COVID-19 in Africa: LDCs, Compulsory Licences and Bolar Provisions

We recognise the gravity of the public health problems afflicting many developing and least-developed countries, especially those resulting from... epidemics...Each member has the right to grant compulsory licences and the freedom to determine the grounds upon which such licences are granted. Article 1 of the Doha Declaration on the TRIPS Agreement and Public Health, as read with Article 5(b).

Introduction

There has been a great deal of talk about COVID-19 in IP circles, especially as regards vaccines. Not surprisingly this has led to people thinking about issues such as compulsory licensing and Bolar provisions (for pharmaceuticals under patent which may be of value in combatting COVID-19). Africa is home to 33 of the world’s Least Developed Countries (LDCs)*, countries that are not required to protect pharmaceutical patents until 1 January 2033 in terms of the TRIPS flexibilities (you will find a list of these countries at the end of this article). Issues like compulsory licensing really matter in Africa!

What follows is a general overview of the situation in Africa as regards compulsory licensing. After that, we move on to discuss compulsory licensing provisions in a number of African countries across the various regions, in some cases also giving examples of compulsory licences that have been granted.

General overview

Africa comprises some 56 states. Compulsory licensing provisions exist in practically every one. The only countries that have no compulsory licensing provisions are Eritrea, Somalia and Somaliland.

In most cases these compulsory licensing provisions cover both non-working or public interest issues, as well as those relating to public health or public benefit. But there are exceptions. Libya has no provision for compulsory licences on grounds of non-working or public interest issues. South Africa has no provision for “ex officio” licences on grounds of public health, public benefit issues or national emergency but the Government may obtain a compulsory licence on various grounds of abuse of patent rights.

Bolar and research provisions are also fairly common in Africa. The African countries that do not have Bolar provisions are Angola, Djibouti, Eritrea, Gambia, Libya, Madagascar, Malawi, Nigeria, Somalia, Somaliland and Sudan.

Selected country overview

What follows is a discussion of the compulsory licensing provisions that exist in a number of important African countries. The provisions that pertain in these countries are fairly typical of the provisions that apply throughout the continent. In the case of some countries there are also examples of licences that have actually been granted.

Algeria

The legislation provides that if the patentee fails to work the patent (importation of articles will not suffice) within a period of three years of grant or four years of filing (whichever is the later) a compulsory licence can be granted. Further provisions are that:

  • The applicant must show that it unsuccessfully attempted to obtain an equitable commercial licence from the patentee
  • There must be appropriate compensation
  • The licence must be registered
  • The licence can be withdrawn if the conditions that justified it cease to exist, or if the conditions laid down are not followed
  • The licence will not be exclusive and its object will be to supply the national market
  • The licence can be granted to a state department in the national interest, including public health

ARIPO (a designation regional system covering Botswana, Eswatini (formerly Swaziland), Gambia, Ghana, Kenya, Lesotho, Liberia, Malawi, Mozambique, Namibia, Rwanda, Sao Tome e Principe, Sierra Leone, Sudan, Tanzania (mainland), Uganda, Zambia and Zimbabwe)

The national law of each country applies to compulsory licences. A number of the ARIPO countries are LDCs* 

Ghana

If the patentee fails to work the patent sufficiently within a period of three years of grant or four years of filing (whichever is the later) an interested party can apply to a tribunal for a compulsory licence. Grounds on which an application can be based are:

  • A failure to work or insufficient working to meet demand
  • Working of the patent being hindered by importation or refusal by the patentee to licence on reasonable terms
  • The development of commercial activity or export being unfairly and substantially prejudiced

There are further provisions relating to compulsory licences for products or processes declared to be of vital importance to the defence, economic or public health interest of Ghana. The applicant must establish that it has sought a contractual license and that it has been unable to get one on reasonable terms and within a reasonable period of time.

Example: In 2015 the Minister of Health declared an emergency situation regarding HIV/AIDS and issued compulsory licences for the importation of Indian generic HIV/AIDS drugs for government use only.

Kenya

If the patentee fails to work the patent sufficiently within a period of three years of grant or four years of filing (whichever is the later) a compulsory licence can be granted on the grounds that the patented invention is not being supplied on reasonable terms in Kenya.

The applicant will need to satisfy a tribunal that it has unsuccessfully sought a commercial licence. It will also need to undertake to work the invention sufficiently. If the patentee can establish circumstances justifying the non-supply of the goods it may be able to avoid the grant of a compulsory licence.  

