Drug resistance, patent resistance: Indian pharmaceuticals and the impact of a new patent regime

Abstract

This article highlights potential public health effects of India's Patents Act of 2005, which was implemented to conform to the requirements of the World Trade Organisation's Trade-Related Aspects of Intellectual Property Agreement (TRIPS), a new legal regime that will likely have a significant impact on access to HIV/AIDS medications in much of the world. This new patent law may play a role in keeping new antiretroviral (ARV) medications, including improved first-line medications and second-line drugs that are being developed for first-line drug resistant HIV, financially out of reach for many people living with HIV/AIDS in poor countries. India's drug industry, which had thrived under earlier patent laws that protected processes but not products in the case of medications, had brought down the price of ARV drugs in South Asia and Africa by more than 90%. While most existing drugs are grandfathered under the new patent laws, newer ARV medications may be barred from manufacture by Indian companies. This article analyses the effects of the coming together of this new legal regime, the global political economy and emerging resistance to HIV/AIDS medications, and evaluates efforts to mitigate the negative public health effects of the new patent laws.

Keywords:

• patents
• AIDS
• TRIPS
• India
• antiretroviral therapy
• poverty

Notes

1. Among the sparse commentary on World AIDS Day in 2006, a Boston Globe editorial (Zeitz 2006) discussed problems of violence against women and the plight of AIDS orphans, while the Columbus Dispatch ( 2006 ) urged that more should be done to fight AIDS while critiquing President Bush's AIDS programme for overemphasising abstinence. The Columbus Dispatch editorial, ironically, noted the advent of an Indian generic drug that made adherence easier and reduced the price of AIDS medications ‘as good news for the overseas AIDS fight’ without mentioning the patent regime that will now limit such developments. In 2007, while some reported President Bush's announcement of increased funding for his overseas AIDS initiatives, a Washington Post article pointed to another culprit that, in addition to local corruption, is usually highlighted as an obstacle in AIDS interventions, that is, lack of education about HIV/AIDS in a developing country (in this case, India) (Lakshmi 2007, p. 29).

2. This is too large of a literature to review here, but recent representative examples include Ka'opua and Linsk (2007), Rajabiun et al. (2007) and Vajpayee et al. (2007).

3. As mentioned earlier [section on Drug resistance and the emerging two-tier system of antiretroviral therapy (ART)], GlaxoSmithKline has backed off their claim for at least a particular formulation of combivir, and there are reports that Novartis may have been swayed in its pursuit of a patent for atazanavir. Updates on patent cases, at www.i-mak.org, say Novartis may be withdrawing its patent claim for atazanivir, but add that reports on this are unclear. Novartis says that its patent application for atazanavir has lapsed, yet ‘Novartis has not given up its rights in India to patent atazanavir’ and is pursuing a different type of patent application (Novartis 2008).

4. A partial exception is Abbott Laboratories’ Kaletra® which is sold for $500 per person per year in a select group of the poorest low-income countries, mostly in Africa. This is below the price of the cheapest generic (which sells at US$695 per person per year), but still out of the range of affordability in those countries. In India and several other low-income countries, primarily in South and Central Asia, however, Kaletra® is offered at US$1000 per person per year, well above the price of the generic alternatives (Médecins Sans Frontières 2007, p. 29, 48).

5. These estimates are based on the author's ethnographic fieldwork, carried out between 1994 and 1999 in South India. Other findings related to this research have been published in (Halliburton 2003 ,2004).

6. The number treated comes from the KSACS website (KSACS 2008), and the range of estimates of the total number living with HIV/AIDS is derived from numbers reported on the KSACS website as well as estimates reported to the author by AIDS specialists he spoke with in Kerala.