The mechanism for providing and protecting Exclusive Marketing Rights for certain pharmaceutical products, jointly formulated by the Ministry of Health, King Abdul Aziz City for Science and Technology and the Ministry of Commerce and Industry, has received the approval of His Majesty the King on 11.10.1430H (30.9.2009).This mechanism applies to pharmaceutical products for which patent applications had been submitted under the old Patent Law issued by Royal Decree No. 38/M dated 10.6.1409H (18.1.1989) and were still pending at the time of coming into force of the Law on Patents, Layout Designs of Integrated Circuits, Plant Varieties and Industrial Designs issued by Royal Decree No. 27/M dated 29.5.1425H (17.7.2004).
Consequently, the Saudi Food & Drug Authority will provide exclusive right for marketing and manufacturing in the Kingdom, of those pharmaceutical products covered by the mechanism. The term of exclusive marketing and manufacturing right will expire on the same date the patent expires in the United States or the European Union whichever comes first. The applications for products covered by the mechanism must meet the following conditions:
- Such application was still pending at the time the Law on Patents, Layout Design of Integrated Circuits, Plant Varieties and Industrial Designs, came into effect by Royal Decree No. 27/M dated 29.5.1425H (17.7.2004).
- The subject matter to which the product relates is patentable under the Laws of the Kingdom of Saudi Arabia
- A patent has been issued for the product by the country of origin and/or the United States or European Union.
- The patent granted by the United States or European Union has not expired.
The application for getting the right of exclusive marketing and manufacturing should be submitted to the General Department of Industrial Property at King Abdul Aziz City for Science & Technology, supported by all necessary documents, within six months period from the date of approval by His Majesty the King. After scrutinizing the application and making sure that it meets all the conditions, the application will be transferred by KACST to the Saudi Food & Drug Authority.