A. Patenting trends
Graph 1 below depictshealth-related patent application trends at ARIPO and OAPI. Data showsthat there was a sharp increase in patent applications at both offices from 1994 to 1999, which started to decline in the period 1999 - 2000. This trend matches that reported in a study on inventions and patenting in Africa44. The observed increase in patent applications in the late-1990s may have been caused by developments in molecular biology, genetics and genomics and their application in the biopharmaceutical sector45.
According to the 2018 Report on the State of Health in the WHO African Region46, 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 repositoriesthe 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.
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, whose implications meritfurther interrogation, is the ranking of cancer-related patents, which was 2nd at both patent offices.
An analysis of the countries of originof 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 inthe 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 inthe 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 threedisease 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.
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. The Intellectual Property Regulation and Governance Landscape in the WHO African Region
Countries of the WHO African Region operate within a multi-layered IP regulation and governance landscape. The Paris Convention for the Protection of Industrial Property (1883) and the TRIPS Agreement (1994) regulate the global IP framework within which African Region countries operate. Most countries (40 out of the 47) in the Region are members of the World Trade Organization (WTO) and are Parties to the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement), which provides a minimum standard for the regulation of intellectual property. Article 1.1 of the TRIPS Agreement states that signatory Members States may, but shall not be obliged to, implement in their law more extensive protection than is required by TRIPS, making it open for them to determine the appropriate level of implementing it within their own legal system and practice. At the time of writing this article Algeria, Comoros, Equatorial Guinea, Eritrea, Ethiopia, Sao Tome and Principe, and South Sudan were not members of the WTO. All countries with the exception of Eritrea had commenced accession discussions leading to eventual membership.
At the Regional level,countries are either signatories to the Harare Protocol on Patents and Industrial Design (1982), which is administered by ARIPO or the Bangui Agreement (1977) administered by OAPI.
The African Regional Intellectual Property Office (ARIPO) System and TRIPS Flexibilities
The African Regional Intellectual Property Office (ARIPO) was established by the Lusaka Agreement in 1976; and has 20 memberstates, 1847 of whom are members of the WHO African Region. The objective of ARIPO is to promote the harmonization and development of intellectual property laws appropriate to the needs of its members, fostering the establishment of a close relationship between its members on intellectual property matters and establishing such common services or organs as may be necessary or desirable for the co-ordination, harmonization and development of intellectual property activities affecting its members.
The Harare Protocol on Patents and Industrial Designs (Harare Protocol) was adopted in 1982 and came into force in 1984. There are 18 contracting parties to the Harare Protocol namely Botswana, Eswatini, Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tome and Principe, Sierra Leone, Sudan, Tanzania, Uganda, Zambia and Zimbabwe. Of these, Gambia, Lesotho, Liberia, Malawi, Mozambique, Rwanda, Sao Tome & Principe, Sierra Leone, Uganda, Tanzania and Zambia are classified as LDCs.
Under the Harare Protocol, an application for the grant of a patent is made with any Contracting Party or directly with ARIPO,in which the applicant designates any one of the Contracting Parties in which they wish the invention to be accorded protection. The Protocol establishes a regional mechanism that administers the filing, examination and grant of patents, in all fields of technology, including the pharmaceutical field (section3.10.a). A review of how the TRIPS flexibilities identifiedin the methods section above are implemented by the Harare Protocol shows that patentability criteria extends to cover pharmaceutical products under Rule 10 of the Regulations to the Harare Protocol. Additionally, Rule 7 (3) on drafting patent claims implies that ARIPO allows claims relating to second uses of known and already patented pharmaceutical products, which is likely to encourage frivolous patent applications and ever-greening. 48495051
Rule 3.3 of the Regulations to the Harare Protocol makes provision for ARIPO to, upon request, undertake or arrange for the substantive examination of a patent application. According to one of the ARIPO officials interviewed for this study, substantive examination is ordinarily conducted at ARIPO. However, ARIPO has bilateral agreements with the European Patent Office (EPO), the Australian, German and Swedish patent offices as well as with WIPO, for the conduct of substantive examination in technical fields or for complex inventions that ARIPO may not have adequate examination capacity52.A study conducted in 201453 revealed that ARIPO had only 6 patent examiners at the time, which is a grossly low number of examiners. Rule 19bis of the Regulations to the Harare Protocol provides for the publication of patent applications as soon as possible after the expiry of 18 months from the date of filing or from priority date, and does not make provision for opposition of patents granted by ARIPO.
The Organisation Africaine De La Propriété Intellectuelle (OAPI) System and TRIPS Flexibilities
The Organisation Africaine De La PropriétéIntellectuelle (OAPI) was created in 1977 by the Bangui Agreement and has the objective of implementing and applying common administrative procedures deriving from a uniform system for the protection of industrial property, providing services related to industrial property, and promoting the economic development of Member States by means of effective protection of intellectual property and related rights, according to Article 2.1 of the Agreement. According to Articles 2 (2), 8 (1) and 8 (2) of the Bangui Agreement OAPI serves as both a national and central patent documentation body for all its member countries and for Member States party to the Patent Cooperation Treaty (PCT). In this case, OAPI serves as the national, designated, elected, and/or receiving office within the context of Article 254 of the PCT, and the Bangui Agreement is the law governing industrial property rights in each of its member states. This being the case, patent applications at OAPI are designated for protection in all OAPI member countries.
