NIRMATRELVIR pf-07321332 Licence

Patent Holder: Pfizer

Date: November 2021

In November 2021, Pfizer and the Medicines Patent Pool signed a licence agreement to facilitate affordable access of Pfizer’s oral COVID-19 antiviral treatment nirmatrelvir in combination with low dose ritonavir in 95 countries.

Nirmatrelvir in combination with low dose ritonavir is strongly recommended by the World Health Organization for mild and moderate COVID-19 patients at highest risk of hospital admission. These include unvaccinated, older, or immunosuppressed patients.

— Licence agreement

— Sublicence agreement - Form

Key Features

Eligibility for sublicences	Sublicences can be issued to any qualified entity worldwide.
Manufacturing	Allows manufacturing of the active pharmaceutical ingredient and the finished formulations of nirmatrelvir anywhere in the world.
Geographical scope for sale	Allows for sale of nirmatrelvir in 95 countries. For South Africa, the sales are allowed only in public market.
Sales outside the licensed territory	Nothing in this Agreement shall be construed to prevent the Licensee from engaging in activities inside or outside the Territory where such activities would not (1) infringe the Patents and/or any other intellectual property rights; and/or (2) use or misappropriate Licensed Know-How ; and/or use or require the use of any of Pfizer’s Confidential Information, including where a compulsory licence has been issued.
Royalties	The licence is royalty free during the WHO Public Health Emergency of International Concern (PHEIC). After the PHEIC ends, royalties are 5% of net sales for sales to governmental authorities or Public Purchasers, and 10% of net sales for commercial entities. Pfizer will not collect royalties on sales to low-income countries or on sales of product made and sold in countries within the licensed territory where the product is not patented and does not benefit from regulatory exclusivity.
Quality assurance	Licensees must obtain approval from the World Health Organization (WHO) Pre-qualification (WHO-PQ), or a Stringent Regulatory Authority (SRA). Where such approval is not yet available, provisional or emergency use authorisations available through WHO or an SRA may be obtained.
Data exclusivity	Data exclusivity is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics.
Patent disclosure	The licence discloses to MPP and the Licensee the list of patent applications worldwide at the time of licence signing.

Announcement

Board resolution

Advisory Group Report

Country List

Afghanistan, Algeria, Angola, Armenia, Bangladesh, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Botswana, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, Comoros, Congo, democratic Republic of the, Congo, Côte d'Ivoire, Djibouti, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Gabon, Gambia (the), Georgia, Ghana, Guatemala, Guinea, Guinea-Bissau, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Jordan, Kenya, Kiribati, Korea (Democratic People's Republic of), Kosovo, Kyrgyzstan, Lao People's Democratic Republic (the), Lesotho, Liberia, Madagascar, Malawi, Mali, Mauritania, Micronesia (Federated States of), Moldova, Republic of, Mongolia, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Papua New Guinea, Philippines, Rwanda, Samoa, Sao Tome and Principe, Senegal, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, State of Palestine, Sudan, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Timor-Leste, Togo, Tonga, Tunisia, Uganda, Ukraine, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, Yemen, Zambia, Zimbabwe