- Patenting trends
Graph 1 below depicts health-related patent application trends at ARIPO and OAPI. Data shows that there was a sharp increase in patent applications at both offices from 1994 to 1999, which started to decline in the period 1999 - 2000.
According to the 2018 Report on the State of Health in the WHO African Region[1], the main five causes of morbidity and mortality in the Region, are lower respiratory infections, HIV/AIDS, diarrheal diseases, malaria and tuberculosis. Other top causes of morbidity and mortality include stroke and ischemic heart diseases, preterm birth complications, birth asphyxia and congenital anomalies.
An analysis of the top 10 diseases covered by patents granted at ARIPO and OAPI corresponds to a certain extent, with the top 10 causes of morbidity as illustrated by graphs 2 and 3 below. In both repositories the three top categories of diseases covered by granted patents were inflammatory diseases; cancers, tumors and abnormal cell proliferation; and cardiovascular diseases. Within the inflammatory diseases category, there were patents for lower respiratory diseases such as chronic obstructive pulmonary disease and asthma. HIV/AIDS, which was the second cause for morbidity and mortality, was 7th among the top 10 ARIPO patents and 10th for OAPI. Stroke and ischemic heart diseases which ranked 4th and 5th as causes of mortality respectively, fall within the broad category of patents covering cardiovascular diseases, which ranked 3rd on the list of top 10 diseases covered by patents at ARIPO and OAPI.
These observations point to modest alignment of pharmaceutical knowledge production (through R&D and innovation) with addressing health challenges in the Region. Diarrheal diseases, tuberculosis and malaria, which are among top causes of mortality and morbidity did not appear among the top diseases covered by patents in the Region. There were only 23 TB patents at ARIPO and 25 at OAPI, while there were only 37 malaria patents at ARIPO and 47 at OAPI.
The top 10 categories of diseases covered by patents taken at ARIPO and OAPI were the same, the only difference being in the ranking. Another interesting finding is the ranking of cancer-related patents, which was found to rank 2nd at both patent offices indicating an increase in cancer research.
An analysis of the countries of origin of health-related patents at ARIPO and OAPI shows that the top 10 sources of patents at ARIPO were USA, Great Britain, the European Patent Office, France, India, China, South Africa, Germany, Italy and Denmark. South Africa was the only African country in the top 10 list. The top 10 sources of patents at OAPI were USA, France, Great Britain, Germany, India, Belgium, Japan, Cameroon, Switzerland and Ireland. Cameroon was the only African country in the top 10 list. The African Region countries that had health-related patents at ARIPO were Kenya, Mauritius, Namibia, Zambia, and Zimbabwe and Egypt from the Eastern Mediterranean Region (EMRO) of the WHO. While in OAPI the African Region countries were Burkina Faso, Benin, Central African Republic, Congo Republic, Cote d’Ivoire, Cameroon, Guinea, Mali, Mauritius, Namibia, Nigeria, Senegal, Togo, South Africa and Egypt and Morocco from EMRO.
An analysis of the African country patents shows that the top three disease categories covered are HIV/AIDS, cardiovascular diseases, and cancer and tumors. Table 3 below provides a summary of the main diseases covered by African country patents. The fact that HIV/AIDS, cardiovascular diseases, malaria and tuberculosis which were mentioned as top causes of mortality and morbidity in the Region also feature among African country patents highlights a modest alignment between research and health challenges of the Region.
Table 3: Summary of main diseases covered by African country patents
Disease
|
Number of mentions in patents
|
Disease
|
Number of mentions in patents
|
HIV/AIDS
|
20
|
Tuberculosis
|
5
|
Cardiovascular diseases
|
18
|
Bacterial infection
|
5
|
Cancer and Tumors
|
14
|
Antimicrobial
|
4
|
Diabetes
|
14
|
Antiviral
|
4
|
Malaria
|
13
|
Ulcers
|
4
|
Skin
|
10
|
Hemorrhoids
|
4
|
b) Application of Flexibilities
An analysis of the TRIPS flexibilities database summarized in Table 4 below shows that 39 out of the 47 African Region Countries have used one or more TRIPS flexibility, with all applications being between 2002 and 2009. African Region countries that were not recorded as having applied any flexibility are Algeria, Botswana, Madagascar, Mali, Mauritius, Namibia, Nigeria, and Seychelles. Majority of the applications were for sourcing treatments for HIV/AIDS, except in the cases of Angola, Cape Verde, Chad, Gambia, Kenya, Lesotho, Malawi, Niger, Rwanda, South Sudan, Tanzania and Togo that applied flexibilities for sourcing all medicines.
