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 This authorisation, granted under the Austrian 1947 medicines regulations then in force, was withdrawn in 2001.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AMG 1976 -- came into force, Nivalin remained on the market in Germany under its provisions, but that authorisation was withdrawn between July 2000 and January 2001.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.