Directive 65/65, Reminyl was authorised in March 2000. Six months later, the United Kingdom also issued a market authorisation for Reminyl.
All good fictions come to an end, and the fictitious authorisation of Nivalin was no exception: the German and Austrian authorisation were withdrawn in the second half of 2000 and in 2001 respectively.
In December 2000 Synaptech applied for a UK SPC for galantamine, listing the Swedish marketing authorisation as the first authorisation to place the product on the market as a medicinal product in the Community. Based on that marketing authorisation, Synaptech's application was granted with a maximum term of five years, expiring in January 2012, with the basic galantamine patent expiring on 16 January 2007.
Generics was not happy about this, taking the view that the SPC’s date of expiry had not been calculated correctly by the UK Patent Office when it chose to rely on the Swedish marketing authorisation. Generics therefore sought rectification under section 34 of the Patents Act 1977. That claim was rejected, so Generics appealed to the Court of Appeal. The company accepted that the German and Austrian marketing authorisations had never complied with the requirements of Directive 65/65 and that the first authorisation that did comply with it was the Swedish authorisation. The Court of Appeal (England and Wales) (Civil Division) had doubts as to the interpretation which should be given to the concept of ‘first authorisation to place the product on the market in the Community’ in Article 13(1) of Regulation 1768/92, so it decided to stay the proceedings and to refer the following questions to the Court of Justice for a preliminary ruling:
‘(1) For the purposes of Article 13(1) of [Regulation 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 [Directive 65/65] (now replaced with Directive 2001/83/EC [of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67)]) or will any authorisation that enables the product to be placed on the market in the Community or [European Economic Area] suffice?
(2) If, for the purposes of Article 13(1) of [Regulation 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] (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]) and that was never amended to comply with [that directive] and was ultimately withdrawn in 2001, to be treated as an authorisation granted in accordance with [that directive] for that purpose?’The Court today, in a very short ruling indeed, observed that the answer to these questions is relevant only if galantamine is within the scope of that regulation and can thus be the subject of an SPC. Citing this morning's other SPC in Case C‑195/09 Synthon  (noted here), the Court said Article 2 of Regulation 1768/92 means that a product like galantamine, placed on the market in the Community as a medicinal product for human use before receiving a Directive 65/65 marketing authorisation and without undergoing safety and efficacy testing, was not within the scope of Regulation 1768/92 and could not therefore be the subject of an SPC. Since galantamine couldn't be the subject of an SPC, Articles 13 and 19 of Regulation 1768/92 don't apply. If they don't apply, the Court doesn't need to interpret them.
"A product, such as that at issue in the main proceedings, which was placed on the market in the European Community as a medicinal product for human use before obtaining a marketing authorisation in accordance with Council Directive 65/65 ... as amended ... may not be the subject of a supplementary protection certificate.".