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EU Commission Report: Saudi Arabia Must Improve IP Protection

To attract foreign investment and drive economic growth in alignment with its Vision 2030, Saudi Arabia is diversifying its economy and developing its health care sector.

Improving intellectual property (IP) protection and enforcement will be critical to achieving Saudi Arabia’s health care goals. But the European Commission’s biennial Report on the Protection and Enforcement of Intellectual Property Rights in Third Countries shows there is still much work to do.

Recently, the country has made progress with the Ministry of Commerce and Investment’s establishment of the Saudi Authority for Intellectual Property Rights (SAIPR). This initiative aims to harmonize the jurisdiction of IP under a single entity. Standardizing the process of IP registration promises to contribute to achieving a high standard of protection and enforcement of IP and provide a more level playing field for IP stakeholders.

However, the EU report notes that Saudi Arabia still has systemic IP challenges to address. In the last two years, for example, the Saudi Arabia Food and Drug Authority (SFDA) has granted marketing approvals to Saudi companies to produce generic versions of medicines that are still under patent protection in the Kingdom.

Additionally, in 2018, the SFDA granted marketing approvals for generic medicines that relied on the clinical trial data of reference medicines before their regulatory data protection period had expired. Draft regulations released in January 2020 would further weaken protection of regulatory test data in Saudi Arabia.

Effective IP protection and enforcement is vital for the development of innovative medicines and treatments for patients in Saudi Arabia and around the world. It creates incentives for companies to invest the considerable resources required to bring new treatments to market. Saudi Arabia can only fulfill its vision by significantly improving IP protections.


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