Patents, Licensing and Technology Transfer: Working with Generic Companies and other Partners
Intellectual property protection is critical to foster and reward scientific innovation and to ensure the continued development of new medicines that address unmet medical needs. Bristol-Myers Squibb is 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 are continually searching 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 medicines to the poorest countries. We continue to abide by that pledge today and utilize patent, licensing and technology transfer approaches wherever appropriate. Most compelling in driving these efforts has been the significant medical need in many of the poorest countries, coupled with the challenges in making product available to patients in Africa, India and other parts of the world. In 2011, Bristol-Myers Squibb signed a new agreement with Matrix Laboratories [see below], a generics manufacturer in India, with the Brazil Ministry of Health [see below].
Bristol-Myers Squibb is committed to ensuring that its patents do not prevent inexpensive HIV/AIDS therapy in sub-Saharan Africa and India. Bristol-Myers Squibb has signed 11 immunity-from-suit agreements with Africa- and India-based generics companies under our patents/licenses for stavudine and didanosine and four agreements regarding atazanavir. We enter into these agreements with generic manufacturers if they are deemed capable to manufacture adequate volumes of quality product to appropriately address the need within the target country.
- In February 2006, Bristol-Myers Squibb 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 Apsen and Emcure personnel at Bristol-Myers Squibb facilities as well as their respective manufacturing sites in Africa and India. In February 2008, Emcure was granted FDA “Tentative Approval.” Emcure has submitted dossiers in over 25 sub-Saharan Africa countries and has received approval in 6 countries. Aspen is currently evaluating its FDA filing strategy. In May 2010, Bristol-Myers Squibb provided Emcure with our consent to include atazanavir in a co-formulation for commercialization in India and sub-Saharan Africa.
- In 2006, Bristol-Myers Squibb 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, Bristol-Myers Squibb announced a new agreement to expand access to Reyataz® (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. Read our press release.
- Bristol-Myers Squibb allows generic manufacturers with immunity-from-suit agreements with Bristol-Myers Squibb to include our HIV medicines in co-formulations, provided that such co-formulations meet medically sound criteria and that any other patent holders involved allow such co-formulation.
- In November, 2011, Bristol-Myers Squibb 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 to a yet to be named local manufacturer of active pharmaceutical ingredients (API).
- Regarding the Medicines Patent Pool, Bristol-Myers Squibb shares with UNITAID the goal of increasing access to antiretroviral therapy. We applaud their work in helping to provide appropriate therapeutic options to patients in need.
- In 2005, Bristol-Myers Squibb 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. For further information, go to www.ipmglobal.org.
- 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. Bristol-Myers Squibb Foundation will provide WHO with technical assistance through community care experts from the Foundation’s SECURE THE FUTURE program.
- In January 2012, Bristol-Myers Squibb was one of many companies that jointly announced a collaborative approach to addressing Neglected Tropical Diseases (NTD)s. We committed to provide access to select proprietary compound libraries to third parties, including DNDi, to help develop potential new medicines for targeted NTDs.