For the sake of completeness, here's the Generics ruling

Also before the Court of Justice of the European Union today was Case C‑427/09, Generics (UK) Ltd v Synaptech Inc., a reference for a preliminary ruling from the Court of Appeal (England and Wales).  This time the contested substance was not memantine but galantamine -- which had been on sale as a medicinal product in various European countries for more than 40 years. In central Europe, it was used to treat neuromuscular conditions. In 1963 a marketing authorisation was issued in Austria, under that countty's 1947 medicines regulations, to use galantamine in the treatment of poliomyelitis under the trade mark Nivalin. In Germany, galantamine was already on the market in the 1960s under the same trade mark and, under the German Law of 1976, galantamine could remain on the German market as a product deemed to be authorised as a medicinal product under a ‘fictitious’ authorisation.

In January 1987 Synaptech filed an application for a basic galantamine patent in the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s Disease. In 1997 Janssen-Cilag took over distribution of Nivalin in Austria and, in 1999, filed an application in Sweden for a marketing authorisation for the use of galantamine in a medicinal product to treat Alzheimer’s Disease under the brand name Reminyl. After an assessment carried out in accordance with 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to an end, and the fictitious authorisation of Nivalin was no exception: the German and Austrian authorisation were withdrawn in the second half of 2000 and in 2001 respectively.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 [2011] (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.

The ECJ therefore ruled as follows:

"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.".

AG advises recognition of ancient authorisations

Galantamine -- it has been
around a long time

The second of today's two Advocate General's Opinions on SPC references, also authored by AG Mengozzi, arises from Case C‑427/09 Generics (UK) Ltd v Synaptech Inc, another British reference but this time from the Court of Appeal for England and Wales. 

In short, Galantamine received marketing authorisation in Austria in 1963 as a treatment for polio, under the trade mark ‘Nivalin’. This authorisation, granted under the Austrian 1947 medicines regulations then in force, was withdrawn in 2001. In the 1960s, Nivalin was also marketed in Germany under the legislation then in force. After the Law restructuring the legislation on medicinal products --the AMG 1976 -- came into force, Nivalin remained on the market in Germany under its provisions, but that authorisation was withdrawn between July 2000 and January 2001. In 1987 Synaptech applied for a galantamine patent at the European Patent Office, claiming the use of galantamine for the treatment of Alzheimer’s disease. The patent expired on 16 January 2007 (‘the basic patent’). In 1999 Janssen-Cilag appliedfor a marketing authorisation in Sweden for galantamine as a treatment for Alzheimer’s disease under the brand name Reminyl. This authorisation was granted on 1 March 2000. A marketing authorisation for Reminyl was granted in the UK in September 2000 based on the earlier Swedish authorisation.

In December 2000 Synaptech applied to the UK IPO for an SPC for the basic patent, listing the Swedish marketing authorisation as the first marketing authorisation for galantamine in the Community. The SPC for galantamine was granted with a term of five years, expiring on 15 January 2012. Taking the view that the SPC’s date of expiry had not been calculated correctly under Regulation 1768/92, Generics brought an action for rectification of the register of patents, which was dismissed. Following Generics' appeal, the Court of Appeal referred two questions to the ECJ:

"(1) For the purposes of Article 13(1) ..., 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 ... (now replaced with Directive 2001/83...) 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) ... 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 ...), 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 [it] and was ultimately withdrawn in 2001 to be treated as an authorisation granted in accordance with Directive 65/65 ... for that purpose?".

AG Mengozzi has advised 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 ... in conjunction with Article 39 of Council Directive 75/319 ... 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 ... 1768/92 ....

For the purposes of the application of Article 13 ..., 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) 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 ...".

As with today's earlier post, this is for informational purposes only. Further comment will follow.