The multinational pharma companies have stepped up their campaign against Section 3(d) of the Indian Patent Act 1970 which denies patents to incremental pharmaceutical innovation or 'evergreening'. After a recent MNCs-sponsored study that identified potential benefits of incremental pharmaceutical innovation for India, the MNCs have now taken the help of the present swine flu crisis to spread their message that Section 3(d) is a potential deterrent to a healthy India.

A prime example of how Section 3(d) is a potential deterrent to a healthy India, is the present swine flu crisis. Currently, 50 cases of this virus have been detected in India. Unlike the bird flu virus, the swine flu virus is yet to develop different strains. It is a well known fact that as time progresses, many diseases and viruses develop different strains, some of which are immune to the vaccinations available. If strains do develop for the swine flu virus, pharmaceutical companies will be required to constantly improve the drugs available, where an insignificant alteration can lead to a cure for the virus. However, Section 3(d) prohibits India to reap the benefits of such improvements, whereas small changes can help improve millions of lives and enhance healthcare, a US-India Business Council (USIBC) statement said. USIBC is an organisation comprising top-tier US companies.

Last month, a USIBC had released a study in Washington in which it 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."

The study evoked knee-jerk reaction from the NGOs working in the health sector in India who asked the Indian government to clarify its stand on the USIBC study. These NGOs said that 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 version of existing molecules, the NGOs argued.

Earlier, a multinational pharma company, Novartis, had challenged the Section 3(d) before the Madras High Court. But 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.