ABACAVIR – PAEDIATRICS (ABC)
In February 2013, the Medicines Patent Pool (MPP) announced a paediatric collaboration with ViiV Healthcare. The collaboration includes a licence on paediatric abacavir (ABC), part of the World Health Organization (WHO)-preferred treatment for children from three months to 10 years of age. The parties also signed a Memorandum of Understanding (MoU) detailing MPP and ViiV’s commitment to collaborate in other areas to improve HIV paediatric care.
With MPP and ViiV’s agreement, 118 countries, including those with the highest populations of children living with the virus, can benefit from low-cost ABC. In November 2014, MPP and ViiV Healthcare extended the licensing agreement to three more countries: Ukraine, Peru and Venezuela. The licence now includes at least 121 countries, covering 99.3% of children 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 active pharmaceutical ingredient and finished paediatric formulations of abacavir anywhere in the world.|
|Geographical scope for sale||Allows for sale of abacavir in 121 countries representing 99.3% of children living with HIV.|
|Sales outside the licensed territory||Sales to countries outside the 121 countries are permitted where there is no granted patent or where sales of a generic version do not infringe on an existing patent, such as in cases in which a compulsory licence has been issued.|
|Royalties||The licence is royalty-free.|
|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 ABC with other ARVs and to develop suitable 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 all pending and granted patents at the time of signing the licence in the 121 licensed countries.|
|Additional flexibilities for licensees||Licensees can challenge any of the licensed patents.|
Quality assured formulations from MPP generic partners: Abacavir oral solution 20mg/ml, Abacavir 60mg + lamivudine 30mg tablets