Merck: a case note

"Where do we stand on negative and zero term SPCs: analysis of the views of the AG Bot Merck v Deutsches Patent Case C-125/10" -- this is the title of a case comment that has just been published in volume 11, issue 6 of the bimonthly Bio-science Law Review, published by Lawtext Publishing (here).  The authors are Maria Isabel Manley (Partner and Head of Regulatory Practice, Bristows) and Muriel Riba (Associate, Regulatory Practice, at the same firm).  According to the abstract:

"Merck v Deutsches Patent is the first case at EU level to consider the possibility of granting a negative or zero term SPC. Advocate General Yves Bot recently gave his opinion on this issue of crucial commercial importance to the industry, which so far has been approached inconsistently by various Member States.

Although the SPC Regulation provides the tools to calculate the duration of an SPC, it does not address the situation where the period between the date on which the application for a basic patent was lodged and the date of grant of the first MA is less than five years, such that the SPC would have a negative or zero term. If the SPC was an independent right, this lacuna in the law would not have much importance. However, given that the option to apply for a paediatric extension depends on the prior existence of an SPC, the issue of negative or zero term SPCs is of major relevance.

This article assesses the impact of the Advocate General's opinion and an alternative interpretation that we consider to be more consistent with the objectives pursued by both the SPC and the Paediatric Regulations".