Life Sciences and Pharma IP Litigation 2025

SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland

Important Factors/Difficulties with Asserting Different Types of Patents Process patents Asserting process patents can be particularly challenging due to the difficulty in proving that the infringing party is using the patented process. This often requires detailed technical evidence and expert testimony to establish infringement. Product patents These are generally easier to enforce as the infringing product can be directly compared to the patented invention. Biotechnology and pharmaceutical patents These patents often involve complex scientific data and regulatory considerations, making enforcement more complicated. Reversal of Burden of Proof for Certain Types of Patents In Saudi Arabia, there is a reversal of the burden of proof for process patents. According to Article 48 of the Patent Law, if the subject matter of a patent is a process for obtaining a product, the defendant must prove that the identical product was not manufactured by this process without the consent of the owner of the patent, under two specific conditions: • when the product obtained through a patent - ed industrial process is a new product; or • when there is a substantial probability that the identical product was manufactured through the patented industrial process and the owner of the patent was unable to determine the method actually used despite reasonable efforts. This provision is designed to address the inher - ent difficulties in proving infringement of process patents.

son other than the applicant or the owner of the protection document, then this person may request the Committee to transfer the owner - ship of the application or protection document to him. The case for the transfer application shall not be heard after the lapse of five years of granting the protection unless bad faith on the part of the applicant is established.” Notification of Main Action The notification process for the alleged infringer (in the case of an infringement action) or the pat - entee (in the case of a nullity action) is as follows. • The notification is typically carried by the court through SMS (if the defendant is located in Saudi Arabia). • The service takes place once the first hearing is scheduled. • The location of the infringing entity can impact the service process. If the entity is located outside Saudi Arabia, international service procedures may apply, potentially causing delays. Usual Time to a First Instance Hearing and Decision The time to a first instance hearing and decision can vary, but it generally takes several months from the filing of the action. 1.6 Requirements to Bring Infringement Action Although the Patent Law doesn’t explicitly specify when an infringement action can first be filed, in practice, a main infringement action can only be filed once the patent has been granted. The patent must be validated, and any neces - sary translations must be filed before it can be asserted.

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