Date: 15 Oct 2020
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.
What is the data exclusivity period provided to pharma originators under Decree 321?
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”).
Can a generic pharma company apply for marketing approval before the expiration of 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.
Is there any exception to the Data Exclusivity Period?
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.
How patent protection can help to prevent generic companies from entering the UAE market?
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.
Are patents of origin recognized under Decree 321?
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.
When does Decree 321 starts to apply?
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”).
Is Decree 404 still applicable?
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.