Patent Holder: MedinCell

Date: September 2022

In September 2022, MedinCell and the Medicines Patent Pool (MPP) MedinCell signed a licence agreement for a candidate long-acting drug formulation that could be used to fight malaria in low- and middle-income countries.

This non-exclusive licence agreement, made possible with funding to both parties from global health agency Unitaid, will enable MPP to support the identification of suitable partners for the development and commercialisation of mdc-STM, an injectable formulation of ivermectin with a three-month action-duration, using MedinCell’s BEPO® technology. Under the terms of the licence, the manufacturing can be carried out in any country worldwide, for distribution in low- and middle-income countries.

Key Features
Field Administration to impact on malaria transmission
Eligibility for sublicences Sublicences can be issued to any qualified entity in any country of the world (for development and/or commercialisation)
Manufacturing Allows manufacturing worldwide
Geographical scope for sale Allows for sale in all LMICs. The licence contains a requirement of Affordable Price
Sales outside the licensed territory Allowed if country issues compulsory license, or where the activity does not infringe a licensed patent granted and in force or rely upon licensed know-how
Royalties Sublicences are royalty-free for sales in public market in LMICSs. Reasonable royalties (to be agreed before the Commercialisation Agreement signature) are due for the sales in private market in LMICs.
Quality assurance Products will comply with the following standards: WHO Pre-qualification Programme(PQ), Global Fund/Unitaid Expert Review Panel(ERP), US FDA and/or another WHO Listed Regulatory Authority as agreed between MPP & sublicensee
Data exclusivity MPP sublicensee will not seek and will waive, regulatory exclusivity in LMICs in relation to any data relating to licensed products.
Patent disclosure Obligation for licensor to list licensed patents, also for improvements of LA. A right to maintain and enforce them remains with licensor
Term Until last licensed patent has expired, lapsed or has been invalidated
Grant back Parties will discuss:

  • a suitable arrangement for Severable Improvements with a fair and reasonable compensation for the inventor
  • an assignment of Non-Severable Improvements against a fair and equitable compensation for the inventor
Announcement
Board resolution
Advisory Group Report
Country List
Afghanistan, Albania, Algeria, American Samoa, Angola, Argentina, Armenia, Azerbaijan, Bangladesh, Belarus, Belize, Benin, Bhutan, Bolivia (Plurinational State of), Bosnia and Herzegovina, Botswana, Brazil, Bulgaria, Burkina Faso, Burundi, Cabo Verde, Cambodia, Cameroon, Central African Republic, Chad, China, Colombia, Comoros, Congo, democratic Republic of the, Congo, Costa Rica, Côte d'Ivoire, Cuba, Djibouti, Dominica, Dominican Republic, Ecuador, Egypt, El Salvador, Equatorial Guinea, Eritrea, Eswatini, Ethiopia, Fiji, Gabon, Gambia (the), Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Indonesia, Iran (Islamic Republic of), Iraq, Jamaica, Jordan, Kazakhstan, Kenya, Kiribati, Korea (Democratic People's Republic of), Kosovo, Kyrgyzstan, Lao People's Democratic Republic (the), Lebanon, Lesotho, Liberia, Libya, Madagascar, Malawi, Malaysia, Maldives, Mali, Marshall Islands, Mauritania, Mexico, Micronesia (Federated States of), Moldova, Republic of, Mongolia, Montenegro, Morocco, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, North Macedonia, Pakistan, Papua New Guinea, Paraguay, Peru, Philippines, Russian Federation, Rwanda, Samoa, Sao Tome and Principe, Senegal, Serbia, Sierra Leone, Solomon Islands, Somalia, South Africa, South Sudan, Sri Lanka, Saint Lucia, Saint Vincent and the Grenadines, Sudan, Suriname, Syrian Arab Republic, Tajikistan, Tanzania, United Republic of, Thailand, Timor-Leste, Togo, Tonga, Tunisia, Turkey, Turkmenistan, Tuvalu, Uganda, Ukraine, Uzbekistan, Vanuatu, Venezuela (Bolivarian Republic of), Viet Nam, West Bank and Gaza, Yemen, Zambia, Zimbabwe