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.
Gilead faces the first pre-grant opposition to an application seeking a patent in India. Brazilian Interdisciplinary AIDS Association 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”.
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.
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.
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.
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.
Gilead faces the first pre-grant opposition to an application seeking a patent in India. Brazilian Interdisciplinary AIDS Association 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”.
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.
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.
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.
No comments:
Post a Comment