PATENTS, TRIPS, FLEXIBILITIES & ACCESS TO MEDICINES LESOTHO August 2014 Maseru, Lesotho

OUTLINE OF PRESENTATION - TRIPS Agreement - Industrial Property Order 1989 - Flexibilities - Pre-grant measures - Post-grant measures - The Way Forward / Recommendations

TRIPS AGREEMENT - Signed on 15 April 1994 - Into force on 1 January 1995 - Countries to be compliant by - Developed Countries 1996 - Developing Countries 2000 - Least Developing Countries 2006 date later extended to 2016 further extended to 2021

INDUSTRIAL PROPERTY ORDER, 1989 The Industrial Property Order, 1989, governs patents in Lesotho.

ARIPO ARIPO (automatic applications submitted) Is need to change Letter to ARIPO, no more patents for medicines / pharmaceuticals

FLEXIBILITIES Doha Declaration Reaffirmed - that TRIPS does not and should not prevent Member Countries from taking measures to protect public health and promote access to medicines for all; - the rights of countries to issue compulsory licences at their discretion and not only in cases of emergencies. LDCs Extension of transitional periods (2016, now 2021)

PRE-GRANT MEASURES Patentability standards (S.5 of IP order) Pre-grant patent opposition (public domain, administrative system) Specific exclusions, including the early working of patents, Bolar provisions Section 4 of IP Order lists the exclusions

POST-GRANT MEASURES - Parallel importation of medicines / international exhaustion (pooled procurement) - Government use (e.g. Zimbabwe HIV / AIDS) - Compulsory Licensing (including adequate compensation, and to redress anti- competitive practices e.g. South Africa HIV /AIDS, effectiveness of threat, US biggest user of compulsory licences

POST-GRANT MEASURES CONTINUED - Post-grant opposition (is available but could be made more accessible by administrative system) - Section 16 of IP Order

THE WAY FORWARD / RECOMMENDATIONS - Incorporation of TRIPS Flexibilities - Avoidance of TRIPS Plus (such as data exclusivity provisions in Free Trade Agreements, Patent term extensions, Also in Free Trade Agreements avoid limiting conditions for Compulsory Licensing, patent linkage, patent policing)

THE WAY FORWARD / RECOMMENDATIONS CONTINUED - This presentation was about public health priorities for the law reform process. - There other law reform initiatives affecting access, these are separate.

THANK YOU