The European Court of Justice has ruled that regulatory agencies engaged in the EU’s decentralised procedure for generic drug marketing authorisation lack the authority to review the point when data exclusivity periods start to run on innovative drugs, finding instead that courts hearing challenges against generic market entry have the power to review such periods.

The 14 March decision holds that articles 28 and 29 of Directive 2001/83/EC on the community code relating to medicinal products for human use, which require national agencies to recognise marketing authorisations granted to generic drugs in another member state, bar those agencies from making an independent call as to when the original drug’s exclusivity period began.

In cases where the maker of an innovative drug brings a challenge against a national agency’s decision to grant marketing authorisation to a generic, however, article 10 of the directive – which provides for generics to be brought to market after innovative drugs’ exclusivity periods have elapsed – read alongside article 47 of the EU’s Charter of Fundamental Rights – ensuring the right to a fair trial – means the court hearing the proceedings has jurisdiction to review the determination of the point when exclusivity starts to run.

The ruling came in response to questions referred by Finland’s Supreme Administrative Court, which is hearing a challenge by a German subsidiary of Japan’s Astellas Pharma against the Finnish regulator’s recognition of marketing authorisation for German chemical company Helm’s generic drug based on a non-Hodgkin’s lymphoma and multiple myeloma treatment originally made by Astellas.

Article 28 of Directive 2001/83/EC requires drug companies seeking marketing authorisation in multiple EU countries states to designate one “reference member state” to assess the application. If approved, regulatory agencies in other states are required to recognise the authorisation within 90 days of receiving the relevant documents. Article 29, meanwhile, allows an agency to decline to recognise a reference member state’s authorisation only if it believes there is a “serious potential risk to public health.”

Astellas challenged the Finnish authority’s recognition of market authorisation granted to Helm’s generic drug Alkybend by Denmark (the reference member state) in 2014, arguing that the exclusivity period for the Astellas products on which the generic was based had not elapsed.

In its application, Helm said that the active substance of Alkybend was based on Astellas’ drug Levact, which received marketing authorisation in 2010, but that the true reference drug for the generic should be regarded as Astellas’ Ribomustin, authorised five years earlier.

The Administrative Court of Helsinki took the view that because the original authorisation was granted in 2005, Levact’s exclusivity was not protected beyond 2011, meaning the Finnish regulator was clearly free to grant authorisation to Alkybend in 2014.

Astellas applied to the Supreme Administrative Court arguing that the data exclusivity period should be viewed as having started in 2010. The company added that the 2005 authorisation never actually came into effect in respect of one of the indications requested for Ribomustin, claiming that the authorisation process for Levact required “extensive additional tests”.

The Finnish court asked the ECJ for guidance on the limit of the regulatory agency’s ability to check exclusivity periods during recognition procedures, and further questioned whether the national courts had any power to review such periods.

On the first question, the ECJ said there was a “general agreement” among EU countries that authorities are required to adopt a market authorisation decision in conformity with a reference member state’s assessment report of a drug. “Therefore, once that general agreement is acknowledged, the competent authorities of those Member States may not, when making their decision on the placing on the market of that medicinal product in their territory, call into question the outcome of that procedure,” the court held.

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, as a precondition of granting them marketing authorisation, and precludes the authorities in other member states from repeating such verification.

As to the competence of national courts, the ECJ referred to its previous decision in a case involving Latvian pharmaceutical company Olainfarm, where it ruled that the holder of market authorisation for an innovative drug had the right to demand, under article 10 of Directive 2001/83/EC, 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 authorisation were entitled to “effective judicial protection” for their data rights, the ECJ said, as well as the right to “a judicial remedy against the decision of the competent authority” to grant marketing authorisation to a generic drug. This right, in turn, can only be assured if innovative drugmakers are able to plead before national courts that there has been an error relating to the beginning of the drug’s exclusivity period, the ECJ held.

In the Court of Justice for the European Communities

Astellas Pharma GmbH

  • Judge Marko Ilešič (President)
  • Judge Allan Rosas
  • Judge Camelia Toader
  • Judge Alexandra Prechal
  • Judge Egidijus Jarašiūnas (Rapporteur)

Advocate General Michal Bobek

Counsel to Astellas

  • Sträter Rechstanwalte

Burkhard Sträter in Bonn

  • Sidley Austin

Marie Manley in London

  • Roschier

Mikael Segercrantz in Helsinki

Counsel to Helm

  • Preu Bohlig & Partne

Peter von Czettritz in Munich

  • HPP Attorneys

Klaus Nyblin in Helsinki