SPCs and RDP compared

The SPC Blog has just spotted a recent general interest article, "The Supplementary Protection Certificate for Medicinal Products: An Update", written by Carla Schoonderbeek (NautaDutilh) for Who's Who Legal. The article contrasts SPC protection and paediatric extensions with Regulatory Data Protection (RDP) and concludes:

"The SPC has proven an effective instrument in protecting innovation for medicinal products. The most important difference with the instrument of RDP is the duration of the protection. Both RDP and SPC use the first marketing authorisation date as the starting point for the protection period, but RDP is limited to 10 or 11 years, and an SPC can stay valid until 15 years have elapsed.

A disadvantage of both SPC and RDP is that both use the first original marketing authorisation for a specific medicinal product as the basis for protection. The major importance of incremental development of medicinal products after their first marketing is not recognised by either protection mechanism. This may lead to ‘orphaning’ of medicinal products, which could have been extremely useful for different applications other than the one they were originally authorised for, because it is difficult for industry to invest in know-how that will not lead to additional returns".