Hogan Lovells International LLP v Bayer CropScience AG.
Date: 2010-11-11
26. Under the second paragraph of Article 252 TFEU, it is the duty of the Advocate General, acting with complete impartiality and independence, to make, in open court, reasoned submissions on cases which, in accordance with the Statute of the Court of Justice of the European Union, require the Advocate General’s involvement. In carrying out that task, the Advocate General may, where appropriate, analyse a reference for a preliminary ruling by placing it within a context which is broader than that strictly defined by the referring court or by the parties to the main proceedings. The Court is not bound either by the conclusion reached by the Advocate General or by the reasoning which led to that conclusion.
27. Having regard to the very purpose of the adversarial procedure, which is to avoid a situation in which the Court may be influenced by arguments which have not been discussed by the parties, the Court may of its own motion, or on a proposal from the Advocate General, or at the request of the parties, order the reopening of the oral procedure in accordance with Article 61 of its Rules of Procedure if it considers that it lacks sufficient information, or that the case must be dealt with on the basis of an argument which has not been debated between the parties (see, inter alia, order in Case C‑17/98 Emesa Sugar  [2000] ECR I‑665, paragraph 18; and Case C‑42/07 Liga Portuguesa de Futebol Profissional and Bwin International  [2009] ECR I‑7633, paragraph 31 and the case-law cited).
32. It must be observed that Article 3 of Regulation No 1610/96 is to be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part (see, to that effect, Case C‑482/07 AHP Manufacturing  [2009] ECR I‑7295, paragraph 27).
33. In order to interpret Article 3(1)(b) of Regulation No 1610/96, according to which a plant protection product must have been granted a MA ‘in accordance with Article 4 of Directive 91/414’, reference must be made, more particularly, to the provisions of that directive which govern the conditions under which a MA may be granted for plant protection products.
34. Those provisions are based on a distinction between, on the one hand, the authorisation of an active substance, which is issued at the level of the European Union, and, on the other, authorisations of products containing active substances, which come within the competence of the Member States, as can be seen, in particular, from Articles 3 to 6 and 8 of Directive 91/414.
35. According to Article 3(1) of Directive 91/414, a plant protection product may not be placed on the market and used in a Member State unless the competent authorities of that Member State have authorised the product in accordance with that directive. Article 4(1)(a) of the directive provides that a Member State may not authorise a plant protection product unless its active substances have been approved at European Union level and are listed in Annex I to the directive. The conditions for inclusion of such substances in the abovementioned annex are laid down in Article 5 of Directive 91/414 and must be the subject of a dossier satisfying the requirements of Annex II thereto.
36. The scientific criteria which a plant protection product must fulfil in order to obtain a MA are set out in Article 4(1)(b) to (f) of Directive 91/414 and the requirements for the dossier to be submitted in order to obtain an authorisation are set out in Annex III to that directive.
37. However, Article 8 of Directive 91/414, entitled ‘Transitional measures and derogations’, permits the Member States to grant, in three situations, a provisional MA for a plant protection product containing active substances which have not yet been listed in Annex I to that directive. Of those three situations, only that provided for in Article 8(1) is material for the purpose of replying to the national court’s question in the present case.
38. That provision concerns the placing on the market of a plant protection product containing an active substance not yet listed in Annex I to Directive 91/414 and not yet available on the market two years after notification of the directive (a ‘new active substance’). The reasons for that provision are set out in the 14th recital in the preamble to Directive 91/414, which states that ‘the Community procedure should not prevent Member States from authorising for use in their territory for a limited period plant protection products containing an active substance not yet entered on the Community list, provided that the interested party has submitted a dossier meeting Community requirements and the Member State has concluded that the active substance and the plant protection products can be expected to satisfy the Community conditions set in regard to them’.
39. The first subparagraph of Article 8(1) of Directive 91/414 sets out the requirements which must be satisfied in order to obtain a provisional MA, to be granted for a period not exceeding, in principle, three years, for a plant protection product which contains a new active substance.
40. With regard to the assessment of that new active substance, Article 8(1), first subparagraph, point (a), of Directive 91/414 requires, first, that it be ‘found that the dossier on the active substance satisfies the requirements of Annexes II and III in relation to the projected uses’. In addition, Article 8(1), first subparagraph, point (b), requires the Member State to establish that the active substance can satisfy the requirements of Article 5(1) of the directive and also that ‘the plant protection product may be expected to satisfy the requirements of Article 4(1)(b) to (f)’.
