Abstract
In the pharmaceutical context, many Southern African Development Community (SADC) members grant patents on drugs without substantially reviewing applications first, thus routinely granting patents for new versions of old medicines, thus extending patent life beyond the normal 20-year period. In contrast, Brazil and India, homes to major generic drug manufacturers in the BRICS grouping, examine each application before a patent is granted. It has been argued by health activists and academics that excessive patenting results in too many patents for minor innovations in medical technology and this in turn leads to higher prices of medicines, thus frustrating SADC citizens' right to access affordable essential medicines. This paper highlights how the legislative inclusion of World Trade Organisation (WTO) Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities around the requirements for patentability can be effectively used to curb incremental patenting and limit the proliferation of evergreen patents. This is achieved through a critical analysis the 2013 Supreme Court of India case of Novartis AG v Union of India before extracting useful lessons for the SADC. The highlighted lessons will in all likelihood inform the current intellectual law reform projects in most SADC members, including South Africa.
Highlights
The Southern African Development Community (SADC) continues to face health related challenges in the context of HIV/AIDS, tuberculosis, malaria, heart disease, cancer, hepatitis and a host of other ailments
As members of the World Trade Organisation (WTO), SADC members can take advantage of the flexibilities introduced by the Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) and override patent rights in some specified instances in order to access affordable essential medicines
One of the TRIPS flexibilities is the leeway given to WTO members to decide within the confines of their national laws and contexts what amounts to patentable subject matter and to exclude certain inventions, such as diagnostics, methods of treating the human or animal body, and new uses of existing patents from registration as patents.[2]
Summary
The Southern African Development Community (SADC) continues to face health related challenges in the context of HIV/AIDS, tuberculosis, malaria, heart disease, cancer, hepatitis and a host of other ailments. One of the major causes of high drug prices, which create affordability barriers, is the notorious practice by pharmaceutical companies of extending patent life spans beyond the mandatory 20 year period by filing for secondary patents.[3] Secondary patents may be granted for minor additions or embellishments to drug formulae, extending the life span of the patent, preventing the entry of generic drugs onto the market, and thereby creating monopolistic prices. In India the relevant law[19] allows members of the public to bring to the attention of the patent controller evidence which may lead to patent rejection.[20] The existence of this remedial measure made it possible for the Indian Network of People living with HIV/AIDS and the Manipur Network of Positive People to successfully oppose GlaxoSmithKline (GSK)'s patent application for the drugs zidovudine and lamivudine in 2006 on the basis that the patent claim in the specific instance was not for a new invention.[21]. It is submitted that the case discussed below demonstrates that at least in the Indian context, having higher patentability requirements in order to prevent weak or evergreen patents does have positive results for access to medicines
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