Patent term extension system in Middle Eastern countries

A patent term extension (PTE), also known as a supplemental patent certificate (SPC) in some countries, is a mechanism by which a patent owner can apply to extend the term of a patent, and is generally used by pharmaceutical and biotechnology companies.

The protection period of a patent is generally 20 years from the date of application, but due to the long examination period for patent applications, especially for biopharmaceuticals, it may take 10-12 years for the drug to be put into commercial use, so the patent owner may only have 8 years of patent protection. The delay in bringing the invention to market may not be caused by the inventor. It may be caused by regulatory delays. Therefore, the patent system of some countries allows patent owners to request an extension of the validity period of the patent. The patent protection period of biopharmaceuticals in some European countries can be extended by up to 5 years.

In the patent system of some countries, the patent owner can also apply for a patent term extension if the patent authorization is delayed due to the long review time of the patent office. This is the PTE system. In the Middle East and North Africa (MENA) region, the countries where patent owners are eligible to apply for a patent term extension are Bahrain, Morocco and Oman .

The patent laws of Bahrain and Oman provide for the same conditions for applying for a PTE. However, the implementing regulations related to these provisions are unclear. According to the latest regulations issued in Bahrain, these regulations do not specify the guidelines or procedures for patent owners to apply for and obtain a PTE.

Under the laws of these two countries, a patent owner may request a patent term extension in the following two circumstances:

1. Patent holders may seek compensation for unreasonable delays in granting patents due to reasons beyond their control. If a patent is granted more than four years after the filing date or more than two years from the date of the request for examination (whichever is later) and the reasons are beyond the applicant's control, the term of protection of the patent shall be extended to compensate for the delay. Bahrain's law does not provide for a maximum extension period, while Oman's extension period shall not exceed five years after the normal expiration date.
2. The laws of Bahraini and Oman further provide that if the marketing approval process related to the first commercial use of a product is delayed due to actions not attributable to the patent owner, the patent term may be adjusted. However, the Bahraini law does not provide a specific definition of delay, while the Omani law defines delay as more than 24 months from the date of application for marketing approval.
3. In Morocco, the patent owner can apply for a PTE only in the latter case and only for pharmaceutical products. The period is equal to the number of days between the expiration of the deadline for the marketing authorization and the effective date of the marketing authorization. The patent owner must apply for a PTE within three months of receiving the marketing authorization. The laws of Bahrain and Oman do not provide for such a period. Moroccan law stipulates that a PTE shall not exceed two and a half years.
4. Since there are no specific regulations and/or guidelines in the PTE regulations of various countries, there are no restrictions on the types of patents that are eligible for extension. In terms of pharmaceutical patents, small molecules, biologics, second medical uses, preparations, etc. can all apply for PTE. However, in practice, the number of PTE applications and approvals is relatively small.