Patents, Licensing and Technology Transfer: Working with Generic Companies and other Partners

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] and entered into discussions with the Medicines Patent Pool around our HIV patents.
By June 2011, to help benefit HIV patients in sub-Saharan Africa and India, Bristol-Myers Squibb had signed 11 immunity-from-suit agreements with Africa- and India-based generics companies for certain of our HIV medicines, as well as signing four immunity-from-suit agreements specifically for our most advanced HIV medicine. We have entered into these agreements with generics manufacturers if they are deemed capable to manufacture adequate volumes of quality product to appropriately address the need within the target countries. In addition, Bristol-Myers Squibb entered into technology transfer agreements in 2006 with two generics companies -- Aspen PharmaCare, for sub-Saharan Africa, and Emcure Pharmaceuticals, for sub-Saharan Africa and India, for one HIV product. Pursuant to the terms of such technology transfer agreements, we transferred intellectual property and know-how related to the manufacturing, testing, packaging, storage and handling of its active pharmaceutical ingredient and finished dosage form.
  • The most recent agreement was concluded in June 2011 with India-based Matrix Laboratories Limited enabling the generics company to manufacture and sell Bristol-Myers Squibb HIV medications 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.
  • Brazil: In 2011, Bristol-Myers Squibb signed a new agreement with the Brazilian Ministry of Health to expand access to a company HIV medication.
  • Also in 2011, Bristol-Myers Squibb entered into negotiations with the Medicines Patent Pool, which will allow us to determine whether our potential participation would complement our existing Global Access Program and help enable access to affordable HIV medicines in developing countries in a systematic way.
  • An earlier royalty-free license agreement with the International Partnership for Microbicides (IPM) also remains in effect. This agreement permits IPM to develop a topical biocide for the prevention of sexual transmission of HIV that contains a Bristol-Myers Squibb compound, and distribute the product at little or no cost to women in resource-poor countries. For further information, go to www.ipmglobal.org.

December 2011