The CJEU rendered its judgement in Merck (C-125/10) in December 2011, stating that it is possible to obtain a negative term Supplementary Protection Certificate.
The term of an SPC
The term of an SPC is laid down in Regulation 469/2009, article 13 (1), which states that the duration of an SPC is equal to the period elapsed between the date on which the application for a basic patent was lodged and the date of the first Marketing Authorization (MA) in the Community, reduced by a period of five years.
The facts
Merck's application for an SPC was rejected by the German authorities on the ground that only four years eight months and sixteen days had elapsed between the date on which the patent application was lodged and the date on which the first MA was issued.
Enabling paediatric extension - without going all in
Merck submitted that even if the SPC cannot result in a positive duration, it can nevertheless have a zero or negative duration, emphasizing that an SPC is a requirement for obtaining a paediatric extension. A paediatric extension is prolonging the patent protection period by 6 months and can be obtained by conducting paediatric studies and submitting the results thereof.
Accepting Merck's reasoning, the CJEU stated that a negative term SPC can be granted. However, the CJEU further stated that the patent holder will not be entitled to the full 6-month paediatric extension running from the expiry day of the basic patent (zero-term SPC).
The paediatric extension starts on a date to be determined by deducting from the patent expiry date the difference between five years and the duration of the period elapsed between the lodging of the patent application and the grant of the first MA. In this case a paediatric extension would thus start to run 3 months and 14 days prior to the expiry date of the patent, thus prolonging the patent protection period by only 2 months and 14 days.
Conclusion
Provided the negative duration is not more than 6 months, the patent holder will benefit from a paediatric extension. The possibility of having a negative-term SPC is thus clearly good news for the pharmaceutical industry and may encourage companies to undertake paediatric research and development to a greater extent.
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