1. 2 ND WIPO INTER-REGIONAL MEETING ON SOUTH-SOUTH COOPERATION ON PATENTS, TRADEMARKS, GEOGRAPHICAL INDICATIONS, INDUSTRIAL DESIGNS AND ENFORCEMENT CAIRO 6-8 MAY 2013 DR. MOHAMMED EL SAID (UCLAN, UK) Patent-Related Flexibilities in Multilateral Treaties and their Importance for Developing Countries and LDCs

2. Summary Meaning of flexibilities Development of flexibilities Categories of flexibilities Impact Recommendations and final thoughts

3. Meaning of flexibilities? policy space which includes a range of rights, safeguards and options that countries can exploit in their implementation of IP obligations

4. Flexibilities: Purpose: striking the balance TRIPS Non uniform in nature: depending on each country Non automatic applicability: such options, must be incorporated under national law

5. Historical development of flexibilities Emerging trend: reduction in policy space Total freedom Paris and Berne Conventions 1883 and 1889 National treatment MFN TRIPS Agreement and the notion of Minimum standards TRIPS-Plus and the reduction of policy space

6. General categories of Flexibilities under TRIPS First: Implementation flexibilities Second: Substantive standards flexibilities Third: Enforcement related flexibilities

7. First: Implementation flexibilities Art 1.1 of TRIPS stipulates that: Members shall be free to determine the appropriate method of implementing the provisions of this Agreement within their own legal system and practice. Example, Transition periods. LDCs under 2013 and 2016 respectively

8. Second: Substantive standards flexibilities Defining subject matter of protection Patents: patentability criteria Exceptions, example of patents: Compulsory licensing and government use Education, experimental and personal use Parallel importation Regulatory review (Bolar exception) Utility models Procedural flexibilities: pre and post-grant oppositions

9. Third: Enforcement related flexibilities TRIPS first ever to deal with enforcement measures. General guidelines Enforcement procedures to effective action against IP infringement IP Enforcement Procedures shall be fair and equitable Parties to a proceeding shall have an opportunity for review by a judicial authority of final administrative decisions No obligation to put in place a IP distinct judicial system Border measures: Art 51 applies to two types of IP infringements: Counterfeited trademarks Pirated copyrighted goods NO OBLIGATION ON PATENTS No requirement to adopt provisional measures ex officio or specialized courts.

10. Importance and Impact Parallel importation reduced the price of first-line anti-retroviral medicines to one-third of the price of the patented version in Kenya. Oxfam (2006) Malaysia became the first country in Asia to issue a government use licence for the importation of generic ARVs in 2003. This reducing the average cost of the Malaysians MoH treatment per patient per month from US $315 to US $58, an 81% reduction. Khor (2007) Ecuador latest country to issue one for ARVS in 2010. The License immediately reduced cost of drug by 27%

11. Importance and Impact Indias use of transition period Indias use of patentability criteria (sec 3.d) In march 2013, supreme court rejected Novartis application for Gleevec as it did not consider it new invention. Gleevec, for example, can cost as much as $70,000 a year, while Indian generic versions cost about $2,500 a year.

12. Importance and impact Following the declaration of government use for the ARV treatment lopinavir/ritonavir in 2008, the number of patients in Thailand using lopinavir/ritonavir has reportedly increased from 39 to 6,246. In February 2007, the patent holder announced a global price reduction on efavirenz, benefiting HIV/AIDS patients around the world. WHO/WTO/WIPO 2013

13. Developing and LDCs challenges WIPO Study Patent Flexibilities 2010 With regard to regulatory review (Bolar) exception, of the 95 countries with available information, only 56% had integrated it into their patent legislation. The percentage of countries integrating this flexibility varied from 0% (0/20) for least developed countries to 93% (25/27) for high-income countries. With regard to parallel imports, an analysis of the legislation of 112 countries showed that 29 (26%) have an international exhaustion regime, 36 (32%) have a regional exhaustion regime, thus allowing for parallel imports, and 42 (37.5%) have a national exhaustion regime.

14. Regional perspective incorporation vrs application Arab countries incorporation (largely) Arab countries application (v poor utilization)

15. Threats and Challenges Incorporation of flexibilities Easy, user friendly Awareness about their use Checks and balances Collaborative effort nationally Regional cooperation International agenda Rejection of TRIPS-Plus conditions (FTAs)

16. Thank you Mel-said@uclan.ac.uk