Pharma update: questions to EU Court of Justice on carve out policy Dutch MEB
In its interim decision of 4 July 2017 in the case of Warner-Lambert Company LLC vs. The State (Ministry of Health, MEB), the The Hague Court of Appeal referred questions to the Court of Justice of the European Union (CJEU)
The questions are the result of interim relief proceedings initiated by Warner Lambert Company LLC (“WLC”) against The State, in which the Provisions Judge of the District Court of The Hague in its judgment of 15 January 2016 ordered the Dutch Medicines Evaluation Board (“MEB”) to replace the online versions of the full label SmPC and PIL for generic pregabalin products by versions of these documents containing a carve out of the patented indication for neuropathic pain (Pharma Update of 18 January 2016). Prior to the judgment, the MEB had indicated that it was unwilling to do so, as this would not be in compliance with its policy, which policy is unique in Europe. The Provisions Judge found that the MEB had acted unlawfully by the online publishing of the patented indication in the SmPC and PIL, without any warning or note that the indication is patented, thereby refusing the request of the (generic) MA applicant.
The MEB filed an appeal against this judgment of the Provisions Judge. WLC and the MEB have a fundamental difference of opinion on the interpretation of article 11 of Directive 2001/83/EC, which stipulates that for authorisations for generic products, those parts of the SmPC of the reference medicinal product referring to a patented indication need not be included (the MEB did include those patented indications online). In light of this, the Court of Appeal of The Hague decided to refer the following questions to the CJEU:
- Should article 11 of Directive 2001/83 or any other rule of Union law be interpreted in the sense that a notification, in which the applicant or holder of a marketing authorisation for a generic medicine in light of article 10 of Directive 2001/83 informs the authorities that it wishes to exclude from its SmPC and its PIL the parts of the SmPC of the reference product that refer to indications or dosage forms that fall under the patent protection of a third party, should be viewed as a request for a limitation of the marketing authorisation which leads to the marketing authorisation not being granted for the patented indications or dosage forms?
- If the answer to question 1 is negative, do articles 11 and 21(3) of Directive 2001/83, or other rules of Union law, prevent the Competent Authority to publish, along with a marketing authorisation granted pursuant to article 6 in conjunction with article 10 of Directive 2001/83, the SmPC and the PIL including the parts that refer to indications or dosage forms that are protected by a patent of a third party, in the situation that the applicant or holder of a marketing authorisation has informed the Authority that it will not include those parts of the SmPC of the reference product that refer to indications or dosage forms that are protected by a patent of a third party?
- For the answer to question 2, does it matter that the Competent Authority requires that the authorisation holder includes, in the PIL that the authorisation holder is obliged to include in the packaging of the medicinal product, a reference to the website of that Authority on which the SmPC has been published including the parts that refer to indications or dosage forms that are protected by a patent of a third party, whereas those parts, applying article 11 of Directive 2001/83, have not been included in that PIL?
The answer to these questions will hopefully provide clarification on the permissibility of the Dutch MEB’s policy to not process a carve out in the online versions of the SmPC and the PIL.
For more information, please contact Marleen van den Horst or Claudia Zeri.