GSK retracts AIDS drug Combivir's patent appeal

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GSK retracts AIDS drug Combivir's patent appeal

Our Services Sector Bureau / Mumbai August 21, 2006

GlaxoKline (GSK) has withdrawn its patent application in India

for anti-AIDS drug Combivir, which has been facing opposition from

NGOs and healthcare activists in the country.

" GSK, like any research-oriented company believes in protecting its

patent. It also reviews its patent applications as a routine matter

and the parent company has withdrawn its application for Combivir in

India, " a GSK India spokesperson said.

He, however, refuted the claims that the company had withdrawn the

application under pressure from activists, who had challenged the

company's patent over the drug at the Kolkata patent office.

" Making patent application and reviewing it is a routine matter

undertaken by the company, " he said.

The company had filed the patent application for Combivir, which is

a combination of Epivir and Retrovir, nearly eight years back.

However, the Indian Network for People Living with HIV/AIDS and the

Manipur Network of Positive People had filed a pre-grant opposition

at the Kolkata patent office stating the drug was not a new

invention.

Combivir is a widely-used fixed dose combination and used preferably

in projects run by several international organisations.

The NGO had claimed that Combivir, a fixed-dose combination of two

essential AIDS drugs zidovudine and lamivudine does not deserve an

exclusive patent right as both these drugs are already off patented

and

are int he public domain. GSK has currenlty filed applications for a

patent on Combivir in many developing countries affected by HIV/AIDS

including India.

GSK, had earlier projected Combivir as one of the most promising

products in its portfolio to be launched in the country. However,

the current move to withdraw the patent application in India would

create roadblocks for the company's plan to launch the drug here

with exclusivity.

The activists associated with Manipur Network of People Living with

HIV/AIDS said its pre-grant opposition was valid as this drug is a

widely used fixed dose combination of zidovudine and lamivudine and

is used extensively in the AIDS treatment programs of India,

Thailand and other developing countries.

" Patents create monopolies on drug manufacture and prevent the

production of affordable generic versions of the same drug by local

pharmaceutical companies. The manufacture of affordable quality

generic versions of Combivir and other anti-retroviral medicines has

allowed

developing country governments to put more people on treatment and

thus extend their lives, " Anand Grover, project director, Lawyers

Collective HIV/AIDS Unit, an NGO which helped the Manipur Network of

People Living with HIV/AIDS, in filing the pre-grant opposition.

This was the second instance of a multinational drug company facing

strong opposition from the healthcare activists and NGOs over

patenting lifesaving drugs in India in the post TRIPs period.

Earlier, health NGOs and generic companies in India had launched an

opposition aganist Novartis' patent application for its cancer drug

Glivac. Subsequently, the company lost the case in India early this

year following a legal battle.

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