Negative Term SPCs: Clarity Provided by the CJEU

The Court of Justice of the European Union (CJEU) has delivered its judgement in Merck Sharp & Dohme Corporation (C-125/10), relating to negative term Supplementary Protection Certificates (SPCs). The full decision can be accessed via the link below.

http://curia.europa.eu/juris/document/document.jsf?text=&docid=116141&pageIndex=0&doclang=en&mode=req&dir=&occ=first&part=1&cid=236089

Background

The term of a SPC is determined by calculating the amount of time which elapsed between the filing date of the patent application (on which the SPC is to be based) and the date of the first marketing authorisation, minus 5 years. There is an overriding proviso that the term of SPCs cannot exceed 5 years from the date on which they take effect, unless a paediatric extension has been granted. A paediatric extension is a 6 month extension of a SPC which can be obtained when certain requirements are fulfilled.

The Question

In the present case, Merck applied for a SPC in numerous countries across Europe covering the drug sitagliptin. The SPC application was based on the European Patent EP1412357 which was filed on 5 July 2002. The first EU marketing authorisation for sitagliptin was approved on 21 March 2007. Thus, the term of the SPC would have been a negative duration of 3 months and 14 days.

Why would anyone seek to obtain a negative term ‘extension’ to their patent rights?  Would this not, in effect, decrease the term of protection? 

The answer is that if, as in the case of sitagliptin, the term of the negative term SPC is less than six months, then if a paediatric extension to the SPC is obtained, this will provide a net extension to the term of protection.

The question of whether a negative term SPC could be granted was considered by numerous patent offices and Courts around Europe, with some countries (including the UK and the Netherlands) deciding that a negative term SPC could be granted, while others (including Germany) stated that it could not.  A third camp (including Greece) said that in the situation, a zero term SPC could be granted.

The German court referred the question to the CJEU for clarification, and the CJEU have now confirmed that negative term SPCs can indeed be granted.  It was also decided that where the term of an SPC was exactly zero, zero term SPCs can also be granted.