The analysis shows that only three flexibilities were applied, namely Article 31 of TRIPS which allows for compulsory licensing including for non-commercial use; paragraph 7 of the Doha Declaration on LDC country transition periods and paragraph 5 (d) of the Doha Declaration allowing for parallel importation. The most commonly applied flexibility is paragraph 7 of the Doha Declaration on transition provisions with 27 countries having applied it, followed by Article 31, allowing compulsory licensing, which has been applied by 16 countries. Parallel importation has only been used by Kenya once (in 2002) for the importation of generic medicines.
Some countries have applied flexibilities more than once; the highest being five times by Kenya, four times by Zimbabwe, and three times by Benin, Congo, Gabon, Ivory Coast, Mozambique, Togo and Zambia. Central African Republic, Chad, the Gambia, Guinea, Lesotho, Malawi, Niger, Rwanda and Sierra Leone have all applied flexibilities twice respectively. Guinea, Mozambique and Zambia adopted a mixed approach of using both Article 31 and paragraph 7, and Kenya both Article 31 and paragraph 5 at different times. In the case of Kenya, it did not execute 4 of its applications which were under Article 31 for HIV/AIDS medications. The pharmaceutical companies involved in these cases GSK and Boehringer Ingelheim entered into voluntary license agreements with a Kenyan manufacturing company Cosmos Ltd. The 5th application by Kenya, and only one to be executed was under paragraph 5 and related to sourcing of generic drugs.
Cameroon and South Africa too did not execute their flexibilities applications which were both under Article 31 and were both for HIV/AIDS drugs. The database does not record why Cameroon did not execute its application. In the case of South Africa, the concerned pharmaceutical companies GSK and Boehringer Ingelheim entered into a voluntary license with Cipla, an Indian manufacturing company.
Table 4: Summary of application of TRIPS flexibilities by African Region countries
Country
|
Date
|
Flexibility
|
Product
|
Patent filed/granted
|
Disease
|
Executed
|
Reason if not executed
|
Angola
|
2005
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Benin
|
2004
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Benin
|
2007
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Benin
|
2009
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Burkina Faso
|
2005
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
Burundi
|
2005
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
Cameroon
|
2005
|
Art 31
|
NVP, 3TC, 3TC/AZT
|
Yes
|
HIV/AIDS
|
No
|
No response
|
Cape Verde
|
2004
|
Par7
|
All medicines
|
Unknown
|
All
|
Yes
|
|
CAR
|
2004
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
CAR
|
2005
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
Chad
|
2005
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Chad
|
2007
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Comoros
|
2007
|
Par7
|
ARVs +
|
Unknown
|
HIV/AIDS
|
Yes
|
|
Congo
|
2007
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Congo
|
2014
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Congo
|
2005
|
Art 31
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
DRC
|
2005
|
Par7
|
ARVs
|
No
|
HIV/AIDS
|
Yes
|
|
Eritrea
|
2005
|
Par7
|
ARVs
|
No
|
HIV/AIDS
|
Yes
|
|
Ethiopia
|
2004
|
Art 31
|
ARVs
|
No
|
HIV/AIDS
|
Yes
|
|
Gabon
|
2005
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Gabon
|
2006
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Gabon
|
2013
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Gambia
|
2004
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Gambia
|
2007
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Ghana
|
2005
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Guinea
|
2004
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Guinea
|
2005
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Guinea Bissau
|
2005
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Guinea Equatorial
|
2009
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Ivory Coast
|
2004
