Protecting Pharmaceutical And Medical Device Patents In Saudi Arabia: The Two-step Process Every Innovator Must Know

Saudi Arabia’s health care and life sciences market continues to grow rapidly, driven by the Kingdom's Vision 2030 healthcare reform agenda and sustained demographic expansion. For innovator pharmaceutical and medical device companies seeking to protect their patented products in this market, understanding the regulatory landscape is essential.

Notably, a common misconception is that registering a patent with the Saudi Authority for Intellectual Property (SAIP) or having a registered patent with the Gulf Cooperation Council Patent Office (GCC Patent Office)¹ is, on its own, sufficient to prevent generic infringing versions of a patented drug or device from entering the Saudi market. In practice, however, patent holders must take an additional and equally important twofold step: registering their patented drug or device with and notifying the Saudi Food and Drug Authority (SFDA) of their registered patents.

Two-step process

In this respect, comprehensive patent protection for originator drugs and medical devices hinges on a practical two-step process:

1. source the existing registration for, or register the patent with SAIP or source the existing patent registration from GCC Patent Office; and
2. ensure that SFDA has a file on record regarding the innovator product in question and the related patent when reviewing generic applications.

The roles of SAIP and SFDA: patent registration, product registration and patent listing

The SFDA and SAIP have contemplated the creation of a "Patent Listing" – a consolidated database of valid and enforceable patents for drugs in Saudi, intended to serve as a centralised reference point when assessing subsequent generic applications. However, the Patent Listing has not yet been made publicly available as a searchable database, and there is no confirmed timeline for its launch.

While a SAIP or GCC Patent Office registration provides the legal basis to enforce a patent, it does not, in the absence of the Patent Listing, trigger any SFDA check by itself. The key practical point here is whether SFDA already has a file on the innovator product and the relevant patent documents when a generic drug or medical device application is reviewed. The patent holder must therefore register its innovator product and submit its patent information to SFDA under the current framework. Innovators should include the SAIP/GCC patent certificate in the SFDA file or update SFDA promptly if the certificate is issued after initial submission of the innovator product.

SFDA's approach to applications

SFDA’s handling of a generic drug or device application depends on whether patent information is already on file for the corresponding innovator product.

Where SFDA has patent information on file: SFDA typically requires the applicant (within 60 working days) to submit (a) a Freedom to Operate (FTO) letter, obtained from an intellectual property agent licensed by SAIP, which must include the name, strength, and dosage form of the generic drug or specifications of the medical device; (b) a copy of the IP agent's licence; and (c) a formal declaration from the applicant confirming that its product does not infringe any existing patent rights and accepting full responsibility for any infringement that may occur.

Early registration before patent expiry for innovator drugs: A generic may apply for registration of a drug up to 24 months before patent expiry of the innovator drug for which a patent is on file with the SFDA, but it may not be marketed until the patent expires.

Where SFDA does not have patent information on file for the innovator product: SFDA may register the product without an FTO letter or declaration, because SFDA has no patent basis to flag a potential infringement.

Resolving patent infringement disputes

The registration of a generic drug or device without an FTO letter does not constitute a confirmation from the SFDA that the product is non-infringing. Likewise, the registration of a generic drug or device with an FTO letter, does not constitute SFDA's approval of the contents of that letter - SFDA does not independently verify the contents of an FTO letter.

If an innovator believes that a registered product infringes its patent, its recourse is to file a patent infringement claim against the applicant before the Commercial Courts. In 2020, the Saudi authorities passed a Commercial Courts Law that now governs the litigation of all claims and violations arising from the implementation of the applicable patent laws within Saudi Arabia.

To file a patent infringement claim before the Commercial Courts, the claimant must appoint a Saudi licensed lawyer with rights of audience before the Saudi courts. The Courts may choose to hear from the SAIP and/or the SFDA and may appoint an expert in the field to further examine the case and provide their opinion before ruling. The SFDA will implement a final enforceable judgment from the Commercial Courts in all cases.

Practical recommendations for innovator companies

As the framework continues to develop in Saudi, pairing regulatory filing discipline with a clear patent protection and enforcement plan to better protect market exclusivity is key.

As such, innovator pharmaceutical and medical device companies seeking to protect their patented products in Saudi Arabia should consider the following checklist:

1. Register the patent with SAIP and the innovator product with SFDA

File early and ensure the claims cover the relevant active ingredient, formulation, and uses for drugs and the relevant specifications for devices for the Saudi market. In parallel, complete SFDA's product registration requirements, including the submission of product information, labelling, samples, manuals, expert reports, and pricing, as well as the designation of an authorised distributor, if applicable.

2. Proactively submit the patent certificate and details to SFDA

Provide the issued certificate (SAIP/GCC) for inclusion on the innovator file and promptly update SFDA if issuance occurs after initial product registration submission.

3. Align your SFDA product registration file with your patent strategy

Ensure the SFDA file clearly maps the registered product (e.g. name/strength/dosage form/specifications/methods of use/administration) to the relevant patent(s) to support SFDA's internal check when generic applications are reviewed.

4. Monitor for generic/infringing activity and be ready to enforce through the Commercial Court

Track potential generic filings especially within the 24-month pre-expiry registration window and move quickly to seek a final enforceable judgment where infringement is suspected.

5. Appoint SAIP-licensed legal counsel to coordinate the strategy and execution

Engage a SAIP-licensed attorney and law firm early to support the SAIP filing, SFDA submissions, monitoring, and any required court enforcement.

Footnote

1. As of the latest amendment of January 2021, the GCC Patent Office no longer grants GCC patents on behalf of GCC member states. Yet protection of a valid patent that is registered under the GCC Patent Law with the GCC Patent Office is still enforceable throughout the GCC countries including Saudi Arabia.

Read the original article on GowlingWLG.com

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.