BMS Technology Transfer & ARV Licensing

Partnership Objective

Expand access to ARV therapy for patients with HIV/AIDS in resource constrained countries.

In 2013, Bristol-Myers Squibb entered into an agreement with the Medicines Patent Pool which aims to further access to atazanavir in developing world countries. In 2013, Bristol-Myers Squibb entered into an agreement with the Medicines Patent Pool which aims to further access to atazanavir in developing world countries. Copyright BMS

Description of partnership activities and how they address needs and challenges

BMS was one of the first companies to state that it would not enforce its patents on antiretrovirals in sub-Saharan Africa. Since 2001, the company has entered into twelve immunity-from-suit agreements for their antiretrovirals Videx® (didanosine) and Zerit® (stavudine). In addition, BMS has entered into two Technology Transfer and Licensing agreements and two Immunity From Suit agreements covering their antiretroviral Reyataz® (atazanavir).

In 2013, Bristol-Myers Squibb entered into an agreement with the Medicines Patent Pool which aims to further access to atazanavir in developing world countries.  This agreement includes 110 least developed, low- and middle- income countries where approximately 29 million people are living with HIV.  There is no fixed limit on the number of sublicensees, instead, the aim of this agreement is to create a supply of licensed product that can sustainably meet the demands for atazanavir in the territory, including pediatric formulations.  A key feature of the agreement is that there are no royalties for countries that were part of the legacy agreements or for sublicensee sales of pediatric formulations in any of the 110 countries included in the Territory.  The Medicines Patent Pool collects a small royalty for sales in countries where there are atazanavir patents when the country was not previously included in a legacy atazanavir agreement, however, Bristol-Myers Squibb never receives any of these royalties – instead, as part of the agreement, Bristol-Myers Squibb requested that the Medicines Patent Pool reinvest any royalties collected back into community-based HIV programs. 
 
In 2006, BMS granted a royalty-free license to two generics companies, Aspen (Africa) and Emcure (India), to sell atazanavir in sub-Saharan Africa and India. BMS also transferred technical know-how related to the manufacturing, testing, packaging, storage and handling of the active pharmaceutical ingredient and finished dosage form of atazanavir to these two generic companies. Also in 2006, BMS agreed to allow generic companies seeking approval of generic combination products (including one or more of BMS’ antiretroviral medicines) for developing countries, under the U.S. PEPFAR program, access to confidential regulatory information as long as these companies were operating under appropriate laws and regulations.

 

Partnership information

Company(ies) Bristol-Myers Squibb

Partner(s) Aspen Pharmacare, Emcure Pharmaceuticals, Medicines Patent Pool, Mylan, Ranbaxy

Type of Partner(s) Generic Manufacturers, NGOs

Therapeutic Focus Infectious Diseases

Disease(s) HIV/AIDS

Program Type(s) Availability of Treatment - Technology Transfer - Manufacturing and Entrepreneurial Know-How

Targeted Population(s) Children, Men, Mothers, Patients in needs of treatment, People with low income, Women

Region(s) East Asia & Pacific, Europe & Central Asia, Latin America & Caribbean, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 109

Country(ies) Afghanistan, Angola, Antigua and Barbuda, Armenia, Azerbaijan, Bangladesh, Belarus, Belize, Benin, Bhutan, Bolivia, Botswana, Burkina Faso, Burundi, Cambodia, Cameroon, Cape Verde, Central African Republic, Chad, Comoros, Congo, Costa Rica, Côte d'Ivoire, Cuba, Democratic Republic of the Congo, Djibouti, Dominica, Ecuador, El Salvador, Equatorial Guinea, Eritrea, Ethiopia, Fiji, Gabon, Georgia, Ghana, Grenada, Guatemala, Guinea, Guinea-Bissau, Guyana, Haiti, Honduras, India, Iran, Iraq, Jamaica, Kazakhstan, Kenya, Kiribati, Kyrgyzstan, Lao PDR, Lesotho, Liberia, Madagascar, Malawi, Maldives, Mali, Marshall Islands, Mauritania, Mauritius, Micronesia, Moldova, Mongolia, Mozambique, Myanmar, Namibia, Nepal, Nicaragua, Niger, Nigeria, Pakistan, Palau, Panama, Papua New Guinea, Rwanda, Samoa, Sao Tome and Principe, Senegal, Seychelles, Sierra Leone, Solomon Islands, Somalia, South Africa, South Korea, South Sudan, Sri Lanka, St. Kitts and Nevis, St. Lucia, St. Vincent and the Grenadines, Sudan, Suriname, Swaziland, Syria, Tajikistan, Tanzania, The Gambia, Timor-Leste, Togo, Tonga, Turkmenistan, Tuvalu, Uganda, Uzbekistan, Vanuatu, West Bank and Gaza, Yemen, Zambia, Zimbabwe

Research Country(ies) India, South Africa

Start Date 2001

More information BMS Access to Medicines

Anticipated completion date Ongoing