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

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

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

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

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

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

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

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

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

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

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

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

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

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

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