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

opportunity to exclude one of the proposals. The Khibra portal will then automatically choose one of the experts to complete the mission. Technical or Scientific Advisors Courts in Saudi Arabia do not appoint technical or scientific advisors and only appoint experts when needed. PIs Practically speaking, PI proceedings do not involve the appointment of court experts. 1.13 Use of Experiments There is no mechanism to adduce results from experiments in order to prove or disprove infringement or validity. Additionally, using experiments is not common in Saudi Arabian courts. 1.14 Discovery/Disclosure There is no specific discovery and disclosure process for patent litigation in Saudi Arabia. Dis - covery and disclosure are not actually specifically addressed in Saudi Arabian law. However, parties are required to prove their cases by submitting the evidence they have in their possession either in the form of documents or submitting dispositions (as to be accepted by the court). Additionally, a party can ask the court to order the counterparty to submit documents proving evidence in their possession in certain circumstances. 1.15 Defences and Exceptions to Patent Infringement Defences and Exceptions In Saudi Arabian law, several defences and exceptions are available in infringement actions. Some of the key defences and exceptions are as follows.

• Invalidity: a common defence where the defendant argues that the patent or intellectu - al property right in question is invalid. Article 32 of the Patent Law provides that any party with an interest may challenge the decision granting a protection document before the Committee for Reviewing Patent Disputes, and seek total or partial revocation, relying upon the violation of the stipulated conditions for granting the protection document. • Consent/licence: if the alleged infringer has obtained permission or a licence from the rights holder, this can serve as a defence against infringement claims under Article 21 of the Patent Law. • Exhaustion: once a patented product is sold by or with the consent of the patent owner, the patent owner’s control over the product is exhausted, and the buyer is free to use or resell the product. • Compulsory licence: under certain conditions, the government can grant a compulsory licence to use a patented invention without the consent of the patent owner, typically to address public health needs under Article 24 of the Patent Law. Special Considerations for Life Sciences Cases Life sciences products, including pharmaceuti - cals and medical devices, must comply with reg - ulations set by the Saudi Arabian Food and Drug Authority (the “SFDA”). This includes obtaining necessary approvals and adhering to guidelines for clinical trials. All clinical studies must be registered with the SFDA and comply with guidelines for good clini - cal practice and ethical standards. The SFDA has provisions for the emergency or compas - sionate use of unapproved medical products,

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