ATAZANAVIR (ATV)
In December 2013, the Medicines Patent Pool (MPP) announced an agreement with biopharmaceutical company Bristol-Myers Squibb to increase access to a key HIV medicine, atazanavir (ATV), part of the WHO-preferred second-line treatment for adults and children.
In July 2017, MPP signed an extension of its licence agreement to include 12 additional countries, namely, Algeria, Cook Islands, Egypt, Equatorial Guinea, Indonesia, Malaysia, Morocco, Niue, the Philippines, Tunisia, Ukraine and Vietnam.
The licence allows generic manufacture of ATV for sale in at least 122 countries that together are home to 89% of people living with HIV in low- and middle-income countries.
| Eligibility for sublicences | Sublicences can be issued to qualified entities worldwide. |
| Manufacturing | Allows for the manufacturing of generic active pharmaceutical ingredient and finished formulations of ATV anywhere in the world. |
| Geographical scope for sale | Allows for sale in at least 122 countries where 89% of people with HIV in low- and middle-income countries live. |
| Sales outside the licensed territory | Enables manufacturers that do not rely on BMS technology to sell outside the 122 countries if no granted patent is being infringed. This includes cases in which a compulsory licence is issued. |
| Royalties | Three percent royalty for adult formulations in countries where granted patents on ATV are in force. Royalties to be collected by MPP and channeled back to a community-based HIV organization in the country paying the royalty. Royalties not payable for paediatric formulations or for sales of adult formulations in Sub-Saharan Africa and India. |
| Quality assurance | Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority. Where such approval is not yet available, temporary approval from a WHO Expert Review Panel may be obtained. |
| Combinations | Sublicensees have the right to combine ATV with other ARVs and to develop 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 pending and granted patents worldwide at the time of licence signing. |
| Technology transfer | A technology transfer package is provided to all the sub-licensees, but there is no obligation to use the technology. |
Amendments
Quality assured formulations from MPP generic partners: Atazanavir capsule 100mg, Atazanavir capsule 150mg, Atazanavir capsule 200mg, Atazanavir capsule 300mg, Atazanavir/ritonavir tablet 300/100mg
GENERIC PARTNERS AND PRODUCT DEVELOPERS
Click the logos below to access the sublicensing agreements:
