1 Recital 9 Directive 91/414 of 15 July 1991 concerning the placing of plant protection products on the market (OJ 1991 L 230, p. 1), as amended by Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 (OJ 2005 L 70, p. 1) (“Directive 91/414”). The general purpose of Directive 91/414 is to harmonise across EU Member States the rules on conditions and procedures for the authorization of plant protection products.

2 Article 3 Directive 91/414.

3 Article 5(1) Directive 91/414. When deciding the insertion of active substances in Annex I, the following factors should be taken into consideration: (i) an acceptable daily intake (ADI) for man, if relevant; (ii) an acceptable operator exposure level, if necessary; and (iii) an estimate of its fate and distribution in the environment and its impact on non-target species (Article 5(2) Directive 91/414). Authorizations in relation to active substances are issued at EU level. An active substance is included in Annex I for a period not exceeding 10 years, and the inclusion is renewable once or more for additional periods not exceeding 10 years (Article 5(5) Directive 91/414).

4 Article 4(1)(b) Directive 91/414. Moreover, according to Article 4(1)(c)-(f), plant protection products will not be authorized unless: “[…] (c) the nature and quantity of its active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods […]; (d) its residues, resulting from authorised uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use; (e) its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; (f) where appropriate, the MRLs [maximum residue levels] for the agricultural products affected by the use referred to in the authorisation have been set or modified in accordance with Regulation (EC) No 396/2005”. Authorizations of products containing active substances are within the competence of EU Member States.

5 A term of protection of 20 years is required by Article 33 TRIPS Agreement.

6 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 (OJ 1996 L 198, p. 30) (“Regulation 1610/96”). Recital 5 Regulation 1610/96 clearly explains the needs for SPCs: “[…] 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”. For an analysis of Regulation 1610/96 see de Pastors, Alice, “Plant Protection product supplementary protection certificates”, 11 World Patent Information (2000), pp. 59–61 CrossRefGoogle Scholar.

7 Regulation (EC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products (OJ L 182, 2.7.1992, pp. 1–5).

8 See also the opinion of Advocate General Verica Trstenjak of 17 June 2010, paras. 46–47. The provisional approval is valid for a period not exceeding three years.

9 Indeed, Article 15(1)(a) Regulation 1610/96 provides that SPCs are invalid if they are granted contrary to the provisions of Article 3.

10 Para. 31 ECJ's decision.

11 Para. 32 ECJ's decision.

12 See also para. 44 ECJ's decision.

13 See supra notes 3 and 4.

14 Para. 46 ECJ's decision.

15 Paras. 47 et sqq. ECJ's decision.

16 Para. 45 ECJ's decision.

17 See also Article 14 Regulation 1610/96.

18 See the position paper by the European Crop Protection Association of 28 September 2009, quoted in the opinion of Advocate General Verica Trstenjak, para. 84.