SAUDI ARABIA Law and Practice Contributed by: Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed AlDhabaan & Partners Eversheds Sutherland
3.5 Reimbursement and Pricing/Linkage Markets The key difference is in the pricing rules, as outlined in Article 15 of the Pricing Rules. The price of bio ‑ logical products manufactured locally under licence from foreign companies can be fixed for up to seven years if all manufacturing phases are transferred to Saudi Arabia. Beyond the pricing differences noted in 3.2 Data and Regulatory Exclusivity , the same basic reimbursement and pricing procedures apply to both biologics or biosimilars and small molecules. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Availability and Legal Framework In Saudi Arabia, supplementary protection certificates (SPCs) or similar patent term extension instruments are available. These are governed by the Patent Law and its implementing regulations, which aim to extend the protection of patents beyond their standard term to compensate for the time taken to obtain regulatory approval. Applicable Laws and Main Provisions The main provisions related to SPCs in Saudi Arabia are found in the Patent Law. This law provides the framework for extending the patent term for pharma ‑ ceuticals and other regulated products to account for the time required for regulatory approval. Patents Eligible for SPCs Patents that can form the basis of an SPC include those covering: • active pharmaceutical ingredients (APIs); • medicinal products; • processes for manufacturing medicinal products; and • medical devices. Identity of the Applicant The identity of the applicant for an SPC matters. Typi ‑ cally, the originator or the patent holder is the one who applies for the SPC. However, third parties can also apply for an SPC if they have obtained the necessary
rights from the patent holder. The originator can be denied an SPC if a third party has already obtained an SPC based on the originator’s basic patent, provided the third party has the legal rights to do so. Rules for Different Products Under the Same Patent In terms of different products under the same patent, an SPC can be granted for each product covered by the same patent, provided each product meets the criteria for SPC eligibility. In terms of a single prod ‑ uct protected by multiple patents, an SPC can be granted for each patent, but the total duration of the SPCs cannot exceed the maximum extension period allowed. Rules for Combination Products For combination products, the SPC can be granted if the combination is covered by the basic patent and meets the regulatory approval requirements. The com ‑ bination must be specifically claimed in the patent or be clearly derivable from the patent claims. Specific Considerations and Jurisdictional Nuances Saudi Arabia does not currently have specific pro ‑ visions for SPC manufacturing waivers. However, the general principles of patent law and regulatory approval processes apply. The time taken for regula ‑ tory approval by the SFDA is a critical factor in deter ‑ In Saudi Arabia, paediatric extensions are available as part of the broader framework for patent term exten ‑ sions. These extensions are designed to encourage the development of medicines specifically for paedi ‑ atric use by providing additional market exclusivity. Applicable Laws and Main Provisions The primary legal framework governing paediatric extensions in Saudi Arabia includes the Patent Law and its implementing regulations. The main provisions are as follows. mining the duration of the SPC. 4.2 Paediatric Extensions Availability
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