Advocate General gives opinion on SPCs
Memantine, a drug developed by Merz back in the 1960s, had been on the market in Germany even before September 1, 1976, when it was authorised on the basis of Article 3(7) of the AMG 1976 on the basis of transitional arrangements, provided for under the national legislation transposing Directive 65/65, which exempted medicinal products already on the market from the application of the Community authorisation procedure for a period of 12 years. This old German transitional authorisation expired on January 1, 1990, however, Merz remained on the German market until July 9, 2002.
In Luxembourg, Merz apply for a marketing authorisation for Memantine on June 30, 1983, the authorisation was granted on September 19, 1983. Prior to this, namely on April 29, 1983, EU Directive 65/65 was transposed by a grand-ducal regulation in Luxembourg.
On April 14, 1989, Merz applied for a European patent regarding the use of, among others, the known substance Memantine hydrochloride for the preparation of drugs to treat Alzheimer's disease.
In 2002, Merz applied to various patent offices in Europe for a SPC citing the European patent and a marketing authorisation dating from 2002 as the basic patent and the first marketing authorisation within the EEA, respectively. The SPCs where granted, and subsequently challenged by one of Merz's competitors in various revocation actions, also in Austria. The parallel action before the British High Court of Justice (Chancery division) Patents Court was finally referred to the European Court of Justice as Case C-195/09 for a preliminary ruling regarding four questions. The questions concerned:
- whether for a first marketing authorisation according to Directive 65/65 the national authorities indeed had to follow an assessment of data as required by said Directive
- whether the term "first marketing authorisation" includes authorisations permitted by national law and coexisting with an authorisation regime which complies with Directive 65/65
- whether a product that 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 is within the scope of Regulation 1768/92 as defined by Article 2 and, if not,
- whether a SPC granted in respect of such a product is invalid.
The Advocate General now delivered his opinion in this interesting case and stated with regard to the third and fourth questions that he does not consider it compatible with the objectives of the Regulation 1768/92, now 469/2009, to extend the protection provided under a SPC to products which were already present on the Community market on a different basis before the marketing authorisation was obtained in accordance with Directive 65/65 and that such SPCs must be regarded as invalid.
As to the first and second questions, he concluded that an authorisation granted by the authorities of a Member State in accordance with the national provisions transposing Directive 65/65 may constitute the first marketing authorisation in the Community for the purpose of Articles 13 and 19 of the regulation, even when the administrative procedure for which the Directive provides has, in fact, not been implemented or has not been properly implemented, particularly as regards the carrying out of the toxicological and pharmacological tests and the clinical trials required by Article 4(8) of the Directive and the notification of the results of those tests and trials. Similarly, a marketing authorisation granted by the competent authorities of a Member State, under the transitional arrangements provided for and on the basis of a marketing authorisation granted before the transposition of Directive 65/65 into the legal order of that Member State, may be regarded as the first marketing authorisation in the Community within the meaning of the above provisions.
In summary, the Advocate General came to the conclusion that the term of Merz's SPC was calculated incorrectly inasmuch as the 2002 marketing authorisation was taken into consideration rather than the old German transitional authorisation, which old German transitional authorisation must be regarded as the first marketing authorisation in the Community for the purpose of Article 13 of the regulation. Assuming the German marketing authorisation to be the authorisation of reference, the term of the SPC granted to Merz must be fixed at zero.
DI Peter Pawloy