Sarah Hiddleston

Tenofovir is a modification of an already known compound, it says

Patent will prevent import of low-cost generic medicines from India: Brazil group

“We want more options to promote competition and bring down prices”

CHENNAI: Patients from Brazil have asked the Delhi patent office not to grant a patent pending on the HIV drug tenofovir because it would prevent the import of low-cost generic medicines from India they say are important for their national AIDS treatment programme, upon which 1,80,000 Brazilians depend.

This is the first time that a group from outside the country has challenged a patent pending in the country since the introduction of product patents in India in 2005. It shows how far other developing countries rely on the production of generic medicines and illustrates the strength of the demand for exports from the Indian pharmaceutical industry.

ABIA (Brazilian Interdisciplinary AIDS Association) filed the opposition jointly with the Indian non-governmental organisation SAHARA (Centre for Residential Care and Rehabilitation) on Thursday to a patent submitted by Gilead Sciences before 2005 and kept in waiting. The Patent Amendment Act, 2005 (Section 25) allows any affected party to object to a patent before it is granted. ABIA and Sahara are appealing on the grounds that the drug is a modification of an already known compound and therefore not eligible for a patent under Section 3(d) of India’s patent law. Gilead also has a patent pending for tenofovir before the patent office in Rio de Janeiro, Brazil.

“We want more options to promote competition in the market and bring down drug prices,” Gabriela Chavez, a pharmacist with ABIA told The Hindu over telephone from Brazil. “If the patent is granted in Brazil but not in India, Brazil has the option to apply for a compulsory licence [a provision for public health emergencies sanctioned by the World Trade Organisation] to buy the drug at lower cost from Indian companies. If the patent is not granted in Brazil or India, Brazil has the option to import either the key ingredients or the finished medicines from Indian companies,” she said.

Drug resistance

Tenofovir is recommended by the World Health Organisation as a treatment for those who suffer side effects from other HIV drugs or those who develop drug resistance. An estimated 31,000 people living with HIV are expected to receive tenofovir through Brazil’s national AIDS programme by the end of 2008, said Gabriela Chavez. The Brazilian government is buying the drug direct from Gilead at the negotiated price of $1,387 (Rs. 59,571) per patient a year, according to its 2007 budget figures. The lowest priced generic versions of the drug are available in the Indian domestic market at $158 (Rs. 6,770). Some Indian pharmaceutical companies in 2006 signed an agreement with Gilead enabling them to manufacture the drug but preventing them from exporting it or its raw materials to some middle income countries including Brazil. If the patent is not granted in India, companies can compete for the domestic market but only those who have not signed the agreement with Gilead will be able to export.