In July 2007, in a predecessor publication to Scrip Regulatory Affairs, my colleague John Miles and I introduced the revolutionary concept of zero or negative term supplementary protection certificates (SPCs). Our view was that the granting of such SPCs was necessary in order to provide full effect to the reward of a six-month SPC extension governed by Article 36(1) of the EU Paediatric Regulation. In a decision issued on 8 December 201 1, the Court of Justice of the EU has now agreed with our proposition and has effectively ruled that Model A of our 2007 article represents the correct approach for calculating the term of an extended SPC.The decision of the Court of Justice follows the opinion previously provided by advocate general Yves Bot.
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