Patents, Licensing and Technology Transfer
Intellectual property protection is critical. Without it, we couldn't reward scientific innovation or ensure the continued development of new medicines. However, we won’t let patents stand in the way of getting much-needed therapies to resource-constrained countries.
Bristol-Myers Squibb is committed to ensuring that its patents do not prevent inexpensive HIV/AIDS therapy in sub-Saharan Africa, India and other resource-constrained countries. We are involved in several partnerships with governments and NGOs, as well as with other innovator and generic pharmaceutical companies who share in our commitment to enabling access to therapy.
We continually search for ways to ensure that our HIV drugs reach those in need, particularly in populations hardest hit by the pandemic. At the height of the pandemic we announced we would not let patents stand in the way of getting antiretroviral medicines to the poorest countries. We continue to abide by that pledge today and utilize patent licensing and technology transfer approaches wherever appropriate.
Here are several ways we honor this commitment:
- Since 2001, we've signed 12 immunity-from-suit agreements with Africa- and India-based generic manufacturers under our patents/licenses for stavudine and didanosine and four agreements regarding atazanavir.
- In 2005, we granted a royalty-free license to the International Partnership for Microbicides (IPM) to develop, manufacture and distribute a new antiretroviral compound as a potential microbicide to help protect women from HIV.
- In February 2006, we announced a full technology transfer for atazanavir to generic companies Aspen PharmaCare (South Africa) and Emcure Pharmaceuticals (India). In addition to granting a royalty-free license, we also transferred technical knowhow related to manufacture and testing, including training Aspen and Emcure personnel at our facilities as well as their respective manufacturing sites in Africa and India. In February 2008, Emcure’s generic version of atazanavir was granted FDA “Tentative Approval” for use in sub-Saharan Africa and India. In March 2014, Emcure was granted FDA “Tentative Approval” for their co-formulation of atazanavir and a boosting agent.
- Also in 2006, we became a founding partner in the President’s Emergency Plan for AIDS Relief (PEPFAR) Pediatric Initiative. Through this initiative, the U.S. government has partnered with Bristol-Myers Squibb and other pharmaceutical companies to promote scientific and technical discussions on issues and potential solutions related to pediatric anti-HIV treatment, formulations and access.
- In June 2011, we announced an agreement to further expand access to REYTAZ® (atazanavir sulfate) in developing countries. The immunity-from-suit agreement signed with Matrix Laboratories Limited, a Mylan Company, enables the generic company to manufacture and sell atazanavir, as well as stavudine and didanosine, in sub-Saharan Africa and India. A key component of the agreement is the inclusion of pediatric formulations of the medicines to support the treatment needs of children with HIV. Under the terms of the agreement, Matrix Laboratories will secure WHO prequalification for all products covered by the agreement, including pediatric formulations of existing products and powder formulations of others for pediatric use when they become available. WHO prequalification enables procurement organizations to purchase medicines using funding from U.N. agencies, PEPFAR and the Global Fund to Fight AIDS, Tuberculosis and Malaria.
- In October 2011, Bristol-Myers Squibb Foundation announced a collaboration with WHO to strengthen community-based care of TB including HIV co-infection in 5 African countries. Our foundation will provide WHO with technical assistance through community care experts from the Foundation’s SECURE THE FUTURE® program.
- In November 2011, we announced a technology transfer agreement with the Brazilian Ministry of Health to expand access to REYATAZ® (atazanavir sulfate) in Brazil. The agreement is designed to build the capacity and skills required for the Brazilian government to produce a sustainable, high quality supply of atazanavir and will enable the government to become, over time, the sole source of atazanavir in Brazil. The agreement transfers the manufacture and distribution of atazanavir sulfate 200 mg and 300 mg capsules in Brazil from Bristol-Myers Squibb to Farmanguinhos, a technical-scientific unit of Fundação Oswaldo Cruz (Fiocruz) and the largest official pharmaceutical laboratory of the Brazilian Ministry of Health, and Nortec Quimica, a local manufacturer of active pharmaceutical ingredients (API).
- In December 2013, we announced a collaboration with the Medicines Patent Pool (MPP) on an innovative approach to facilitate access to REYATAZ® (atazanavir) in a broad range of resource-limited countries throughout the world. This collaboration is part of our company’s longstanding commitment to expanding access to HIV medicines in the developing world. The company granted the MPP a voluntary license that will be sublicensed to qualified generic manufacturers to produce and distribute atazanavir in 110 countries where approximately 29 million people are living with HIV. READ MORE
- In January 2012, we were one of several innovator companies that jointly announced a collaborative approach to addressing Neglected Tropical Diseases (NTDs). We committed to provide access to select proprietary compound libraries to third parties, including DNDi, to help develop potential new medicines for targeted NTDs. Since that time, thousands of compounds have been tested, with some compounds demonstrating potential activity against select targeted NTDs to be further evaluated.