Patent On AIDS Drug Will Not Limit Access In India, Industry Argues

It is “misleading” and “counter-productive” to assert that a pharmaceutical company’s filing for a patent on a HIV/AIDS drug in India will limit access to the drug in the future, GlaxoSmithKline said in response to an objection submitted today in India.

The comment is a response to the submission of a “pre-grant opposition” to the patent filing in India, staged by the Indian Network for People Living with HIV/AIDS, the Manipur Network of Positive People, and the Lawyers’ Collective HIV/AIDS Unit, reported on by Intellectual Property Watch (IPW, Public Health, 30 March 2006).

The networks protested against GSK’s patent application for its fixed-dose combination of two AIDS drugs, zidovudine/lamivudine or AZT/3TC (Combivir). This is the first application filed in India for an HIV/AIDS medicine since India introduced patents on pharmaceuticals in 2005.

The drug is currently available in copy, or generic, form in India, but the networks are concerned that a future patent would boost the price of the drug and make it difficult for other companies to start producing the drug, thus affecting access. They argue that the product is merely a combination of two existing drugs and thus does not qualify as an innovation.

A GlaxoSmithKline spokesperson told Intellectual Property Watch that the patent “would not affect the cost or availability of generic versions already available in India.” GSK argues that the 2005 patent law that brought India into line with World Trade Organization rules contains provisions on flexibilities such as compulsory licenses to address public health concerns. These flexibilities would meet concerns in India as well as abroad in terms of export, the spokesperson said.

“It is misleading and counter-productive to focus on patents or full implementation of patent protection as a significant barrier to access to medicines in India and beyond,” the spokesperson said. She said that 98 percent of the drugs on the World Health Organization (WHO) Essential Drugs List are not patent-protected, but still two-thirds of the world’s population does not have access to them, according to WHO estimates.

“The root cause of developing countries’ inability to address their healthcare problems does not lie with the patenting system but with a lack of funding, a lack of political will and inadequate healthcare infrastructure,” the spokesperson said.

The spokesperson added that GSK makes Combivir available at not-for-profit prices in the poorest countries in the world and “shipped 126 million preferentially prices Combivir/Epivir tablets to the developing world” in 2005. The company also has granted seven voluntary licenses to generics manufacturers for the sale of antiretrovirals (HIV/AIDS medicines) in sub-Saharan Africa, she said.