India's patent office rejects Boehringer's application for pediatric antiretroviral

India's Patent Office in New Delhi earlier this month rejected German drug maker Boehringer Ingelheim's application for a pediatric version of the antiretroviral drug nevirapine, consequently allowing local generic pharmaceutical companies such as Aurobindo and Cipla to continue marketing low-cost versions of the medicine in the domestic market, the Business Standard reports.

The decision follows objections to the potential patent from civil society groups in the country (Mathew, Business Standard, 6/20).

According to the Lawyer's Collective, a New Delhi-based socio-legal group, this is the first decision on 13 patent oppositions filed by civil society groups against HIV-related drug applications (Economic Times, 6/20). The Indian Network for People Living With HIV/AIDS and the Positive Women's Network in 2006 filed a pre-grant opposition to Boehringer Ingelheim's application, arguing that it was not patentable under the Indian Patent Law (Mukherjee, Times of India, 6/20). The law states that new forms of known substances cannot be patented unless their efficacy has been significantly enhanced (Economic Times, 6/20). According to the Times of India, if the patent had been granted, the price of pediatric nevirapine could have increased.

P. Kousalya, president of PWN, said, "We opposed the patent application on nevirapine hemihydrates (syrup) to ensure that it remains available for our children and to make sure that the government doesn't say it is too expensive to provide" (Times of India, 6/20). Kousalya also said, "Accessing appropriate pediatric formulations of AIDS drugs is a particular problem around the world, and we hope this decision can be a first step in making them more available." K.K. Abraham, president of INP+, said he hopes other patent offices throughout the country "will take note of this decision and subject other patent applications on important medicines to strict scrutiny" (Business Standard, 6/20).