In the ECJ this week

This Thursday the Court of Justice of the European Union's agenda promises us two Advocate Generals' Opinions. We hope to bring news of these Opinions as they come out.

This first is in Case C-195/09 Synthon v Merz Pharma:

Questions referred

1. For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92¹, 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/EEC², 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? 

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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. 1² - 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

The second is Case C-427/09 Generics (UK) v Synaptech Inc:

Questions referred 

For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92¹, is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC² (now replaced with Directive 2001/83/EC³) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice? 

If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?

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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

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

³ - Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use OJ L 311, p. 67