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An important judgment will be pronounced by the Supreme Court on Monday on a Swiss pharma firm's plea asserting its patent over a medicine, and on Tuesday take up Sterlite's plea opposing the order to shut down its plant. In a judgment that would have a far-reaching implication for the Indian pharmaceutical industry, the court will rule on Novartis AG plea seeking a patent for the beta-crystalline form of imatinib mesylate, which is used in the treatment of chronic myeloid leukaemia.
Check out the symptoms of chronic myeloid leukaemia
International drug makers are critical of Section 3(d) of the Indian Patent Act which says that mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance does not qualify for patent protection. Novartis has contended that there could be a situation where a product which is an innovation under 2(j) and 2(j)(a) of the Patent Act is sought to be denuded of invention under 3(d) in terms of pharmaceutical 'efficacy'.
Section 3(d) of the Patent Act seeks to thwart the 'ever greening' of the pharmaceutical products with minor changes in the content and form without any innovation. Section 2(j) and 2(j)(a) deal with the grant of innovation to the product claimed to be original and a novelty. The global drug makers have contended that Indian patent law does not encourage innovation and criteria of efficacy under Section 3(d) are not clearly defined.
Read: Generic drugs: All you need to know
The next important judgment will be on Tuesday on the plea by Sterlite Industries India Limited challenging the Madras High Court order directing it to close down its Tuticorin copper-smelting plant for violating environmental norms.
The Madras High Court, by it Sep 28, 2010 order, had directed the immediate closure of the plant. The apex court, by its interim order of Oct 1, 2010, had stayed the operation of the high court order. However, the Tamil Nadu Pollution Control Board (TNPCB) Friday ordered closure of the plant with immediate effect, and power supply to the plant was cut off. The TNPCB order comes after the leakage of noxious gas from the plant March 23.
Related news: India vs Big Pharma: Compulsory licence for leukaemia drug sought
Source: IANS