|Eligibility for sublicences
||Sublicences can be issued to qualified entities worldwide.
||Allows manufacturing of active pharmaceutical ingredient and finished formulations anywhere in the world.
|Geographical scope for sale
||The paediatric licence allows for sale in 121 countries where 99.3% of children living with HIV in the developing world reside. The adult licence territory covers at least 92 countries with 90% of people living with HIV (see “Sales outside the licensed territory”).
|Sales outside the licensed territory
||Sales outside the licensed countries are permitted where there is no granted patent in force (54 additional countries) or where sales of a generic version do not infringe on an existing patent, such as in cases in which a compulsory licence has been issued. As a result, sub-licensees will likely be able to sell generic DTG in 131 countries representing 93.4% of people living with HIV in the developing world.
||The adult licence is royalty-free for 82 countries and royalty-bearing for ten countries namely: Philippines; India and Vietnam and Moldova (5%); Egypt, Indonesia, Morocco, Armenia and Ukraine (7.5%); Turkmenistan (10%) ; There are no royalties for paediatric formulations.
||Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained.
||Sublicensees have the right to combine DTG with other ARVs and to develop suitable new fixed-dose combinations.
||Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics.
||The licences disclose the list of pending and granted patents in the 121 countries and granted patents in other LMICs.
|Additional flexibilities for licensees
||Licensees can challenge any of the licensed patents.
Afghanistan, Angola, Armenia, Bangladesh, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Côte d’Ivoire, Democratic Republic of the Congo, Djibouti, E.Timor, Egypt, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Gabon, Gambia, Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Kenya, Kiribati, Korea Dem. Republic, Kosovo, Kyrgyzstan, Laos, Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Mauritius, Micronesia, Moldova, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Republic of the Congo, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Swaziland, Syrian Arab Republic, Tajikistan, Tanzania, Togo, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Vietnam, West Bank and Gaza, Yemen, Zambia, Zimbabwe