News & insights

Saudi Arabia: Exclusive Distribution and Production of Pharmaceutical Products

January 19, 2010

Pursuant to a Royal Decree no. 8359/mb issued on September 30, 2009 approving an agreement signed between the Saudi Ministry of Health, the Patent Office (the King Abdulaziz City for Science and Technology), and the Ministry of Commerce and Industry, the Saudi Food and Drug Authority (SFDA) will start granting exclusive rights in the country for the distribution and production of pharmaceutical products that have corresponding patent applications filed under the previous patent law (Law no. M/38 dated January 18, 1989). This means that all patent applications of pharmaceutical products filed before the issuance of the currently applicable patents, layout designs of integrated circuits, plant varieties, and industrial models law (Law no. 159, issued on July 17, 2004) may be granted exclusive distribution and production.

The requirements to apply for exclusivity are as follows:

1. The patent application of the pharmaceutical product filed under the previous law is still pending at the time of issuance of the new law.

2. The invention must be patentable in line with the country’s law and regulations.

3. A corresponding patent for the pharmaceutical product is already granted in the home country, by the US Patent Office, or by the European Patent Office.

4. The corresponding home, US, or European patent is still valid.

The period of exclusivity will continue until the protection term of the corresponding home, US, or European patent expires, whichever comes first.

To obtain exclusive distribution and production, an application must be submitted before the Patent Office (the King Abdulaziz City for Science and Technology) along with all necessary supporting documents. Applications for exclusive distribution and production must be filed at the Patent Office before the deadline of March 26, 2010. Extension of time is not possible. Accepted applications that meet the statutory requirements will then be referred to the SFDA for approval.

The main purpose of Royal Decree no. 8359/mb is to tackle the issue of novelty under the previous and the new patent laws of the country. Under the old system, previously disclosed applications were determined as patentable regardless of the lack of novelty. This means that patents granted in foreign markets such as the US and the European Union were upheld in Saudi Arabia. The new law, however, requires absolute novelty and does not recognize patents granted in other markets. The new law was applied retroactively resulting in the rejection of many patent applications filed before 2004 due to the lack of novelty regardless of the date of filing. Therefore, Royal Decree no. 8359/mb was brought to resolve the issue of novelty of patent applications filed under the previous law.

Saba & Co. IP encourages all clients to benefit from the provisions of this Royal Decree and will be more than pleased to assist in the matter.

Should you have any questions, or require any additional information, please do not hesitate to contact us at info@sabaip.com