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

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

Objectives

SFDA’s patent-linked processes aim to:

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

Generic Companies

For a generic manufacturer seeking to register its product with the SFDA, the steps vary depending on whether the original product is patent-protected.

FTO Requirments

The generic company applies for product registration. If an innovator product is patented, the SFDA will require a Freedom-to-Operate (FTO) letter.

Intellectual Property (IP) Law Firm or Consulting

The FTO must be issued by an IP law firm in Saudi Arabia that is licensed by the Saudi Authority for Intellectual Property (SAIP).

FTO Submission

The generic manufacturer submits the FTO letter to SFDA within the submitted drug dossier.

Infringement Declaration

Generic companies must also sign a formal declaration confirming that the proposed molecule does not infringe any existing patent rights in Saudi Arabia.

The FTO letter should certify under the name of the licensed IP office that “the generic product does not infringe any patent of an innovator product registered in the Kingdom.”

Patent Disclosure

SFDA will provide the relevant patent numbers associated with the innovator product upon request.

Early Registration Window

A generic company may apply for product registration six months before the patent expiry date; however, the marketing approval shall only be effective after expiry.

Innovator Companies

Innovator companies also have new obligations under the framework:

Patent submission: Innovator companies must submit a valid patent document issued by SAIP when registering a product with the SFDA.
Delayed issuance: If the patent has not been issued by the time of product submission, the innovator company must file it within 30 days of issuance.
Products registered earlier: For innovator products already registered with SFDA and subsequently granted patent protection by SAIP or GCC Patent Office, the company shall submit the patent document within 30 days of its publication.
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 favour of the innovator, SFDA will comply and implement the decision.

Need an FTO Support or generic registration?

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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