41. Under those latter provisions, the Member State concerned is required to establish, in the light of current scientific and technical knowledge, that the product is effective and safe. That Member State is thus required to establish that there are no unacceptable or harmful effects on plants, on human or animal health, on groundwater or on the environment. In addition, that Member State must establish that the product does not cause unnecessary suffering and pain to vertebrates to be controlled.
42. That Member State must also establish:
– whether the nature and quantity of the product’s active substances and, where appropriate, any toxicologically or ecotoxicologically significant impurities and co-formulants can be determined by appropriate methods which are harmonised or, if not, agreed by the competent national authorities;
– whether its residues, resulting from authorised uses, and which are of toxicological or environmental significance, can be determined by appropriate methods in general use;
– whether its physical and chemical properties have been determined and deemed acceptable for the purposes of the appropriate use and storage of the product; and
– whether, where appropriate, the maximum residue levels for the agricultural products affected by the use referred to in the authorisation have been respected.
43. It must be added that, as is expressly provided in the latter part of Article 8(1) thereof, the provisions of Article 4(2), (3), (5) and (6) of Directive 91/414 also apply to provisional MAs. That reference thus makes it possible to ensure that provisional MAs granted by Member States for products containing new substances meet the same scientific requirements as to reliability, and may be reviewed or cancelled under the same conditions, as definitive MAs granted on the basis of Article 4.
44. Applications for provisional MAs submitted under Article 8(1) of Directive 91/414 must therefore be examined in accordance with the scientific criteria applicable to definitive MAs governed by Article 4 of that directive. The conditions under which a Member State may, pursuant to Article 8(1) of Directive 91/414, authorise the placing on the market, on a provisional basis, of a plant protection product containing a new substance which is still being assessed with a view to its inclusion in Annex I to Directive 91/414 are t hose set out in Article 4(1)(b) to (f) of that directive (see, to that effect, Case C‑306/98 Monsanto  [2001] ECR I‑3279, paragraphs 30 and 32).
45. It is, admittedly, true that the assessment made by a Member State when considering an application for a provisional MA is, by its nature, prospective and necessarily implies a greater margin of uncertainty than in an assessment made with a view to granting a definitive MA. However, the intention of Article 8(1) of Directive 91/414 is that the conditions under which a provisional MA may be granted in respect of a product should be the same as those for the grant of a definitive MA, in accordance with the objective referred to in the ninth recital in the preamble to Directive 91/414 of ensuring ‘a high standard of protection, which, in particular, must prevent the authorisation of plant protection products whose risks to health, groundwater and the environment and human and animal health should take priority over the objective of improving plant production’.
46. By reason of that link of functional equivalence which exists between the criteria set out in Article 8(1) of Directive 91/414 and those laid down in Article 4 of that directive, there is thus no need to interpret Article 3(1)(b) of Regulation No 1610/96 in a manner which would have the effect of excluding from the application of that provision products which have been granted a provisional MA under Article 8(1) of Directive 91/414.
49. Regulation No 1610/96 seeks to limit the erosion of the effective protection accorded to patented inventions in the area of plant protection by reason, in particular, of the time required to obtain a MA. Recital 5 in the preamble to that regulation states, in that regard, that the period that elapses between the filing of an application for a patent for a new plant protection product and the MA for that plant protection product 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.
50. The supplementary protection certificate is designed to re-establish a sufficient period of effective protection of the patent by permitting the holder to enjoy an additional period of exclusivity on the expiry of the basic patent which is intended to compensate, at least in part, for the delay to the commercial exploitation of his invention by reason of the time which has elapsed between the date on which the application for the patent was filed and the date on which the first MA in the European Union was granted.
51. The supplementary certificate establishes a link between the basic patent and the first MA granted for the plant protection product, with that MA marking the moment at which commercial exploitation of the product can begin. Thus, the grant of that certificate requires that the four cumulative conditions set out in Article 3(1) of Regulation No 1610/96 be met. That provision provides, essentially, that a supplementary protection certificate may be granted only if, at the date of the application, the plant protection product is protected by a basic patent in force and has not already been the subject of a certificate. In addition, the product must have been granted a valid MA ‘in accordance with Article 4 of Directive 91/414/EEC or an equivalent provision of national law’ and, finally, that MA must be the first authorisation of the product as a plant protection product.