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.
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?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.
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?