A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Sunday 14 March 2010

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".

1 comment:

Anonymous said...

1. In general, it is correct that an SPC is more valuable than the RDP. However, if the first marketing authorization is issued after 15 years from patent filing, the RDP offers a longer term of protection than an SPC with a maximum duration of 5 years. The key advantage of the RDP in that case is that you will get 10 or 11 years of protection, regardless of how late the first authorization issues.
2. Thanks to the bilateral treaty between CH and LI, the Liechtenstein effect has no longer much impact on the EEA SPC duration, because at least for all product patents, the Swiss marketing authorization does not extend to LI at least for one year. These products are put on a "Negativliste" to be revised at the request of the patentee. Once the EU authorization has been issued, the product is eliminated from the Negativliste.

Herwig von Morzé