Drug patents: Showdown for pharma companies in Supreme Court

  • 20/08/2012

  • Tribune (New Delhi)

Novartis patent case up for hearing this week; judgment to have far-reaching impact Mumbai/London: The Supreme Court will hear final arguments starting this week in a landmark case over drug patents that could change the rules for the country's healthcare sector and potentially curb its global role as a supplier of cut-price generic medicines. The Supreme Court hearing pits Swiss drugmaker Novartis AG against India's patent office, which has refused to grant a patent on the company's cancer drug Glivec on the grounds that it is not a new medicine but an amended version of a known compound. A patent would give Novartis exclusive marketing rights and stop cheaper versions being produced by India's generic drugmakers, who supply medicine to the country's 1.2 billion people and to poorer nations across the world. The case has rekindled tensions between Big Pharma and India, following a decision by the patent office in March to strip Germany's Bayer AG of its exclusive right to sell another costly cancer drug, Nexavar, because most Indians cannot afford it. The hearing involving Novartis starts on Wednesday. It is expected to last several weeks, with a verdict a month or two later. Western firms see huge potential in India's rapidly growing economy but are wary of lax protection for intellectual property. They argue India is failing to recognize valuable medical innovation. Their critics — who include international aid groups and Indian generic drug manufacturers — say a win for Novartis would jeopardize the supply of cheap medicine to hundreds of millions of people in India and around the world, since India is the world's biggest exporter of cheap generic drugs. "The stakes are very high on both sides," said Leena Menghaney, a manager in New Delhi for Medecins Sans Frontieres (MSF), which relies on Indian-made generic drugs to treat AIDS and other diseases in Africa and many poor countries. Novartis' drug was approved in 2001 in the United States, where it is sold under the trade name Gleevec and can cost $70,000 a year. Discount programmes mean it is available for a lot less in poor countries and in India more than 95% of patients receive it free of charge under a company donation scheme, according to Novartis. Indian generic versions, meanwhile, cost about $2,500 a year. Indian generic companies can produce drugs at a fraction of the cost of originator firms like Novartis or Bayer because their costs are lower and they do not need to plough money back into future research. PATENTS VS PATIENTS: Menghaney fears a decision by India's top court to make it easier for drugmakers to win patents by giving way to Novartis would undermine India's position as "pharmacy to the developing world". Novartis says such fears are unfounded. — Reuters Wockhardt gets US nod for Parkinson's generic Indian drugmaker Wockhardt Ltd (WCKH.NS) said on Monday it has received approval from the U.S. Food and Drug Administration to sell Entacapone tablets, which are used in treatment of Parkinson's disease. Entacapone, which will be launched on September 30 with a 180-day exclusive period, is the generic name for the brand Comtan, owned by Orion Corp, Wockhardt said in a statement on its website.