The legislation governing Supplementary Protection Certificates for medicinal products, EU
Regulation No. 469/2009 ‘the Regulation’, scores well on brevity but it falls down badly when it comes to clarity. David Rose at SJ Berwin LLP, considers whether the “dysfunctional” label is merited and if so why. In doing so, three specific aspects of the SPC system will be considered: combination therapies, new indications and active ingredients.