CJEU Judgment in Synthon v Merz (Case C-195/09)

Today the CJEU gave judgment in the Synthon v Merz preliminary reference (C-195/09). This was a reference from the UK High Court on the memantine SPC. The questions referred were:

1. For the purposes of Articles 13 and 19 of [Regulation No 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 [Directive 65/65], 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 [Regulation No 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 [Directive 65/65]?
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 [Directive 65/65] within the scope of [Regulation No 1768/92] as defined by Article 2?
4. If not, is an SPC granted in respect of such a product invalid?

The Court ignored questions 1 and 2, deciding only on questions 3 and 4. It decided that, when a product is placed on the market in the Community prior to obtaining a 65/65 compliant marketing authorisation, the product does not fall within the scope of the SPC regulation and therefore cannot be the subject of an SPC. An SPC granted in respect of such a product would be invalid. There was no need to go on to consider the Article 13 and 19 arguments as they do not arise.

This means that products that were on the market prior to the Europe-wide rules on regulatory approval being implemented will not be eligible for an SPC, even when based on a later 65/65 compliant MA, and any such existing SPCs will be invalid. This could now give rise to the need for additional factual investigations into whether earlier non-65/65 compliant marketing authorisations existed anywhere in the Community in certain cases, to verify the validity of any SPC in question.

Judgment was also given today in Generics [UK] v Synaptech (C-427/09), which was decided along similar lines.

Lawyers Simon Cohen, Anna Coleman