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On September 21, 2020, the United Arab Emirates (UAE) Ministry of Health & Prevention (MOHAP) issued Ministerial Decree 321 of 2020 (Decree 321) relating to the use of clinical and preclinical data and information regarding innovative pharmaceutical products registered in the UAE.

Decree 321 sets a data exclusivity period of 8 years from the date of marketing approval (Data Exclusivity Period) for innovative pharmaceutical products which contain an active pharmaceutical ingredient for which no other pharmaceutical product has obtained a marketing license in the UAE.  According to Decree 321, generic and biosimilar companies can apply for marketing approval within the last 2 years of the end of the Data Exclusivity Period if evidence is provided that the innovative pharmaceutical product is not protected by any patent in the UAE.  However, there is an exception to the 8-year Data Exclusivity Period.  Specifically, for the purposes of protecting public health or other reasons to be decided on a case-by-case basis, a generic or biosimilar company can obtain a marketing license during the Data Exclusivity Period.

Decree 321 will apply to innovator pharmaceutical products that obtain a marketing license from the MOHAP after its publication.  Publication is expected within the next 6 months.  Innovator pharmaceutical products which have obtained a marketing license prior to the publication of Decree 321 will be subject to Ministerial Decree 404 of 2000 (Decree 404).  Under Decree 404, the MOHAP will deny marketing approval for a product that infringes a patent that exists either in the UAE or in the country of origin from which the product has been imported.  It is important to note that under Decree 321, the requirement for a generic or biosimilar company to provide evidence that the innovative pharmaceutical product is not protected by any patent is limited solely to the UAE and not the country of origin.

Decree 321 seeks to provide a balance for innovator and generic/biosimilar pharmaceutical companies by providing a strong intellectual property system for innovators and increased transparency of the rules for obtaining approval for follow-on products for generic and biosimilar companies.  Given this change in the law, it will be important for innovator pharmaceutical companies to obtain patent protection for their products in the UAE since reliance on the country of origin will no longer be possible once Degree 321 comes into effect.

Please continue to watch BRICS & Beyond for updates on patenting life science inventions in the UAE.

This post was written by Lisa Mueller and Namir Sioufi of Saba IP.

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