Our knowledge, experience, and expertise are now available on the go.
My Tamimi App, a convenient new tool for anyone with an interest in the legal sector, from law students to General Counsel.Find out more
The UAE Ministry of Health & Prevention (“MOHAP”) issued Ministerial Decree 321 of 2020 dated 21 September 2020 (“Decree 321”) which regulates the use of data and information related to innovative pharmaceutical products registered inside the UAE.
The data exclusivity period provided under Decree 321 is set to 8 years from the date of marketing approval inside the UAE (the “Data Exclusivity Period”).
According to the Decree 321, generic companies can apply for marketing approval within the last 2 years from the end of the Data Exclusivity Period, provided they produce evidence on absence of a valid patent protection of the originator drug inside the UAE.
Decree 321 leaves a space for the MOHAP to grant exceptions to generic companies despite the Data Exclusivity Period for public health or other reasons which are decided on a case by case basis.
The MOHAP requires generic companies to provide evidence of absence of patent protection of the originator drugs inside the UAE as a condition to granting any marketing approval or registration of a generic product.
Decree 321 indirectly rejects the recognition of patents of origin as a vehicle to restrict generic companies for all products approved or registered after the New Decree Publication Date. Decree 321 refers to the application of Decree 404 with respect to pharmaceutical products registered or approved prior to the New Decree Publication Date, which indirectly recognized the patents of origin.
The effective date of Decree 321 will come into effect from its publication date in the UAE Official Gazette which is expected to take place during the month of October 2020 and will be communicated to our clients in due course (the “New Decree Publication Date”).
Decree 404 will continue to apply only for pharmaceutical products approved or registered before the New Decree Publication Date.
Decree 321 issued by MOHAP is aligned to set a fair balance between a strong IP regime protecting the interests of innovators and originators, and a generic pharma market with an enhanced regulated and transparent marketing penetration process and rules. Patent protection inside the UAE is a key vehicle for originator pharmaceutical companies to strengthen and extend their protection against generic products inside the UAE, and should not rely on patents of origin which are no longer recognized in relation to any future products. This initiative by the UAE is likely to inspire other GCC countries to revise their regulations with respect to originator and generic drugs in a way which is consistent with their wider innovation and economic diversification ambitions and visions. We will provide updates in due course.
Our Patents & Designs (R&D and Innovation) team regularly advises on all legal aspects related to the protection an enforcement of IP rights related to pharmaceutical companies inside MENA.
Patent Analyst, Intellectual Property
Disclaimer: This chat service should not be relied upon as a substitute for professional advice which takes account of your specific circumstances and any changes in the law and practice. No warranty is made as to the accuracy or completeness of the information provided via this service and no liability is accepted by Al Tamimi & Company Limited, its affiliates, partners or employees for any loss arising as a result of reliance upon the information provided.
Kindly accept the disclaimer to proceed to a live chat.
Thank you for your inquiry. We will connect you to one of our agents now.
Thank you for your interest in working with Al Tamimi & Company. Please click here to view our latest job openings.