SAUDI ARABIA Law and Practice Contributed by: Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed AlDhabaan & Partners Eversheds Sutherland
Forum and Timeframes The Patent Law does not provide for a specific forum regarding data and market exclusivity. However, in general, commercial courts have jurisdiction over intellectual property law claims and violations accord ‑ ing to Article 16 (3) of the Law of Commercial Courts. 2.3 Acceptable Pre-Launch Preparations Article 47 of the Patent Law only mentions a limited exemption for “non-commercial activities relating to scientific research”, but does not explicitly address Bolar-type exemptions for generic manufacturers’ pre-launch activities. The regulatory framework does not provide clear guidance on what preparatory acts are permitted before patent expiry. 2.4 Publicly Available Drug and Patent Information Saudi Arabia does not have an Orange Book equiva ‑ lent system. The SFDA maintains a public list of the approved drugs and those awaiting approval. While the SFDA issued the Regulatory Framework for Drugs Approval (the “Regulatory Framework”), it does not include a system for notifying marketing authori ‑ sation (MA) reference product holders about generic/ biosimilar applications. Monitoring is probably needed as there is no sufficient data on the existence of an automatic notification system. 2.5 Reimbursement and Pricing/Linkage Markets There is no formal patent linkage system in Saudi Arabia that connects MA or pricing/reimbursement decisions to patent status. However, the SFDA’s Pric ‑ ing Rules for Pharmaceutical Products (the “Pricing Rules”) provide some relevant guidelines. Patent Status Considerations Innovative and biological products manufactured locally under licence from international companies during the patent term must be priced the same as the innovative product (Article 3 (D) and 3 (E) of the Pricing Rules). Once patents expire, products are treated as generics for pricing purposes.
Committee for Reviewing Patent Disputes, which includes two technical members. Forum shopping is not permitted in Saudi Arabia. The principle of avoiding forum shopping is upheld to ensure judicial efficiency and consistency in rulings.
2. Generic Market Entry 2.1 Infringing Acts
The Patent Law and its implementing regulations do not contain specific provisions regarding patented pharmaceutical products. In addition, there are no published Saudi Arabian court decisions addressing when infringement rights crystallise, what constitutes infringing, special considerations for second medical use patents and skinny labelling, or rules governing parallel imports. In Saudi Arabia, tender submissions for pharmaceu ‑ ticals are accessible to the public. The Government Tenders and Procurement Law requires all public ten ‑ ders, including those from the Ministry of Health and other governmental agencies, to follow principles of publicity (Article 6) and be published through a desig ‑ nated unified electronic portal (Article 16). 2.2 Regulatory Data and Market Exclusivity Data and Market Exclusivity The Patent Law does not contain specific provisions regarding data and market exclusivity periods for pharmaceutical products, including orphan drugs, paediatric formulations, new indications, combina ‑ tions or reclassifications. However, under Article 19 of the Patent Law, patents receive 20 years of protection from the filing date. Challenges and Frequency The frequency of challenges cannot be reliably assessed due to the lack of a specific legal framework for data/market exclusivity, limited publicly available records, and no dedicated challenge process in the Patent Law. Regulatory Authority The SFDA serves as the regulatory authority for phar ‑ maceuticals and health-related products.
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