Health and Patent Law in FTAs: Latin American Perspectives

1. ATRIP Annual meeting Parma, Italy September 4 – 6, 2006 Main Hall, Chamber of Commerce of Parma Sensitive Issues of Health and Patent Law in FTAs Recently Executed by the USA: The Latin American Situation by Horacio RANGEL-ORTIZ ATRIP Dr. jur. Professor of International Intellectual Property Law, School of Law, National University of Mexico, (UNAM) and Universidad Panamericana (UP), Mexico City. Attorney at Law. President of ATRIP (1997-1999) and of the Mexican Group of AIPPI (1992-1995). President of the International Treaties Committee of the Mexican Group of AIPPI.

2. NAFTA Standards (1993) • TRIPS Standards (1994) • TRIPS Plus Standards (2002)

3. PATENT and HEALTH Issues

4. U.S. Trade Promotion Authority Act (2002) • and • DOHA DECLARATION on the TRIPS Agreement and Health (2001)

5. Post-NAFTA Times • Developments incorporated in FTAs recently executed by the U.S. with Latin American nations • Pharmaceutical and Agricultural Chemical Products

6. OTHER BILATERAL U.S. TRADE AGREEMENTS (2004) • NORTH AFRICA (Morocco) • THE PERSIAN GULF (Bahrain) • OCEANIA (Australia)

7. POST-NAFTA INNOVATIONS • Protection of Undisclosed Information and Marketing Approval Proceedings • Marketing Approval Requested by Third Parties Other than the Patentee • Extension of the Patent Term and Unreasonable Delays at the Patent Office • Extension of the Patent Term and Unreasonable Delays at the Marketing Approval Process • Identity of a Third Party Requesting Marketing Approval During the Term of the Patent

8. Patentability of New Uses or Methods of Using Known Products • Exhaustion of Patent Rights • Traditional Knowledge, Genetic Resources and Equitable Sharing of Benefits • Bilateral Trade Agreements do not Derogate Understandings Under the Doha Declaration on TRIPS and Public Health

9. Protection of Undisclosed Information Involved in Marketing Approval Proceedings • Five-year period from the date of approval: pharmaceutical product • Ten-year period from the date of approval: agricultural chemical product NAFTA 1993 Chile 2003 Yes CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

10. Obligation Not to Grant Marketing Approval to Third Parties Prior to the Expiration of the Patent Term of Pharmaceutical Products NAFTA 1993 No Chile 2003 Yes CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

11. Extension of the Patent Term to Compensate for Unreasonable Delays at the Patent Office. NAFTA 1993 No Chile 2003 Yes CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

12. Extension of the Patent Term to Compensate for Unreasonable Delays Resulting from the Marketing Approval Process NAFTA 1993 No Chile 2003 Yes CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

13. Obligation to Make Available to the Patent Owner the Identity of a Third Party Requesting Marketing Approval During the Term of the Patent NAFTA 1993 No Chile 2003 Yes CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

14. Patentability of New Uses or Methods of Using Known Products NAFTA 1993 No Chile 2003 No CAFTA 2004 No Peru 2006 No Colombia 2006 No Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

15. Exhaustion of Patent Rights NAFTA 1993 No Chile 2003 No CAFTA 2004 No Peru 2006 No Colombia 2006 No Morocco 2006 Yes Bahrain 2006 Yes Australia 2006 Yes

16. Traditional Knowledge, Genetic Resources and Equitable Sharing of Benefits NAFTA 1993 No Chile 2003 No CAFTA 2004 No Peru 2006 No Colombia 2006 “Yes” Morocco 2006 No Bahrain 2006 No Australia 2006 No

17. Bilateral Trade Agreements do not Derogate Understandings Previously Adopted Under the Doha Declaration on TRIPS and Public Health NAFTA 1993 No Chile 2003 No CAFTA 2004 Yes Peru 2006 Yes Colombia 2006 Yes Morocco 2006 Bahrain 2006 Australia 2006

18. CONCLUSIONS www.horaciorangelortiz.org.mx