Financial Daily from THE HINDU group of publications
Sunday, Jan 25, 2004
Financial Daily from THE HINDU group of publications Sunday, Jan 25, 2004 |
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Pharmaceuticals Marketing - Courts/Legal Issues Industry & Economy - Pharmaceuticals Exclusive marketing rights — Novartis gets stay against 6 firms P.T. Jyothi Datta
Mumbai , Jan. 24 THE saga of litigation on the issue of exclusive marketing rights (EMR) for a drug took a fresh turn with Novartis getting a stay from the Madras High Court restraining six drug companies from manufacturing and distributing imatinib mesylate — the active ingredient in Novartis' blood cancer drug sold under the brandname Glivec. The six companies are Cipla, Sun, Ranbaxy, Hetero, Emcure and Intas and they have been restrained from the manufacture, sales, distribution, marketing and export of the generic version or chemical equivalent of Novartis' Glivec. Mr Ranjit Shahani, Vice-Chairman and Managing Director, Novartis India Ltd, confirmed the development and told Business Line that the stay order against the six companies was got last week and the companies would now have to respond. Representatives of some of the companies against whom the stay has been issued, also confirmed the development, however under conditions of anonymity. Novartis was the first company in India to be granted an EMR by the Indian Patent Office for its Glivec. But the Patent Office's decision had domestic drug companies up in arms, as a clutch of Indian companies produced chemical equivalents of the same drug, albeit at lower prices. Natco, one of the manufacturers of the drug promptly challenged the patent office's decision and filed a case in the Delhi High Court. An EMR gives a company exclusive marketing rights for a period of five years. But the twist in the tale is that companies can be given EMRs only for drugs patented after January 1,1995 and domestic pharma companies are challenging the patent office's decision on these grounds. Pharma industry representatives told Business Line that several companies were exploring the legal option, either in an individual capacity or as part of an association, following Novartis' efforts to enforce its EMR. "The decision to Natco's case will be a water-shed of sorts as it will give some direction on the issue," observes a representative with Mumbai-based pharma company that also produces the generic version of the mentioned cancer drug. Meanwhile, it is not just generic companies that are mulling the legal recourse. In September last year, GlaxoSmithKline had filed a case in the Delhi High Court against the Government's decision not to grant an EMR to GSK for its anti-diabetic drug rosiglitazone. A similar case was filed, this time in the Calcutta High Court, by Swiss company Hoffmann-La Roche, for the rejection of its EMR application for its anti-retroviral or anti-AIDS drug saquinavir. While other drug companies have applied for EMRs, with varying degrees of luck, Wockhardt's topical antibacterial drug nadifloxacin or Nadoxin is the other company that has been granted an EMR.
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