B9 10538. Gertjan Kuipers en Tjibbe Douma, De Brauw Blackstone Westbroek: Negative term SPC possible says CJEU. Legal alert bij HvJ EU, 8 december 2011, zaak C‑125/10, B9 10529. Merck/DPMA).
“On 8 December 2011, the Court of Justice of the European Union ("CJ") delivered its decision on another SPC matter that has caused disharmony in Europe: the possibility to grant zero and/or negative term SPCs. The CJ ruled that it is possible to grant a negative term SPC; it also clarified that negative term SPCs should not be rounded up to zero.
Why is a negative term SPC useful? Supplementary Protection Certificates ("SPCs") are intended to compensate pharmaceutical companies for the loss of effective patent term caused by the delay in obtaining regulatory approval. SPCs will have a negative term if this delay is less than five years. At the time the first SPC Regulation (1768/92) came into effect, a negative term SPC was fruitless and thus not applied for. This changed with the introduction of the Paediatric Regulation (1901/2006), which provided for a six-month paediatric extension for an SPC already in place for a medicinal product, in order to promote research regarding the paediatric effects of the medical product at issue. As the grant of a paediatric extension is possible only if an SPC is in place, a six-month extension of a negative term SPC could still result in considerable benefits for the proprietor, provided the negative term is not more than six months. Disharmony in Europe In Merck Sharp & Dohme Corp. ("Merck") v. Deutsches Patent- und Markenamt C-125/10, Merck applied for an SPC throughout Europe for its product sitagliptin. This resulted in various decisions, including the grant of a negative term SPC in the UK and the Netherlands and a zero term SPC in Greece (because it was believed a negative term was not possible and should be rounded up to zero).”
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