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Extension of SPC"s for medicinal products for pediatric use

On 26 January 2007 new Regulation (EC) No. 1901/2006 will enter into force.

This regulation is aimed at providing European legislation that should improve the development and accessibility of drugs for use in the “pediatric population” (children up to the age of 18).

Maximum duration
One of the measures by which this is effected is an extension of the maximum duration of supplementary protection certificates (SPC”s) for drugs in case these are (also) for pediatric use. SPC”s can be applied for by the patentee to compensate for the time-consuming procedures that are required to obtain marketing authorization. The maximum duration of an SPC is five years. The new regulation provides for an extension of a further six months, thus extending the total possible patent protection to 25.5 years.

Pediatric investigation plan
To obtain the extra six months protection, studies must be conducted in compliance with an agreed pediatric investigation plan. A copy of the statement indicating compliance with this completed pediatric investigation plan must be filed at the competent industrial property office.

The SPC Regulation (EEC) No. 1768/92 will be amended to reflect these changes.