EU: Advocate General’s Opinions in the Synthon and Generics SPC references

03 May 2011

Ewan Grist

In Synthon v Merz (C-195/09), Merz had been marketing memantine (Akatinol) since before 1 September 1976 in Germany in accordance with the system in force at that time. The 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 At this time the German and Luxembourg marketing authorisations were withdrawn.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 marketing authorisation 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 it should have a term of zero years. Synthon argued that the 2002 marketing authorisation was not the first marketing authorisation for memantine and so the SPC is, therefore, invalid in that it fails to satisfy the requirements of Article 3 of the regulation or, in the alternative, is invalid or has zero term, pursuant to Article 13 of the regulation, because the first marketing authorisation in the Community predates the filing of the patent application. In the further alternative, Synthon argued that the SPC is invalid because the first marketing authorisation in the Community was obtained before 1 January 1985 in breach of Article 19(1), or because memantine was marketed as a medicinal product before authorisation was obtained in accordance with Directive 65/65, in breach of Article 2.

The High Court referred a number of questions to the CJEU and on 31 March 2011, AG Mengozzi delivered his opinion. The questions referred were:


  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?

Looking at questions 3 and 4 first, the Advocate General reformulated those questions to in essence ask whether by virtue of Article 2 products for which a marketing authorisation under Directive 65/65 was granted after those products had first been placed on the market fall within the scope of the regulation. Whilst the AG accepted that there were arguments in favour of both Merz’s and Synthon’s interpretation of Article 2, the AG held that it was on the basis of the objective of the Regulation that the issue should be resolved and that objective was to limit the extent to which the duration of the exclusive patent right is eroded as a result of the need to go through the regulatory authorisation procedure which, by delaying the placing of the product on the market, defers the point at which the patent can begin to be commercially exploited. The AG found that he did not consider it “compatible with the objectives of the regulation to extend the protection provided under the 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”.

Accordingly, the AG’s answer to the questions 3 and 4 was that:

'Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, must be interpreted, pursuant to Article 2 thereof, as meaning that products placed on the market as medicinal products in Community territory before obtaining a marketing authorisation in accordance with Council Directive 65/65/EEC on the approximation of the provisions laid down by law, regulation or administrative action relating to proprietary medicinal products or with Council Directive 81/851/EEC of 28 September 1981 on the approximation of the laws of the Member States relating to veterinary medicinal products do not fall within the scope of the regulation. Supplementary protection certificates granted for such products must be deemed to be invalid.'

If followed by the CJEU, this would mean that as memantine had been marketed by Merz in Germany before obtaining the 2002 marketing authorisation (being a marketing authorisation in accordance with Council Directive 65/65/EEC), it does not fall within the scope of the SPC Regulation and as such the SPC granted to it is invalid.

In case the CJEU were not in agreement with him on questions 3 and 4, the AG also went on to consider whether the earlier German and Luxembourg authorisations which had allowed the marketing of memantine in the Community long before the 2002 authorisation, constituted relevant marketing authorisations for the purposes of Article 13 (which sets the term of the SPC) and Article 19 (transitional provisions). 

To answer these questions, the AG felt it was first necessary to look at the German and Luxembourg authorisations in more detail.

The German authorisation was granted in accordance with transitional arrangements, provided for under the national legislation transposing Directive 65/65 into national law. Those arrangements implemented Article 24 of Directive 65/65, which expressly made it possible to apply progressively the provisions of Directive 65/65 to medicinal products placed on the market before the Directive’s entry into force by virtue of previous provisions and, consequently, permitted, on a transitional basis, the continued marketing of medicinal products on which the requisite tests had not been carried out, as was the case for memantine.

The Luxembourg authorisation, which was granted after the Luxembourg Law of 11 April 1983 (which transposed Directive 65/65 into national law), was however granted solely on the basis that memantine was already marketed in Germany and not therefore on the basis of the national transitional arrangement implementing Article 24 of Directive 65/65.

The AG accepted that a marketing authorisation issued pursuant to the provisions transposing Directive 65/65 would be regarded as the 'first authorisation to place on the market in the Community', even if the administrative procedure laid down under the directive had not in fact been carried out.

However, while both the German and the Luxembourg marketing authorisations were issued on the basis of the respective national provisions transposing Directive 65/65, neither could be regarded as having been issued pursuant to national provisions transposing the administrative authorisation procedure laid down by the directive. However, it was still necessary to consider whether these authorisations might nonetheless be taken into account.

The AG took the view that, particularly in the case of the German authorisation, the answer had to be in the affirmative, following Novartis. Since Directive 65/65 permitted, albeit on a transitional basis, the possible co-existence of two authorisation regimes, namely, the regime actually established by the Directive 65/65 and the regime permitted under Article 24, authorisations issued on the basis of Article 24 must, if appropriate, be regarded as the first marketing authorisations within the meaning of Articles 13 and 19 of the SPC Regulation. In this case, that was the German marketing authorisation.

That solution was again consistent with the objective of the SPC Regulation. If, when calculating the term of the SPC, account were not taken of the authorisations issued under national arrangements set in place pursuant to Article 24 of Directive 65/65, it would be possible to obtain far longer marketing exclusivity for products than was intended by the SPC regime.

The AG’s answer to questions 1 and 2 was therefore that:

A marketing 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 Regulation No 1768/92, even when the administrative procedure for which the directive provides has 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 the directive.

A marketing authorisation granted by the competent authorities of a Member State, under the transitional arrangements provided for by Article 24 of Directive 65/65, in conjunction with Article 39 of Second Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and 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 into the legal order of that Member State.

