To ensure smooth patent linkage and prevent conflicts, pharmaceutical and biotech companies are encouraged to disclose any relevant Saudi and/or Gulf Cooperation Council (GCC) patents when applying for product registration with the regulatory authority. If a patent is granted post-registration, companies have a 30-day window to inform the regulatory authority for proper linkage. The linkage system primarily serves to safeguard the regulatory authority from approving potentially infringing products. Generic companies are expected to acquire a freedom-to-operate report, prepared, and signed by a qualified local IP attorney.
By way of background, Saudi Arabia has a patent linkage system in place to link the approval of generic drugs with the status of the corresponding patents on brand-name drugs. The Saudi Food and Drug Authority (SFDA) is responsible for regulating the pharmaceutical market in the country and enforcing the patent linkage system.
A generic drug can only be registered and marketed in the country if the corresponding patent on the brand-name drug has expired or if the SFDA has determined that the patent is not valid or not infringed upon by the generic drug. This helps to protect the exclusivity period of the brand-name drug and prevent the approval of generic drugs that would infringe on the patents of the brand-name drug.
One of the main benefits of patent linkage is that it helps to provide a strong incentive for pharmaceutical companies to invest in research and development for new drugs. By protecting the exclusivity period of brand-name drugs, companies can recoup their investment in R&D and generate revenue from their patented drugs before generic competition enters the market.
For any inquiries regarding patent linkage, please reach out to us at news@sabaip.com for expert consultation