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	Court of Justice of the European Communities (including Court of First Instance Decisions)
You are here: BAILII >> Databases >> Court of Justice of the European Communities (including Court of First Instance Decisions) >> Synthon v Merz Pharma Gmbh & Co KG (Approximation of laws) [2009] EUECJ C-195/09 (15 August 2009) URL: http://www.bailii.org/eu/cases/EUECJ/2009/C19509.html Cite as: [2009] EUECJ C-195/9, [2009] EUECJ C-195/09

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Justice (Chancery Division)
(Patents Court)
(England and Wales)

made on 29 May 2009
Synthon BV v Merz Pharma Gmbh & Co KG

(Case C-195/09)
(2009/C 193/10)
Language of the case: English

Referring court

High Court of Justice (Chancery Division)

Parties to the main proceedings

Applicant: Synthon BV
Defendant: Merz Pharma Gmbh & Co KG

Questions referred

1. For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92^[1], is an authorisation a 'first authorization to place. on the market in the Community', if it is granted in pursuance of a national law which is compliant with Council Directive 65/65/EEC ^[2], or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority followed an assessment of data as required by the administrative procedure laid down in that Directive?

2. For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, does the expression 'first authorization to place. on the market in the Community', include authorisations which had been permitted by national law to co-exist with an authorisation regime which complies with Council Directive 65/65/EEC?

3. Is a product which is authorised to be placed on the market for the first time in the EEC without going through the administrative procedure laid down in Council Directive 65/65/EEC within the scope of Council Regulation (EC) 1768/92 as defined by Article 2?

4. If not, is an SPC granted in respect of such a product invalid?

Note 1    Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products OJ L 182, p. 1     [Back]

Note 2   Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products OJ 22, p. 369 English special edition: Series I Chapter 1965-1966 p. 24     [Back]