April 15, 2005

By M.N.Aydin Deris, Senior Partner, Attorney At Law

Data Exclusivity

The regulation on "Data Exclusivity" has come into force on 19 January 2005 upon its publication in the Official Journal of 19 January 2005 - No. 25705.

The Article 9 of the regulation under the heading “ Shortened Application” provides for a period of protection of 6 years running:

• from 1 January 2001 for original products which obtained their very first regulatory clearance in anyone of the Customs Union (E.U.) Countries in respect of which no application for a generic has been filed in Turkey until 1 January 2005,
• or from 1 January 2005 for original products which applied for their very first regulatory clearance in anyone of the Customs Union (E.U.) Countries,

with the proviso that the protection is limited with the duration of the patent in Turkey covering the molecule in question.