There is no ambiguity in Indian legislation

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: Novartis is upset with the Madras High Court for its judgement striking down its patent on its drug Glivec, used to treat blood cancer, because it was really not an invention, but the same stuff with marginal add-on value. However, Novartis will not challenge the judgement. This has lead to a huge debate in the country on the future progress in R&D of drugs and pharmaceuticals in India.

Novartis had challenged Section 3(d) of the Indian Patent Act, which deals with such situations, and argued that the provision is arbitrary and inconsistent with the World Trade Organisation’s trade-related aspects of intellectual property rights (Trips) agreement. Novartis and many other pharma giants argue that this unfavourable judgement would undermine incentives for pharmaceutical innovation, incremental innovation in particular.

Why was such a decision taken? The Indian Patent Amendment Ordinance, 2004 is perhaps the only law in the world that included a provision to protect public health from companies who seek extension of their patents by marginal value addition. The law states that “patents would not be given for the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant”.

Parliament, in its wisdom, incorporated this clause to address the sham of patent life extension while ensuring patentability of known substances when the inventor is able to demonstrate enhancement of known efficacy. In other words, this provision promotes incremental innovation, but restrains evergreening. Albeit difficult to discern evergreening from incremental innovation, in practice, though, the so-called evergreening process is importantly different.