Synthon v Merz - More SPC Confusion

The IPKat has been passed an early copy of Mr Justice Floyd's judgment from earlier today in the case of Synthon v Merz, which relates to the esoteric outer reaches of how European Community law on Supplementary Protection Certificates (SPCs) should be interpreted. The final version is now available from BAILII here.

SPCs are intended to provide a limited extension of patent protection for medicinal products in order to partly compensate for delays in obtaining marketing authorisations.  SPCs can last for a maximum of 5 years after expiry of a'basic patent' covering the product, and can extend to no more than 15 years from the first marketing authorisation in a member state.  

In this case, the question related to what should happen when the basic patent in question relates to a second medical use of a known product.  Merz had obtained a patent relating to a second medical use for memantine, and was able to place the product on the market without requiring a further authorisation, partly because the same product had been on the market since 1976.  Merz did, however, obtain a marketing authorisation within the definition provided in the SPC regulation in 2002, and argued that they should be allowed an extra five years on their patent on this basis.  Synthon argued that earlier marketing authorisations should count instead, which would make any SPC granted have a zero term.  

Given that various issues relating to the issue of marketing authorisations had been considered in cases before other national courts, Floyd J thought that it was appropriate that some questions should be put to the ECJ in order to resolve the apparent discrepancies.  These questions are as follows:

1. For the purposes of Articles 13 and 19 of Council Regulation (EC) No 1768/92, 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, or is it necessary that it be established in addition that, in granting the authorisation in question, the national authority complied with 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 are 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?

Floyd J leaned towards Synthon's arguments, which would result in Merz being unable to obtain their SPC.  The IPKat, who does not practice in this area (and is not therefore swayed by any financial inducements), would also tend to lean in the same direction, and suspects that the ECJ will agree.  He also, however, finds it a bit odd that a second medical use patent could even be considered to be the 'basic patent' for the product in question, but further suspects that some of his more knowledgeable readers will be able to enlighten him.