Dear reader, between protecting innovation and encouraging generic medicines, the Saudi Food and Drug Authority (SFDA) has to manage an essential balance: how can it protect the rights of companies that spent huge time and money developing new drugs, while at the same time allowing cheaper generic versions to enter the market and reduce the burden on the health system and on patients? The regulation that explains how SFDA handles patents when registering generic drugs, prepared in cooperation with the Saudi Authority for Intellectual Property, was created to provide a clear framework for this balance, grounded intransparency, clear responsibilities, and an organized path for generics to enter the market.

This methodology has three main goals that matter to any patient or person interested in healthcare. First, to increase transparency in SFDA procedures so that the registration path for both innovative and generic medicines is clear and understandable for everyone. Second, to build trust in how SFDA handles patents so it is not seen as favoring one side over another. And third, to make it easier to register generic medicines, so they are more available at lower prices, without affecting the legal protection period of patent holders.

The system works in two main stages: one for the originator (innovative) companies and one for the generic companies. In the first stage, innovative companies registering a new drug must submit a copy of the patent document issued by the Saudi Authority for Intellectual Property as part of the registration file, or add it later as soon as it is granted, and they bear the responsibility for any delay. If the innovative drug is already registered and protected by a Saudi or GCC patent, the company must attach that patent to its documents.

SFDA makes it very clear that receiving a patent document does not mean it is responsible for protecting it or deciding patent disputes. Suppose an originator company believes a generic product infringes its patent. In that case, the proper legal route is to go to the commercial court, not to SFDA, while SFDA’s role is to implement any final court judgment in favor of the patent owner.

In the second stage, it is the turn of generic companies, which want to register an equivalent version of an innovative drug whose patent protection has ended or is about to end. Here, SFDA follows a precise mechanism: when a company applies to register a generic medicine. SFDA finds that the original drug still has a valid patent in the Kingdom, it asks the generic company to provide a “Freedom to Operate” (FTO) letter from an intellectual property office or agent licensed by the Saudi Authority for Intellectual Property.

This letter is a professional statement in which the specialist confirms that the generic product, with its name, strength, and dosage form, does not infringe any registered patent for the innovative drug inside Saudi Arabia. The company must attach this letter, together with a copy of the agent’s license, and submit it within a defined time limit, along with a formal declaration from the generic company that it is not infringing any protected IP rights in the Kingdom.

Based on this letter and declaration, SFDA continues the registration process, but at the same time, it stresses that it is not “approving” or legally certifying the content of the FTO letter. It simply relies on it as a procedural document, while full legal responsibility stays with the generic company and the IP agent if any dispute arises later. If an innovative company claims that ageneric medicine infringes its patent, the matter is returned to the commercial court for decision, not to the SFDA.

The methodology also offers generic companies a smart option for accelerating market entry after patent expiry. It allows them to submit a registration application up to 24 months before the patent expires without an FTO letter, provided that the registration is not activated and the product is not allowed on the market until the patent actually lapses. This way, SFDA enables early preparation so the generic drug is ready to enter the market as soon as protection ends, reducing the time gap between patent expiry and the arrival of cheaper alternatives for patients, while fully respecting the innovator’s protection period.

At its core, this methodology clearly defines each party’s role. SFDA is responsible for the quality, safety, and availability of medicines and is not a court for patent disputes. The Saudi Authority for Intellectual Property is the body responsible forgranting and registering patents and licensing IP agents. The commercial court is the legal venue where patent infringement claims are decided. Both innovative and generic companies are responsible for the accuracy of their documents, their strategic choices, and whether they rely mainly on strong patent protection, price competition, quality, or other tools.

Dear reader, what this framework aims to achieve is a delicate balance. On the one hand, it sends a strong message to global pharma companies that the Saudi market respects intellectual property and does not open the door to patent infringement. On the other side, it reassures the health system and the patient that the door to generic medicines will not be closed and that there is a clear, organized path for them to enter the market once protection ends. In this way, the regulation helps make the Kingdom an attractive environment for investment in innovative drugs, while also supporting access to generics and price competition that benefits both patients and the health system in the long run, an essential but sensitive balance between fostering innovation and making medicines affordable.