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ECJ decides on granting of SPCs

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ECJ decides on granting of SPCs

Ruling by the European Court of Justice (ECJ) on prejudicial questions.

On 3 September 2009 the European Court of Justice (ECJ) gave its ruling in Case C-482/07 on prejudicial questions regarding the interpretation of Regulation (EEC) No. 1768/92, concerning Supplementary Protection Certificates (SPCs) for medicinal products, and Regulation (EC) No. 1610/96, which concerns SPCs for plant protection products.

SPCs may extend the period of protection for a new medicinal product for a period of maximally 5 years. Art. 3(c) of the Medicinal Products Regulation provides that a certificate shall be granted if “the product has not already been the subject of a certificate”. This does not preclude the granting of more than one SPC to different parties based on the same marketing authorization. This interpretation follows from the wording of the � very similar � Plant Protection Products Regulation, which was written at a later date. The Plant Protection Products Regulation was specifically intended to clarify the interpretation of various aspects of the earlier Medicinal Product Regulation.

The Plant Protection Products Regulation provides (in Art. 3(2) that “where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders”.

In 2003 F. Hoffmann-La Roche AG filed an SPC application with Octrooicentrum Nederland (OCNL), the Dutch patent office (formerly “BIE”) for Enbrel (etanercept). These rights were later transferred to AHP Manufacturing BV (AHP). At the time of filing this SPC application, several other SPCs for etanercept were already granted.

According to the (strict textual) interpretation of the relevant regulations by OCNL, this would mean that a further certificate could only be granted on an application filed by AHP Manufacturing BV (AHP) if at least one further application for a SPC had been pending. This not being the case, OCNL refused AHP”s SPC application.

AHP filed suit against this decision of OCNL and the court in The Hague (Rechtbank “s-Gravenhage, the Netherlands) referred the relevant questions to the ECJ on 2 November 2007.

The ECJ now decided that Art. 3(2) “must be interpreted not solely on the basis of its wording, but also in the light of the overall scheme and objectives of the system of which it is a part”. As a result, the regulations do not preclude the grant of an SPC for a product for which, at the time the certificate application was submitted, one or more certificates had already been granted to one or more holders of other basic patents.

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