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Table 4 Implementation of available TRIPS Flexibilities by WHO African Region Countries

From: The role of intellectual property rights on access to medicines in the WHO African region: 25 years after the TRIPS agreement

Flexibility

WHO African countries with relevant legislation

Observation

Patentability criteria and exemption from patentability based on what constitutes novelty.

Namibia, Rwanda and Zambia have specifically legislated against new or second use of already patented pharmaceutical products to stop “ever-greening” of patents

 

Research exception

Algeria, Botswana, Burundi, Cabo Verde, Democratic Republic of Congo, Eswatini, Ethiopia, Ghana, Kenya, Lesotho, Liberia, Madagascar, Mauritius, Mozambique, Namibia, Rwanda, Sao Tome & Principe, Seychelles, Sierra Leone, Tanzania, Uganda,

OAPI countries –Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal and Togo do not provide legislative exceptions for research purposes.

Regulatory review exception (Bolar exception)

Botswana, Cabo Verde, Kenya, Liberia, Namibia, Rwanda, Sao Tome & Principe, Seychelles, South Africa, Uganda, Zambia, Zimbabwe

OAPI countries –Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal and Togo do not provide legislative exceptions for regulatory review purposes.

Compulsory licensing

Algeria, Angola, Botswana, Burundi, Cabo Verde, Democratic Republic of Congo, Eswatini, Ethiopia, The Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Nigeria, Rwanda, Sierra Leone, Sao Tome & Principe, Seychelles, South Africa, South Sudan, Tanzania, Uganda, Zambia, Zimbabwe, and OAPI countries namely Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Mauritius, Niger, Senegal and Togo.

 

Exhaustion of rights and parallel importation

International exhaustion – Botswana, Burundi, Ghana, Kenya, Liberia, Mauritius, Namibia, Seychelles, Sierra Leone, South Africa, Zambia, Zimbabwe

Regional Exhaustion – Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo Republic, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal, Togo – essentially all OAPI countries.

National exhaustion – Eswatini, The Gambia, Lesotho, Rwanda, Madagascar, Mozambique, and Tanzania, Nigeria, Sao Tome & Principe, South Sudan, Uganda

Algeria – legislationa does not specify applicable level of exhaustion whether national or international

 

Patent term extension

Angolab, Zimbabwec

 

Limits on test data protection

Uganda

 

Transition periods for LDCs and exemption of pharmaceutical products from patentable subject matter

Angola, Burundi, Madagascar, Liberia, Rwanda, Uganda have excluded pharmaceutical products from patentability criteria

OAPI countries –Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal and Togo, do not exempt pharmaceutical products from patentable subject matter.

Enactment of a patent opposition system

Countries with a pre-grant opposition system: - Botswana, Burundi, Cabo Verde, Lesotho, Liberia, Malawi, Mozambique, Namibia, Seychelles, Uganda, Zambia, Zimbabwe

Countries with a post-grant opposition system: - Botswana, Comoros, DRC, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mauritius, Mozambique, Namibia, Rwanda, Sao Tome & Principe, Seychelles, South Africa, South Sudan, Tanzania, Uganda, Zambia, Zimbabwe

OAPI countries –Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Comoros, Congo, Cote d’Ivoire, Equatorial Guinea, Gabon, Guinea, Guinea Bissau, Mali, Mauritania, Niger, Senegal and Togo do not have patent opposition legislation.

  1. aArticle 12(2) of Ordinance No. 03–07 of July 19, 2003 on Patents
  2. bArticle 6 (2) of Law No. 3/92 of February 28, 1992 on Industrial Property states that once the patent validity period of 15 years expires, the subject of the patent shall fall into the public domain
  3. cSection 24B (2) of the Zimbabwe Patents Act, 2002 states that where test batches of a patented product (through Bolar exception)… the term of a patented product shall not be extended.