The Court of Justice of the EU rules in favour of negative term SPCs

The present case (C-125/10 - Merck Sharp & Dohme Corp., v Deutsches Patent- und Markenamt) concerned whether or not it was possible to allow a so-called “negative term SPC” (Supplementary Protection Certificate) when the time from the filing of the patent application to the issuance of a Marketing Authorisation (MA) was less than five years, which normally does not result in the issuance of an SPC. This question is of relevance as another six months of extension of patent protection is available for products forming the basis of an MA for which a Pediatric Investigation Plan (PIP) has been performed and for which a “basic” SPC can be obtained. This six months extension adding to the five year SPC term was introduced to further encourage the development of drugs applicable to children. Merck Sharp & Dohme Corp. applied for a negative SPC extension for the diabetes drug Januvia during 2007 and this decision means that the SPC protection for Januvia can be extended by two and a half months.

The ruling reads as follows:
Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as amended by Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006, read in conjunction with Article 36 of Regulation No 1901/2006, must be interpreted as meaning that medicinal products can be the object of the grant of a supplementary protection certificate where the period that has elapsed between the date of lodging the basic patent application and the first marketing authorisation in the European Union is less than five years. In such a case, the period of the paediatric extension provided for by the latter regulation starts to run from the date determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.

For any further questions in relation to the present case, please contact Camilla Lidén (camilla [dot] liden [at] valea [dot] se).