Guidelines for the examination of pharmaceutical patents: Developing a public health perspective
Working Paper
About this working paper
This study is made available as a working paper in order to facilitate broader understanding, consultation and inputs. It is intended to be a contribution towards the improvement of transparency and efficiency of patentability examination for pharmaceuticals inventions, particularly in developing countries. It proposes a set of general guidelines for the assessment of some of the common modalities of pharmaceutical patent claims, and suggests elements for the development of public health-sensitive guidelines for the evaluation and review of pharmaceutical patents at the national level. It examines the practices of some patent offices and suggests some mechanisms that may be adopted to incorporate public health perspectives in procedures for the granting of pharmaceutical patents.
This working paper is the result of an ongoing series of technical consultations and seminars organized by ICTSD, UNCTAD and WHO. Consultations held include the following: 1. Technical consultation, jointly sponsored by ICTSD, UNCTAD and WHO, on 14 September 2006 in Geneva. Participants in this consultation included Andre Escher, Swiss Patent Office; Caroline Ngome Eneme, South Centre; Cecilia Oh, WHO; Christophe Spennemann, UNCTAD; David Vivas, ICTSD; Gaule Patrick, Chairman of Economics and Management of Innovation Ecole Polytechnique; German Velasquez, WHO; Hans Bartels, WIPO; Jayashree Watal, WTO; Johanna Von Braun, ICTSD; Kiyoshi Adachi, UNCTAD; Milani Barbara, WHO; Octavio Espinosa, WIPO; Pascale Boulet, MSF; Preeti Ramdasi, ICTSD; Ricardo Melendez-Ortiz, ICTSD; Roya Ghafele, WIPO; Sangeeta Shashikant, TWN; Sisule Musungu, South Centre; Tony Taubman, WIPO; and Yuvan Beejadhur, UNCTAD.
2. Technical consultation, organized by the Food and Drug Administration (FDA) of Thailand in cooperation with WHO, in October 2005 (comprising representatives of drug regulatory authorities and patent offices of China, Indonesia, Malaysia and Thailand). During the event, comments were provided by Suradet Atsawintarangkun, Departament of Intellectual Property, Thailand; Achara Eksaengsri, Government Pharmaceutical Organization, Thailand; Narumol Dachanantawitaya, Departament of Intellectual Property Thailand; Jade Donavanik, Faculty of Laws, Siam University, Thailand; Farsai Chanjaruporn, FDA, Thailand; Suchart Chongpraesert, FDA, Thailand; Muhammad Farid Wong, Ministry of Health, Malaysia; Sasitorn Kittivoravikul, Thai Manufacturers Association; Nilsuwan Leelararamee, Thai Manufacturers Association; Jiraporn Limpananont, Faculty of Pharmaceutical Science, Chulalongkorn University, Thailand; Cecilia Oh, WHO, Geneva; Linda Sitanggang, FDA Indonesia; Yuwadee Patanawong, FDA, Thailand; Werawan Tangkeo, FDA, Thailand; Karin Timmermans, WHO Regional Office, South-East Asia Region; Frida Tri Hadiati, FDA, Indonesia; Vinit Utsavakitviree, FDA, Thailand; German Velásquez, WHO, Geneva; Krisantha Weerasuriya, WHO, Regional Office, South-East Asia Region; Farid Wong Abdullah, Ministry of Health, Malaysia; Wen Xikai, State Intellectual Property Office, China.
3. Review process held in June 2006, in which patent and public health experts from Australia, UK and WHO were asked for written comments and inputs on the draft guidelines. This review process benefited from comments by Tahir Amin, Solicitor of the Supreme Court of England and Wales, UK; Trevor Cook – former UK Patent Office; Susan Walters – former Australian FDA.
4. Expert consultation, organized by WHO in July 2006, with representatives of the Patent Offices of Argentina, Paraguay and Brazil. This event benefited from the comments made by Mabel Berardoni, Ministerio de Salud y Ambiente de la Nación, Argentina; Fabián Biali, consultor, Argentina; Monica Caetano, ANVISA, Brazil; José Cardillo, INPI, Argentina; Nora Donato, ANMAT, Argentina; Blanca García, MIC, Paraguay; Mirta Levis, CILFA, Argentina; Luís Carlos Lima, ANVISA, Brazil; Lilian Martínez, Ministerio de industria y Comercio, Dirección de la Propiedad Intelectual, Paraguay; Graciela Moltrasio, Facultad de Farmacia y Bioquímica de la UBA, Argentina; Susana Piatti, consultora de patentes, Argentina; Ana Paula Juca, ANVISA, Brazil; Alejandra Stoykowsky, INPI, Argentina; Juliana Vallini, ANVISA, Brazil; Germán Velásquez, WHO.
Note: This study is currently under a review process. If you would like to provide comments or inputs to this working paper, please send them to dvivas@ictsd.ch.