SAUDI ARABIA Law and Practice Contributed by: Dr Saud Alromi, Mostafa Ihab, Mohamed Ramadan and Saleh Albadry, Mohammed Al Dhabaan & Partners Eversheds Sutherland
Specific Considerations and Jurisdictional Nuances Saudi Arabia does not currently have specific provisions for SPC manufacturing waivers. How - ever, the general principles of patent law and regulatory approval processes apply. The time taken for regulatory approval by the SFDA is a critical factor in determining the dura - tion of the SPC. 4.2 Paediatric Extensions Availability In Saudi Arabia, paediatric extensions are avail - able as part of the broader framework for patent term extensions. These extensions are designed to encourage the development of medicines specifically for paediatric use by providing addi - tional market exclusivity. Applicable Laws and Main Provisions The primary legal framework governing paediat - ric extensions in Saudi Arabia includes the Pat - ent Law and its implementing regulations. The main provisions are as follows. Patent Law The Patent Law provides the basis for extending the term of a patent to compensate for the time taken to obtain regulatory approval, including for paediatric medicines. Implementing regulations The implementing regulations to the Patent Law outline the specific procedures and requirements for obtaining a patent term extension, including
• active pharmaceutical ingredients (APIs); • medicinal products; • processes for manufacturing medicinal prod - ucts; and • medical devices. Identity of the Applicant The identity of the applicant for an SPC matters. Typically, 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 and Same Patent In terms of different products and same patent, an SPC can be granted for each product cov - ered by the same patent, provided each product meets the criteria for SPC eligibility. In terms of one product, multiple patents, if a single product is protected by multiple patents, an SPC can be granted for each patent, but the total duration of the SPCs cannot exceed the For combination products, the SPC can be granted if the combination is covered by the basic patent and meets the regulatory approval requirements. The combination must be specifi - cally claimed in the patent or be clearly derivable from the patent claims. maximum extension period allowed. Rules for Combination Products
paediatric extensions. Regulatory approval
The extension is contingent upon obtaining regulatory approval from the SFDA. The SFDA evaluates the safety and efficacy of paediatric
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