘plants’: live plants and live parts of plants, including fresh fruit and seeds;

  6. ‘plant products’: products in the unprocessed state or having undergone only simple preparation such as milling, drying or pressing, derived from plants, but excluding plants themselves as defined 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.

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(6), 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:

  1. the product is protected by a basic patent in force;

  2. 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;

  3. the product has not already been the subject of a certificate;

  4. 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.

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

Article 6 Entitlement to the certificate

Article 7 Application for a certificate

Article 8 Content of the application for a certificate

Article 9 Lodging of an application for a certificate

Article 10 Grant of the certificate or rejection of the application

Article 11 Publication

Article 12 Annual fees

Article 13 Duration of the certificate

Article 14 Expiry of the certificate

Article 15 Invalidity of the certificate

Article 16 Notification of lapse or invalidity

Article 17 Appeals

Article 18 Procedure

TRANSITIONAL PROVISIONS

Article 19

Article 19a Provisions relating to the enlargement of the Community

Article 20

FINAL PROVISION

Article 21 Entry into force