33. Inform all countries in the paediatric license group on the status of paediatric ARV patents.

Commitment 33

 

June 2020

In its continued efforts to inform stakeholders on the geographical scope of licences covering paediatric HIV medicines, and their actual access status – registered and/or supplied – in those countries, MPP has launched a new interactive map that allows visualizing information for all its licensed products, including innovative paediatric DTG- and LPV/r-based fixed-dose formulations. On this map, MPP licence coverage is displayed not only for countries specifically listed in the corresponding licence, but also for countries where supply by MPP licensees may be permitted under some circumstances (e.g., if no patent is being infringed in that country), allowing a broader, more accurate perspective on where access to generic products is possible. For the products that are already on the market, information on in-country registration and supply is also available. The map is available on the MPP website at https://medicinespatentpool.org

Previous

MPP has started developing a summary overview document presenting the patent and licensing status, as well as information on optimal formulations and quality-approved sources of products recommended and prioritized in WHO HIV guidelines and PADO 4. MPP will be seeking input from GAP-f partners shortly as MPP assembles a pilot version to be transformed into a regularly updated webpage. MPP believes that summarizing this content into a single source and widely disseminating it will help countries, procurement agencies, HIV service delivery organizations and other stakeholders navigate access to affordable, quality-approved versions of recommended and priority paediatric ARVs more easily.

On 1 December 2019, MPP announced that generic manufacturer Cipla had become a sublicensee of the MPP/AbbVie licence for paediatric lopinavir/ritonavir (LPV/r). Through this agreement, 21 additional countries, where LPV/r patents are in place (or pending) and representing approximately 74,000 children living with HIV under 5 years of age, will be able to access paediatric LPV/r pellets. The sublicence will also enable access to Quadrimune, Cipla’s incoming 4-in-1 paediatric fixed dose combination of LPV/r with abacavir (ABC) and lamivudine (3TC), currently under review by the US FDA for use in children between 3 and 25 kg. Beyond concluding this agreement, MPP is coordinating with key stakeholders to ensure that countries and procurement agencies are informed of the recently expanded access to these products.

 

The 21 additional countries concerned include 16 countries with a patent in place (Armenia, Azerbaijan, Georgia, Guatemala, Indonesia, Kyrgyzstan, Malaysia, Moldova, Panama, Peru, Philippines, South Africa, Sri Lanka, Tajikistan, Turkmenistan, Vietnam) and 5 countries with an ongoing patent application or appeal but without a granted patent yet (Dominican Republic, El Salvador, Honduras, Nicaragua, Thailand).

In addition to targeted information dissemination efforts, MPP has also updated its webpage dedicated to paediatrics (https://medicinespatentpool.org/what-we-do/our-work/paediatrics), where features relevant to paediatric drug formulation development, manufacturing, distribution and overall access are highlighted for all MPP licences in the areas of HIV, hepatitis C and TB.

Individual Commitment: The Medicines Patent Pool (MPP) commits to facilitating access to the best available medicines for children. Specifically, the MPP will continue to work with patent holders to in-license paediatric drugs as prioritized by the WHO/PADO, and to sublicense to generic manufacturers to ensure that appropriate formulations are rapidly developed, registered and made available in as many developing countries as possible.

Individual commitment: MPP reports having increased the emphasis on recommended and priority paediatric drug formulations listed in WHO 2019 HIV guidelines and PADO 4 in the regular conversations with MPP licensees, while exploring with patent holders practical ways to further expand access to optimal formulations for paediatric populations. As part of this, MPP's dolutegravir (DTG) paediatric licence now allows for MPP licensees to manufacture any pharmaceutical composition that has been approved by the U.S. FDA and/or recommended by WHO for use in paediatric patients (HIV patients of less than 18 years old).

In March 2020, the Medicines Patent Pool (MPP) received a communication from AbbVie indicating its decision to waive any restriction on MPP licensees that would prevent them from supplying lopinavir/ritonavir (LPV/r) anywhere in the world for any purpose, effective immediately. The communication also indicated that AbbVie will no longer be enforcing patents relating to adult and paediatric LPV/r anywhere in the world. This decision has been reflected on MedsPaL.