The CJEU On Supplementary Protection Certificates For Combination Products

The CJEU decisions in Medeva (C-322/10), Georgetown (C-422/10), Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)

The CJEU rendered in late November 2011 its decision in a number of cases referred by the English courts regarding the possibility of obtaining a Supplementary Protection Certificate for combination products. The CJEU stated that Supplementary Protection Certificates are only to be granted in accordance with the wording of the patent claim.

What is an SPC?

The purpose of obtaining a Supplementary Protection Certificate (SPC) for a medicinal product is to prolong the patent protection for a period of up to five years. The conditions for obtaining an SPC are laid down in Regulation no. 469/2009, article 3, which among other things requires that the product is protected by a basic patent in force, cf. article 3 (a), and that a marketing authorization (MA) has been granted in accordance with Directive 2001/83/EC or Directive 2001/82/EC, as