XVIII International AIDS Conference


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Examining pharmaceutical patents from a public health perspective: the role of patent offices

Presented by Tenu Avafia (United States).

T. Avafia, M. Dhaliwal

UNDP, HIV/AIDS Practice, New York, United States

The TRIPS Agreement balances the need to incentivize innovations through the granting of patents on the one hand with the goal of spreading the benefits of that innovation through, for instance, access to essential medicines on the other. To ensure that the benefits of innovation can be assimilated by all WTO Member States, important flexibilities were introduced into the TRIPS Agreement. These include Article 27 which allows WTO members to interpret the three criteria of patentability (novelty, inventive step, and industrial application). There is growing evidence pointing to the proliferation of patents over minor variants of existing products both in developed and developing countries. A large number of granted patents cover minor modifications of older existing drugs or are granted because of new uses for existing medicines. Therefore, while the number of approved new-developed chemical entities has lowered significantly in recent years, the number of patents being granted because of simple changes in the chemical formulation of existing pharmaceuticals, has increased significantly, leading to the exclusion of generic competition in some instances. This, in turn, restricts the availability of affordable medicines and constitutes an important obstacle for the realization of the right to health. UNDP in partnership with the WHO, have been conducting training sessions in developing countries with patent offices which examine pharmaceutical patent applications, with the aim of highlighting the importance of examining pharmaceutical patents from a public health perspective and using the interpretive space provided by Article 27 of the TRIPS Agreement. To date, patent examiners from 7 African countries, 9 Latin American and Caribbean countries as well as 6 Arab states have been involved in the training. The use of this TRIPS flexibility by patent examiners, particularly those in countries with significant generic manufacturing industries could play an important role in stimulating generic competition for ARVs.

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