Over the past several decades the World Health Organization (WHO) has produced the Essential Medicines List (EML) to assist countries in deciding what medicines should be essential and available in National Essential Medicine Lists.1 WHO, through the work of regional offices, supports nations using the EML to ensure the quality, availability, and affordability of pharmaceuticals required to promote and advance public health in nations across the globe. However in some cases, access to EML pharmaceuticals might be complicated by existing patents, i.e., where issued, patent rights might pose obstacles to access and inclusion in national EMLs. Indeed, in developed and emerging economy national jurisdictions patent protection may be in effect for a not insignificant number of the WHO EML pharmaceuticals (Figure 2A). However, in developing countries, it is uncertain whether these patents have been filed or issued. Without patent data predicated on an established, reproducible protocol for accessing and assembling patent information on the EML pharmaceuticals, discussions, debates and strategic approaches to understanding and managing patents with regard to access and delivery to developing countries remain in the dark. Indeed, it is absurd to make policy and formulate strategy without solid patent information: the critical foundation for rational debate. To analyze the degree and scope of patenting of EML pharmaceuticals, WIPO (with WHO) approached the Franklin Pierce Center for Intellectual Property at the University of New Hampshire School of Law, specifically the International Technology Transfer Institute (ITTI) to generate a preliminary overview of patents appurtenant to recently added pharmaceutical updates to the EML.2 As part of this work, with inputs from WHO and WIPO, ITTI developed novel methodology and a detailed protocol for identifying EML pharmaceutical patents in national jurisdictions, with an easily reproducible yet cost effective template. Herein is described the development of such a protocol and a preliminary pool of patent information that illustrates its utility. The protocol yields data in a layered approach thereby allowing a user to quickly and effectively obtain both broad and detailed patent information for medications on the WHO EML. In addition, the protocol can be used as an initial path for targeted strategic analysis of potentially relevant patent information in national jurisdictions. In sum, the objectives for this project were: 1. To develop a robust methodology to assess the patent status of medicines on the WHO Model List of Essential Medicines; 2. To place in the public domain a detailed report on the present (2010) patent status of medicines that were on patent in 2003 and those medicines added to the Model List since 2003 by country and level of development; and 3. To analyze the patent status of these Essential Medicines by the development status of countries. The report describes the development of the protocol and presents a preliminary list of EML and corresponding patents in certain jurisdictions to illustrate the utility of the approach. Results will be discussed both in terms of global access and patents, and in the context of establishing standard, systematic, protocols for periodic patent searches related to EML content. 1 WORLD HEALTH ORGANIZATION, CONTINUITY AND CHANGE IMPLEMENTING THE THIRD WHO MEDICINES STRATEGY 2008--‐2013 20 (WHO Press, 3rd ed. 2009). 2 This report covers the EML up to and including updates until 2009.
Franklin Pierce Center for Intellectual Property at the University of New Hampshire
Jon R. Cavicchi and Stanley P. Kowalski, “Preliminary Report on Patent Literature, Search Methodology and Patent Status of Medicines on the WHO EML 2009,” (The Franklin Pierce Ctr. for Intellectual Prop. at the Univ. of N.H. Sch. of Law, 2009).