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

3. Background on pharmaceutical industry in Jordan Branded generic industry, started 1962 Branded generic industry, started 1962 17 pharmaceutical manufacturers 17 pharmaceutical manufacturers Export oriented Export oriented – 70% – $250 m – 60 countries Major contributor to Jordan economy 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 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 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 Exceptions to rights conferred Extension of patent terms; SPC to compensate 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 Linkage of marketing approval and patents Notification of the patentee when a generic applies for marketing approval 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 Cancellation of Bolar provision Limitations on the grounds for granting compulsory licensing Limitations on the grounds for granting compulsory licensing Limitations on the parallel importation 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 ONE SIZE DOESN’T FIT ALL

13. Recommendations to civil societies Open the channels with the government, SOpen 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 healthFamiliarize governments and public with patents and other IP laws, and their impact on access to medicine &expenditure on health FamiliarizeFamiliarize 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 informationOpen channels with similar organizations, exchange information Consult international organizations, such as UNCTAD, TWN, ICTSDConsult international organizations, such as UNCTAD, TWN, ICTSD Post FTA, do implications assessment studies

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