Licences in the MPP

Negotiating for public-health driven licences with patent holders is the core work of the Medicines Patent Pool. Below is a list of the current licences in the MPP. Sub-licensing forms are linked.

 

AbbVie

Licence covering: lopinavir (LPV), ritonavir (r) 

In December 2015, the Medicines Patent Pool (MPP) and AbbVie signed a new licence agreement to increase access to lopinavir/ritonavir (LPV/r) in South Africa and across Africa.

In November 2014, the Medicines Patent Pool (MPP) signed a licence agreement with AbbVie for lopinavir (LPV) and ritonavir (r) for paediatric use.

 

Bristol-Myers Squibb

Licence covering: daclatasvir (DCV), atazanavir (ATV)

On November 23, the Medicines Patent Pool announced a licence agreement with Bristol-Myers Squibb covering the direct-acting antiviral (DAA) drug daclatasvir (DCV) and its combinations for hepatitis C treatment. The agreement will allow generic manufacture of daclatasvir for sale in 112 low- and middle-income countries.

The full signed text of the agreement is available below:

The Medicines Patent Pool announced on 12 December 2013 an agreement with biopharmaceutical company Bristol-Myers Squibb to increase access to a key HIV medicine, atazanavir (ATV), in 110 developing countries. These countries represent 88.5 percent of people living with HIV/AIDS in developing countries.

The full signed text of the agreement is available below:

 

Gilead Sciences

Licence covering: tenofovir alafenamide (TAF), tenofovir disoproxil fumarate(TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) and the Quad [a combination of TDF, FTC, COBI, and EVG]

 

The Medicines Patent Pool (MPP) signed a licence agreement with Gilead Sciences in July 2014 for tenofovir alafenamide (TAF), expanding upon MPP’s existing collaboration with Gilead Sciences for the production of tenofovir disoproxil fumarate(TDF), emtricitabine (FTC), cobicistat (COBI), and elvitegravir (EVG), as well as a single tablet regimen of all four ARVs.

In June 2015 the agreement was amended. Under the amended licence, EVG can also be manufactured in China, and South Africa has been added as a place for manufacturing. Additionally, patents on the combination of TDF/FTC with efavirenz (EFV), the WHO-recommended first-line regimen for adults, have been added to the licence.

The full signed text of the agreement is available below:

In July, the Medicines Patent Pool signed a licence agreement with Gilead Sciences. It was the first agreement the MPP has made with a pharmaceutical company patent holder.

The licences are in three documents, available below. The first is the primary licensing agreement signed by the MPP and Gilead. This agreement dictates that the MPP use the following two forms in its sub-licensing to generic companies. The first sub-licence document is a form “amended and restated” for existing Gilead sublicensees. The second is a form sub-licence agreement for new sublicensees.

Since its signing, the agreement has been amended four times:

  • On 1 November 2012 [pdf], an amendment was signed adding the obligation for Gilead to transfer certain technology related to the manufacture of emtricitabine
  • On 26 July 2012 [pdf], an amendment was signed removing any royalty payments due to the MPP as a result of the agreement.
  • On 14 November 2011, the MPP and Gilead signed a set of amendments clarifying issues raised by civil society after the licences were announced.
  • On 19 July 2011 [pdf], the MPP and Gilead signed an amendment to the licensing agreement to include the then newly-formed South Sudan in the geographical scope.

The licensing agreement texts linked below reflect these above listed amendments.

 

MSD

Licence covering: raltegravir (RAL) paediatrics

The Medicines Patent Pool (MPP) signed a licence agreement with MSD for raltegravir (RAL) for paediatric use.

 

Roche

Price agreement on valganciclovir for use in people living with HIV.
Instructions on how organisations can access valganciclovir at reduced prices are available here.

The Medicines Patent Pool announced on 5 August 2013 an agreement with Swiss pharmaceutical company Roche to increase access to valganciclovir, a key easy-to-take oral medicine to treat cytomegalovirus (CMV), a viral infection that can cause blindness in people living with HIV. This agreement is unique in being a two-phased approach to better treat the infection. First, an agreement that will significantly improve access to Roche’s valganciclovir for people living with HIV in 138 developing countries by making it up to 90% cheaper than current prices. As a second step, the Medicines Patent Pool and Roche will enter into licensing and technology transfer negotiations to encourage the development of internationally approved quality generic versions of valganciclovir.

The full signed text of the agreement is available below:

 

University of Liverpool

Licence covering: Solid Drug Nanoparticle Technology

On 01 December 2015, the Medicines Patent Pool announced a collaborative agreement with the University of Liverpool  and a licence for the university’s Solid Drug Nanoparticle (SDN) Technology to develop HIV nanomedicines. The agreement covers a territory of 135 low- and middle-income countries as well as two high-income countries in Africa where licensees are allowed to make, use and distribute antiretrovirals based on SDN technology.

The full signed text of the agreement is available below:

 

US National Institutes of Health

Licences covering: patents related to darunavir (DRV)

 

The Medicines Patent Pool received its first licences from the US National Institutes of Health for patents related to the HIV medicine darunavir (DRV) in September 2010.

 

ViiV Healthcare

Licences covering: dolutegravir (DTG) paediatrics and adults, abacavir (ABC) paediatrics

In April 2016, MPP and ViiV Healthcare announced an extension of their current licensing agreement to increase access to dolutegravir (DTG) adults  to cover all remaining lower middle-income countries. The amendment to the 2014 licence specifically benefits four countries with patents, Armenia, Moldova, Morocco and Ukraine, which were not covered in the initial agreement.

The Medicines Patent Pool and ViiV Healthcare announced on April 1, 2014 a new collaboration on HIV medicines, signing two licensing agreements to increase access to dolutegravir (DTG), a promising new antiretroviral, for both adult and paediatric care as well as abacavir (ABC) adults.

The full signed text of the agreement is available below:

The Medicines Patent Pool announced on 27 February 2013 a collaboration with ViiV Healthcare. The collaboration consists of a Memorandum of Understanding which sets out commitments between MPP and ViiV Healthcare to collaborate in several areas with the ultimate goal of making more quality and affordable medicines for children available.  The MOU also contains a legally-binding licence on paediatric abacavir (ABC) for use in the 118 countries where most children with HIV live.

In November 2014, the MPP and ViiV Healthcare extended the licence agreement to include also Ukraine, Peru and Venezuela.

The full, signed texts of the memorandum of understanding and the licence agreement are available below:

 

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