The countries signatory to the Bangui Agreement are Benin, Burkina Faso, Cameroon, Central African Republic, Chad, Congo Republic, Cote d’Ivoire, Gabon, Guinea, Guinea-Bissau, Mali, Mauritania, Niger, Senegal and Togo. Out of the 15 Member States, only 4 countries are not LDCs namely Cameroon, Congo Republic, Cote d’Ivoire, and Gabon.
According to the Bangui Agreement a patentable invention is defined as a product or process that is new, involves an inventive step and is industrially applicable. This broad definition of patentability criteria is construed to cover both pharmaceutical products and processes. In accordance with provisions of Article 20 of the Annex to the Bangui Agreement, OAPI is a formality and not a substantive examination office. Therefore all patent applications that meet the formality examination requirements namely, Articles 655, 14.156, and 1557 of the Annex to the Agreement, are granted under Article 22. The Bangui Agreement just like the Harare Protocol does not make provision for a patent opposition system that would serve to prevent granting of invalid and or frivolous patents.
C. Implementation and Application of TRIPS Flexibilitiesby WHO African Region Countries
Table 4 (see Appendix C) below presents a summary how the TRIPS flexibilities identified in the methods section and discussed in table 2 (onAppendix B below) have been enacted into law by African Region countries. The summary is based on a review of all WHO African countries’ patent legislation and IP policies as accessed through the WIPO Lex depository58.
The analysis shows that 3 countries, namely Namibia59, Rwanda60 and Zambia61 have specific legislation on patentability of pharmaceutical products based on what constitutes novelty to limit ever-greening of patents. These countries have explicit legislation against new or second use patents of already patented pharmaceutical products. Twenty one (21) countries62 make provision for limited exceptions to exclusive patent rights for purposes of research and scientific experimentation (research exception), while twelve63 allow for the use of patented knowledge during the patent term for purposes of developing information necessary for attaining regulatory and market-entry approval (bolar exception). The Bangui Agreement as currently enforced, does not make provision for research and bolar exceptions for signatory member states.
The most commonly legislated flexibilities are compulsory licensing and parallel importation where 45 out of the 47 (95%) countries have enacted legislation to allow for compulsory licensing, and 40 (85%) for exhaustion of rights and parallel importation. The 2 countries that do not legislation on compulsory licensing were Eritrea and Madagascar and the 7 without legislation on parallel importation are Angola, Cabo Verde, Comoros, Ethiopia, Eritrea, DRC and Malawi.
The least commonly legislated flexibilities were those imposing limits to patent term extensions and on test data protection. Only Angola64 and Zimbabwe65were found to have legislative provisions that could be used to limit pharmaceutical product patent term extensions, while only Uganda has legislation which allows the medicines regulatory authority to rely on available data to assess new generic drugs for market entry.
Out of the 30 WHO African Region member states who are classified as LDCs66 and qualify for pharmaceutical product patent waivers, until 1 January 2033, on the mailbox provision and exclusive marketing rights for pharmaceuticals relating to Articles 70.8 and 70.9 of the TRIPS Agreement, only Angola67, Madagascar68, Liberia69,Rwanda70 and Uganda71have explicitly excluded pharmaceutical products from patentability criteria in their national laws. Burundi’s Industrial Property law72 states that this exemption was valid until 1 January 2016. Least developed countries signatory to the Bangui Agreement and members of OAPIdo not exempt pharmaceutical products from patentable subject matter.
Algeria, Angola, Eritrea, Ethiopia, Madagascar, Nigeria, Sierra Leone and all OAPI countries were found not to have any patent opposition procedures (whether pre and/or post grant) in place.
The analysisshows that only threeflexibilities are recorded in the database as having been applied, namely Article 31 of TRIPS which allows for compulsory licensing including for non-commercial use; paragraph7 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 BoehringerIngelheim entered into voluntary license agreements with a Kenyan manufacturing company Cosmos Ltd. The 5th application by Kenya, and the 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 BoehringerIngelheim entered into a voluntary license with Cipla, an Indian manufacturing company.
An analysis of responses provided by twelve WHO African countries77 to an online questionnaire administered by WIPO78, identifies a number of challenges that countries experience in applying TRIPS flexibilities to meet public health needs. The most often cited challenge in the survey was insufficiency or no local manufacturing capacity79 to produce generic pharmaceutical products in relation to the use of compulsory licensing. This arose from the fact that Article 31 (f)80 and (h)81 of the TRIPS Agreement, before entry into force of Article 31bisin 2017, which made it impossible for countries with insufficient or no pharmaceutical manufacturing capacity to use compulsory licensing to access patented medicines.It was however noted from the survey that the considerable burden of proof on governments and potential users of the Article 31bis system82 remains to be a challenge. Another challenge identifiedfrom the WIPO survey and inliterature83, is the risk of having counterfeit pharmaceutical products introduced into the market through parallel importation.