Patent Holder: AbbVie

Date: November 2018

In November 2018, the Medicines Patent Pool (MPP) signed a royalty-free licence agreement with AbbVie for glecaprevir/pibrentasvir (G/P) – a World Health Organization (WHO)-recommended treatment for people living with chronic hepatitis C (HCV).

The licence enables quality-assured manufacturers to develop and sell generic medicines containing G/P in 96 low- and middle-income countries (LMICs) at affordable prices, enabling access to and treatment scale-up with the most effective pan-genotypic regimens.

Key Features
Eligibility for sublicences Non exclusive sublicences can be issued to any qualified entity in the Territory and in India.
Manufacturing Allows for the manufacturing of the fixed-dose combination of G/P anywhere in the territory and in India.
Geographical scope for sale Allow sales in 96 countries accounting for 47.5% of the HCV burden worldwide.
Sales outside the licensed territory Sales outside the Territory are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence is issued.
Non-Territory Purchasers NGOs, UN-related orgs, other not-for-profits, and funding mechanisms such as PEPFAR, Unitaid, USAID, Global Fund, and others based outside the Territory are eligible to procure generic G/P for use in countries within the Territory.
Royalties The licence is royalty-free.
Quality assurance Sublicensees must meet WHO pre-qualification standards or the standards of any stringent regulatory authority as defined by the WHO, or, where such approvals are not yet available, must gain temporary approval by WHO Expert Review Panel.
Data exclusivity AbbVie agrees to provide waivers of data exclusivity in countries with such form of protection, thus facilitating regulatory approval of generics. Sublicensees agree not to seek further regulatory exclusivity.
Patent disclosure The licence discloses the list of pending and granted patents in the Territory and in India at the time of licence execution.
Registration assistance AbbVie will provide, upon MPP request, a copy of clinical data and all non-commercial and non-manufacturing documents to facilitate product registration.
Patent challenges No restrictions on sublicensee patent challenges.

See related licence

Announcement
Board resolution
Advisory Group Report
Country List
Afghanistan, Angola, Antigua and Barbuda, Bangladesh, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cabo Verde, Central African Republic, Chad, Comoros, Congo, Cook Islands, Côte d'Ivoire, Congo, democratic Republic of the, Djibouti, Dominica, Egypt, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia (the), Georgia, Ghana, Grenada, Guinea, Guinea-Bissau, Guyana, Haiti, Indonesia, Jordan, Kenya, Kiribati, Lao People's Democratic Republic (the), Lesotho, Liberia, Libya, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia (Federated States of), Morocco, Mozambique, Myanmar, Namibia, Nauru, Nepal, Niger, Nigeria, Niue, Pakistan, Palau, Papua New Guinea, Philippines, 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, Tanzania, United Republic of, Timor-Leste, Togo, Tunisia, Turkmenistan, Tuvalu, Uganda, Vanuatu, Viet Nam, State of Palestine, Yemen, Zambia, Zimbabwe

GENERIC PARTNERS AND PRODUCT DEVELOPERS

Arene Lifesciences Ltd.
Mylan (Viatris)
Remington Pharmaceutical
USV