ELVITEGRAVIR (EVG)

Patent Holder: Gilead Sciences

Date: July 2011

In July 2011, the Medicines Patent Pool (MPP) signed a licence agreement with Gilead Sciences for the production of elvitegravir (EVG) and combinations containing elvitegravir. The agreement allows generic manufacture of EVG in at least 100 countries.

In June 2015, the two parties amended the agreement to allow manufacturers from China and South Africa to produce EVG.

In September 2017, the two parties amended the agreement to allow for an extension of the territory for EVG to 109 countries that are home to 88.4% of people living with HIV in low- and middle-income countries.

— Licence Agreement

— Amendment to Licence Agreement - September 2017

— 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

Key Features

*Eligibility for sublicences*	Sublicences can be issued to qualified entities in China, India and South Africa.
*Manufacturing*	Allows manufacturing of active pharmaceutical ingredient and finished formulations in China, India and South Africa.
*Geographical scope for sale*	Allows for sale of EVG in 109 countries that are home to 88.4% 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 5% of net sales of finished product. There are no royalties for the sale of the active pharmaceutical ingredient or paediatric formulations.
*Quality assurance*	Licensees must obtain approval from WHO Pre-qualification, the US Food and Drug Administration or the European Medicines Agency.
*Combinations*	Sublicensees have the right to combine EVG 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 109 countries, as of September 2017
*Technology transfer*	All Indian sublicensees 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, Bahamas, Bangladesh, Barbados, 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, 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, Maldives, Mali, Mauritania, Mauritius, Moldova, Republic of, Mongolia, Mozambique, Myanmar, Namibia, Nauru, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Papua New Guinea, 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, Uzbekistan, Vanuatu, Viet Nam, Yemen, Zambia, Zimbabwe