South Africa introduces new patent policy

Home/Policies & Legislation | Posted 13/09/2013 post-comment0 Post your comment

South Africa has become the latest country to examine its patent laws with a view to curbing patent evergreening and increasing production of generics.

Patent 1 V13E17

The South African Government Department of Trade and Industry announced on 4 September 2013 the release of a new National Policy on Intellectual Property.

Due to the fact that South Africa does not examine patent applications to determine their validity, the country hands out an excessive number of pharmaceutical patents compared to most developed or developing countries. This has led to ‘evergreening’ of patents, where pharmaceutical companies obtain multiple patents on the same medicine. In 2008 alone, South Africa granted 2,442 pharmaceutical patents compared to Brazil, which only granted 278 pharmaceutical patents between 2003 and 2008. South African patent law also does not contain provisions for pre- or post-grant opposition of patents by a third party, e.g. a generics maker.

These practices have led to South Africans paying some of the highest prices in the world for their drugs. For this reason, the Treatment Action Campaign (TAC) and International aid agency Médecins Sans Frontières (MSF) have been lobbying the South African Government to reform the system for examining pharmaceutical patent applications in South Africa, in order to ensure patients have greater access to affordable medicines.

The agencies have called for the South African Department of Trade and Industry to limit the number of pharmaceutical patents granted in South Africa by:
1.   ensuring that all pharmaceutical patent applications are substantively examined
2.   strengthening patentability criteria to prevent patent evergreening
3.   enhancing public transparency of the Patents Office concerning pending patent applications and the status of granted patents
4.   allowing a broad range of third parties to file pre-grant and post-grant patent oppositions, and
5.   broadening the grounds and facilitating the procedures for issuing a compulsory license.

It is hoped that the new National Policy on Intellectual Property will address these issues. Comments in the National Policy on Intellectual Property can be sent to the South African Department of Trade and Industry until 17 October 2013.

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The status of generic substitution in South Africa

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Source: South African DTI, MSF, TAC

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