SAUDI ARABIA Trends and Developments Contributed by: Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed AlDhabaan & Partners Eversheds Sutherland
their products and protecting their IP. These guidelines include requirements for bioequivalence studies for generic drugs and clinical trials for vaccines. The SFDA’s guidelines on bioequivalence studies for generic drugs and clinical trials for vaccines are critical for ensuring drug safety and efficacy. These guidelines provide a clear framework for manufacturers to fol ‑ low, reducing the likelihood of rejected applications and facilitating market entry. The SFDA’s approach to developing guidelines involves public consulta ‑ tion, allowing stakeholders to provide feedback and ensuring that the guidelines are comprehensive and practical. SAIP’s role in protecting IP rights is equally impor ‑ tant. SAIP ensures that patents are granted for new and innovative pharmaceutical products, providing a period of market exclusivity that allows companies to recoup their investment and fund future research. SAIP also plays a crucial role in enforcing IP rights, taking legal action against infringers and ensuring that counterfeit products are removed from the market. IP Litigation Process in Saudi Arabia Filing a lawsuit To initiate the litigation process, the party filing the law ‑ suit must submit a complaint to commercial courts. This complaint outlines the basis of the dispute, the relief sought and any supporting evidence. The court then reviews the submission to ensure it meets the After the lawsuit is filed, the court will notify the defendant (the party being sued). This notification is typically carried out through Short Message Service (SMS) if the defendant is located within Saudi Arabia. If the defendant is outside the country, international service procedures may apply, potentially causing delays. Court hearings necessary legal requirements. Notification of the defendant The court schedules hearings where both parties pre ‑ sent their evidence and legal arguments. The timeline for a case to reach a final decision can vary signifi ‑ cantly, often extending over several months or even
years, depending on factors such as court schedules and the complexity of the case. Issuance of judgment Once the court has reviewed all the evidence and arguments, it issues a judgment. This judgment can include various forms of relief, such as injunctions, damages or orders for specific performance. Appeals process Parties have the right to appeal decisions from lower courts to higher courts, including decisions on injunc ‑ tions and main actions. The timing to file an appeal against a first instance main action decision is typi ‑ cally 30 days from receiving a copy of the decision. The appeal process can take several months, depend ‑ ing on the complexity of the case. Infringement Actions In an action for patent infringement in Saudi Arabia, the primary parties involved are: • the patentee – the owner of the patent who holds the exclusive rights to the invention; and • the alleged infringer – the party accused of infring ‑ ing the patent rights. If a patent is co-owned, each co-owner has the right to use the patent independently. However, co-owners must agree to bring an infringement action jointly. An exclusive licensee, who has been granted the exclu ‑ sive rights to use the patent within a specific territory or field, can bring an infringement action. The licence must be registered with SAIP to be enforceable. Non- exclusive licensees generally do not have the stand ‑ ing to bring an infringement action unless explicitly granted this right in the licence agreement. Trends in Life Sciences and Pharma IP Litigation Several trends are shaping the landscape of life sci ‑ ences and pharma IP litigation in Saudi Arabia. • Increased patent filings and litigation: With the growing pharmaceutical market, there has been an increase in patent filings and related litigation. Companies are keen to protect their innovations and market exclusivity, leading to more disputes over patent infringements.
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