The Spanish Central Administrative Court of Appeal has confirmed that the holders of innovator medicaments are not entitled to challenge the marketing approvals of generic medicaments issued by the Spanish Agency of Medicaments and Sanitary Products (AEMPS).

The Central Administrative Court of Appeal upheld the Administrative Court’s decision dismissing that Laboratorios Servier SL lacked legal standing to challenge the marketing approval issued by the AEMPS to Laboratorios Cinfa SA for “diosmine” generic medicaments.

Servier argued that the enactment of the new Law 29/2006 of Guarantees and Rational Use of Medicaments and Sanitary Products meant the consequences of the marketing approval of a generic medicament are especially harmful to the holder of the original medicament, unlike what happened with the prior regulation. Specifically, Servier alleged that said marketing approval was susceptible to activate the reference price system (art. 93) and the so-called prescription of active principle (art. 85).

The mere marketing approval of a generic medicament cannot damage any right or legitimate interest of the holder of the innovator medicament, notwithstanding the civil actions based on intellectual property rights which might be brought, if so, upon the effective commercialization of the generic medicament.

The Court of Appeal concluded that the new Law of 2006 did not involve substantial changes in the system for the marketing approval of generic medicaments, or in its consequences to the holders of innovator medicaments. In this regard, it has considered that with the current regulation there are no substantial differences in the reference price system and/or in the prescription of active principle, thus rejecting the allegations of Servier.

The Court explained that within the marketing approval procedure, the Administration limits itself to analyzing the characteristics of the product in question (i.e. security, toxicity, tolerance, effectiveness, quality, pureness, identification and information) to ensure that the particular medicament examined does not involve any risk to consumer health and that it will not be misleading in the therapeutic effects attributed to it. This analysis is undertaken without considering the circumstances which may bring the owner of the generic medicament to its commercialization and the damages that this could cause to the holder of the original medicament.

This means that the mere marketing approval of a generic medicament cannot affect any right or legitimate interest of the owner of the innovator medicament and the owners of original medicaments will have to go through civil proceedings for the protection of intellectual property rights and/or against unfair competition.

Today’s post is by Guest Barista Eduardo Vila, a lawyer in the Barcelona office of Grau & Angulo.

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