The background to the request was that Warner-Lambert Company (WLC) had obtained a marketing authorisation under the centralised procedure for the drug Lyrica with the active ingredient pregabalin for three indications, two of which were no longer covered by a patent, but the patent for the third did not expire until 17 July 2017. Accordingly, after obtaining the generic marketing authorisation and before marketing the generic drug, the generic company wanted to delete the indication still covered by the patent from the summary of drug characteristics (SmPC) by “carve-out” (“skinny labeling”), which the Dutch authority rejected insofar as it published all indications.
However, the originator WLC took action and the Dutch court first seized decided that the action of the Dutch licensing authority CBG was inadmissible, as it was incompatible with the duty of care incumbent on a licensing authority. The CBG in turn challenged this decision, which led to the question referred to the ECJ by the Dutch Court of Appeal.
The national court asked whether Article 11(2) of Directive 2001/83 must be interpreted as meaning that, in a marketing authorisation procedure for a generic medicinal product, communication to the competent national authority by the applicant or holder of a marketing authorisation for a generic medicinal product of the package leaflet or summary of the product characteristics of that medicinal product which does not include any reference to indications or dosage forms which were still covered by patent law at the time that medicinal product was placed on the market constitutes a request to limit the scope of the marketing authorisation of the generic medicinal product in question.
This question was answered in the affirmative by the ECJ. The ECJ has based its decision on the fact that according to Art. 6 of Directive 2001/83 a medicinal product may only be placed on the market within the EU after a marketing authorisation has been issued by the competent authority and that according to Art. 6 para. 1 subpara. 2 of Directive 2001/83 any additional strengths, pharmaceutical forms etc. as well as all variations and extensions must also be approved. Furthermore, the ECJ points out that it follows from Article 8(3)(j) and Article 21(2) of Directive 2001/83 that the package leaflet and the SmPC are part of the marketing authorisation, that the medicinal product placed on the market must comply with this marketing authorisation, which must be reflected in the SmPC and that the marketing authorisation holder may not change the package leaflet and the SmPC without notifying the competent authority accordingly in order to obtain its authorisation.
In view of the requirement of identity between the reference medicinal product and the generic medicinal product under Article 10(2) of Directive 2001/83 and the possibility provided for in Article 11(2) of Directive 2001/83, of limiting the scope of the SmPC of the generic medicinal product to indications or doses not protected by patent law, the ECJ considers that that affects the scope of the marketing authorisation. The competent authority must amend the marketing authorisation in order to ensure compliance with the SmPC. The SmPC communication, which does not include certain indications, constitutes a removal of therapeutic indications to be submitted by the marketing authorisation holder as a minor variation of Type IB under Article 9 of Regulation 1234/2008. Once the patent protection has expired, the marketing authorisation holder can apply for the inclusion of the indication that was still covered by patent protection within the scope of a Type II variation notification pursuant to Article 10 of Regulation 1234/2008.
With this decision, the ECJ ultimately confirmed a practice that had functioned well for many years, taking into account the reconciliation of interests of all parties involved as intended by the legislator with the generic provisions, even though perhaps not all parties involved were aware of how this handling should be classified in regulatory terms.
Already from the CMDh Question & Answers Usage Patents (CMDh/279/2012) of October 2012 it becomes clear that the decision of the European Court of Justice is nothing substantially new. So far, skinny labelling has been practised unanimously across all Member States to differentiate between regulatory approval and marketing in individual Member States, which may have different patent terms.
Accordingly, most regulatory authorities considered the deletion of the patent-protected indication to be a variation. In Germany, the BfArM has provided the following information on this question on its homepage: “The inclusion of information on already approved patent protected fields of application must be applied for as Type IB variation of the category C.l.z after expiration of the patent protection – as a change to the informative texts”.
Even after the current ruling of the European Court of Justice, there is no need to change this practice in Germany, as the remarks in recital 46 of the judgment only reflect a non-binding assessment of the European Court of Justice in this respect. Only the answer to the question referred for a preliminary ruling reproduced at the end of the judgment according to para. 50 has the force of res judicata and this merely results in the fact that the transmission of the package leaflet and the SmPC, in which a patent-protected indication is not indicated, is to be regarded as an application for restriction of the scope of the marketing authorisation.
How that restriction of the scope of the marketing authorisation is to be reversed is clear from Regulation No 1234/2008 and, since the indication has already been examined once, it is appropriate to make a variation of type IB.
