Data Exclusivity Provisions in Selected Free Trade Agreements: Do They Allow Originator Pharmaceutical Companies to Delay Entry in Different National Markets as Part of Life Cycle Management of Specific Pharmaceuticals?. Owais Hassan Shaikh. IMPRS-CI 2010. WIPO – 31.05.2012.
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Data Exclusivity Provisions in Selected Free Trade Agreements: Do They Allow Originator Pharmaceutical Companies to Delay Entry in Different National Markets as Part of Life Cycle Management of Specific Pharmaceuticals?
Owais Hassan Shaikh
WIPO – 31.05.2012
What is Data exclusivity? Agreements:
Why are FTAs important?
(Art. 14.9(b) US-Bahrain FTA)
(Art. 17.10(c) US-Australia FTA)
Art 18.9.1(b) US-Korea; Art 15.10.1 US-Morocco; Article 15.9.1(b) US-Oman and Article 16.8.2 US-Singapore.
Six Scenarios Agreements:
Assumptions for the scenarios:
Originator company only considers data exclusivity for making market entry;
No patent or other exclusivities are pending;
For originator there are no costs and revenues equal profits;
Once generic competition starts, increase/decrease in the market is distributed according to existing market shares;
Identical market size in all parties;
Drug Authorities take one year (period) to approve both medicines;
Generic companies take one year (period) to come up with a bio-equivalent pharmaceutical; and
Period of data exclusivity is five years in all parties.
Thank you for your attention! Agreements: