Title: Public health-friendly options for protecting pharmaceutical registration data

Authors: Robert Weissman

Addresses: J.D. Harvard Law School, Director, Essential Action, P.O. Box 19405, Washington, DC 20036, USA

Abstract: To gain marketing approval, generic firms typically rely on the clinical safety and efficacy testing data that brand-name pharmaceutical companies previously submitted (||registration data||). Big Pharma and the US government are pushing developing countries to provide brand-name companies with a minimum of five years exclusive rights to registration data. But restrictions on use of registration data delay the introduction of price-lowering generic competition. This paper considers public-health friendly alternatives, emphasising a cost-sharing approach, in which generic firms have an absolute right to use registration data, but must pay a proportionate share of the cost of generating the data.

Keywords: data exclusivity; pharmaceutical registration data protection; WTO; TRIPS; compulsory licensing; public health; misappropriation; cost sharing; marketing approval data; intellectual property management; IPM; Agreement on Trade-Related Aspects of Intellectual Property Rights; IPR; generic medicines; developing countries.

DOI: 10.1504/IJIPM.2006.011025

International Journal of Intellectual Property Management, 2006 Vol.1 No.1/2, pp.113 - 130

Available online: 03 Oct 2006

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