Just two weeks after the administration muscled steep price concessions from Bayer AG for its anthrax antibiotic Cipro, U.S. trade negotiators in Doha, Qatar, will be fighting a bid by developing nations to ease patent protection against knock-off versions of costly drugs that treat AIDS.

At issue in Doha is a declaration proposed by 60 countries that would clearly affirm the right to sidestep patent laws in the name of public health - - in particular "to ensure access to medicines for all."

"Nothing," the draft proposal declares, ". . . shall prevent members from taking measures to protect public health."

Brazil and India, which do not fully recognize patent protections on AIDS drugs and make low-cost versions, are primary backers of the declaration. The United States is staunchly opposed.

"The Cipro thing was timely," said James Love, of Consumer Project on Technology in Washington, D.C., an organization founded by Ralph Nader. "When the U.S. did not like the price of a medicine, we were very fast to say we might override patent rights. When Brazil did the same thing (for AIDS drugs), they were savaged."

Health and Human Services Secretary Tommy Thompson reportedly threatened to sidestep Bayer's patent to win a 50 percent price cut on 300 million Cipro pills destined for the U.S. stockpile of drugs against anthrax. Canada similarly got a price break after a brief legal battle with Bayer.

The Qatar conference -- the first WTO Ministerial Meeting since the Seattle conference in 1999 -- will take up the issue but may not resolve it. Talks are likely to go on for years.

As an alternative to the 60-nation proposal, the U.S. Trade Representative is proposing an extension of the deadline certain poor countries have to comply with international patent rules. The poorest 40 or so countries would have until 2016; sub-Saharan African nations fighting AIDS, malaria and tuberculosis would be shielded from trade actions relating to drug patents.

"As the United States and our trading partners pursue free trade, we need to do so in a way that is consistent with our values and draws on our compassion," said U.S. Trade Representative Robert Zoellick, in a Washington, D.C., speech last week.

AIDS activists dismiss the concessions as empty gestures. Most of the affected countries can already seek extensions under current trade rules, and among those left out are South Africa -- with a huge AIDS problem -- and India, one of the countries that can make generic drugs.

Sub-Saharan Africa is the epicenter of a global AIDS epidemic. An estimated 25.3 million people in that region are infected with HIV, the virus that causes AIDS. Each year, 2.4 million Sub-Saharan Africans die of the disease.

The key question behind all the rule making, according to Love, is whether the United States and Europe will relax rules on the export of generic drugs by countries such as India to AIDS afflicted nations that cannot produce the drugs themselves.

Indian drugmaker Cipla Ltd. has developed a three-drug combination of AIDS drugs it has offered to sell to the French medical group Doctors Without Borders for $350. That compares to prices of $1,000 a year offered by drugmakers in negotiations with a handful of African governments, and to $12, 000 for similar drug combinations sold in the United States.

Although an existing agreement known as TRIPS (Trade Related Aspects of Intellectual Property Rights) gives all nations the right to override patents and a mechanism for compensating the patent-holders, poor nations have been reluctant to invoke it -- fearing lengthy disputes before WTO settlement panels.

"Countries that have tried this have come under pressure from the U.S. and the European Union," said Ellen 't Hoen, a Doctors Without Borders activist.

Mark Grayson, a spokesman for the Pharmaceutical Research and Manufacturers of America, said the 60-nation proposal would be a disaster that would undermine economic development in all poor countries.

"That language is extraordinarily potent," he warned. "With that language, there might as well not be a TRIPS." The definition of public health in the proposal is so broad, he said, that no patent of the drug industry would be safe.

The real agenda of Brazil and India, according Grayson, is to give their generic drug industries a freer hand to "take the property" of the drug companies that research and patent their products.

"They've hijacked the AIDS crisis to hone their own industrial development, " Grayson charged.

©2001 San Francisco Chronicle

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