Saudi Arabia’s New Draft Procedure for Registration of Generic Pharma Products

The Saudi Food and Drug Authority (“SFDA”) published a draft initiative, the “Procedure to deal with patents when registering generic products in SFDA” (the “Initiative“). The Initiative has been published on the Saudi Public Consultation Platform website for consultancy purposes and the SFDA has invited the public and pharmaceutical companies to submit their feedback by 16 June 2022.

What is the main objective of the initiative according to the SFDA?

The Initiative, as reported by the SFDA, aims to raise the level of transparency in the procedures of the SFDA, enhance confidence in the guidelines for patent registration of pharmaceutical products, and facilitate the procedures for registering generic pharmaceuticals.​

What is the procedure for a generic company to register their generic product with the SFDA?

The Initiative outlines the procedure for a generic company to register a generic product with the SFDA.

a)  When there is a valid patent protecting the originator product in Saudi Arabia

The SFDA will request a generic company to submit a Freedom to Operate report (“FTO”) with an acknowledgment that the generic product does not infringe on any existing patents. In case the generic company submits such an FTO, the SFDA will accept the product registration request. In contrast, in absence of such an FTO, the SFDA will reject the request.

In case the originator company believes that the generic product infringes over its KSA patent, the originator company will need to lodge a claim at the commercial courts and obtain a judgment in its favour in order for the SFDA to cancel the generic product registration.

Under the Initiative, one of the IP agencies listed at the Saudi Authority for Intellectual Property (“SAIP”) in KSA should prepare the FTO that is to be submitted to the SFDA. The FTO must be submitted within sixty (60) working days from the date of the submission of the product registration application.

b)  When there is no patent protecting the originator product in Saudi Arabia

In such a case, the generic company is not required to submit a FTO when submitting a product registration application. If there is no patent protecting the originator product in KSA, the SFDA will accept the product registration request.

What is required from originator companies in the registration of their innovative product with the SFDA if they have a valid or pending patent?

For a new registration of an originator product, originator companies must submit a copy of the patent of their product issued by the SAIP in the product registration file submitted to the Authority.

In case a valid patent in KSA has not yet been granted at the time the originator company submits the product registration application to the SFDA, the patent can be submitted within thirty (30) days of its issuance.

With respect to originator products already registered at the SFDA and which are already protected by a valid patent in KSA, the originator company must submit the valid patent to the SFDA within thirty (30) days from the publication of this procedure.

What options are available to an originator company that believes a generic product was registered that infringes on their originator patent?

If an originator company believes that the generic product registered with the SFDA infringes on their originator patent, they may raise a case at the commercial courts in Saudi Arabia.

If the commercial court rules in favour of the originator company and the decision is unchallenged, the SFDA will de-register the generic product in Saudi.

Sharing your feedback and comments

In order to ensure that Al Tamimi’s clients’ opinions and feedback are well heard by the authority, we will be preparing and submitting feedback on behalf of our clients. Please find the link to access the complete Initiative here.

Please email us at 3IP@tamimi.com by 15 June 2022 if you would like to share your feedback, recommendations and/or comments regarding the initiative.

If you have any queries, please feel free to reach out to us.