C-195/09

Summary

Merz are the proprietors of an SPC for a compound called Memantine.

Memantine had first been put on sale in Germany prior to 1976. This marketing, therefore, ante-dated Directive 65/65/EEC. Article 3 of Schedule 7 of the German domestic Act on Restructuring of Medicinal Product Law 1976 automatically granted continuing authorisation to those products still on the market on 1 January 1978.

In 1983, relying on the German authorisation, and with no further investigation, Luxembourg granted a marketing authorisation for Memantine.

Both authorisations were withdrawn in 2002 when an EU wide authorisation was granted.

In 1993 The Patent Office in the UK granted Merz a patent based on a second medical use of Memantine.

Using this later patent, and the 2002 authorisation (but, not the earlier German and Luxembourg authorisations) Merz applied to the Patent Office in the UK for an SPC in November 2002.

Questions

The High Court has asked the European Court of Justice for a preliminary ruling on the following questions:

1. For the purposes of Articles 13 and 19 of Council Regulation (EC) 1768/92, is an authorisation a "first authorisation 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, 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) 1768/92, does the expression "first authorisation 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 procedures laid down in Directive 65/65/EEC within the scope of Council Regulation (EC) 1768/92 as defined in Article 2?

4. If the answer is in the negative, is an SPC granted in respect of such a product invalid?