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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 Pool. Signed sub-licensing agreements are linked where applicable.

Gilead Sciences

Licence covering: tenofovir alafenamide (TAF).

The Medicines Patent Pool (MPP) signed a licence agreement with Gilead Sciences in July 2014 for tenofovir alafenamide (TAF).

The full signed text of the agreement is available below:

ViiV Healthcare

Licences covering: dolutegravir  paediatrics
dolutegravir and abacavir adults

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.

The full signed text of the agreement is available below:

Bristol-Myers Squibb

Licence covering: atazanavir

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, 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:

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:

ViiV Healthcare [GlaxoSmithKline, Pfizer, Shionogi]

Collaboration to increase availability of HIV medicines for children. Licences covering: paediatric abacavir (ABC).

The Medicines Patent Pool announced on 27 February 2013 a collaboration with ViiV Healthcare. The collaboration consists of a Memorandum of Understanding. The Memorandum of Understanding 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. These areas include: a commitment from ViiV Healthcare to license its pipeline products for paediatric use in 118 countries once they are approved by drug regulatory authorities; provide technology transfer to aid in generic manufacture; access to data on medicines quality and efficacy; and planned partnerships with third-party stakeholders to help bring to market as-yet undeveloped new treatments, and to speed the availability of those treatments in developing countries. The MOU also contains a legally-binding licence on paediatric abacavir 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:

Sub-licensees:

Gilead Sciences

Licences covering: tenofovir (TDF), emtricitabine (FTC), cobicistat (COBI), elvitegravir (EVG) and the Quad [a combination of TDF, FTC, COBI, and EVG].

 

The Medicines Patent Pool signed a licence agreement with Gilead Sciences in July 2011. 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.

Sub-licensees:

US National Institutes of Health

Licences covering: patents related to darunavir

 

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

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