Mozambique

If the patentee fails to work the invention within a period of three years of grant or four years of filing (whichever is the later) any person may apply for a compulsory licence to exploit the patent. The applicant must establish that it has unsuccessfully sought a commercial licence on reasonable terms. The patentee can oppose the application. In addition, the Government is authorised to work an invention without the patentee’s consent if it is in the national interest.

Example: In 2004 the Mozambique authorities issued a compulsory licence for patent rights to lamivudine, stavudine and nevirapine to a local company for the manufacture of ARVs as a fixed-dose combination, with royalties not to exceed 2%.

OAPI (a single registration system covering Benin, Burkina-Faso, Cameroon, Central African Republic, Chad, Congo (Republic of), Comoros, Equatorial Guinea, Gabon, Guinea, Guinea-Bissau, Ivory Coast, Mali, Mauritania, Niger, Senegal and Togo)

An application for a compulsory licence will be granted if the invention is not being worked in a single member state, if demand is not being met on reasonable terms, or if the refusal to grant a license is prejudicing industrial or commercial activities.

Rwanda

The legislation in Rwanda creates various options for compulsory licences:

  • Absence of use or insufficient use – the three years of grant or four years of filing-rule applies, and ‘pertinent circumstances’ justifying the non-use may be a defence
  • Abusive exercise of exclusive rights
  • Infringing use of a ‘previous patent’ by a ‘subsequent patent’ – where an invention claimed in a subsequent patent cannot be used without infringing a previous patent, the relevant minister can with the approval of the cabinet grant a compulsory licence for using the invention claimed in the previous patent in certain circumstances, for example where the invention in the subsequent patent represents ‘significant technical progress’ and is of ‘considerable economic importance

South Africa

Compulsory licensing is possible in the event of an ‘abuse of patent rights’. This term is defined as:

  • A failure to work within three years of grant or four years of filing 
  • A failure to meet demand ‘to an adequate extent and on reasonable terms’ 
  • A ‘failure to grant licences on reasonable terms’ coupled with prejudice and public interest 

The local demand being met by imports where the price is ‘excessive’ The licence can include terms that require the licensee to cease working the patent when the conditions under which it was granted have ceased to exist. Few applications have been made in South Africa and none have succeeded.

Zambia

If the patentee fails to work the patent in a manner that meets the reasonable requirements of the public within a period of three years of grant or four years of filing (whichever is the later) it will be possible to seek a compulsory licence. The reasonable requirements of the public are deemed not to have been satisfied, inter alia, if:

  • The invention is not being worked on a commercial scale in Zambia and there are no satisfactory reasons for the non-working
  • Working of the invention is being prevented by importation of the patented article.
  • Demand in Zambia is not being met
  • The refusal by the patentee to licence the patent to Zambian companies is prejudicing the trade or industry in Zambia

Example: In 2004 the authorities issued a compulsory licence for lamivudine, stavudine and nevirapine to a local company, Pharco Ltd, to produce a triple fixed-dose combination, with a maximum royalty rate of 2.5%.

Zimbabwe

If the patentee fails to work the patent sufficiently within a period of three years of grant or four years of filing (whichever is the later) a person may apply for a compulsory licence to exploit the patented invention on the grounds that the reasonable requirements of the public with respect to the invention have not been, or will not be, satisfied. There are also specific provisions relating to food, medicine and surgical devices.

Example: In Zimbabwe the authorities have considerable powers to use inventions disclosed in specifications for the service of the state. In 2002 a period of emergency was declared and this enabled the state, or any person authorised by the state, to use any patented drug including any ARV used in the treatment of HIV/AIDS, and to import any generic drug used for such conditions. This period of emergency ran until 31 December 2008.

Conclusion

There is a very real possibility that issues such as compulsory licensing and Bolar provisions will come to the fore in Africa as a result of COVID-19. Whether or not they do may well depend on how pharmaceutical companies deal with the demand that will be created for vaccines and other medications.

*Least Developed Countries in Africa: Angola, Benin, Burkina Faso, Burundi, Central African Republic, Chad, Comoros, Democratic Republic of Congo, Djibouti, Eritrea, Ethiopia, Gambia, Guinea, Guinea-Bissau, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mozambique, Niger, Rwanda, São Tomé and Príncipe, Senegal, Sierra Leone, Somalia, South Sudan, Sudan, Tanzania, Togo, Uganda and Zambia.

