Patent Information and Transparency: A Methodology for Patent Searches on Essential Medicines in Developing Countries
(2012; 122 pages)

Where patents pose a barrier, the Doha Declaration on the TRIPS Agreement and Public Health signed by WTO Members in 2001 had confirmed that governments may use a range of measures known as TRIPS public health flexibilities (such as compulsory licensing and parallel imports) to ensure access to affordable medicines. In order to make informed and effective use of these TRIPS flexibilities to procure or produce medicines, information about the patent status of the medicines is required.

In many developing countries, this information can sometimes be difficult to obtain. In this context, drug procurement agencies, can be hesitant in choosing the option to procure the more affordable generic versions, for fear of patent infringement. There is thus, a need for a cost effective and pragmatic approach to speedily obtain data on the patent status of essential medicines, so that governments and procurement agencies can make informed decisions on available options for production and procurement of generic medicines. The WHO’s 2008 Global Strategy and Plan of Action on Public Health, Innovation and Intellectual Property (GSPOA) has acknowledged the need for such accurate and up-to-date patent information, in order to effectively use such flexibilities. Accordingly, the GSPOA called for initiatives to facilitate the development of, and access to, global databases of health-related patents on governments. The Medicines Patent Pool, established in 2010, seeks to facilitate access to relevant patents on ARVs so as to enable generic production of new and adapted formulations of ARVs. As part of its work, the Medicines Patent Pool has established and maintains a patent database that provides information on the patent status of selected antiretrovirals in a number of low- and middle income countries, but stresses that the list of medicines, patents and countries is not complete. This has further highlighted the need for accurate patent information on medicines.

Two characteristics of the current patent system are important factors contributing to the difficulties in obtaining relevant patent information on medicines; namely, the technical complexities related to patenting of pharmaceutical products and the lack of institutional capacity for the management of the patent system in developing countries. The Patent Methodology proposed in this paper is thus, premised on the fact that many developing countries do not have sufficient technical and financial resources to effectively respond to requests for patent information on essential medicines. It also takes into consideration that the inaccessibility of relevant patent information on medicines is due to the use of technical language in patent applications, which does not readily link to the end-product medicine or pharmaceutical product. While medicines are often referred to by their International Non-Proprietary Names (INN), patent applications seldom use INNs in their description of the new invention.

A simple and practical method is described in this paper, which enables searches for relevant patent data from publicly available (and free) sources of information. Using a combination of data from patent offices and medicine regulatory authorities that are available on the Internet, this methodology provides an inexpensive and pragmatic option to perform a quick search and access patent information on essential medicines. The Patent Methodology spells out the four steps, by which the patent status of essential medicines can be ascertained...

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