CJEU rules on negative term and zero term SPCs: The Januvia case decision
The Court of Justice of the European Union (CJEU) gave its decision in the Januvia case today, 8 December 2011. The decision has implications not only for the parties involved, but also for the pharmaceutical industry at large, and the wider public interest.
The court concluded that SPCs having a negative term can be granted. The CJEU decision is helpful for pharma companies involved in medicines that are used to treat infants, children, and young people. It widens the circumstances in which companies will have an incentive to dedicate the significant time and resources needed to study the effects of their medicine in the paediatric population. The court also concluded that it is not permissible to round up the "negative term" to a zero term (which would result in companies receiving the full six month SPC extension in every case).
This article covers:
- Background on the Supplementary Protection Certificate (SPC) system
- Background on the Januvia case
- The CJEU decision
- Hogan Lovells analysis of the CJEU negative term SPC decision