On 28 July 2011, the Court of Justice of the European Union handed down its decision in Synthon v Merz (C-195/09) and Generics v Synaptech (C-427/09).
The Court of Justice held that medicinal products placed on the market within the Community prior to having obtained a marketing authorisation in accordance with Council Directive 65/65 and, in particular, without undergoing safety and efficacy testing, are not within the scope of Regulation No 1768/92 and may not, therefore, be the subject of an SPC.
Background to the Synthon reference
Merz had been marketing memantine (Akatinol) in Germany since before 1 September 1976 in accordance with the national system in force at that time. The continued placing on the market of memantine was authorised on the basis of Article 3(7) of the German AMG 1976 (the national medicines act). In 1983, Merz was also granted an authorisation in Luxembourg to place memantine on the market, on the basis of the earlier German authorisation. It was admitted that both authorisations were granted without carrying out the product efficacy and safety tests required under Directive 65/65. In April 1989, Merz filed for a European second medical use patent for the product memantine hydrochloride for the treatment of cerebral ischemia and Alzheimer’s disease. The patent was granted in September 1993 and expired in April 2009. In May 2002, Merz were granted by the EMA a series of marketing authorisations for memantine in the treatment of Alzheimer’s disease. At this time the German and Luxembourg marketing authorisations were withdrawn. In November 2002, Merz applied for an SPC in the UK, citing the 2002 authorisation, but not the earlier German or Luxembourg authorisations as the first authorisation to place the product on the market in the Community, despite the fact that the product had been on the market in Germany since at least 1976. The SPC was granted for 5 years to expire in April 2014.
Synthon brought proceedings before the High Court in the UK seeking revocation of Merz’s SPC or a declaration that it should have a term of zero years. Synthon argued that the 2002 Authorisation was not the first marketing authorisation for memantine and so the SPC was therefore invalid or has zero term pursuant to Article 13 of the Regulation (governing SPC duration), because the first marketing authorisation in the Community predated the filing of the patent application. In the further alternative, Synthon argued that the SPC was invalid because the first marketing authorisation in the Community was obtained before 1 January 1985 in breach of Article 19(1) (the transitional provision), or because memantine was placed on the market as a medicinal product before authorisation was obtained in accordance with Directive 65/65, in breach of Article 2 (governing scope of SPC availability).
The questions referred
The High Court referred a number of questions to the CJEU:
‘(1) For the purposes of Articles 13 and 19 of Council Regulation (EC) 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 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) 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 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?
The CJEU decision
The Court considered the Third Question first. Article 2 provides that:
“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 Directive 65/65…may… be the subject of a certificate.”
The Court considered the Third Question to be asking, in essence, whether Article 2 of the Regulation must be interpreted as meaning that a product which was placed on the market in the Community as a medicinal product without first being subject to an administrative authorisation procedure as laid down in Directive 65/65, and, in particular, to safety and efficacy testing, is within the scope of the Regulation and may, therefore, be the subject of an SPC.
The Court considered that it was not apparent from the wording of Article 2 alone whether in using the concept of ‘placing … on the market’ the legislature intended to refer to the Community market or just the market of the Member State in which the SPC application was submitted and in whose territory the patent is valid. Merz contended that it referred only to the market of the Member State in which the application was submitted whereas Synthon contended that it referred to the placing of the product on the market anywhere in the Community.
In finding that the concept of ‘placing the product on the market’ referred to the Community market, the Court found the following points persuasive:
- to limit the concept of ‘placing the product on the market’ to the Member State in which the SPC application is made would result in Articles 3(a) and (b) (i.e. the conditions for the grant of an SPC) simply replicating Article 2, thereby depriving Article 2 of purpose, which was unlikely to have been the intention of the legislature;
- the objective of the Regulation, as is apparent from its recitals, is to compensate the patentee for loss of effective protection as a result of the time required to acquire the authorisation to place the product on the market. It would be contrary to that objective of offsetting the time taken to obtain a marketing authorisation – which requires long and demanding testing of the safety and efficacy of the medicinal product concerned – if an SPC, which amounts to an extension of exclusivity, could be granted for a product which has already been sold on the Community market as a medicinal product before being subject to an administrative authorisation procedure as laid down in Directive 65/65, including safety and efficacy testing;
- In addition, the interpretation of Article 2 put forward by Merz would give rise to a difference in treatment between certain products placed on the market before the transitional date laid down in Article 19(1), which is not justified in the light of the objective of the Regulation. If Merz were correct – as a result of Article 19(1) – products issued with a compliant marketing authorisation before that date cannot be granted an SPC even if that authorisation was issued in accordance with Directive 65/65, whereas products marketed before that date on a non compliant basis which would have obtained a marketing authorisation in a Member State in accordance with Directive 65/65 after that date could be granted an SPC.
It was common ground that memantine was marketed as a medicinal product in the Community under the German and Luxembourg authorisations without having first undergone safety and efficacy testing as prescribed by Directive 65/65. Such testing was only carried out for the first time when the 2002 marketing authorisation was issued. It followed that memantine was not within the scope of Regulation No 1768/92, as defined by Article 2 thereof, and may not, therefore, be the subject of an SPC.
The Court therefore answered the Third Question accordingly:
“Article 2 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by the Act concerning the conditions of accession of the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded, must be interpreted as meaning that a product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to medicinal products, as amended by Council Directive 89/341/EEC of 3 May 1989, and, in particular, without undergoing safety and efficacy testing, is not within the scope of Regulation No 1768/92, as amended, and may not, therefore, be the subject of a supplementary protection certificate.”
With regard to the Fourth Question, the Court answered that:
“A supplementary protection certificate granted for a product outside the scope of Regulation No 1768/92, as amended, as that scope is defined in Article 2 of that regulation, is invalid”
In view of its answers to the Third and Fourth Questions, the Court declined to answer the First and Second Questions.
The Generics reference
The Court also handed down its judgment in the Generics v Synaptech (C-427/09) reference at the same time holding, for the same reasons as those in Synthon, that as galantamine had already been placed on the market in the Community before undergoing the safety and efficacy testing required by Directive 65/65, it was outside the scope of Regulation, as defined in Article 2, and may not be the subject of an SPC.
Bird & Bird acts for Synthon in these proceedings.