If followed by the CJEU, this would mean that the term of the SPC granted to Merz was incorrectly calculated as the relevant first marketing authorisation was not in fact the 2002 authorisation but the earlier German or Luxembourg authorisation which in fact pre-dated the patent filing date and would therefore render the correct term of the SPC as being zero.

Shortly after the reference was made in Synthon, the UK Court of Appeal also referred a number of closely related questions in Generics v Synaptech (C-427/09). Whilst the two references were not formally joined, they were considered together and on 31 March 2011, AG Mengozzi also delivered an opinion in Generics.

In Generics, the facts were as follows. Galantamine received its first marketing authorisation in Austria in 1963 for the treatment of polio. Galantamine was also marketed in the 1960s in Germany by virtue of the AMG 1976 (the same national law pursuant to which memantine was marketed in Synthon). In 1987, Synaptech applied for a patent claiming the use of galantamine for the treatment of Alzheimer’s Disease. The patent expired in January 2007.

In March 2000, an authorisation was granted in Sweden and in September of that year an authorisation was also granted in the UK on the basis of the earlier Swedish authorisation. In December 2000, Synaptech applied for an SPC listing the Swedish authorisation as the first marketing authorisation for galantamine in the Community. The SPC was therefore granted for the full 5 years.

Taking the view that the SPC’s date of expiry had not been calculated correctly in accordance with the SPC Regulation, Generics brought an action for its revocation.  Generics’ action was dismissed by a judgment dated 20 May 2009. Generics brought an appeal before the Court of Appeal, which referred questions to the CJEU[1].

In his opinion, the AG opened by remarking that if the CJEU were to adopt his conclusions in relation to the third and fourth questions raised in Synthon (namely that products, such as galantamine, which have been placed on the market as medicinal products in Community territory before a marketing authorisation in compliance with Directive 65/65 has been obtained, do not fall within the scope of the regulation as laid down in Article 2), the questions referred by the Court of Appeal in the present proceedings would become irrelevant for the purposes of resolving the dispute in the main proceedings, and the CJEU would not be required to answer them. Nevertheless, he went on to consider the questions referred.

In respect of the first question, the AG noted that it was in essence the same as the second question in Synthon and furthermore the German marketing authorisation for galantamine was granted pursuant to the same provisions of the German legislation under which memantine was granted marketing authorisation after Directive 65/65 had been transposed into German law. In other words, the transitional rules of ‘fictitious authorisation’, applied to the circulation of the two products in Germany on the basis of the provisions of the AMG 1976 which implemented Article 24 of Directive 65/65, are the same in the two cases. Referring to his analysis of this question in Synthon, the AG concluded that an authorisation such as that obtained in Germany for galantamine, granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Directive 65/65 on the basis of a marketing authorisation granted prior to 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 for the purposes of Article 13 of the regulation.

In respect of the second question, in which the national court asked, in essence, whether an authorisation 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, was maintained in force after the accession of Austria to the EEA and to the Community and was never amended to comply with those requirements, is relevant for the purposes of the application of Article 13 of the regulation. The AG noted that both the EEA Agreement and the Act of Accession of Austria, Finland and Sweden contain provisions under which an authorisation to place a product on the market granted in accordance with the national legislation of an EFTA State or of one of the abovementioned States is to be treated as granted in accordance with Directive 65/65 and he saw no reason not to extend this interpretative rule to apply when construing the first authorisation in the Community for the purposes of Article 13. He concluded that it followed that an authorisation granted in 1963 in Austria in accordance with the national legislation in force at that time, although not satisfying the requirements of Directive 65/65, must be treated as an authorisation granted in accordance with that directive for the purposes of applying Article 13 of the regulation.

The AG’s proposed answers to the referred question were therefore as follows:


  1. A marketing authorisation for a medicinal product granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products – in conjunction with Article 39 of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and as amended by Article 37 of that directive – on the basis of a marketing authorisation granted prior to the transposition of Directive 65/65 into the legal order of that Member State, may constitute the first marketing authorisation for the purposes of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

    For the purposes of the application of Article 13 of Regulation No 1768/92, an authorisation granted for use of a product, as a medicinal product, other than that or those protected by the patent which is the basic patent within the meaning of Article 1(c) of the regulation, may also constitute the first authorisation to place the product on the market in the Community[2]
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  2. A marketing authorisation for a medicinal product granted by the competent Austrian authorities in accordance with the national legislation, and maintained in force following the accession of Austria to the European Economic Area, initially, and to the Community, subsequently, must be treated as an authorisation granted in accordance with Directive 65/65 for the purposes of applying Article 13 of Regulation No 1768/92.

If adopted by the CJEU, the answers to the first and second questions would lead to the correct term of Synaptech’s SPC being zero.

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[1]  The questions referred were:


  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?

[2]  This answer was in response to an issue raised by the Commission as to whether one should take into account, when determining the term of the SPC, an authorisation issued for a use of the product different from that protected by the basic patent. In essence, relying on the text of Article 4 of the regulation, the Commission argued that the protection conferred by the SPC covers all of the uses of the product for which a marketing authorisation has been obtained, provided that those uses are caught by the subject-matter of the basic patent. According to the Commission, it followed that, for the purposes of applying Articles 13 and 19 of the regulation, it is not possible to regard as the first marketing authorisation in the Community a marketing authorisation issued for a product use other than the use or uses covered by the basic patent. This was rejected by the AG.