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Ivory Coast
|
2007
|
Art 31
|
3TC, 3TC/AZT, 3TC/AZT/NVP, 3TC/D4T, 3TC/D4T/NVP, DDI, EFV, IDV
|
Yes
|
HIV/AIDS
|
Yes
|
|
Ivory Coast
|
2007
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Kenya
|
2002
|
Par5d
|
Generics
|
Yes
|
All
|
Yes
|
|
Kenya
|
2004
|
Art 31
|
3TC
|
Yes
|
HIV/AIDS
|
No
|
Voluntary licence
|
Kenya
|
2004
|
Art 31
|
3TC/AZT
|
Yes
|
HIV/AIDS
|
No
|
Voluntary licence
|
Kenya
|
2004
|
Art 31
|
AZT
|
Yes
|
HIV/AIDS
|
No
|
Voluntary licence
|
Kenya
|
2004
|
Art 31
|
NVP
|
Yes
|
HIV/AIDS
|
No
|
Voluntary licence
|
Lesotho
|
2004
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Lesotho
|
2006
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Liberia
|
2005
|
Art 31
|
ARVs
|
No
|
HIV/AIDS
|
Yes
|
|
Malawi
|
2004
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Malawi
|
2005
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Mauritania
|
2004
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Mozambique
|
2004
|
Art 31
|
3TC/D4T/NVP
|
No
|
HIV/AIDS
|
Yes
|
|
Mozambique
|
2005
|
Art 31
|
EFV
|
No
|
HIV/AIDS
|
Yes
|
|
Mozambique
|
2005
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Niger
|
2004
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Niger
|
2008
|
Par7
|
ARVs
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Rwanda
|
2007
|
Par7
|
3TC/AZT/NVP
|
No
|
HIV/AIDS
|
Yes
|
|
Rwanda
|
2007
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Senegal
|
2006
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Sierra Leone
|
2009
|
Par7
|
IDV, LPV/r, NVP, TDF
|
No
|
HIV/AIDS
|
Yes
|
|
Sierra Leone
|
2009
|
Par7
|
DDI, IDV, LPV/r
|
No
|
HIV/AIDS
|
Yes
|
|
South Africa
|
2003
|
Art 31
|
AZT, 3TC, AZT/3TC, NVP
|
Yes
|
HIV/AIDS
|
No
|
Voluntary licence
|
South Sudan
|
2007
|
Par7
|
All medicines
|
Yes
|
HIV/AIDS
|
Yes
|
|
Swaziland
|
2005
|
Art 31
|
NVP, AZT
|
Yes
|
HIV/AIDS
|
Yes
|
|
São Tomé and Príncipe
|
2006
|
Art 31
|
ARVs
|
No
|
HIV/AIDS
|
Yes
|
|
Tanzania
|
2008
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Togo
|
2004
|
Par7
|
All medicines
|
Yes
|
All
|
Yes
|
|
Togo
|
2008
|
Par7
|
TDF/3TC
|
Yes
|
HIV/AIDS
|
Yes
|
|
Togo
|
2009
|
Par7
|
EFV, NVP, 3TC/AZT
|
Yes
|
HIV/AIDS
|
Yes
|
|
Uganda
|
2006
|
Par7
|
3TC/D4T/NVP
|
Yes
|
HIV/AIDS
|
Yes
|
|
Zambia
|
2004
|
Art 31
|
3TC/D4T/NVP
|
Yes
|
HIV/AIDS
|
Yes
|
|
Zambia
|
2004
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Zambia
|
2006
|
Par7
|
ARVs +
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Zimbabwe
|
2002
|
Art 31
|
ARVs +
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Zimbabwe
|
2003
|
Art 31
|
ARVs +
|
Yes
|
HIV/AIDS +
|
Yes
|
|
Zimbabwe
|
2004
|
Art 31
|
ARVs
|
Yes
|
HIV/AIDS
|
Yes
|
|
Zimbabwe
|
2005
|
Art 31
|
ARVs +
|
Yes
|
HIV/AIDS
|
Yes
|
|
Table 5 below provides a snapshot of flexibilities that have been enacted into law by African Region countries. Our analysis did not find any country that had legislated on research exception, regulatory review exception and patent term extension.
Table 5: Summary of flexibilities enacted into law by African Region countries
Flexibility provision
|
Country
|
Patentability criteria
|
Namibia, Rwanda and Zambia have legislated against new or second use of already patented pharmaceutical products to stop “evergreening” of patents
|
Compulsory Licensing
|
Botswana, The Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sierra Leone, Swaziland, South Africa, Tanzania, Uganda, Zambia, Zimbabwe, and OAPI countries
|
Exhaustion of rights and parallel importation
|
International exhaustion – Botswana, Ghana, Kenya, Liberia, Rwanda, Namibia, Sierra Leone, South Africa Uganda, Zambia
Regional Exhaustion – Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo Republic, Cote d’Ivoire, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal, Togo – essentially all OAPI countries within the framework of the Bangui Agreement).
National exhaustion – The Gambia, Lesotho, Mozambique, Swaziland, and Tanzania, Nigeria
|
Limits on test data protection
|
Uganda
|
Transition periods for LDC
|
Liberia, Rwanda & Uganda allow for pharmaceutical product exemption from patentability.
|