Source: https://thespcblog.blogspot.com/2011/03/ag-offers-alternative-solutions-in.html
Timestamp: 2018-07-16 10:19:53
Document Index: 85286627

Matched Legal Cases: ['Art. 2', 'Art. 128', 'Art. 13', 'Art. 3', 'Art. 128', 'Art. 3', 'Art. 2']

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 Since 2nd December 2001 at the latest, however, they are repealed by Art. 128 of Directive 2001/83/EC.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 Therefore, the provisions mentioned above are no longer in force for 10 years now. Regulation 1768/92/EEC dated 18th June 1992 is repealed in the meantime as well and been replaced by Regulation 469/2009/EC.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