BICTEGRAVIR (BIC) licence assistance for Countries

Patent Holder: Gilead Sciences

Date: September 2017

In September 2017, the Medicines Patent Pool (MPP) signed a licensing agreement with Gilead Sciences for bictegravir (BIC), benefiting at least 116 countries that together are home to 90.5% of people living with HIV in low- and middle-income countries. The BIC licence broadened MPP’s collaboration with Gilead and the parties’ earlier licence for the production of tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG).

In September 2019, the agreement was amended to allow for the inclusion of Azerbaijan to the territory for BIC, COBI, TAF and TDF.

— Licence Agreement

— Amendment to Licence Agreement - September 2017

— Amendment to Licence Agreement - September 2019

— Sublicence Agreement - Form for existing licensees in India

— Amendment to Sublicence Agreement - Form for existing licensees in India

— Sublicence Agreement - Form for new licensees in India

— Amendment to Sublicence Agreement - Form for new licensees in India

— Sublicence Agreement - Form for new licensees in China

— Amendment to Sublicence Agreement - Form for new licensees in China

— Sublicence Agreement - Form for new licensees in South Africa

— Amendment to Sublicence Agreement - Form for new licensees in South Africa

— Amendment to Sublicence Agreement - Form for all licensees (to include Azerbaijan)

Key Features

*Eligibility for sublicences*	Sublicences can be issued to entities based in China, India and South Africa
*Manufacturing*	Allows manufacturing of active pharmaceutical ingredient and finished formulations in India, China and South Africa
*Geographical scope for sale*	Allows for sale of BIC in 117 countries representing 90.5% of people living with HIV in low- and middle-income countries
*Sales outside the licensed territory*	Sublicensees may supply outside the licensed territory if a country issues a compulsory licence
*Royalties*	The royalty rate is five (5) percent of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations
*Quality assurance*	Licensees to manufacture in accordance with WHO Pre-qualification standards, standards of the European Medicines Agency, or USFDA tentative approval standards. Licensees to apply for WHO-Prequalification in the event BIC is included in the WHO Guidelines or in the expression of interest for WHO pre-qualification of medicines
*Combinations*	Sublicensees have the right to combine BIC with other ARVs and to develop suitable new fixed-dose combinations
*Data exclusivity*	Data exclusivity is waived in countries with such form of protection, thus facilitating regulatory approval of generics
*Patent disclosure*	The licence discloses the list of all pending and granted patents in the 116 licensed countries
*Technology transfer*	All Indian and South-African sub-licensees benefit from a one-time technology transfer
*Additional flexibilities for licensees*	Licensees have the right to terminate the agreement at any time on a product-by-product basis and can challenge any of the licensed patents

See related licence

Announcement

Board resolution

Advisory Group Report

Country List

Afghanistan, Angola, Anguilla, Antigua and Barbuda, Armenia, Aruba, Azerbaijan, Bahamas, Bangladesh, Barbados, Belarus, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Virgin Islands (British), Burkina Faso, Burundi, Cambodia, Cameroon, Cabo Verde, Central African Republic, Chad, Comoros, Côte d'Ivoire, Cuba, Congo, democratic Republic of the, Djibouti, Dominica, Dominican Republic, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia (the), Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Jamaica, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Lao People's Democratic Republic (the), Lesotho, Liberia, Madagascar, Malawi, Malaysia, Maldives, Mali, Mauritania, Mauritius, Moldova, Republic of, Mongolia, Montserrat, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, Philippines, Congo, Rwanda, Saint Kitts and Nevis, Saint Lucia, Saint Vincent and the Grenadines, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Sudan, Suriname, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Thailand, Timor-Leste, Togo, Tonga, Trinidad and Tobago, Turkmenistan, Turks and Caicos Islands, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Viet Nam, Yemen, Zambia, Zimbabwe