Word: patents
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...India showed two years ago it could take on the giants on their home turf when Dr. Reddy's won the right to hawk generic versions of Eli Lilly's best-selling antidepressant, Prozac. That success opened the floodgates: there are currently at least a dozen patent challenges filed by Indian firms against U.S. drugmakers. In all, Indian companies have received either judicial or administrative clearance to sell 87 generic drugs in the U.S., and 68 more are awaiting approval. "It's a great time for the Indian pharmaceutical industry," exults G.V. Prasad, CEO of Dr. Reddy...
...reason Indian companies are doing so well in America: they have learned to exploit U.S. patent laws that two decades ago were amended to allow for the sale of generic pharmaceutical products. In the mid-1990s, Indian companies searching for overseas revenue streams began pushing into the U.S., where chronically high prices for prescription drugs created a ready market for generics. Dr. Reddy's, for example, now generates one-third of its sales in the U.S. Though domestic sales for Indian drugmakers as a whole are growing at less than 10% a year, their exports soared by 20% last year...
...Even as they succeed overseas, however, trouble is brewing at home. As part of an agreement with the World Trade Organization (WTO), India will apply international patent standards to its domestic pharmaceuticals market in 2005, ending three decades of protectionism and making it easier for multinationals to compete on Indian soil without being relentlessly copied. Currently, India's top 10 pharmaceutical companies spend only 3.3% of their revenues on research into new products?compared with the 10-15% their Western peers spend. Once the new patent laws are enforced, local drugmakers that don't want to be buried by multinationals...
...There are looming problems on the international front too, as Western drugmakers fight back. WTO representatives meeting in Geneva last month hammered out an agreement that allows poor countries, when faced with crises such as AIDS or malaria, to waive international patent laws and buy cheap foreign copies of expensive drugs. Though Indian companies have had a huge impact on the prices of AIDS drugs in Africa (see chart above), they're not actually selling much of their products there because many African nations honor international patent laws. Cipla's Hamied estimates that his company provides drugs to no more...
...theory, the WTO agreement should benefit India's generic-drug companies by shielding them from strict patent laws. But many of India's drugmakers are angry about the agreement's fine print. According to D.G. Shah of the Indian Pharmaceutical Alliance, which represents the nation's largest drugmakers, the U.S. pharmaceutical lobby won key restrictions?for instance, a stipulation that generics sold under the agreement be manufactured in a different shape, dosage and packaging from the original?that make it difficult for non-U.S. companies to sell their products in poor countries and still turn a profit...