Supplementary protection certificates for combination products: new combinatorics?

Abstract

According to the WHO, the development of fixed-dose combinations of drugs is becoming increasingly important from a public health perspective. Furthermore, such combination products play a more and more critical role in lifecycle strategies of originator pharmaceutical companies. It is not a coincidence that the vexed issue of the precise prerequisites of protection for combination products under Regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products (SPC Regulation) has occupied courts and patent offices in several EU Member States in recent years. One central conundrum, not yet clarified by the ECJ but analysed in AG Trstenjak's Opinion of 17 June 2011, is whether or not a patent is suitable to qualify as a ‘basic patent’ within the meaning of Article 3(a) of the SPC Regulation for an SPC on a combination product when the patent is directed towards only one active ingredient of that combination. Which test is to be applied in such or a similar constellation? Is AG Trstenjak's proposal valid? AG Trstenjak's Opinion, if followed by the ECJ, will have an enormous impact on both lifecycle strategies of originators and market entrance options of generic producers of combination drugs. Furthermore, it could well be the case that the validity of existing SPCs will be challenged before the national patent courts in this respect.