On 28 July the ECJ handed down two rulings primarily concerning the interpretation of Article 2 of Regulation 1768/92 (the Supplementary Protection Certificate Regulation, now replaced by 469/2009/EC). The Court held that only a product which, as a medicinal product, obtained a marketing authorisation as laid down in Directive 65/65 (now replaced by 2001/83) prior to being put on the market in the Community, could be the subject of a Supplementary Protection Certificate ("SPC").  


Both cases involved referrals made by Mr Justice Floyd, sitting in the UK High Court. The cases, Synthon BV v Merz Pharma GmbH & Co KG1 and Generics (UK) Ltd v Synaptech Inc2 involved similar facts but were not consolidated.

For these cases, the relevant legislation was Directive 65/65, which required that medical products cannot be marketed without first having undergone safety and efficacy testing; and Regulation 1768/92, concerning the grant of SPCs. In particular, Article 2 of Regulation 1768/92 reads as follows:

"Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorization procedure as laid down in Council Directive 65/65/EEC or Directive 81/851/EEC may, under the terms and conditions provided for in this Regulation, be the subject of a certificate."

In both cases, products had been marketed in Europe well before the coming into force of Directive 65/65. Merz's product, memantine, had been marketed for the treatment Parkinson's disease since 1961. The Synaptech case involved galantamine, which had been on sale in Europe since the 1950s for the treatment of neuromuscular conditions.

Second medical uses were subsequently developed for each product and, in due course, Merz and Synaptech filed patents for the second medical uses, marketing authorisations, and then SPC applications, for their respective products. The ECJ was asked to consider whether Article 2 of Regulation 1768/92 must be interpreted as meaning that a product, which, as a medicinal product, was placed on the market in the EC without first being subject to an authorisation granted under Directive 65/65, and so has not been subject to the relevant safety and efficacy testing, is within the scope of Regulation 1768/92, such that it may be the subject of an SPC.

The Decision

The ECJ held that the "market" referred to in Article 2 of Regulation 1768/92 is the Community market; and that, on a correct interpretation of Article 2, in order to obtain an SPC, a product must be protected by a valid patent and must, prior to being put on the market as a medicinal product, have been subject to an administrative authorisation procedure as stipulated in Directive 65/65.

As a conclusion of the earlier authorisations and marketing, which were not conducted under Directive 65/65, the products did not fall within the scope of Regulation 1768/92 and could not, therefore, be subject to a SPC. In reaching this decision, the ECJ considered the objective of Regulation 1768/92, to grant SPCs to offset the length of time taken to obtain a marketing authorisation, against  circumstances where the product had already been sold in the community before there was a need to comply with Directive 65/65.

The ruling of the ECJ accords with the Opinion of AG Mengozzi, and the view expressed by the UK High Court in making the referral. A more detailed analysis of the reasoning of the AG can be found in our newsflash of 1 April 2011. Having concluded that infringement of Article 2 comprised a ground of invalidity that takes effect in addition to those set out in Article 15, the ECJ found that it was unnecessary to consider the additional questions referred to it.