RALTEGRAVIR (RAL) PAEDIATRICS
The Medicines Patent Pool (MPP) signed a licence agreement with Merck Sharp & Dohme (MSD) for raltegravir (RAL) for paediatric use. The WHO recommends raltegravir as a second-line treatment for children from four weeks to the age of three.
The licence covers at least 92 countries covering 98% of children living with HIV in low and middle-income countries. The licence also allows additional countries, where RAL is not patented, to procure generic versions.
|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 RAL anywhere in the world.|
|Geographical scope for sale||Allows for sale of paediatric RAL in at least 92 countries where 98.1% of children living with HIV in the developing world reside (see “Sales outside the licensed territory”).|
|Sales outside the licensed territory||Sales to countries outside the 92 countries are permitted if no granted patent is being infringed. This includes cases in which a compulsory licence has been issued.|
|Royalties||The license is royalty free.|
|Quality assurance||Licensees must obtain approval from WHO Pre-qualification, or a Stringent Regulatory Authority.|
|Combinations||Sublicensees have the right to combine RAL 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 pending and granted patents on RAL in the 92 countries at the time of licence signing.|
|Additional flexibilities for licensees||Licensees have the right to challenge any of the licensed patents.|