SPCs: Questions of validity

Over the years, there have been numerous requests to the Court of Justice of the European Union (CJEU) to issue preliminary rulings in relation to the EU regulation (469/2009) concerning supplementary protection certificates (SPCs) for medicinal products. So far, Danish courts have not engaged in this move to the CJEU, but in a pending court case between Teva and Amgen concerning an SPC that Amgen obtained for lipegfilgrastim (the active ingredient of neutropenia treatment Lonquex) based on Teva’s marketing authorisation (MA) for Lonquex, the issue of a reference to the CJEU has been raised.