Difficulties in asserting rights to data exclusivity

A court ruling on use of the European decentralised procedure for approval of a generic product shows the limited options available to an innovator company in protecting its data exclusivity rights.

What is data exclusivity?

Data exclusivity offers a limited period of protection for innovators in the pharmaceuticals field, by preventing reliance on their regulatory submissions by generic producers for an eight year period from the approval of the original product.  After that period, generic producers can begin their application for a marketing authorisation relying on the data submitted in support of the original application – the abridged procedure. If approved, marketing can begin two years later.

Astellas's product

In this case the innovator, Astellas Pharma GmbH, obtained a German national approval of its medicinal product Ribomustin in July 2005 for the treatment of non-Hodgkin’s lymphoma and multiple myeloma.  In 2010, Astellas obtained an approval in France of Levact, through the decentralised procedure. This product contained the same active ingredient and was approved for the same conditions plus chronic lymphocytic leukaemia.

The generic application

In 2012, Helm AG began an application for approval of generic product Alkybend, again through the decentralised procedure. Helm cited Levact as the reference medicinal product, but said that Ribomustin should be regarded as the reference medicinal product for the purposes of the data exclusivity period calculation. The Danish regulator was the reference member state for the purposes of the procedure, and in its assessment report, it accepted that Ribomustin should be taken as setting the date for the data exclusivity period. The Finnish regulator, FIMEA, then approved Helm’s application – a decision that Astellas challenged in the Finnish courts.

The court challenge

The Finnish courts recognised that Astellas faced a problem. An innovator company is not involved in the procedure for a generic approval application relating to one of its products. It has no formal role in the procedure and cannot readily make submissions to protect its data excluvity rights.

And the role of national regulators in other member states is also limited. The reference member state charged with making the assessment (here Denmark) must come to a decision. Once that decision is made by the reference member state it must be accepted by the other concerned regulators, unless they have an objection based on a serious risk to public health.

The Finnish courts asked the European court (the CJEU) for its opinion.

The CJEU confirmed that national regulators other than the reference member state have limited scope to separately assess the data exclusivity point. The decentralised procedure requires them to accept the assessment of the reference member state (here Denmark). They could raise objections based on data exclusivity at an earlier stage in the procedure, but not after the assessment report is finalised.  The CJEU also ruled that the Finnish court could not review the correctness of the decision on data exclusivity taken by the reference member state.

Three routes to approval in the EU system

This case highlights some of the difficulties inherent in the European system. Although extensively harmonised, there are still three routes to approval. The centralised route through the European Medicines Agency is the most harmonised. But the mutual recognition and decentralised routes rely on the involvement of national regulators and require cooperation and mutual reliance between them. These bring in the possibility of national discrepancies in interpretation and complexity as to how to challenge a decision. The Advocate General giving the analysis in this case explained that the decentralised procedure “remains somewhat distant from a unified procedural framework for the internal market in medicinal products”.

This complexity may be a factor for innovator companies to consider when deciding whether the centralised procedure is the best choice for them in a situation where it is optional.

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