The Court of Justice of the European Union (CJEU) ruled yesterday in an important case (C-125/10, Merck Sharp & Dohme Corp. v Deutsches Patent- und Markenamt), relating to Supplementary Protection Certificates (SPCs). The decision of the CJEU is binding upon all national patent offices and courts, and dictates how the term of an SPC is calculated, especially in view of a 6-month extension of term that may be available.

In essence, the CJEU has approved "Model A" of an article published on 7 July 2007 by Mike Snodin and John Miles of this firm, which introduced the revolutionary concept of zero and negative term SPCs.

That is, the CJEU has decided that SPCs can be granted even if they initially have a zero or negative term, i.e. if less than 5 years and 1 day has elapsed between patent filing and Marketing Authorisation (MA) issuance. This is because, provided that at least 4 years, 6 months and 1 day has elapsed from between patent filing and MA issuance, a zero or negative term SPC can serve as the basis for an extended SPC with a positive term.

The particular factual background to this case is discussed in our IP Update no. 153 (relating to the opinion of the Advocate-General that has effectively been confirmed by the Court). However, the essential points of the case, as well as possible actions that you may wish to take, are outlined below.

Legal Principles

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.

The "normal" (unextended) duration of an SPC after the patent expiry is X - 5 years, where X is the period between the patent filing date and the (subsequent) issuance of the marketing authorisation. Although the normal duration is capped at a maximum of 5 years after the patent expiry, this duration can be extended by 6 months if the product has been the subject of clinical trials in the paediatric population in accordance with an investigation plan that has been agreed with the European Medicines Agency.

The question addressed by the CJEU is whether the potential availability of a 6-month extension of term gives rise to the possibility of obtaining, as an initial step, an SPC with a normal term that is either zero or negative. Such zero or negative terms could arise if less than 5 years and 1 day has elapsed between patent filing and Marketing Authorisation issuance (i.e. if X in the paragraph immediately above is less than 5 years and 1 day).

The point of having the potential 6 month extension is to provide a reward to drug companies for carrying out clinical trials in the paediatric population. Mike Snodin and John Miles argued in their article that zero or negative term SPCs should be granted, in order to maximise the effect of this reward.

CJEU Decision

The CJEU has now decided that SPCs can indeed be granted even in situations where X is less than 5 years and 1 day, i.e. the normal term is zero or even negative. For example, if the normal term of the SPC were to be "minus 2 months" and an appropriate paediatric trial had been carried out, then the 6 month extension would mean that the actual term would be 4 months post-expiry of the patent.

Action points

Please contact us for advice if you have a medicinal product for which the following criteria apply:

  • Marketing Authorisation for the medicinal product could be (or has been) issued in Europe at least 4 years 6 months and 1 day after the date of filing of a patent protecting the product.
  • The results from clinical trials in the paediatric population have been (or will be) submitted to one or more regulatory bodies in Europe.

If these conditions are met, there could well be a benefit in applying for Supplementary Protection for the product.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.