RegulinkedThe Saudi Food & Drug Authority (“SFDA”) has issued a new guidance document on the approach to dealing with patents when registering generic drugs with the SFDA.
🔍 What’s new:
SFDA’s updated guidance how patent rights are handled during generic drug registration and introduces clear procedural steps for both generic applicants and innovator (patent-holding) companies.
Key points include:
• Patent documentation from innovators: Innovator companies are required to submit copies of patent documents issued by SAIP to support any patent claims and to be recorded in the SFDA product file.
• Freedom-to-Operate (FTO) requirement: Generic applicants must provide both a Freedom-to-Operate (FTO) letter (from a SAIP-licensed IP agent, along with the agent’s license copy) and a formal non-infringement declaration from the applicant. Both documents are required within 60 working days from the SFDA request date when a patent is recorded against the innovator product.
•Patent number(s) request: Upon Applicant request with supporting letter from IP Agent, SFDA will provide the patent number(s) for an innovated (reference) product.
•The Applicant has the right to apply for the registration of a generic product of an innovative product without submitting FTO Letter 24 months prior to the patent expiry.
However, the generic product will be registered after the patent has expired.
💡 Why it matters:
This guidance introduces patent transparency and raises the operational bar for generic registrants in Saudi Arabia. Generic manufacturers and MAHs must proactively manage IP risk — failing to address patent issues correctly can lead to registration delays, legal exposure, or denied approvals. Innovator companies gain clearer mechanisms to protect IP while SFDA retains a role to ensure public access and regulator neutrality.
📌 How ReguLinked can support you:
• Patent Form coordination and FTO coordination: Assist innovators and generics with the documentation and procedural steps needed when a patent notification is made to SFDA. Coordinate Freedom-to-Operate via SAIP-licensed IP agents.
• Regulatory filing strategy: Design submission pathways that minimize review risk and align with SFDA expectations.
📨 Facing patent issues for a planned generic submission in Saudi Arabia? ReguLinked helps you convert IP complexity into a clear, registerable plan, protecting market access while managing legal risk.
Book your complimentary consultation today
📧 bd@regulinked.com | 🌐 www.regulinked.com
📎 Official source: SFDA guideline (D2811E). Saudi Food and Drug Authority
آلية التعامل مع براءات الاختراع
Dealing with Patents
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