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Monday 23 February 2009

First paediatric extension application filed in Denmark

In October 2008 the first application for extension of a supplementary protection certificate under Regulation 1901/2006 on Medicinal Products for Paediatric Use was filed in Denmark. The filing took place before the Danish Patent and Trade Mark Office had even issued a request form and formal guidelines regarding supplementary protection for medicinal products for paediatric use, but it was still in accordance with the amended patent regulations that entered into force on 1 May 2008. In addition, the filing took place before the Danish Agency for Governmental Management had approved the official fee for such types of application. 

[Source: note by Casper Struve and Ellen Wetke (Zacco) for Intellectual Asset Management magazine].


Anonymous said...

For which product (which basic SPC) was the extension filed?

Anonymous said...

I have checked the register at the danish patent office. It relates to Caspofungin (Merck & Co). The application is currently being examined at the Danish Patent Office.

Please note that the reference in the note to the application for SPC extension being made "in accordance with the amended patent regulations that entered into force on 1 May 2008", seems to relate to the fact that prior to 1 May no provisions in the Danish patent regulations existed for applying for a SPC extension, and not that the SPC extension has been granted. I believe that the above sentence should be interpreted such that this application conformed to the formal provisions of the amended Danish patent regulations.