New SPC decision handed down by the Court of Justice of the European Union (CJEU)
The Court of Justice of the European Union (CJEU) has handed down its decisions in two cases Synthon
v Merz Pharma (C-195/09) and Generics v Synaptech (C-427/09).
With these new decisions it may follow that a medicinal product which has been placed on the market in the Community before obtaining a Directive 65/65 compliant marketing authorization (in particular, without
undergoing safety and efficacy testing) cannot be the subject of a Supplementary Protection Certificate (SPC), because the product does not fall within the scope of the SPC regulation and therefore cannot be the subject of an SPC.
In short Merz had been offering memantine for sale on the German market since before 1 September 1976, for use in the treatment of Parkinson's disease. That product was covered by an early German marketing authorisation, which did not require medicinal products to be tested for safety or efficacy.
Merz obtained a European patent relating to memantine as a second medical use of memantine in treating Alzheimer's disease. In May 2002, Merz were granted a series of marketing authorisations for memantine in the treatment of Alzheimer's disease. These authorisations did involve safety and efficacy testing in accordance with the relevant European Directive, Directive 65/65. Merz used these marketing authorizations to apply for and obtain SPC’s for a term of five years.
Synthon brought proceedings before the UK's High Court, requesting that the SPC be declared
invalid. The High Court referred a number of questions to the CJEU and the CJEU finally decided that, when a product has been placed on the market in the Community as a medical product before obtaining a Directive 65/65 compliant marketing authorisation (in particular, without undergoing safety and efficacy testing), the product does not fall within the scope of the SPC regulation and therefore cannot be the subject of an SPC.
The CJEU has also handed down its decision in Generics v Synaptech (C-427/09). The Court held, for
the same reasons as those in Synthon v Merz Pharma, that since Synaptech's product galantamine had already been placed on the market in the Community before undergoing the safety and efficacy testing required by
Directive 65/65, it did not fall within the scope of the SPC regulation and therefore could not be the
subject of a valid SPC.
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