African countries which have compulsory licensing provisions/Bolar provisions 

Country/Regional Organisation

Compulsory licensing provisions

Government Use Provisions

Bolar and/or Research provisions

Algeria

Yes

Yes

Yes

Angola

Yes

Yes

No

African Regional Intellectual Property Organisation (ARIPO)

See individual member countries

See individual member countries

See individual member countries

Benin (OAPI)

See OAPI

See OAPI

See OAPI

Botswana (ARIPO)

Yes

Yes

Yes

Burkina Faso (OAPI)

See OAPI

See OAPI

See OAPI

Burundi

Yes

Yes

Yes

Cameroon (OAPI)

See OAPI

See OAPI

See OAPI

Cape Verde

Yes

Yes

Yes

Central Africa Republic (OAPI)

See OAPI

See OAPI

See OAPI

Chad (OAPI)

See OAPI

See OAPI

See OAPI

Comoros (OAPI)

See OAPI

See OAPI

See OAPI

Democratic Republic of Congo

Yes

Yes

Yes

Djibouti

Yes

Yes

No

Egypt

Yes

Yes

Yes

Equatorial Guinea (OAPI)

See OAPI

See OAPI

See OAPI

Eritrea

No

No

No

Eswatini (ARIPO)

Yes

Yes

Yes

Ethiopia

Yes

Yes

Yes

Gabon (OAPI)

See OAPI

See OAPI

See OAPI

Gambia (ARIPO)

Yes

Yes

No

Ghana (ARIPO)

Yes

Yes

Yes

Guinea (OAPI)

See OAPI

See OAPI

See OAPI

Guinea Bissau (OAPI)

See OAPI

See OAPI

See OAPI

Ivory Coast (OAPI)

See OAPI

See OAPI

See OAPI

Kenya (ARIPO)

Yes

Yes

Yes

Lesotho (ARIPO)

Yes

Yes

Yes

Liberia (ARIPO)

Yes

Yes

Yes

Libya

No

Yes

No

Madagascar

Yes

Yes

No

Malawi (ARIPO)

Yes

Yes

No

Mali (OAPI)

See OAPI

See OAPI

See OAPI

Mauritania (OAPI)

See OAPI

See OAPI

See OAPI

Mauritius

Yes

Yes

Yes

Morocco

Yes

Yes

Yes

Mozambique (ARIPO)

Yes

Yes

Yes

Namibia (ARIPO)

Yes

Yes

Yes

Niger (OAPI)

See OAPI

See OAPI

See OAPI

Nigeria

Yes

Yes

No

Organisation Africaine de la Propriété Intellectuelle (OAPI)

Yes

Yes

Yes

Republic of Congo (OAPI)

See OAPI

See OAPI

See OAPI

Rwanda (ARIPO)

Yes

Yes

Yes

Sao Tome e Principe (ARIPO)

Yes

Yes

Yes

Senegal (OAPI)

See OAPI

See OAPI

See OAPI

Seychelles

Yes

Yes

Yes

Sierra Leone (ARIPO)

Yes

Yes

Yes

Somalia

No

No

No

Somaliland

No

No

No

South Africa

Yes

Yes

Yes

St. Helena

Yes

Yes

Yes

Sudan (ARIPO)

Yes

Yes

No

Tanzania*(mainland) (ARIPO)

Yes

Yes

Yes

Togo (OAPI)

See OAPI

See OAPI

See OAPI

Tunisia

Yes

Yes

Yes

Uganda (ARIPO)

Yes

Yes

Yes

Zambia (ARIPO)

Yes

Yes

Yes

Zanzibar*

Yes

Yes

Yes

Zimbabwe (ARIPO)

Yes

Yes

Yes

 

 

*Although mainland Tanzania and offshore Zanzibar are united politically to form the Republic of Tanzania, they are treated separately for registration purposes, and separate patent applications are required. Despite merger into the United Republic of Tanzania since 1964, Zanzibar retains its own legislature, courts and laws on industrial property

This article was first published in April 2020 in Intellectual Property Magazine.

Date published: 22 May 2020
Author: Craig Kahn & Margaret Le Galle

Tags: COVID-19 Africa LDCs Compulsory Licences Bolar Provisions