2ND WIPO INTER-REGIONAL MEETING ON SOUTH-SOUTH COOPERATION ON PATENTS,

TRADEMARKS, GEOGRAPHICAL INDICATIONS, INDUSTRIAL

DESIGNS AND ENFORCEMENTCAIRO 6-8 MAY 2013

DR. MOHAMMED EL SAID (UCLAN, UK)

Patent-Related Flexibilities in Multilateral Treaties and their

Importance for Developing Countries and LDCs

Summary

Meaning of flexibilities Development of flexibilities Categories of flexibilitiesImpact Recommendations and final thoughts

Meaning of flexibilities?

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

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

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

General categories of Flexibilities under TRIPS

First: Implementation flexibilitiesSecond: Substantive standards flexibilities Third: Enforcement related flexibilities

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

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

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.

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 Malaysian’s 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%

Importance and Impact

India’s use of transition period India’s 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.

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

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.

Regional perspectiveincorporation vrs application

Arab countries incorporation (largely)Arab countries application (v poor utilization)

Threats and Challenges

Incorporation of flexibilitiesEasy, user friendlyAwareness about their useChecks and balancesCollaborative effort nationallyRegional cooperationInternational agendaRejection of TRIPS-Plus conditions (FTAs)

Thank youMel-said@uclan.ac.uk