Why South Africa should Examine Pharmaceutical Patents

Treatment Action Campaign is running a campaign FIX THE PATENT LAWS in South Africa demanding for amendment of South Africa’s Patents Act 57 of 1978 to ensure access to affordable medicines, improve the health and save the lives of millions of South Africans. They are specifically demanding for change in patent law to include all the public health safeguards given in the TRIPS agreement. To know more about this campaign, read their blog www.fixthepatentlaws.org

Highlighting the importance of key flexibilities under TRIPS agreement that can be used by developing countries like South Africa to ensure access to essential medicines, a policy brief has been issued by Research & Information System, TAC and MSF:

Why South Africa should Examine Pharmaceutical Patents (TAC, MSF and RIS January 2013)

Abstract: In order to fulfill international obligations under the TRIPS Agreement, middle-income developing countries were required to introduce a product patent regime for medicines by 2005.

This policy brief highlights that South Africa has failed to take advantage of the flexibilities allowed within WTO rules. The absence of a local patent examination system means patents are granted without substantive review, without verifying whether they meet the patentability requirements provided for in the South African Patents Act. The patent office has no filter to ensure that patents are granted only when they are deserved. This undermines the country’s ambition to provide free access to medicines and boost local production by its own generic industry. Currently, the multinational pharmaceutical industry is fully exploiting this weakness in South Africa’s legal and patent system to extend market exclusivity on key medicines that are nearing patent expiry. According to a recent study, 2,442 pharmaceutical patents were registered in South Africa in a single year, in 2008.

The paper discusses the advantages of a local examination system through a case study. India is one of the few developing countries that has set up a local examination system for pharmaceutical product patents. India also included several key safeguards including an examination system, a stringent patentability criteria and the possibility for anyone to object to a patent both before and after it is granted (known as pre- and post-grant oppositions). While the system is not perfect, it has had some tangible successes. Patent applications on some important antiretrovirals, cancer and hepatitis medicines were rejected by the patent office after opposition and examination.

This paper discusses the process and cost of establishing a patent examination system in a developing country. Contrary to common perception of policy makers an examination system need not be a burden on the state. It can and should be self-sustaining. The Indian experience proves that this is possible.