kimson /
1 October 2015Big PharmaMichael Pitzner-Bruun

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.

Already registered?

Login to your account

To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.

Two Weeks Free Trial

For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at