New Delhi: Signalling mounting global resistance to patenting of drugs in India, a Brazilian public health group has filed an opposition in India against US drug maker Gilead Sciences Inc.’s patent filing for their anti-AIDS drug, Viread.
This is the first pre-grant opposition filed by an overseas body against a patent grant in India and reflects a growing concern about ensuring that the supply of cheaper, non-patented drugs from India is not blocked.
Brazilian Interdisciplinary AIDS Association (ABIA) and the Indian non-governmental organization SAHARA, or Centre for Residential Care and Rehabilitation, on Thursday submitted their opposition in the Delhi patent office citing the implications the patent grant will have in restricting Brazil’s ability “to produce and access affordable generic versions of the drug”.
Bitter pill: Gilead’s headquarters in California. The firm faces the first pre-grant opposition to an application seeking a patent in India. (Photo: Kimberly White/Mint)
The drug is crucial for Brazil, which has a large patient population living with HIV. Brazil accounted for roughly 40% infected people in Latin America, which had a HIV-positive population of 1.6 million in 2007. The government there intends providing 31,000 people with tenofovir disoproxil fumarate, sold as Viread, and declared it a drug of “public interest” in April.
“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, adding that such an option was crucial for 180,000 Brazilians who depended on the national programme “for their lives”.
By procuring the drug from India, the South American country estimates it can save $38 million (Rs162.26 crore) on the drug.
The opposition is on the grounds that tenofovir consists of a previously known compound and hence not sufficiently inventive to qualify for a patent under section 3(d) of India patent law. This provision bars patenting of tweaked versions of existing drugs unless the modification leads to a substantial improvement in efficacy. Mumbai-based Cipla Ltd and patient groups, such as the Indian Network of Positive People and Delhi Network of Positive People, had previously filed opposition in the Delhi patent office in 2006.
The drug patent filing is facing similar oppositions in Brazil as well from civil society groups. The patent offices in both the countries will be reviewing the case in July, according to a statement issued by the Brazilian advocacy group.
Calls as well as an email questionnaire to Gilead’s senior vice-president and general counsel Gregg Alton seeking comments on the development went unanswered.
“This signifies India’s importance in providing access to cheaper drugs globally,” said Leena Menghaney, a drug access campaigner for Medecins Sans Frontieres in India. The World Health Organization recommends tenofovir for use in first and second-line drug regimens for HIV-infected people who suffer side-effects and have developed resistance to other drugs.
In 2006, Gilead had signed a spate of voluntary licensing agreements with 11 Indian non-patented, or generic drug makers, allowing them to make copies of the anti-HIV drug and selling it in 95 low-income countries including India, in a bid to take the sting out of the patent oppositions.
The public health activists refuse to believe such licence—called “patent settlements and not pure licensing agreements” by one of them— would solve the problem.
“The voluntary licences come with several restrictions on geographies, exports and back-end supplies for the generic companies. There is a lack of transparency on these deals,” said Menghaney, adding that all voluntary licensing agreements should be put out in the public domain and scrutinized for anti-competitive clauses.
The statement explains that the deals forged with Indian companies “are restrictive and do not permit export of the drug or raw material (active pharmaceutical ingredient) to certain middle-income countries, including Brazil”, allowing the innovator Gilead to charge exorbitantly for the drug.
Gilead sells tenofovir for $1,387 (Rs59,224 today) to a patient for a year’s treatment—almost 8.8 times costlier than $158 (Rs6,746) that the cheapest available Indian generic version will cost for the same drug regimen.