The Medicines Patent Pool (MPP) is an organisation designed to improve the health of people living in low- and middle-income countries. The Pool’s goal is to increase access to quality, safe, effective, more appropriate and affordable medicines, focusing on HIV/AIDS.
They do this by negotiating with patent holders to share their HIV medicines patents with the Pool, and then licensing to generic companies and other producers to facilitate the production of affordable generic medicines well-adapted for use in resource-poor settings.
MPP and ViiV Healthcare UK Limited (ViiV) announced in February their License Agreement on an older antiretroviral (ARV), abacavir (ABC), for pediatric treatment only, in 118 countries where 98.7% of child living with HIV live. They also entered into a separate, non-binding Memorandum of Agreement (MoU), which promises collaboration on pediatric licensing of pipeline ARVs, development of novel combination pediatric formulations, and availability of novel pediatric formulations outside of the licensed territory.
Abacavir, which is widely protected by a range of primary and secondary patents in dozens of low- and middle-income countries, is a WHO preferred medicine for 1st and 2nd-line pediatric use. This License Agreement and its subsidiary Sublicense Agreement will be a presumptive template for pediatric access to all of ViiV’s current pipeline ARVs once they are approved by for use by the US Food and Drug Administration (FDA) or by the European Medicines Authority (EMA).
ABC is not widely used for adults, but it is a WHO recommended 1st and 2nd line regimen for pediatric ART. It is also a prime candidate for co-formulation with lamivudine (3TC), which is widely available generically but which is also a patent-protected combination in some countries. In this regard, it is regrettable that ViiV and the MPP did not directly grant a license to all ABC, 3TC, and AZT combinations, since all three are subject to ViiV ownership and control.
ABC has no known additional field of use beyond the treatment of HIV/AIDS, though another use might eventually be discovered. At this point in time, however, the Agreement only covers antiretroviral therapy (ART). The licensed patent rights are explicitly limited to “pediatric use” via the definition of “products” in the Sub-License Agreement, also directly permits co-formulation through the definition of “products” ( “products shall mean pharmaceutical combinations and compositions for pediatric use produced under this Agreement … which contain the compound (ABC)”). A desirable feature of the MoU, is that ViiV will collaborate with the MPP and others to use formulation development and transfers of manufacturing technologies; access to regulatory data; and partnership to develop fixed–dose combinations, including approaches to other IP rightholders – to develop pediatric formulations that might not otherwise be developed.
Although the MoU is non-binding, it defines ViiV’s intention to grant pediatric licenses to the MPP for current pipeline ARVs upon approval by the FDA or EMA.
This Agreement will undoubtedly be of benefit in the treatment of pediatric HIV/AIDS, where treatment coverage is currently only 50% of adult coverage. It could also help lead to the development of improved fixed-dose pediatric formulations that can be dosed according to size/weight. However, it is important to realize that the pediatric market for ARVs in low- and middle-income is not commercially sensitive for ViiV. These are not high mark-up markets and the pediatric market in rich countries is quite small because of success in using ART and ARV prophylaxis to prevent vertical transmission to infants during pregnancy, birthing, and/or feeding.