Fabricantes de Medicamentos Censuran Derecho de propiedad industrial indio

MUMBAI - Multinational drug companies have pushed big-time into India in recent years after the country agreed to respect intellectual property rights for pharmaceutical products.

But India's patent office and courts have repeatedly declined to defend patents widely accepted in many other countries on some of the world's best-selling medicines. As a result, multinational pharmaceutical firms have been thrown a curve ball as they seek to expand in one of the world's fastest-growing markets.

In the latest example, Bayer AG failed this week to persuade the Delhi High Court to direct India's chief drug regulator to not give marketing approval to a competitor's copy of its cancer medicine Nexavar.

Top-selling, life-saving medicines, including the anticancer treatment Glivec from Novartis SA; anticancer drug Tarceva from Roche SA; and HIV medicine Viread from Gilead Sciences Inc. all have failed to win protection from India's patent office or the judicial system.

The Drug Controller General of India is the equivalent of the U.S. Food and Drug Administration. But the Indian agency has a higher bar for issuing patents, and doesn't automatically refuse to approve copies of patented medicines while any outstanding patent issues are being resolved in court, as the FDA does.

Without the regulator holding off on approvals, companies that get patents in India frequently are left to pursue copycats in court-where they also have run into unfavorable decisions.

Executives at multinational drug companies say India will suffer if it fails to recognize patents that are widely accepted elsewhere or protect patent holders from copycat competitors.

"If this science and innovation can't be patented, it is sending a very strong message about how limited India's patent protections are," says Gregg Alton, executive vice-president of corporate and medical affairs at Gilead Sciences.

Until 2005, Indian law recognized only process patents for making pharmaceutical products-and not the actual products. Indian companies were well-known for selling lower-cost copies of some of the most expensive, branded medicines in the world.

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