The Netherlands: Paediatric reward for orphan drugs

April 25 2016

In interim proceedings between Novartis and Teva, the Dutch Court of The Hague has decided that a medicinal product may benefit from the six-month extension of the supplementary protection certificate (SPC) provided for by paediatric regulation (EC) No 1901/2006, even taking into account that the drug had previously been registered as an orphan medicinal product.

The proceedings related to the drug Glivec, which contains imatinib as the active compound. Novartis had a patent and subsequent SPC granted for imatinib, based on which it has exclusivity up to June 2016. Upon request by Novartis, imatinib had also been registered from 2001 to 2005 as an orphan drug for the treatment of several rare diseases. Accordingly, Novartis received market exclusivity for 10 years for such treatments based on regulation (EC) No 141/2000, which was created to stimulate the development of orphan drugs. However, in view of the patent and SPC, this market exclusivity did not seem to provide any additional protection.

Novartis further conducted studies on the use of imatinib in the paediatric population. As a reward for such studies, regulation (EC) No 1901/2006 either grants a six-month extension of the SPC, or, in the case of an orphan medicinal product, a two-year extension of the 10-year period of orphan market exclusivity.

In order to qualify for the SPC reward rather than the orphan award, Novartis decided to withdraw the orphan designation of imatinib in 2012, thereby intending to extend the duration of the SPC up to December 2016. Teva BV contested the validity of this extension of the SPC, as imatinib had been an orphan medicinal product and could therefore exclusively benefit from the orphan reward of the paediatric regulation. However, the Dutch Court decided that the six-month extension of the SPC was valid. Thus, paediatric research is also rewarded by the paediatric regulation for patented drugs that were previously registered as orphan drugs.