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We are excited to share the latest edition of the Law Update, beautifully and appropriately titled “Sustainable Horizons: The Saudi Arabian Vision.” Giving special honor to the Kingdom’s 2030 vision, this update focuses on a collection of both informative and inspiring articles.
For those in construction, you can learn about how the tendering environment impacts risk-pricing for contractors, the updates on the legal framework of the construction industry and how contractors can protect themselves against financial difficulties.
There is good news too from the kingdom’s banking sector, from which the practice of “Open Banking” is being pushed for! But what is open banking? We’re answering that too.
Also . . . Are there any women trail blazers in Saudi Arabia you can name? We’ll help you with that. We cover how the Middle East has been making strides in empowering women in the entrepreneurial space,most notably in STEM fields.Read the full edition
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.
Partner, Head of Patents & Designs (R&D and Innovations)
Patent Analyst, Intellectual Property
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