Pharmaceuticals – Abridged registration of generic products

The Advocate General Jacobs rendered an opinion on 8 July 2004, in the case C-36/03, between the applicant for a generic medicine authorization and the UK licensing authority.

We informed you in the last ECLN issue (ECLN 2 – 5/2004) of the amended EC rules on medicinal products, including Directive 2004/27/EC of the European Parliament and of the Council amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use.

New provisions inserted in Directive 2001/83, specifically its Articles 6 and 10 extend the possibility of abridged applications for generic medicines. In particular, Directive 2001/83 newly provides that “when a medicinal product has been granted an initial marketing authorization […] any additional strength, pharmaceutical forms, administration routes, presentations, as well as any variations and extensions shall also be granted an authorization […] or be included in the initial marketing authorization. All these marketing authorizations shall be considered as belonging to the same global marketing authorization, in particular for the purpose of the application of Article 10 (1) [abridged application for generic medicines]” (Article 6 (1) subparagraph 2).

In other words, this new provision effectively limits the data protection period applicable to the contents of the file of a particular medicine and its later developments to ten years from the date of first marketing in the Community. As a result, new versions of the medicine, based on the initial application file, are subject to the data protection period initially granted. The data protection period initially granted is extended “to a maximum of eleven years only if, during the first eight years of those ten years, the marketing authorization holder obtains an authorization for one or more therapeutic indications which during the scientific evaluation prior to their authorization, are held to bring a significant client benefit in comparison to existing therapies” (Article 10 (1) subparagraph 4).

In the present case before the High Court of England and Wales, the generic medicine is fluoxetine, also the name of the active ingredient, in a liquid pharmaceutical form (product C). The abridged application made in 1999, refers to Product B, the medicine Prozac, containing the same active ingredient, also manufactured in liquid form. Although the marketing authorization of product B was granted in 1992 (less than the ten year data protection period with regard to the application of product C) the application of product B was made in reference to Product A, also Prozac but in tablet form which was authorized in 1988 (i.e. more than ten years data protection period).

The question asked by the High Court of England and Wales to the Court of Justice is whether the relevant Community rules should be interpreted as allowing an application for product C to refer to product B authorized for less than ten years, and take into account product A, reference medicine of product B and authorized for more than ten years.

The conclusions of Advocate General Jacobs which, essentially, build on the provision decisions of the Court in cases of Generics (C-368/96) and Novartis (C-106/01), and recommends that the generic marketing application of product C should be accepted as submitted, are followed by the Court of Justice, the result may be equivalent to an early application of the new provisions of Directive 2001/83.