Open letter to Novartis (10.10.06)

Dear Mr. Vasella,

Alerted by Indian patients with cancer, health organizations and public interest groups, we are writing to you to express our concerns regarding the legal proceedings that Novartis has started in May 2006 in order to challenge the rejection of its patent application for imatinib mesylate (Glivec®/Gleevec®) as well as the compliance of the Indian Patents Act with the World Trade Organization’s Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). We are joining the Indian organizations in their demand that Novartis withdraws these cases.In particular, we are extremely concerned with Novartis’s challenge of Section 3(d) of the Indian Patents Act, which Novartis claims is not compliant with the TRIPS Agreement.Section 3(d), which prevents the grant of patents for new forms or new uses of known substances, is one of the recognized flexibilities of the TRIPS Agreement that countries are utterly free to adopt in their legislation. The importance of these flexibilities has been highlighted by the United Kingdom Commission on Intellectual Property Rights in its 2002 report[1] as well as by the World Health Organization Commission on Intellectual Property Rights, Innovation and Health in its 2006 report[2].Such a challenge is in contradiction with the spirit and the letter of the Doha Declaration on the TRIPS Agreement and Public Health. The Declaration states that the TRIPS Agreement "can and should be interpreted and implemented in a manner supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all"[3]. With this challenge, Novartis is seeking to limit the ability of the Indian Government to take measures to protect the public health of its population and to have a patent system adapted to the Indian socio-economic context.We are very concerned that the changes sought by Novartis in the Indian Patents Act could negatively affect access to essential generic medicines (in particular HIV/AIDS medicines) not only in India but also in all the developing countries that import Indian generic medicines.Novartis sells Glivec®/Gleevec®, a life-saving medicine at prohibitive prices in India (Rs. 1.44 million, or US$ 26'000, per patient per year) and in other developing countries. This price is well above the financial capacity of the majority of patients in developing countries. Novartis recognizes that only a small number of patients in India are paying for the medicine.Access to health care and medicines in developing countries depends on different factors and requires solutions at various levels. However, it is everyone's duty to remove barriers within its own abilities.We are shocked that five years after the end of the trial brought by Novartis and other pharmaceutical companies against the South African government, Novartis is trying again to restrict the flexibility given to a country to adapt the TRIPS Agreement to its public health needs.The undersigned organizations demand that Novartis withdraws the cases against the Indian Patents Act and the decision of the Indian Patent Office on Glivec®/Gleevec®.Sincerely yours,Julien ReinhardCampaign DirectorBerne DeclarationThe following organizations and persons are endorsing this letter:Organizations
· Aids-Hilfe Bern, Mr Kurt Pärli, Chairman & Mrs Béatrice Aebersold Krähenbühl, Director
· Aids-Hilfe beider Basel, Mr Stefan Moser, Director
· Association of European Cancer Leagues (ECL), Mr Bruno Meili, President
· Berne Declaration, Mr Julien Reinhard, Campaign Director
· Bethleem Mission Immensee, Mr Stefan Siebenhaar, Campaign Director
· CO-OPERAID, Dr. Rao Satapati, Director
· Groupe sida Genève, M. David Perrot, Director
· Médecins Sans Frontières - Suisse, Mr Christian Captier, General Director
· medicuba, Dr. med. Christian Jordi, President
· MIVA Schweiz, Mr Marco Medici, Director
· Pharmaciens Sans Frontières - Suisse, Mrs M.-J. Barbalat, President
· SID'Action (Lausanne), Mme Patricia Grigolin, Director
· SolidarMed Suisse, Dr. med. Pepo Frick, Vice-President
· Swiss Aids Care International, Mme Susann Mäusli, Director
· Swiss Cancer League, Prof. Dr med. Thomas Cerny, President
· Swiss Aids Federation, Mr Franz Walter, Director
· terre des hommes schweiz, Mr Michael Herzka, Director
· terre des hommes suisse, Mr Jean-Luc Pittet, Secretary General
In a private capacity:
· Mrs Ruth Dreifuss, Chairperson from the Commission on Intellectual Property Rights, Innovation and Public Health, appointed by the World Health Organization
· Dr Claudia Kessler Bodiang, member of aidsfocus.ch
· Mr Thomas Schwarz, Co-Director de Medicus Mundi Suisse
· Mrs Helena Zweifel, Coordinator of aidsfocus.ch
[1]Commission on Intellectual Property Rights. Integrating Intellectual Property Rights and Development Policy. London: CIPR, September 2002 (http://www.iprcommission.org/)[2]Report of the Commission on Intellectual Property Rights, Innovation and Health. Public Health, Innovation and Intellectual Property Rights,Geneva: April 2006 (www.who.int/intellectualproperty/documents/thereport/en/index.html). See also: Carlos CORREA. Integrating Public Health Concerns into Patent Legislation in Developing Countries. Geneva: South Centre, 2000 // UNCTAD-ICTSD. Ressource Book on TRIPS and Development. Cambridge University Press, 2005 // Sisule MUSUNGU (South Centre) and Cecilia Oh (World Health Organization). The Use of Flexibilities in TRIPS by Developing Countries: Can they Promote Access to Medicines? Study 4C for the Commission on Intellectual Property Rights, Innovation and Public Health. Geneva: August 2005.[3]Declaration on the TRIPS agreement and public health adopted on 14 November 2001 (WT/MIN(01)/DEC/2)