While Saudi Arabia is becoming an increasingly attractive investment destination for global pharma, some stakeholders continue to have concerns about whether the country’s intellectual property (IP) protection system is truly fit for purpose.
Oscar Delgado of BMS is one such stakeholder. “An adequate IP system, including regulatory data protection that rewards the time and effort we put into generating the data for clinical trials, can truly help create an environment in which biopharma companies can thrive,” he states.
We welcome the commitment of Saudi authorities to improve the IP environment and recent work on IP protection, which is a good start, but there is still an opportunity to improve the regulatory data protection (RDP) laws
“We welcome the commitment of Saudi authorities to improve the IP environment and recent work on IP protection, which is a good start, but there is still an opportunity to improve the regulatory data protection (RDP) laws. RDP is not only about protecting against the disclosure of the innovator’s data, underpinning regulatory approval by the SFDA, but also preventing the reliance on it by generic manufacturers. Where in some cases local manufacturers take advantage of the innovator’s clinical data which should have RDP in place, this undermines the predictability and sustainability of Saudi Arabia in attracting further investments from the private sector.”
Amr Seif of Astellas also feels that there is room for improvement in Saudi Arabia’s IP landscape. “Not all companies have registered their patency rights in Saudi Arabia, and the Saudi authorities have five years of data protection on any file, which is a good thing,” he notes.
A country like Saudi Arabia, which is prioritising innovation within Vision 2030, should respect global IP
“The challenge is that this has not always been respected. A country like Saudi Arabia, which is prioritising innovation within Vision 2030, should respect global IP. I do not think that it is appropriate to see generics coming onto the Saudi market when the originator product is still patented under the US FDA and EMA. Since Saudi Arabia is taking these two authorities as references, there can be more stringent rules on IP protection.”
An opposing viewpoint comes from Ayman Tamer of local firm Tamer Group, who urges global pharma to adapt to a new competitive reality in Saudi. He asserts that “IP protection in Saudi today is quite mature and companies cannot complain that their IP is not in safe custody. However, the days of foreign companies requesting excessive guarantees on IP protection in order to enter the country are over; there is now a willingness to make FDI without unwarranted preconditions thanks to a greater understanding of Saudi regulations and economy. The recent creation of Saudi Authority for Intellectual Property is a reflection of the protective landscape for IP.”
The rules of the game have changed, and Saudi wants local content. If one company is not interested, another will be
Tamer continues, “Big Pharma does not want to build factories in every country in which it operates, especially for high tech products like biologics or vaccines; arguing that the technology transfer required wastes time, damages their bottom line, and creates inefficiencies. However, the rules of the game have changed, and Saudi wants local content. If one company is not interested, another will be.”