For the past 7 years, the Indian government has faced on-going court challenges and bullying by the pharmaceutical company Novartis. Novartis’s challenge has centred on provisions in the Indian Patents Act that exclude new uses and formulations of existing medicines from patentability. Specifically, Novartis challenged India’s rejection of its patent application for the cancer medicine Imanitib (Gleevec). Novartis’s application was rejected on the grounds that Imanitib is not a new medicine, but merely a new formulation of an existing compound.
In an important victory for access to medicine across the developing world, the Indian Supreme Court on Monday upheld both the Indian Patents Act and the rejection of Novartis’s patent application on Imanitib. A ruling in favour of Novartis would have restricted India’s ability to produce and export generic medicines to developing countries and threatened its role as the pharmacy of the developing world.
A ruling in favour of Novartis would also have had a chilling effect on other developing countries seeking to amend their national patent legislation along the lines of the Indian example. With the favourable ruling however, India’s strict patentability standards have now been shown to be in line both with India’s national law and with international trade agreements. The ruling should thus put to rest any remaining legal concerns that countries may have about rejecting patents on new uses and new formulations of existing compounds.
South Africa should follow India’s example and undertake legislative reform to prevent ‘ever greening’ of patents by excluding new uses and new formulations of existing medicines from patentability. (Amending South Africa’s law in this way is a key focus of the TAC and MSF ‘Fix the Patent Laws’ campaign.) The cost to patients and health systems of granting poor quality patents can be very high. South Africans currently pay almost twenty times higher prices for patented Imanitib than what is charged for generic versions of the drug in India.
TAC congratulates our colleagues and comrades in India for their hard work and the important victories that they have won. We call on the South African government to take heed of this ruling and join countries like India that are pushing back against abuse by pharmaceutical companies to protect the health of their citizens.
Note: Novartis and others have argued that rejecting patents on new formulations and new uses of existing medicines disincentivises research and development. We disagree. By raising the bar for patentability the incentive to invest in meaningful innovation would be increased – while the incentive for incessant patenting of minor tweaks to existing medicines will be reduced.
Read more about the ruling at: http://www.