With the recent issuance of a Royal Decree No. 8359/MB dated 30 September 2009 by the Saudi government, a mechanism for providing Exclusive Marketing Rights (EMR) for certain pharmaceutical related patent applications filed under the former Saudi Patent Law No. M/38 on 18 January 1989, has been adopted by the Saudi Food and Drug Authority (SFDA) in collaboration with the Ministry of Health, the Saudi Patent Office and the Ministry of Commerce and Trade. 

Based on the above, SFDA will grant an exclusive marketing and manufacturing right of pharmaceutical products within the Kingdom of Saudi Arabia, under the following conditions:

 1. That the patent application was still pending at the time of the implementation of the new law of Patents, Layout Designs of Integrated Circuits, Plant Varieties and Industrial Designs.

 2. The subject matter of the invention must be patentable pursuant to  the provisions of the Saudi Patent Law. 

3. A corresponding patent, must have been granted for the same invention in home country or in U.S. or European Union.

 4. The term of protection of the corresponding U.S. or European Union patent has not expired yet.

 In order to obtain such right for marketing and production, a written application MUST be submitted to the General Directorate of Industrial Property (Saudi Patent Office) accompanied by all supporting documents, well before 25 March 2010.

 The accepted applications that meet the statutory provisions will be referred to SFDA, for approval. 

Should you require further details or have any questions with regards to the above, please do not hesitate to contact us.