Advocate General Mengozzi delivers his Opinion on the scope of the SPC Regulation and what constitutes the first authorisation to place a product on the market

31 March 2011

Advocate General Mengozzi today delivered his Opinion in two cases before the Court of Justice ("CJ") concerning the scope of Article 2 of Council Regulation (EC) No 1768/92 (the "SPC Regulation") and the types of marketing authorisation which could be considered to be "the first authorisation to place the product on the market in the Community" for the purposes of the SPC Regulation.

The first reference to the CJ was from the High Court of Justice of England and Wales in Synthon BV v Merz Pharma GmbH & Co KG (C 195/09) ("Synthon").  The second reference was from the Court of Appeal of England and Wales, in Generics (UK) Ltd v Synaptech Inc (Case C 427/09) ("Generics (UK)").   The Synthon case concerns the medicinal product memantine and the Generics UK case relates to galantamine. 

In both cases the medicinal products in question had been on the market in at least one country in the Community for over 40 years, pursuant to national marketing authorisations, but had more recently been the subject of "new" applications for marketing authorisations made following compliance with the administrative procedure laid down in Council Directive 65/65/EEC. The date of these new authorisations had been used by the patent holder as the reference date for the first authorisation to place the product on the market in the Community for the purposes of calculating the term of a supplementary protection certificate (SPC).

In summary, the Advocate General agreed with Synthon's submission that Article 2 of the SPC Regulation should be construed as limiting the scope of the Regulation so as to exclude products placed on the market as medicinal products in the Community before having obtained a marketing authorisation in accordance Council Directive 65/65/EEC (or Council Directive 81/851/EEC, which relates to veterinary products).  However, in case the full Court were not in agreement with him on this point, he also went on to consider whether the various earlier authorisations which had allowed the marketing of memantine and galantamine products in the Community for a number of years, constituted relevant marketing authorisations for the purposes of the SPC Regulation.  In relation to this issue, he agreed with Synthon and Generics (UK)'s submissions, and was of the opinion that they did.

If the full Court follows the opinion of the Advocate General, the English courts will either find the SPCs were granted invalidly or should be given a zero term.

The full facts of each case are set out in each of the opinions, and due to their complexity are not repeated here.  However, the highlights of the Advocate-General's Opinions, and the questions referred, are set out below.

Synthon: The Advocate General answered the third and fourth questions (see below for the questions referred) first and then gave answers to the first and second questions.

In relation to the third and fourth questions the Advocate General based his opinion on the purpose of the SPC Regulation, particularly recitals 2, 3 and 4, which was to provide a means for the Pharmaceutical Industry to secure an adequate economic return on the investment needed for research.  He also stressed that the SPC Regulation was designed to provide a uniform solution at Community level.  Bearing these factors in mind his opinion favoured the arguments set out by Synthon and he did not consider it compatible with the objectives of the SPC Regulation to extend the protection provided under an SPC to products which were already present on the Community market on a different basis before a marketing authorisation was obtained in accordance with Directive 65/65/EEC.  He therefore considered that the answers to questions 3 and 4 should be that products placed on the market before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC do not fall within the scope of the SPC Regulation and therefore SPCs granted for such products must be deemed invalid.

In the alternative, the Advocate General proposed that the Court should answer the first and second question as follows:-


(i) That an authorisation granted by the authorities of a Member State in accordance with national provisions transposing Directive 65/65/EEC may constitute the first marketing authorisation in the Community for the purposes of Articles 13 and 19 of the SPC Regulation, even when the administrative procedure has not been implemented properly or at all, particularly the carrying out of the toxicological and pharmacological tests and clinical trials required under Article 4(8) of the directive. 

(ii) that a marketing authorisation granted by the authorities of a Member State, under the transitional arrangements provided for by Article 24 of Directive 65/65/EEC, in conjunction with Article 39 of Second Council Directive 75/319/EEC, as amended by Article 37 of that directive, may also constitute the first marketing authorisation of the product in the Community, on the basis of a marketing authorisation granted before the transposition of Directive 65/65/EEC into the legal order of that Member State.

(iii) for the purposes of the application of Articles 13 and 19 of Regulation No 1768/92, a marketing authorisation granted for a use of the product as a medicinal product different from the use or uses protected by the patent constituting the basic patent under Article 1(c) of that regulation may also be regarded as the first marketing authorisation in the Community.


Therefore the term of the SPC granted to Merz was incorrectly calculated by basing the term on the 2002 marketing authorisation.  However, assuming that the earlier German authorisation granted under transitional provisions was the relevant reference authorisation, the term of the SPC granted should be fixed at zero.

Generics (UK): The Generics (UK) opinion cross-references the longer opinion in Synthon, and the answers are unsurprisingly consistent, although the questions asked were different.

The Advocate General states at paragraph 35 that if the Court were to adopt his conclusions in relation to the third and fourth questions raised in Synthon, the questions referred by the Court of Appeal would become irrelevant for the purposes of resolving the dispute in the main proceedings.  He therefore only answered questions specific to the facts of the galantamine case (the questions referred are set out below).  In this regard he considered that an authorisation, such as that obtained in Germany for galantamine under transitional provisions, and an authorisation granted in Austria in 1963, while not satisfying the requirements of Directive 65/65, may be regarded as the first Marketing Authorisation in the Community for the purposes of Regulation 13 of the SPC Regulation (and hence would lead to an SPC term of zero).

Synthon – Questions Referred:-


  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?

Generics (UK) – Questions Referred:-


  1. For the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, is the "first authorisation to place the product on the market in the Community" the first authorisation to place the product on the market in the Community which was issued in accordance with Council Directive 65/65/EEC (now replaced with Directive 2001/83/EC) or will any authorisation that enables the product to be placed on the market in the Community or EEA suffice?

  2. If, for the purposes of Article 13(1) of Council Regulation (EEC) No 1768/92, an "authorisation to place the product on the market in the Community" must have been issued in accordance with Directive 65/65/EEC (now replaced with Directive 2001/83/EC), is an authorisation that was granted in 1963 in Austria in accordance with the national legislation in force at that time (which did not comply with the requirements of Directive 65/65/EEC) and that was never amended to comply with Directive 65/65/EEC and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65/EEC for that purpose?

Click here for the Advocate General's Opinion in the Synthon case

Click here for the Advocate General's Opinion in the Generics (UK) case

Rob Williams and Ewan Grist of Bird & Bird LLP were solicitors acting for Synthon BV, instructing Michael Silverleaf QC of 11 South Square Chambers.