SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland
drug, its intended use, and evidence supporting its designation as an orphan drug. The SFDA reviews these applications and grants designa - tion based on the criteria outlined.
If a PI is issued, the plaintiff will file the main claim within seven days as from the date of issu - ing the injunction. Appealing the decision imposing the PI does not result in the PI enforcement being stayed. 5.2 Final Injunctive Relief There is no distinction in Saudi Arabian law between PIs and final injunctions as both are dealt with as per as a form of interim/summary relief. The same provisions which apply to PIs apply to final injunctions. In terms of enforceability of final injunctions in Saudi Arabia, final injunctions in Saudi Arabia become enforceable upon the issuance of a written decision by the court. The enforcement process begins once the judgment is final and binding. 5.3 Discretion to Award Injunctive Relief (Final or Preliminary) Courts in Saudi Arabia are granted the power to award damages in lieu of an injunction. 5.4 Damages Damages are awarded according to the Civil Transactions Law to the extent required to rem - edy the sustained harm and compensate the aggrieved party for the lost profit. Saudi Ara - bian law does not recognise punitive damages or legal interest. There is no prescribed way to be followed by judges in awarding damages for patentee/exclusive licensees, and Saudi Arabian judges will apply the general rules prescribed in the Civil Transactions Law while calculating damages. There is no typical court judgment for the pharma/biopharma/medical device industry, as
5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
Undertakings in the form of a financial guarantee can be requested by the court ahead of issu - ing a PI. This undertaking serves as a guarantee to compensate the defendant for any damages incurred if it is later determined that the injunc - tion was wrongfully granted. The undertaking typically remains in force until the final resolu - tion of the case. PIs are enforced as per the terms of the Saudi Arabian Enforcement Law. Enforcement takes place through an application to be filed to the competent enforcement court and the method of actual enforcement will differ depending on the nature of the injunction. Once an enforcement application is accepted by the enforcement court, the respondent will be notified to voluntarily com - ply with the injunction within five days. If the five days lapse before the respondent voluntary com - plies with the injunction, the enforcement court will proceed with compulsory enforcement. If a financial guarantee is required before the PI is issued, the court may decide the quantum of such guarantee. However, there are no guide - lines on how this quantum will be determined. It will usually be an amount sufficient to compen - sate the defendant for the potential harm should the plaintiff lose the case.
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