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.
|Eligibility for sublicences
|Sublicences can be issued to any qualified entity worldwide.
|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.
|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.
|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 is waived in countries of the Territory with such form of protection, thus facilitating regulatory approval of generics.
|The licence discloses to MPP and the Licensee the list of patent applications worldwide at the time of licence signing.
LIC : Low-Income Country
LMIC : Lower Middle-Income Country
UMIC : Upper Middle-Income Country
Burkina Faso LIC
Cabo Verde LMIC
Central African Republic LIC
Congo, Dem. Rep. LIC
Congo, Rep. LMIC
Côte d’Ivoire LMIC
Egypt, Arab Rep. LMIC
El Salvador LMIC
Equatorial Guinea UMIC
Gambia, The LIC
Korea, Dem. People’s Rep. LIC
Kyrgyz Republic LMIC
Lao PDR LMIC
Micronesia, Fed. Sts. LMIC
Papua New Guinea LMIC
São Tomé & Principe LMIC
Sierra Leone LIC
Solomon Islands LMIC
South Africa (Public Market) UMIC
South Sudan LIC
Sri Lanka LMIC
Syrian Arab Republic LIC
West Bank and Gaza LMIC
Yemen, Rep. LIC