Brazil AIDS group opposes drug patent in India

[Metropolitanjury]

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.

By Ms.Bobby Aanand, Metropolitan Jury.

[jimmy03]

Brazilian AIDS advocacy group ABIA (Brazilian Interdisciplinary AIDS Association) and the Indian NGO SAHARA (Centre for Residential Care & Rehabilitation) submitted an opposition against the grant of a patent in India to Gilead Sciences for the key AIDS drug tenofovir. A patent in India would not only restrict generic competition in India, but would also have a direct impact on the ability of Brazil to produce and access affordable generic versions of the drug.

The opposition has been filed on the ground that the drug consists of a previously known compound, and should not be considered an invention according to India's Patents Act. India's patent law is pro-public health, with strict patentability criteria. A major public-health safeguard in the law is the provision against patenting of minor improvements of known medicines (section 3(d)). The law also allows any party to oppose patent applications that do not deserve patents under Indian law.

Civil society groups have also filed an opposition to Gilead's patent application on tenofovir in Brazil. The patent offices in both India and Brazil will be reviewing the case in July.

"Although we are confident the tenofovir patent will not be granted in Brazil, we must ensure that the option of importing affordable generic versions from India remains open to our AIDS programme," said Veriano Terto, ABIA's general coordinator. "This will contribute to the sustainability of our national AIDS program's universal access policy, upon which 180,000 Brazilians depend on for their lives".

The WHO recommends tenofovir disoproxil fumarate (TDF) for use in first and second-line drug regimens for people living with HIV who suffer side effects from other drugs and those who have developed drug resistance. Access to affordable tenofovir is particularly important for Brazil, as by the end of 2008, an estimated 31,000 people living with HIV will receive the drug through the national treatment program. In April, the Brazilian government declared tenofovir to be of 'public interest' in treating people living with HIV.

As a result of patent oppositions filed in India previously in 2006, Gilead offered voluntary licenses to several Indian generic manufacturers, even though no patent on the drug had been granted. These agreements are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil. This allows Gilead to continue to charge high prices in these countries. In Brazil, Gilead sells tenofovir for US $1,387 (Rs 59,571) per patient per year, and in comparison, the cheapest available generic version manufactured in India costs only US $158 (Rs 6770) per patient per year.

Brazil would not be able to procure generic versions from India if the patent were granted. If the patent were rejected, Indian generic companies that did not sign the voluntary license agreement with Gilead would be able to supply tenofovir to Brazil and other middle-income countries. This would mean Brazil could purchase affordable generic versions of tenofovir from multiple producers competing against each other, helping bring prices down.

The Indian Network for People Living with HIV/AIDS (INP+) and the Delhi Network of Positive People (DNP+) filed oppositions to the patent applications on tenofovir at the Delhi Patent Office in 2006.

"There's a global momentum building against the granting of a patent in India on tenofovir," said Loon Gangte, president of the Delhi Network of Positive People (DNP).