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02 May 2018

Data exclusivity for medicines: who is protected?


On March 14 2018 the Court of Justice of the European Union (CJEU) delivered judgment in Case C-557/16, Astellas Pharma v Helm AG and FIMEA in which Astellas, the innovator company of a reference medicinal product, challenged a previous decision of the Finnish regulatory authority on the granting of a decentralised marketing authorisation of Helm's generic product.

Fundamentally Astellas disagreed with the method of calculation for data exclusivity performed during the assessment of Helm's application.  Astellas challenged the regulatory basis upon which the marketing authorisation was issued by the Finnish regulatory authority (with Denmark acting as the reference member state) before the Finnish courts.

The case centred on two main regulatory issues:

  1. Whether EU Concerned Member States (CMS) are co-responsible for marketing authorisations granted under the decentralised procedure (DCP); and
  2. The power afforded to the competent authorities of the Member States concerned to determine the point in time from which the data exclusivity period starts to run for generic products and the jurisdiction of the courts of the Member States concerned to review such determinations made by regulatory authorities.
    With regard to the first issue the court ruled that under Directive 2001/83/EC ("The Directive") articles 28 and 29(1) dictate that in a decentralised marketing authorisation procedure for a generic medicinal product, the competent authority of a member state concerned by that procedure could not itself determine the point in time from which the data exclusivity period for the reference medicinal product started to run. Therefore, it is for Member States, after a marketing authorisation application has been submitted, and before acknowledgement of the approval, to oppose an application if that precondition period is not satisfied. In the case of generic drugs this procedure involves the verification of the expiry date of the exclusivity period for the innovative drug on which they are based, prior to the approval of a marketing authorisation, and precludes the authorities in other member states from repeating such verification.
    In relation to the second issue of member state court jurisdiction to determine the commencement period of data exclusivity, the CJEU referred to its previous decision in a case involving the pharmaceutical company Olainfarm. In this case it was held that the holder of a marketing authorisation for a medicinal product had the right, under article 10 of Directive 2001/83/EC, to request from the court that its product not be used as a reference drug for generics until it had enjoyed market exclusivity for at least eight years. The effect of Olainfarm was that holders of marketing authorisations were entitled to “effective judicial protection” for their exclusive data rights.  Article 10 of the Directive read in conjunction with article 47 of the Charter of Fundamental Rights does provide authority for the CJEU to review the determination of the commencement of a data exclusivity period. Such a court cannot however determine whether the approval of an initial marketing authorisation in another Member State was granted in accordance with the Directive.

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