1. INTERNATIONAL CONFERENCE ON INTELLECTUAL PROPERTY IN THE PHARMACEUTICAL INDUSTRY Warsaw, April 24, 2009 Patents for Pharmaceuticals Products - Legal options and flexibilities WIPO Secretariat

2. Leading products in 2005 by global pharmaceutical sales**

3. LIFE CYCLE OF A DRUG* * Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medicine, Michael A. Gollin, 2001 drug available safety literature know-how education funding equipment time biological materials bioinformatics data Basic research Applied research Applied research Pre-Clinical research Clinical trials Biological model Conception Reduction to practice (in vitro) Animal tests positive 1st clinical trial positive 2nd clinical trial positive Regulatory approval (country by country) ResearchDevelopment Generic Testing Generic drug available (patent expires or invalid) Patentee Commercialization publication Generic Commercialization patent application efficiency sales bioequivalent 3-10 years patent prosecution exclusive rights patent issuance (country by country) 20 years + New delivery system New method of use

4. Patents to Pharmaceuticals in the international context yThe Multilateral Context: 1.Paris Convention 2.Trips Agreement; and y The Bilateral Context

5. 5 The Paris Convention and the asymmetries Some developing countries had excluded from patentability pharmaceutical products, without any challenge to the Paris Convention (Art. 4 bis, 4 ter, 5, 5 ter). This situation that has been gradually changing due multilateral commitments that were adopted in the framework of the TRIPS Agreement or because unilaterally some countries decided to do so.

6. TRIPS AGREMMENT zPatentable Subject Mater. Art. 27. 1), 2) y 3) -Ordre public or morality -Diagnostic, therapeutic and surgical methods (Art.27.3 (a)) -Plants and animals (other than micro-organism) and essentially biological processes for the production thereof (other than non-biological and microbiological) -second uses of known substances; (Art. 27.1) zDelay product protection (Art.65.4)(LDC Art. 66.1) zExceptions to rights Conferred (Art. 30) zOther uses without authorization (Art. 31)

7. 7 Doha Declaration on TRIPS and Public Health z“We recognize that intellectual property protection is important for the development of new medicines. We also recognize the concerns about its effects on prices” z“We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all”.

8. 8 Doha and Public Health. Decisions of the WTO Bodies zDecision of the Trips Council of 1 July 2002 for the extension of the transition period (Art. 66.1) for Least Develop Countries respect to pharmaceuticals products (2016) zDecision of the Trips Council of 8 July 2002, which waive for least Developed Countries the obligation under paragraph 9 of article 70 (2016) zDecision of the General Council of 30 August 2003 for the implementation of the paragraph 6 of the Doha Declaration

9. Patents to Pharmaceuticals in the bilateral context (USA bilateral Agreements) yPending Congressional Approval ColombiaColombia Panama Republic of KoreaPanamaRepublic of Korea yIn Force IsraelIsrael NAFTA Jordan Chile Singapore Australia Morocco BahrainNAFTAJordanChileSingaporeAustralia MoroccoBahrain yPending Implementation PeruPeru OmanOman yOther FTA Negotiations MalaysiaMalaysia Thailand SACU UAEThailandSACUUAE

10. 10 Patent provisions on recent U.S. FTAs

11. 11 Democrat's wish to incorporate key priorities on IP in FTAs (letter March 12 to USTR) The proposal yData protection. The inclusion of caps in the periods available; measures to facilitate the approval of generics to stimulate competition. yPatent extension. To limit the total duration permitted. yLinkage. To mitigate the burden on the regulatory authorities, like the obligation to withhold the approval if a patent could be violated. yCompulsory licensing. Recalled each country freedom to determine the grounds upon which such licenses are granted. Avoid the use of side letters which are “non binding to the parties”. yConsumer safeguards. Bolar provision; the applicant indications of the best mode to reproduce the invention and measures to avoid evergreening patents.

12. 12 The Agreement (just for pharmaceutical products). yDATA EXCLUSIVITY. Five years of data exclusivity for NCEs, considering the nature of the data and efforts and expenditure. If the parties grants the approval within six months when relying in FDA approval, the terms will count from them (concurrent period). yPATENT EXTENSIONS. The obligation “shall” would be changed to “May”. Cooperation and assistance to avoid “unreasonable delays” is envisaged.

13. 13 The Agreement (just for pharmaceutical products). Cont… yTHE LINKAGE. There is no obligation to establish a linkage between drug regulatory agencies and patent issues, particularly, no requirement that the agency withhold approval of the generic until it can certify that no patent would be violated. yNEW KING OF LINKAGE. The party would be required: 1. to provide procedures and remedies (judicial or administrative) and preliminary injunctions (equivalent) do dealt with patent infringement and validity disputes; and 2.A transparent system to give patent holders sufficient time and opportunity to enforce their rights (notifications, website info, etc). yLINKAGE OPTION. A party can be free to chose to fulfill this obligations (procedures and remedies) through a linkage system, if at the same time: adopt an expeditious system to challenge the validity or the infringement of a patent and a system to reward to those who successfully challenge a patent.

14. IP DECISION TREE FOR ACCESS TO ESSENTIAL DRUGS* Subject to Regulatory Drug Approval NY N N N N N Y Y Y Y Y Y Make itComply with Approval Regulations AND Patented in country X? Available to purchase at low price? Support Generic Manufacturing Patent Term Short?Long? Get ready to Jump in! Buy and Distribute Once Approved as a Drug *Generic Drugs, Compulsory Licensing, and other Intellectual Property Tools for Improving Access to Medecine, Michael A. Gollin, 2001 Non-infringing version available? Make itPatent Invalid? Negotiate License 1) Negotiate; 2) Litigate-challenge in Country X Patentee offer High?Slow? Compulsory License Available? - Law is in effect and is applicable? Buy License Government License Take compulsory license

15. 15 Thank you! Marco M. Aleman Deputy Director, Division for Public Policy and Development marco.aleman@wipo.int