A host of NGOs working in the health sector in India have asked the central government to clarify its stand on a US study, identifying potential benefits of incremental pharmaceutical innovation for India. The study was released at a function in Washington recently in which Union commerce and industry minister Anand Sharma was also present. The NGOs have also sent a copy of the letter to the Ambassador of India to the US Meera Shankar.

Expressing grave concern over the presence of the Union minister at the release function of a US business funded study on India's patent law at the USIBC Summit in Washington on June 17, the NGOs asked the government to immediately clarify the position on this report. "Section 3(d) and other public health safeguards in India's patent law directly impact the lives of millions of patients not only in India but across the developing world who rely on access to safe, effective and affordable medicines from India. We trust that the Ministry of Commerce and Industry will take all steps and actions to continue to defend this key provision of Indian law," the NGOs said.

The NGOs which have raised a banner of revolt in this regard included Indian Network for People living with HIV/AIDS (INP+), Cancer Patients Aid Association (CPAA), National Working Group on Patent Laws, Lawyers Collective HIV/AIDS Unit, Delhi Network of Positive People (DNP+), Trade and Public Health Team, Centre for Trade and Development, Initiative for Health, Equity and Society, All India Drug Action Network, International Peoples Health Council, South Asia Diverse women for diversity and SATHI-CEHAT.
The NGOs said that the study reportedly, "reasons that Section 3(d) of India's Patents Act, which prevents incremental pharmaceutical innovations from receiving patent protection inhibits development of safer, more efficacious and more useful drugs for Indian patients."

This is not a new allegation made by US-based pharmaceutical industry and their representatives. Nor is it accurate. Section 3(d) of India's patent law is a key public health safeguard introduced by the Indian Parliament in the 2005 amendments to the Patents Act, 1970. The Indian Parliament recognized public health concerns regarding 'evergreening' - a common practice of pharmaceutical companies to extend their patent monopolies on known medicines by making insignificant or minor changes and accordingly introduced Section 3(d). This provision acts as a check on pharmaceutical companies obtaining patent monopolies for medicines that are not actual inventions, such as combinations or slightly modified formulation of existing medicines, the NGOs in the letter said.

Section 3(d) is being used by public interest and patients groups to ensure that frivolous patents are not granted in India. Moreover, the Indian government put up a strong defence of this provision in a legal challenge by a multinational pharmaceutical company before the Madras High Court. The challenge to Section 3(d) was rejected by the Court, which recognized the importance of the provision in light of the obligation on the Indian government to protect the right to life and health of all citizens.