Developments related to the Registration of Generic Pharmaceutical Products in Saudi Arabia

The Saudi Food and Drug Authority (SFDA) is the regulatory body responsible for oversight and registration of pharmaceutical products within Saudi Arabia. Responsible over both innovator and generic products, SFDA has recently amended its rules when it comes to generic pharmaceutical registration and has provided guidelines on best practice for obtaining Marketing Authorisation of a generic product. These changes to the rules have also placed certain obligations on innovator companies. The SFDA, through these updates, looks to create a closer working relationship with the Saudi Authority for Intellectual Property (SAIP), in particular the Patent Office, in creating a “Patent Linkage” system in Saudi Arabia.

With all the talk around pharmaceutical registration in Saudi Arabia, what actually happened?

The SFDA first released a draft initiative on the “Procedure to deal with patents when registering generic products in SFDA” for public comment in 2022. The period for comment lasted several months and ended on 16 June 2022.  After review, and consideration of the comments, the SFDA released the final version of the document entitled [the] “Mechanism to Deal with Patents when Registering Generic Pharmaceutical Products in SFDA”. The final set of rules was published on the 28th of November 2022 and came into effect on the 1st of January 2023.

Does the “Mechanism to Deal with Patents when Registering Generic Pharmaceutical Products in SFDA” (the “New Rules”) deal with Data Exclusivity or Confidential Information?

No, Data Exclusivity and Confidential Information is dealt with under the Regulations for the Protection of Confidential Commercial Information, issued on 4 May 2005 by the Minister of Commerce and Industry. 

What does “Registering Generic Pharmaceutical Products” have to do with Innovator companies and their innovator products?

To begin creating the patent linkage system in Saudi Arabia, the SFDA requires that all patents held by innovator companies, related to their innovator products, must be shared with the SFDA for addition to their “Patent Listing” database. The Patent Listing is intended to mimic the “Orange Book” of the U.S., once up and running. If an innovator company’s patent is not yet granted, they must submit a copy of the registration certificate within 30 days of the patent actually granting. 

How long do I have to submit my patents for the “Patent Listing”?

Initially, innovator companies were given 30-days from the implementation of the New Rules to provide their list of patents. The New Rules were implemented on 1 January 2023, which gave companies until 31 January 2023 to comply. 

What if my patents have not been submitted for the “Patent Listing”?

The Patent Listing will be the only source of information referred to by the SFDA when determining Market Authorization for a Generic Product. Despite the 30-day period for submission stated in the New Rules, the SFDA is still accepting patents for the Listing. There is no confirmation on when this period will end, therefore it is recommended that all innovator companies comply with this requirement as soon as possible to avoid any loss of rights in Saudi.

I am a Generic Pharmaceutical Company, how do these New Rules apply to me?

Under the New Rules, Generic companies seeking Marketing Authorisation for their Generic Products, must accompany their applications to SFDA with a Freedom To Operate (FTO) opinion and confirmatory Undertaking. 

A Freedom To Operate opinion for Marketing Authorisation of a Generic Product?

Although not strictly a Freedom to Operate, which would typically be an internal document created by a company, this FTO is akin to a “Clearance Search” or “Confirmation of Non-Infringement”, which the SFDA requires. The “FTO” must describe the steps taken by the generic company to determine that no existing patent rights have been, or will be, infringed, by granting the authorisation, and set out the process used to confirm the non-infringement. The FTO must also be certified by a local Saudi law firm registered with the Saudi Authority for Intellectual Property (SAIP).

How do I determine that no patent rights have been, or will be, infringed?

To confirm non-infringement, the Generic company must perform a patent search of the online Saudi Patent Database, to look for all patents and corresponding patents, related to the innovator product. If relevant patents are uncovered in the search, they must be discussed in the FTO and accompanied by reasoned arguments as to why there is no infringement, or overlap, between the innovator product patent and the proposed Generic product. Marketing Authorisation will be dependant on the arguments presented. 

If no patents of relevance are uncovered in the search, then a FTO is not strictly required to accompany the marketing request. However, it is recommended that a FTO explaining that no patents were uncovered is submitted with the application – this avoids the application being rejected for being ‘incomplete’.

Is that the only Database I should be checking?

In addition to the Saudi Patent Database, a search must be performed of the Gulf Cooperation Council (GCC) Patent Office. The GCC Patent Office is a Regional Office which covers all 6 countries of the Gulf States, namely; Bahrain, Oman, Kuwait, Qatar, Saudi Arabia and the United Arab Emirates. A single patent filed before the GCCPO will have force and effect in all 6 countries. Therefore, it is important to confirm that no additional patent rights are protected in Saudi Arabia, even if there are no patents in the Saudi Patent Database.

But wait, what was that about the “Patent Listing”?

Once made public, the Patent Listing will be the only source to consider when performing the search and preparing the FTO. However, as the Listing is still not available, and there is no indication of when the Listing will be made public, the current practice dictates that searching both the Saudi and GCC Patent Office Databases is the most prudent approach.

What about the Undertaking?

The Undertaking is a standard document, available from your attorneys handling the matter, which must be signed by the Marketing Authorisation Holder and submitted with the FTO.

How long do I have to submit my FTO and Undertaking?

The FTO and Undertaking must be filed within 60-days of first submitting the request for Marketing Authorisation. Therefore, it is advised to begin searching and preparing the FTO documents and Undertaking ahead of the submission date. 

Will the contents of my FTO be made public? If there is a dispute, or at all?

It is unclear whether the FTO will be made public, in the case of a dispute, or at all. Currently the FTO is held by the SFDA and is not a public document. Companies are unable to approach SFDA to review FTO’s on record and gain insight over the Generic Market in the country. However, the position is unclear if SFDA incorrectly grants Marketing Authorisation to a Generic product and is notified of such by the Innovator company. As mentioned above, the FTO serves as an indemnifying document for SFDA to avoid any liability in such an instance.  Whether this means the SFDA will share the FTO with the Innovator company, or will only provide certain information, is unknown. Requests have been made to the SFDA to resolve this position, but as yet, the position remains unclear. 

Who can help me with Pharmaceutical Registrations in Saudi Arabia

Melissa Murray is the head of the IP Group for the Middle East at Bird & Bird. Richard Gaugeler is an Associate in Melissa’s team and has been working with the pharmaceutical registration process in Saudi Arabia since the implementation of the New Rules. Any questions, comments or requests can be directed to either of them at;

[email protected] (+971 56 665 1954) or [email protected] (+971 52 250 7022).

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