1. Intellectual Property, Free Trade Agreements and sustainable Development
Hanan Sboul
Secretary General/ The Jordanian Association of Pharmaceutical Manufacturers
American University Washington College of Law
27-28 Feb 2006

2. Contents
Background on pharmaceutical industry in Jordan, and Jordan agreements
TRIPS flexibilities related to patents & data protection curtailed in different FTAs
Implementation: “Clawing back” policy space and flexibilities after an FTA

3. Background on pharmaceutical industry in Jordan
Branded generic industry, started 1962
17 pharmaceutical manufacturers
Export oriented
70%
$250 m
60 countries
Major contributor to Jordan economy

4. Jordan Agreements WTO membership in December 1999
Jordan-US Free Trade Agreement, 2001
Jordan-EFTA States Free Trade Agreement, 2002

5. Major implications on IP in Jordan
Product and process patents for 20 years from filing date
Data protection for five years for new chemical entities and three years for new uses of old chemical entities
Copyright and Trade mark protection related legislations

6. TRIPS flexibilities related to patents, curtailed in different FTAs
In FTAs, inconsistent with US legislations
Broadened patentable subject matter
Plants
Animals
New uses or methods of using a known product
Diagnostics, therapeutics & surgical procedures for treatment of humans & animals
Conditions on patent applicant; elimination of best mode, resulting in
Weak standards to obtain a patent
Reinventing the inventions, defeating patents’ main purpose

7. TRIPS flexibilities related to patents, curtailed in different FTAs cont.
Exceptions to rights conferred
Extension of patent terms; SPC to compensate
For unreasonable delay in granting a patent –
For unreasonable delay in granting marketing approval

8. TRIPS flexibilities related to patents, curtailed in different FTAs cont.
Revocation / Forfeiture of patents; opposition proceedings are not available prior to the grant of the patent
Linkage of marketing approval and patents
Notification of the patentee when a generic applies for marketing approval

9. TRIPS flexibilities related to patents, curtailed in different FTAs cont.
Cancellation of Bolar provision
Limitations on the grounds for granting compulsory licensing
Limitations on the parallel importation

10. TRIPS flexibilities related to data protection, curtailed in different FTAs
New chemical entity was not defined
Any clinical info = any development of old chemical entities

11. TRIPS flexibilities related to data protection, curtailed in different FTAs
No conditions of un-disclosure
Data protection beyond patent expiration
Any data submitted can be protected not necessarily data requested by regulatory bodies

12. “Clawing back” policy space and flexibilities after FTA
ONE SIZE DOESN’T FIT ALL

13. Recommendations to civil societies
Open the channels with the government, Show the government the importance of balancing the rights of innovators and generics
Familiarize governments and public with patents and other IP laws, and their impact on access to medicine &expenditure on health
Familiarize the governments with the US IP legislations and the international practices

14. Recommendations Always read the agreements with the preambles
Open channels with similar organizations, exchange information
Consult international organizations, such as UNCTAD, TWN, ICTSD
Post FTA, do implications assessment studies

15. Thank You for your attention