17 April 2019

ECJ’s landmark ruling on “skinny labeling” impacts practice for generic medicinal products

In proceedings between Warner-Lambert Company LLC and the Netherlands, the ECJ recently held that “skinny labeling” constitutes a request to limit the scope of marketing authorisation for the generic medicinal product in question.  This ruling bolsters the position of holders of second medical use patents in Europe. Supplying a generic medicinal product for indications still protected by patent law and not included in the “skinny label” is in fact being done without valid market authorisation.

 

Consequences of the decision

The ruling especially impacts the longstanding practice of the Dutch Medicinal Product Evaluation Board (CBG) to not publish on its website the skinny label of the summary of product characteristics (SmPC) of generic medicinal products. Now that skinny labeling constitutes a limiting of scope for the marketing authorisation applicant, national authorities no longer have discretion to limit the scope. Patentees had long argued that the CBG’s practice encouraged general practitioners to prescribe generic versions of medicinal products for indications or dosage forms which are still patented.

Background

EU law provides for an abridged marketing authorisation procedure for the corresponding generic medicinal product of an authorised reference medicinal product. For the abridged authorisation, parts of the reference medicinal product’s SmPC – which refer to indications that are still patented, or dosage forms – do not need to be included (in other words, skinny labeling). This is an exception to the principle that the marketing authorisations of a generic medicinal product and of a reference medicinal product must be the same.

As of 2009, the CBG has applied the practice of systematically publishing in full, on its website, the package leaflets and summaries of product characteristics of generic medicinal products – even where the applicant had informed the CBG of its intention to omit certain information. Warner-Lambert brought an action before The Hague District Court, seeking an order for the CBG to abandon this practice and, instead, publish the skinny label. On appeal, The Hague Court of Appeal held that the outcome of the dispute depended on the interpretation of EU legislation relating to medicinal products.

The dispute and the ECJ’s ruling

The discussion between the parties turned on the consequences of skinny labelling. Does notification of intent to use a skinny label constitute a request to limit the scope of the marketing authorisation for the generic medicinal product in question? If this is the case, then the CBG should limit the marketing authorisation and publish the skinny label. The court of appeal put this question before the ECJ.

In its ruling, the ECJ held that the rationale behind skinny labeling is not to delay generic medicinal products from entering the market until the expiry of all patents – covering indications or dosage forms of the reference medicinal product – without relaxing the safety and efficacy requirements observed for generic medicinal products. Accordingly, under a decentralised procedure – such as that at issue in the main proceedings – if the marketing authorisation applicant or holder for a generic product chooses the option of skinny labeling, then the marketing authorisation for that product only covers the non-patented indications and dosage forms. By using the skinny labelling option, the marketing authorisation applicant limits the scope of the application and the competent national authority does not have any discretion in that respect.

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