This document discusses two regional intellectual property organizations in Africa - the African Regional Intellectual Property Organization (ARIPO) and Organisation Africaine de la Propriété Intellectuelle (OAPI). It notes weaknesses in how they examine and grant pharmaceutical patents, including a lack of rigorous standards and capacity. This risks granting invalid secondary patents and undermining countries' ability to utilize TRIPS flexibilities. The document recommends reforms like adopting rules to avoid patent evergreening, increasing civil society engagement, and fully implementing LDCs' transition period for pharmaceutical patents.

1. Why Patent Examination Matters: A review of pharma
patents at OAPI and ARIPO
Sangeeta Shashikant
Third World Network

2. AFRICAN REGIONAL INTELLECTUAL
PROPERTY ORGANIZATION (ARIPO)

3.  ARIPO was established with the adoption of the Lusaka Agreement
on 9 December 1976.
 Since the Lusaka Agreement, several Protocols have been developed
to address specific intellectual property areas.
 On Patents - Harare Protocol on Patents and Industrial Designs
adopted in Harare on 10 December 1982 to address matters in
connection with patents, utility models and industrial designs.
 ARIPO main regional IP organization for the filing and grant of
patents for ARIPO member countries (mainly English speaking)

4. ARIPO Membership
 19 countries are members of ARIPO’s constituting treaty - the Lusaka
Agreement: Botswana, the Gambia, Ghana, Kenya, Lesotho, Malawi,
Mozambique, Namibia, Sierra Leone, Liberia, Rwanda, São Tomé and
Príncipe, Somalia, Sudan, Swaziland, Tanzania, Uganda, Zambia and
Zimbabwe.
 Of these some are not even members of WTO (Sao Tome and Principe,
Somalia and Sudan)
 Except for Somalia, the rest are Parties to the Harare Protocol
 12 of these ARIPO countries are Least Developed Countries. As
LDCs they should not be granting pharmaceutical product patents due
to the LDC pharmaceutical transition period.

5. Most pharmaceutical patent applications fall within IPC sub-class A61K. For the
period 2003 to 2013, 587 pharmaceutical patents (falling within the A61K
classification) were granted by ARIPO. Table below provides a breakdown of
pharmaceutical patent grants by ARIPO (sub-class A61K) in each ARIPO State.
Grants relating to pharmaceuticals by ARIPO per designated state for the
duration 1/1/2003 - 31/12/2013.
State Totals (A61K) State Totals (A61K)
1. Botswana 273 10. Rwanda 0
2. Ghana 543 11. Sudan 538
3. The Gambia 548 12. Sierra Leone 489
4. Kenya 580 13. Swaziland 516
5. Liberia 15 14. Tanzania 450
6. Lesotho 517 15. Uganda 565
7. Malawi 560 16. Zambia 345
8. Mozambique 421 17. Zimbabwe 569
9. Namibia 219
Source: ARIPO Office

6. Issue (Harare Protocol):
Section 3(6)(b) and (7) of the Harare Protocol: If the ARIPO Office decides to grant a
patent, it shall notify the applicant and each designated State….. The designated State
shall have 6 months within which to respond to the notification.
After the expiration of the said 6 months, the Office shall grant the patent which shall
have effect in those designated States which have not made the communication referred
to in sub-section (6).
 Lapses in the notification system: When ARIPO informs designated states of its
intent to grant a patent, most LDC IP offices do not object due to lack of human
resources and capacity.
 Failure to object, results in a pharmaceutical patent being granted by ARIPO
Office even if the national law of a LDC excludes pharmaceuticals from being
patented.
 Is this a valid patent? Creates a lot of uncertainty as to patent status of a product.
 Negates the intended impact of incorporating TRIPS flexibilities in national
patent legislations.

7. Recommendation:
The Harare Protocol should exempt the territory of LDCs
from the grant of any pharmaceutical patents.

8. Issue (Harare Protocol):
 Evidence suggests that the standards applied in the examination of
pharmaceutical patent applications by the ARIPO Office are not
rigorous. Examination capacity at the ARIPO office is very limited.
 A number of secondary patents granted.
Examples of Secondary Patents Granted:
Abacavir (hemisulfate salt, composition for pediatric use, combination of
ABC+3TC (lamivudine));
Darunavir (pseudopolymorph); combination Tenofovir+FTC (emtricitabine)
;
Combination Tenofovir+Rilpivirine;
Bedaquiline salt (patent expires in 2027).

9. Section 3(10)(j) Harare Protocol: Patents shall not be granted in respect
of
….methods for treatment of the human or animal body by surgery or
therapy and diagnostic methods practised on the human and animal
body; this provision shall not apply to products, in particular
substances or composition for use in any of these methods.
e.g. patents granted on Bedaquiline to treat MDR TB (expires May
2025) and to treat latent TB (Dec 2025).
e.g. compound patent (expires 2023). Use claims extends monopoly by
2 years.
Provisions of the Harare Protocol (e.g. Section 3 (10) (j)) and Rule 7(3)
of the Regulations allows use claims including second medical
indication (where a product already known to have a pharmaceutical
use is discovered to have a further pharmaceutical use that is unrelated
to the known use).

10. RECOMMENDATION:
• ARIPO should adopt rigorous patentability standards with regard to
pharmaceutical applications, with the aim of avoiding secondary
patents and patent evergreening.
• In addition, specific rules should be established for the examination
and grant of pharmaceutical patents paralleling those adopted by
Argentina.
• New patent examination guidelines being established by the ARIPO
Office should be thoroughly reviewed to ensure that they are sensitive
to public health concerns.
• The Harare Protocol should include other TRIPS flexibilities such as
pre and post grant opposition systems.
• Need to increase CSO engagement.

12. Organisation Africaine de la Propriété
Intellectuelle or OAPI

13.  Organisation Africaine de la Propriété Intellectuelle or OAPI is an
intellectual property organization, headquartered in Yaoundé, Cameroon
 Main Instrument: Bangui Agreement. Covers various intellectual property
categories including patents.
 Membership: 17 mainly French speaking member states from western and
central Africa of which 13 are LDCs.
 Grants many pharmaceutical products patents including many frivolous
patents. Secretariat barely conducts examination of pharmaceutical patent
applications.
 Recent amendment of the Bangui Agreement – LDC pharmaceutical
transition period mentioned.
 Unclear whether and how it is being operationalized.
 Weak capacity in the region on intellectual property matters.

14. For more information: contact
sangeeta@twnetwork.org