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Wednesday 30 March 2011

AG offers alternative solutions in Synthon reference

Case C‑195/09 Synthon BV v Merz Pharma GmbH & Co KG is the first of two Court of Justice Opinions published today on the Curia website on issues arising from Regulation 1768/92.  This reference for a preliminary ruling from the Patents Court, England and Wales, arose from an action in which Synthon claimed that a 2002 marketing authorisation for memantine was not its first marketing authorisation as a medicinal product since it had already been authorised, in 1983, in Luxembourg, as an ingredient of Akatinol, and that Merz’s SPC was therefore (i) invalid for failure to meet the requirements of Article 3 of the regulation or (ii) invalid or zero-term under Article 13 in that the first marketing authorisation in the Community predated the filing of the patent application (the SPC was invalid, said Synthon, because the first marketing authorisation in the Community was obtained before 1 January 1985 either 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 Articles 2 and 3). The court sought guidance on the following questions:
"(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?".
This morning Advocate General Mengozzi gave the following somewhat bifurcated advice to the Court:
"95. Council Regulation ... 1768/92 ... 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 ...or with Council Directive 81/851 ... do not fall within the scope of the regulation.

Supplementary protection certificates granted for such products must be deemed to be invalid.’

96. Should the Court not adopt that solution, I propose that it should give the following answers to the first and second questions ...

‘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 ...as amended ..., 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.

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".
This post is simply to alert readers to the availability of the Opinion. Further comment will follow.

1 comment:

Anonymous said...

Opinion of the Advocate General Mengozzi dated 31st March 2011 in the Proceeding
C-195/09 Synthon v. Merz
here: Comment

I am a German lawyer set up in Bonn. I am specialising in questions of national and European law on the authorisation for medicinal products.

Therefore, I have read with great interest the opinion of the Advocate General in the above mentioned proceedings. Among others, the question is dealt with as to whether the distribution of medicinal products on the basis of transitional provisions in Germany is to be classified as an authorisation within the meaning of Directive 65/65EEC in connection with Directive 75/319/EEC.

Such an interpretation is in any case forbidden by the German wording of the Regulation 1768/92/EEC which speaks of "Erteilung einer Genehmigung für das Inverkehrbringen". Accord-ing to German linguistic perception no authorisations are granted by the legislative body. It be-comes unequivocal, however, by the wording of Art. 2 which speaks of "administrative authori-zation procedure". This cannot be such permissions which occur by act of law.

As a lawyer, who is involved on a daily basis with the application of EC Directives and EC Regu-lations on the European law on authorisations, however, I was particularly surprised by the statements by means of which the provisions of Directive 65/65/EEC are interpreted. These provisions were in effect when I dealt with the law on medicinal products for the first time 25 years ago. Since 2nd December 2001 at the latest, however, they are repealed by Art. 128 of Directive 2001/83/EC. This provision makes clear in particular that references in other legal acts to former Directives are construed as references to Directive 2001/83/EC.

In my opinion, Regulation 1768/92/EEC with its references in Art. 13 and Art. 3 to Directive 65/65/EEC can therefore only be interpreted as a reference to Directive 2001/83/EC. Art. 128 of Directive 2001/83/EC makes this explicitly clear. This receives no mention in the opinion of the Advocate General. Therefore, the provisions mentioned above are no longer in force for 10 years now. Regulation 1768/92/EEC dated 18th June 1992 is repealed in the meantime as well and been replaced by Regulation 469/2009/EC. This is not mentioned in the opinion of the Ad-vocate General, either. Neither does the authoritative provision in Art. 3 of the new Regulation 469/2009/EC refer to Directive 65/65/EEC but to Directive 2001/83/EC which does no longer contain transitional provisions of the type interpreted by the Advocate General.

The statements on applicability of the Regulation 1768/92/EEC pursuant to Art. 2 cannot con-vince even in the event of teleological interpretation. The principle: "The patent protection term is running, market access is delayed to authorisation requirements, therefore a supplementary protection certificate has to be granted" is applicable in any case with respect to the Member State in which the product is not authorized and not marketed. The protection certificate has been applied for the UK where the medicinal product has clearly not been in circulation and was neither allowed to be in circulation - especially not on the basis of German transitional provisions. This is why granting a SPC for the UK is in line with the above mentioned principle.

Prof. B. Sträter