Insights | March 15, 2018
Pharmaceutical Regulatory case – Roschier successfully represented Astellas Pharma in the Court of Justice of the European Union
On 14 March 2018, the Court of Justice of the European Union rendered its ruling in the case C-557/16 (Astellas Pharma) regarding the exclusivity period for pre-clinical and clinical trials data for pharmaceuticals. In essence, the case concerned the duties and powers of national pharmaceutical authorities and national courts to verify whether the data exclusivity period during the so-called decentralized procedure has expired before a marketing authorization for a generic pharmaceutical product can be issued. The Court of Justice confirmed that the authorities of the concerned Member States have such a duty and, if necessary, the beneficiary of the data exclusivity may also bring legal action in the concerned Member State to determine whether or not the data exclusivity period has expired.
This ruling is welcome news for the innovative pharmaceutical industry, which invests a substantial amount of time and money on pre-clinical and clinical trials to ensure the safety and efficacy of their products.
Data exclusivity for pharmaceuticals is a specific form of intellectual property right which confers on the holder of a marketing authorization for a new pharmaceutical product temporary exclusivity for data from comprehensive pre-clinical and clinical trials. Such data is needed to demonstrate the safety and efficacy of the pharmaceutical product before it is made available to patients. The data is generated by the relevant pharmaceutical company at substantial expense and effort. In return, the company enjoys a period of exclusivity during which the data is not available to other parties and may not to be used as a basis for granting a marketing authorization for a generic pharmaceutical product. In the European Union, the period of exclusivity runs for at least eight years.
The Court of Justice stated that, in the decentralized procedure for granting a marketing authorization the competent national regulatory authority has a duty to verify that all the preconditions for issuing a marketing authorization have been met. According to the Court of Justice, this includes verifying that the data exclusivity period has expired. The Court of Justice also confirmed that the holder of the marketing authorization for the reference pharmaceutical product (i.e. the beneficiary of the data exclusivity) can also bring legal action against the authority of a concerned Member State to determine the data exclusivity period. Accordingly, the Court of Justice rejected the opposing view that, generally speaking, only the relevant authority and courts in the reference Member State are competent to determine when the data exclusivity period has expired.
The rules on data exclusivity are set out in Directive 2001/83/EC of the European Parliament and of the Council relating to medicinal products for human use, as implemented in the Member States’ national legislation.
Astellas Pharma was represented in the Court of Justice by Partner Mikael Segercrantz, and Senior Associates Sami Sunila and Elina Saxlin-Hautamäki.