SFDA Guide on Dealing with Patents When Registering Generics

The 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.

Back in 2022, the SFDA issued for public consultation a draft “procedure to deal with patent when registering generic products in the SFDA”. SFDA’s goal is to raise the level of transparency in the procedures of the SFDA, promote trust int he procedures for dealing with patents related to pharmaceutical products, and facilitate the procedures for registering generic pharmaceuticals.

Now, in cooperation with the Saudi Authority for Intellectual Property (“SAIP”), the new guidance provides requirements for 1) generic companies wishing to register their products with the SFDA, and 2) innovator companies who claim that the generic company has violated their patents.

1: Requirements for Generic Companies When Seeking to Register Products Covered by an Innovator Patent

• when the generic company applies for registration of its product in SFDA, if there is a patent in the innovator product file in SFDA, then SFDA will request a Freedom to Operate (“FTO“) letter from the generic company (in the form specified by the SFDA, which includes a declaration from the generics company);
• Generic companies must assign an intellectual property agent licensed by SAIP to conduct such studies;
• In addition, the generic company must submit a declaration that its generic product does not infringe a patent of any product (SFDA provide a specific form for this);
• Based on the FTO letter, SFDA will register the generic product; and
• If an FTO letter is not produced, registration of the generic will be rejected.

Of particular interest is that the generic company has the right to apply for the registration of a generic product of an innovative product, without submitting FTO letter, if the application is made within six months before the expiry of the patent, taking into consideration that the marketing of the generic product will not be allowed before patent expiration.

2. Actions Required by Innovator Companies

In terms of the innovator companies, they must submit a copy of the patent document issued by SAIP in the registration file for products submitted to SFDA.

If the patent document of the innovated product has not been issued at the time of submitting the registration file, the innovator company must submit such document to SFDA within (30) days from its date of issue. If the innovator company seeks to claim that the generic product infringes the patent of its product, the company may process their claims in the Commercial Court. If a final judgment is issued by the court in favor of the innovator company, then SFDA will comply with that judgment.