Posts by: Sidsel Hauge | (1) posts

Court of Justice of the EU confirms zero or negative duration for SPCs

On 8 December 2011, the Court of Justice of the European Union (CJEU) issued its judgment in case C-125/10 (“Merck”). This case concerns the duration of a Supplementary Protection Certificate (SPC) according to Article 13 of the SPC Regulation EG/469/2009.

Summary of the case
Merck applied for a SPC for the product Sitaglipin under conditions where the duration of the SPC as calculated according to Article would result in a negative term of the SPC, with the prospect of being eligible for a subsequent six month extension of the SPC. The application was rejected by the Deutches Patent- und Markenamt. Merck appealed this decision to the Bundespatentgericht which referred the following question to the CJEU for a preliminary ruling:

“Can an [SPC] for medicinal products be granted if the period of time between the filing of the application for the basic patent and the date of the first [marketing authorisation] in the community is shorter than five years?”

The court has now ordered that such SPC can be granted despite the fact that the duration is zero or negative when calculated according to Articles 13(1) and (2), because the same SPC subsequently may be the subject of a further six month extension provided for under Article 13(3) of the same Regulation – that is when the marketing authorisation includes all studies conducted in compliance with an agreed pediatric investigation plan (PIP) according to Regulation No 1901/2006.

Conclusion
This means that when the period between the filing of a patent application and the date of the first marketing authorisation is less than five years but more than 4½ years, applicants could benefit from between one day and six months in addition to the normal 20 year term of the basic patent.

The applicant of an SPC must observe the time limit for filing an SPC which according to Article 7(1) of the Regulation is six months from the later of the grant of the patent or the date of the first marketing authorisation of the product in question. At that time there might not be an pediatric extension of the regular patent term, but if the product were to be the subject of a pediatric study in accordance with Regulation 1901/2006 there is provisions for a further six months term of the SPC.

Sidsel Hauge, European Patent Attorney