Case 2 – Escitalopram

This case was chosen for the course because it lies squarely at the crossroads between patent law, supplementary protection certificate (SPC) law, and regulatory law. After studying this case, you will appreciate how the conditions for obtaining market approval of a medicinal product can interact with the conditions for the validity of an SPC. You will also learn how the legal term “new product" is viewed differently under patent law on one hand and SPC / regulatory law on the other hand.