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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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