Synthon BV v Merz Pharma GmbH & Co. KGaA.
Date: 2011-07-28
38. In those circumstances, in order to determine the market to which Article 2 refers, that provision must be interpreted in the light of the context in which it occurs and the objective pursued by the rules of which it is part (see, to that effect, Case 292/82 Merck  [1983] ECR 3781, paragraph 12; Case C-34/05 Schouten  [2007] ECR I-1687, paragraph 25; Case C-466/07 Klarenberg  [2009] ECR I-803, paragraph 37, and Case C-433/08 Yaesu Europe  [2009] ECR I-11487, paragraph 24).
41. Indeed, as is apparent from the respective headings of Articles 2 and 3 of Regulation No 1768/92, namely, ‘Scope’ and ‘Conditions for obtaining [an SPC]’, first, Article 2 of that regulation seeks to determine in a general manner which products may be the subject of an SPC and, then, Article 3 sets out the conditions under which those products may be granted an SPC.
46. As is apparent from the first to fourth recitals in the preamble to Regulation No 1768/92, in order to ensure sufficient protection to encourage pharmaceutical research, that regulation seeks, through the creation of an SPC for medicinal products granted marketing authorisation, to make up for the fact that the period of effective protection under the patent is insufficient to cover the investment put into the research, given the period that elapses between the filing of an application for a patent for a new medicinal product and authorisation to place that product on the market (see, to that effect, in particular, Case C-110/95 Yamanouchi Pharmaceutical  [1997] ECR I‑3251, paragraph 7; Case C‑392/97 Farmitalia  [1999] ECR I‑5553, paragraph 19; and Case C-482/07 AHP Manufacturing  [2009] ECR I‑7295, paragraph 30).
48. In addition, the interpretation of Article 2 of Regulation No 1768/92 put forward by Merz would give rise to a difference in treatment between certain products placed on the market before the date laid down in Article 19(1) of the regulation, which is not justified in the light of the objective pursued by the regulation. Whereas – as a result of Article 19(1) – products issued with a compliant marketing authorisation before that date cannot be granted an SPC even if that authorisation was issued in accordance with Directive 65/65, products marketed before that date on a non‑compliant basis which would have obtained a marketing authorisation in a Member State, in accordance with Directive 65/65, after that date could be granted an SPC.
51. In the light of all the foregoing, the answer to the third question is that Article 2 of Regulation No 1768/92 must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Directive 65/65, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation No 1768/92 and may not, therefore, be the subject of an SPC.
The fourth question
55. The Court has already held, at paragraphs 90 and 91 of the judgment in Case C‑127/00 Hässle [2003] ECR I‑14781, that, even if it is not possible to infer from the wording or the origin of Article 15(1) of the regulation that the list of grounds of invalidity of an SPC set out therein is not exhaustive, the infringement of an article of that regulation not referred to in Article 15(1) – in the present case Article 19 of the regulation – can render an SPC invalid owing to the connection between the provision in question and Article 3 of the regulation.