EU ? Top court confirms validity of negative term SPCs

摘要

The decision by the Court of Justice of the European Union to confirm the validity of negative term supplementary protection certificates (SPCs) means that some innovator companies could generate considerably more revenue from having carried out research into how suitable their medicines are for children.Merck Sharp & Dohme's anti-diabetic Januvia (sitagliptin), the drug which was at the centre of the case, is one such product: the decision means the SPC protection for Januvia can be extended by two and a half months, ie until mid-September 2022, Global sales of Januvia in the third quarter of 2011 alone totalled $846 million. Merck has welcomed the 8 December 2011 decision, which upholds the opinion issued by a CJEU advocate general earlier this year. "We believe this broad-reaching decision is in the public interest because it resolves the diversity of opinions concerning negative terms SPCs and sends an encouraging message for future pharmaceutical innovation in Europe," the company said.