DOLUTEGRAVIR – PAEDIATRICS (DTG)
In April 2014, the Medicines Patent Pool (MPP) and ViiV Healthcare announced two licensing agreements to accelerate access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care. The agreements allow generic manufacturers to produce low-cost versions of DTG for at least 94 countries for the adult agreement and 121 countries for the paediatric agreement.
The two parties extended the adult licence to cover all remaining lower middle-income countries in April 2016. The amendment specifically benefits four countries with patents – Armenia, Moldova, Morocco and Ukraine – that were not included in the initial 2014 agreement. As a result, countries that together are home to 94% of adults and 99% of children living with HIV in low- and middle-income countries, are covered by the licence.
Coverage rates at time of announcement.
|Eligibility for sublicences||Sublicences can be issued to qualified entities worldwide.|
|Manufacturing||Allows manufacturing of active pharmaceutical ingredient and finished formulations anywhere in the world.|
|Geographical scope for sale||The paediatric licence allows for sale in 121 countries where 99.3% of children living with HIV in the developing world reside. The adult licence territory covers at least 92 countries with 90% of people living with HIV (see “Sales outside the licensed territory”).|
|Sales outside the licensed territory||Sales outside the licensed countries are permitted where there is no granted patent in force (54 additional countries) 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. As a result, sub-licensees will likely be able to sell generic DTG in 131 countries representing 93.4% of people living with HIV in the developing world.|
|Royalties||The adult licence is royalty-free for 82 countries and royalty-bearing for ten countries namely: Philippines; India and Vietnam and Moldova (5%); Egypt, Indonesia, Morocco, Armenia and Ukraine (7.5%); Turkmenistan (10%) ; There are no royalties for paediatric formulations.|
|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||Sub-icensees have the right to combine DTG 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 licences disclose the list of pending and granted patents in the 121 countries and granted patents in other LMICs.|
|Additional flexibilities for licensees||Licensees can challenge any of the licensed patents.|
Memorenda of Understanding:
In 2018, we signed a MoU with Aurobindo agreeing to exchange information and business leads to fast-track the development and uptake of the antiretroviral dolutegravir (DTG). MPP signed licences with ViiV Healthcare for DTG for adult and paediatric care and has signed sublicences with 17 generic manufacturers to produce DTG and DTG containing formulations for low- and middle-income countries (LMICs). Under the terms of this agreement, Aurobindo shares information on development timelines, regulatory status, technical challenges and sales of DTG in developing countries. MPP may provide Aurobindo with technical assistance and inform procurers about the company’s state of readiness to supply DTG products. Aurobindo holds licences for other MPP-licensed treatments – abacavir (paediatric), atazanavir, bictegravir, daclatasvir, elvitegravir, emtricitabine, lopinavir/ritonavir and tenofovir alafenamide.
Aurobindo has a similar but bilateral licence for DTG with ViiV Healthcare, and since the signature of the above MoU, Aurobindo has regularly shared data on the development and uptake of DTG with MPP.
Under the terms of the collaborative agreement signed by the three parties in 2019, a sub-set of Aurobindo’s data is shared by MPP with ViiV Healthcare. Such a sub-set is valuable for ViiV Healthcare to assess the overall impact on access to DTG made by all generic manufacturers (MPP sublicensees and Aurobindo).
Quality assured formulations from MPP generic partners: Tenofovir disoproxil fumarate/lamivudine/dolutegravir 50 mg/300 mg/300 mg