The judgment of the ECJ of 18 June 2009 in case C-527/07 Generics (UK) Limited, Regina v Licensing Authority (acting through the Medicines and Healthcare products Regulatory Agency) followed closely, both in terms of time and substance, the decision Advocate General Mazák which we reported on in the last (May) edition of Life Sciences Update.
It was held that only those medicinal products benefiting from a Marketing Authorisation issued in accordance of Directive 2001/83 can be considered reference medicinal products. For medicinal products authorised before the entry in its force of this Directive, the applicant must show that the reference medicinal product was authorised on the basis of Community law in force at the time of the application for the Marketing Authorisation for the reference medicinal product.
In this case, Nivalin (containing the active ingredient galantamine) was placed on the market in Austria in 1963 following authorisation under legislation in force in Austria at the time. This authorisation was never updated in accordance with Community law following accession of Austria to the EEA and then the European Union. Therefore the authorisation in Austria could not be used as a reference authorisation in the Community. The relevant authorisation for products containing galantamine is one granted on 1 March 2000 in Sweden under Directive 65/5 (now Directive 2001/83) to Janssen-Cilag for ‘Reminyl’. Therefore the 10 year data exclusivity for galantamine will expire on 1 March 2010.
This is an important judgment which will apply to a number of products, as some older Member States still have products on the market which do not conform and have not been updated in accordance with Community law, and the large number of nationally authorised products in the newer Member States.