The Indian Patent Office in New Delhi has rejected a patent application filed by the multinational pharmaceutical company Boehringer Ingelheim claiming a paediatric form of the anti-AIDS drug nevirapine. The rejected patent application covers the syrup form of nevirapine, which is particularly important for children living with HIV who are unable to swallow tablets.
This is the first decision from the Patent Offices on 13 patent oppositions filed by Indian civil society groups against HIV-related patent applications, and will set an important precedent for the others that are still pending. In May 2006, the Indian Network of People Living with HIV/AIDS (INP+) and the Positive Women's Network (PWN) had filed a pre-grant opposition against this application.
"PWN has been involved in looking at the issues of women and children in the context of HIV. We opposed the patent application on nevirapine hemihydrate 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. This is important not just for us but for PLHIV across the world," said P Kousalya, president of PWN. "Accessing appropriate paediatric formulations of AIDS drugs have been a particular problem around the world, and we hope that this decision can be a step towards making them more available".
The Indian Patents Act contains some important safeguards designed to ensure that frivolous patent applications are not granted at the cost of public health. These include section 3(d) of the Patents Act, which prevents many 'new forms' of known substances from being patented unless there is a significant improvement in efficacy, and section 3(e) of the Act, which prevents 'mere admixtures' of substances from being patented.
The opposition filed by INP+ and PWN had argued, among other things, that the particular application was not patentable under India law because the hemi-hydrate form of nevirapine was obvious to a person skilled in the art; that it was just a 'new form' of an already known substance without any increased efficacy; and that the manufacture of nevirapine hemihydrate in an aqueous solution was just a 'mere admixture' of ingredients that did not demonstrate any synergistic effects.
The Patent Office agreed with INP+ and PWN on all these grounds. In considering these arguments, the Patent Office considered as "facts of law" the need to 'give a strict interpretation of patentability criteria as decision thereof shall affect the fate of people suffering from HIV/AIDS for want of essential medicine'. The Patent Office also cited approvingly to the Madras High Court's judgment in Novartis v Union of India, which had observed that the "object which the [Patents (Amendment) Act, 2005] wanted to achieve [was] to provide easy access to the citizens of this country to life saving drugs and to discharge their Constitutional obligation of providing good health care to its citizens".
"For many of us living with HIV/AIDS, low cost generic anti-retrovirals offer hope of continuing treatment. With patents interfering with our lives we have no choice but to oppose them. The patent order sets an important precedent for the examination of other drug patent applications," said K K Abraham, president of INP+. "We hope that the other Patent Offices in Chennai, Kolkata and Mumbai will take note of this decision, and subject other patent applications on important medicines to strict scrutiny," he continued.
The hearing on the opposition had been held in August 2007, and the parties were directed to submit written submissions to the Patent Office shortly thereafter. In its Decision, the Patent Office adopted large portions of the Opponents' legal arguments. For instance, the Patent Office agreed with the Opponents that under section 3(d) of the Indian Patents Act, which states that 'new forms' of known substances may not be patented unless there is a significant enhancement of "efficacy," the burden is upon the patent applicant to put forth evidence of the therapeutic efficacy of both the known substance and the 'new form' of the known substance. In doing so, the Patent Office made clear that other 'improvements' to an existing drug, such as improved stability, would not be sufficient to meet the standards of section 3(d) of the Indian Patents Act.