Patent term extension

Patent term extension (PTE), also known as a Supplementary Protection Certificate (SPC) in many jurisdictions, is only available in Bahrain, Oman, Morocco, and Jordan within the MENA region. Economically important jurisdictions such as the UAE and Saudi Arabia do not include provisions for patent term extension in their legal framework.

Bahrain and Oman

Bahrain and Oman have similar provisions for PTE in their patent laws. Below are the main points of comparison:

Administrative delays

• Both Bahrain and Oman allow PTE when a patent grant is unreasonably delayed by the patent office.

• In Bahrain, if a patent is granted more than four years after filing or two years from the request for examination (whichever is later), the owner may request a PTE. There is no clear maximum cap on the extension.

• In Oman, similar provisions apply, but the law caps the PTE period at five years beyond the normal 20-year patent term. During the extension period, the protection scope aligns with the originally granted claims without expansion or alteration. There is no prescribed limit on the number of PTE applications an applicant can file for a product (i.e., where multiple patents have been granted for the same product), with each case being assessed independently.

Regulatory delays

• Both Bahrain and Oman permit PTE to compensate for delays in obtaining marketing approval for commercial use, provided the delay is not attributable to the patent owner.

• In Oman, a delay of more than 24 months from the date of the filing of marketing approval is required to trigger eligibility for PTE. Although there is no strict deadline for applying for PTE, it is recommended to request it within six months of the triggering event.

• In Bahrain, the law is silent on what constitutes a regulatory delay, creating ambiguity in its application.

Morocco

In Morocco, PTE is limited to pharmaceutical products and applies only to delays in obtaining marketing authorization. Key aspects include:

• The PTE term is calculated based on the number of days between the expiration of the marketing authorization deadline and the actual approval date.

• The PTE request must be submitted within three months of receiving marketing authorization.

• The total extension cannot exceed two and a half years.

Morocco’s system provides a clearer regulatory framework with well-defined criteria and deadlines. However, the scope is narrower compared to Bahrain and Oman, as only pharmaceutical products qualify for PTE.

Jordan

In Jordan, there are currently no precedents for patent term extensions. Given that Jordan is a member of the Patent Cooperation Treaty and other international intellectual property frameworks, it tends to align its practices with international standards, particularly in the case of pharmaceutical products.
While it is unlikely that a PTE request will be rejected, the process will be experimental as officials will need to explore how to manage and implement this first-of-its-kind request.

Not surprisingly, the number of PTE requests in the MENA region remains low, indicating a lack of awareness as well as difficulty in navigating the available legal frameworks.

Data exclusivity

Data exclusivity protects information submitted by an innovator company for their pharmaceutical product when applying for marketing approval. If data exclusivity is provided, this information cannot be used by a generic company for seeking approval of an equivalent generic drug during the data exclusivity period.

UAE

In the UAE, the data exclusivity period is eight years from the date of marketing approval. However, a generic company can apply for marketing approval in the last two years prior to the expiration of the data exclusivity period, provided they produce evidence of the absence of a valid patent for the innovator product in the UAE.

Bahrain

Saudi Arabia, Oman, and Bahrain have also provided data exclusivity provisions in their laws.

In Bahrain, the Law on Trade Secrets governs data exclusivity.

Any natural or legal person is prohibited from disclosing information in their possession if such information contains the following features:

• The information is confidential, i.e., if the information in its final form or its specifics is not made known nor circulated and is not accessible to those who usually deal with such type of information.

• It has commercial value due to its confidentiality.

• Its confidentiality depends on the effective measures undertaken by its legal holder to preserve it.

The competent authorities shall prohibit unfair commercial use of data or tests submitted to it (e.g., for the purpose of marketing authorization) by not permitting any person without consent from the owner of the data or tests until five years after the date of marketing approval in Bahrain.

Oman

In Oman, unfair commercial use of information includes reliance by a governmental authority upon undisclosed test or other data concerning safety and efficacy submitted to it as a condition for marketing approval, without the consent of the person submitting the data, within the applicable minimum five or 10-year period, in the approval of the same or similar product. This means that a generic company cannot rely on the data submitted to said authority when submitting its own approval request. The minimum five or 10-year period begins on the marketing approval date of the innovator product in Oman.

Saudi Arabia

In Saudi Arabia, data exclusivity and confidential information are dealt with under the Regulations for the Protection of Confidential Commercial Information.

Where an official competent authority requires the submission of information about secret tests or any data obtained as a result of substantial efforts, as a precondition for approving the marketing of drugs or chemical agricultural products in which new chemical substances are used, the said authority shall undertake to protect such information against unfair commercial use, for a minimum period of five years from the date of obtaining the approval.

The competent registration authority may, during the data exclusivity period, permit third parties to use the undisclosed data submitted by the innovator in the following cases:

(1) If the product first registered in the Kingdom has not been the subject of trading within a reasonable period of time determined by the registration authority, after approving its marketing.

(2) If this is required by a pressing necessity determined by the competent authority to protect the public.

Apart from providing for data exclusivity, Saudi Arabia is also moving towards providing a patent linkage system. The SFDA is the regulatory body responsible for the oversight and registration of pharmaceutical products within Saudi Arabia. It is responsible for both innovator and generic products.

Since 1 January 2023, innovator companies seeking to register a pharmaceutical product with the SFDA must submit a copy of the patent document issued by the SAIP in the registration file for a pharmaceutical product submitted to the SFDA. If the patent application of the innovator product has not yet proceeded to grant at the time of submitting the application for registration with the SFDA, the innovator company shall submit such document to SFDA within (30) days from its date of grant.

Following submission of an application and if there is a patent in the innovator product file at the SFDA, the SFDA will request a Freedom to Operate (FTO) letter from the generic company. The search carried out for the purposes of an FTO letter must be conducted by an intellectual property agent licensed by the SAIP, and the FTO letter must be provided to the SFDA within 60 days of submitting the request for marketing authorization together with a copy of SAIP’s license for the intellectual property agent.

The FTO letter shall include the following wording:

“I (the name of an intellectual property agent licensed by SAIP) hereby certify that the generic product (the name of the generic product) does not infringe any patent of an innovator product registered in the Kingdom.”

Based on the FTO letter, SFDA shall register the generic product.

The generic company has the right to apply for the registration of a generic product of an innovator product without submitting an FTO letter six months before the expiry of the relevant patent, taking into consideration that the marketing of the generic product will not be allowed before patent expiration.

At present, patent information is not linked to authorised pharmaceutical products listed in the database of the SFDA but there are plans to implement this in future. Patent linkage will help reduce infringement of on-patent pharmaceutical products as well as registration of generics for on-patent pharmaceuticals. Once made public, the patent linkage will be the only source to be consulted when conducting a search in preparation for an FTO letter. For now, generic companies will need to rely on the searches conducted by the Saudi Arabian and the Gulf Cooperation Council patent offices.

In conclusion, although Middle Eastern countries have been somewhat slow in aligning themselves with practices in jurisdictions in which the protection of intellectual property has evolved over decades, there are encouraging signs that avenues such as patent term extension and data exclusivity will be more readily available going forward.

This article first appeared in The Global IP Directory 2025.