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INDIA: THE PHARMACY OF THE WORLD
In the Rs 70,000 crore
Indian pharma market, patent wars are heating up. In a landmark judgment, the Supreme Court of India ruled against the patent claims of Novartis on its cancer drug, Glivec. The judgment allows suppliers to continue making generic copies of Glivec, providing relief to around 300,000 patients in India. It is estimated that $150 billion worth drugs will lose patent protection between 2010 and 2017.
Process-to-Product Patent Regime
India's patent laws allow Indian companies to produce generic versions of drugs that are under patent elsewhere. Competition between manufacturers drives down prices of drugs. Cipla is one of the largest suppliers of low cost generic drugs in the world.
For many years, India didn't recognise drug patents. In 1994, India signed the TRIPS agreement (Trade Related Aspects of International Property Rights) which gives drug companies a 20-year patent on the production of drugs. TRIPS required India to introduce patents on medicines in 2005. In 2005, India passed the latest amendments to the India Patents Act 1970, shifting over from process- to product-patent regime. This was necessary for India to comply with existing WTO norms.
The Supreme Court's judgment has set a precedent against the practice of "evergreening"—a strategy through which drug manufacturers introduce modifications of drugs to extend the five-year patents on them. 'Evergreening' is where a company extends its patent on a drug by re-patenting slightly modified versions of the drug. For example, they might release the original drug in its salt form, even if this does not bring a therapeutic improvement.
India—along with Brazil, Thailand, and South Africa—is one of the few countries with laws against 'evergreening'. The Indian Patent Act, as amended by the Patents (Amendment) Act 2005 under Section 3(d), states that drugs cannot be patented if they result from "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." This has allowed the continued production of cheap generic versions of drugs by Indian companies.
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