In Saudi Arabia, the registration of generic drugs is linked to patent protection. To harmonize innovation with market access, the Saudi Food and Drug Authority (SFDA) mandates that both the generic and innovator companies follow defined procedures that protect Intellectual Property (IP) while enabling the timely market entry of generics.

SFDA provides requirements for generic companies on how to register their products with SFDA, subject to the active patent status of the innovative product, and for innovator companies on how to document patents against infringement.

In this article, we outline the key requirements that both generic and innovator companies must consider regarding patents.

Objectives

SFDA’s patent-linked processes aim to:

Improve transparency around generic product registration.
Build trust among innovators, generic applicants, and the regulator.
Enable timely access to generics while protecting valid patents.

What to know before filing a generic product?

Prior to filing a patent-related submission, companies should evaluate the patent status of the innovative product, conduct a Freedom To Operate (FTO) assessment, and ensure alignment with applicable SFDA regulatory and IP requirements to avoid potential legal and registration risks.

The requirements for filing patent applications differ between generic and innovator companies.

Submitting a generic drug while the patent is still active

If there is a patent in the innovated product file with the SFDA, it is mandatory for a generic manufacturer seeking to register its product with the SFDA to meet these prerequisites.

FTO letter: A generic company must obtain this letter from an IP agent licensed by the Saudi Authority for Intellectual Property (SAIP), certifying that the generic product, in terms of name, strength, and dosage form, does not infringe any patent of an innovator product registered in the Kingdom. 
Formal declaration form: The company must submit this disclosure form stating that the generic product does not infringe IP rights in the Kingdom.

Why is an FTO letter important?

The FTO letter certifies that the generic product does not infringe the patent on the innovator product registered in Saudi Arabia. Based on the FTO letter and the submitted declaration, SFDA proceeds with registering the generic product. If it is unavailable, registration of the generic product will be rejected.

When a company applies for a generic drug registration while the innovator product is still under patent, the SFDA will request a Freedom-to-Operate (FTO) letter from the generic company.

The FTO letter and a copy of the intellectual property agent’s license issued by SAIP must be submitted to the SFDA within 60 working days of the request date.

When can a generic drug be submitted for a protected innovator?

The SFDA allows generic companies to apply for registration as early as 24 months before the innovator drug’s patent expiry date. However, the marketing authorization will be granted only after the protection expires.

Patent requirements for innovator companies?

Innovator companies have to comply with the following:

Patent submission: Innovator companies must submit a valid patent document issued by SAIP in the drug dossier when registering a product in the SFDA. SFDA has the right to provide the relevant patent numbers associated with the innovator product upon request by the generic company, provided that a supporting letter from an IP agent is submitted.
Delayed issuance: If the patent document has not been issued by the time of registration submission, the innovator company must provide it upon its issuance; otherwise, the company will bear the consequences.
Products registered earlier: The company must provide the patent document for innovator products already registered with SFDA and subsequently granted patent protection by SAIP or the Gulf Cooperation Council (GCC) Patent Office.
Infringement Disputes: If an innovator company claims that a generic is infringing its patent, the matter must be pursued before the Commercial Court.
Judgments of Court: If a final judgment is in favor of the innovator, SFDA will comply and implement the decision.

FTO Support

At PharmaKnowl, we help companies successfully register generics in Saudi Arabia by ensuring full compliance with SFDA patent-linked requirements and reducing the risk of delays or rejections.

Contact us for FTOs and drug patent support.

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