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Gilead's AIDS drug patent faces patient networks' opposition

P.T.Jyothi Datta

The fear is inexpensive versions will get blocked if patent is given


The oppostition
The Alternative Law Forum has filed the pre-grant opposition for Delhi Network of Positive People at the Delhi-arm of the Indian Patent Office.
A pre-grant opposition allows people to oppose patent applications filed by a company.

Mumbai , May 10

More than a month after opposing GlaxoSmithKline's (GSK) patent application on the AIDS-medicine Combivir, HIV/AIDS patient networks have now opposed the patent application on another AIDS-drug, Tenofovir.

Tenofovir from Gilead Sciences is used in the second-line treatment of HIV/AIDS, when patients develop resistance to the first-line of drugs. Gilead has a global patent on Tenofovir till 2018.

Chemically similar or generic versions of Tenofovir are available in India from Cipla. But, people living with HIV/AIDS fear that inexpensive versions of Tenofovir will get blocked if Gilead does indeed get a patent on the drug in India.

"We are not against big pharma or patents, we are not promoting generic companies. Our concern is for life," says Mr Loon Gangte, explaining the rationale behind the pre-grant opposition filed by Delhi Network of Positive People, under the aegis of the Indian Network of People living with HIV/AIDS.

The Alternative Law Forum has filed the pre-grant opposition for Delhi Network of Positive People at the Delhi-arm of the Indian Patent Office. The pre-grant against GSK's Combivir was filed in March at the Kolkata Patent Office by Lawyers' Collective for the Manipur Network of Positive People.

A pre-grant opposition allows people to oppose patent applications filed by a company. A decision on the patent is given after the Patent Controller's office hears arguments from different stakeholders. The Patent Office in Chennai had rejected Novartis' patent on cancer drug Glivec after opposition from cancer-patient organisations, among others.

The Tenofovir patent application has been opposed on the ground that it is an existing compound. "The addition of a salt (fumaric acid) to an existing compound (tenofovir disoproxil) is a common practice within the pharmaceutical industry, and should not be considered a new invention," said the Alternative Law Forum's Mr Tahir Amin.

Gilead's patent application on Tenofovir, despite not having a presence in India, is to possibly prevent generic companies from exporting the drug to other markets, he observed. Other generic companies are being cautious and will invest in making Tenofovir depending on how the patent-issue plays out, he added.

Alternative Law Forum is a Bangalore-based non-profit group of intellectual property experts and `public interest lawyers'.

Tenofovir lacks the toxicity and side effects of other AIDS-drugs, said the Delhi Network of Positive People President, Mr Gangte, who has been HIV-positive for the last nine years.

While Tenofovir is priced $800 per person, per month, it is priced $208 per person, per month in the least developed countries.

However, it is registered in only 10 of the 90 countries that are eligible to get this drug, said Mr Gangte.

In contrast, the generic version of the drug is priced at $603 per patient, per year, he said.

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