Indian anthrax drug offer rekindles patent row
Reuters
(Bombay/London, October 17)
hindustantimes.com
Tuesday, Sep 11
An Indian generic drugmaker on Wednesday offered to supply the United States with 20 million tablets a month of anthrax antibiotic, reopening controversy about whether drug patents should hold in medical emergencies.
Brian Tempest, president of Ranbaxy Laboratories Ltd, said he was ready to start shipping ciprofloxacin, the generic name for Bayer AG's Cipro, from December.
"Representatives of our US arm, Ranbaxy Laboratories Inc, made an offer to US Senator Schumer on Tuesday indicating we would be willing to supply this amount," he told Reuters.
Senator Charles Schumer, a Democrat from New York, has called on the federal government to increase the supply of Cipro, the only approved oral treatment for inhaled anthrax, by purchasing cheaper generic versions.
Shares in Indian generic drug companies have risen strongly this week on the perceived new market opportunity.
But industry observers said any move to override Bayer's patent would be highly controversial especially after recent bitter rows over access to AIDS drugs in poor countries.
"DANGEROUS AREA"
"It's a very dangerous area for the US government to get involved in," said Neil Turner, editor of the British-based Pharma Pricing & Reimbursement journal.
"I suspect this will not get very far because the potential damage to the U.S. position on intellectual property rights would be enormous."
Bayer itself said on Tuesday it planned to more than triple Cipro production over the next three months to some 60 million tablets a month, enough to treat about 1.7 million people with the normal regimen of two pills per day over a 60-day period.
US officials, however, want to set aside enough medicine to treat 12 million in case of a crisis.
SG Asia analyst Jesal Shah said there could be a $500 million opportunity for generic firms if they were allowed to sell copies before Bayer's U.S. Cipro patent expires in 2003.
Anthrax, a deadly bacterium, has been mailed to numerous Americans in recent weeks, one of whom has died, in a campaign which may be linked to the September 11 attacks on the World Trade Center and the Pentagon.
Schumer argues US law allows the government to buy drugs from producers other than the patent holder. But US Health and Human Services Secretary Tommy Thompson said he had been advised by government lawyers he did not have the power to buy generics.
International patent rules allow governments to ignore patents in an event of a national healthcare emergency, but how this should be interpreted is contentious.
The issue came to a head earlier this year when 39 drug companies took the South African government to court over its plans to secure cut-price versions of expensive AIDS drugs.
Turner said it seemed unlikely the current anthrax scare yet constituted a genuine emergency, especially in comparison with the AIDS pandemic which kills more than two million Africans each year.
The international drugs industry, criticised by some for restricting access to medicines, is very wary.
"The fear, from the drug industry perspective, is that AIDS drugs may have been the thin end of the wedge -- the question now is where do you stop?" said Franc Gregori, pharmaceuticals analyst at BNP Paribas in London.
MUCH CHEAPER
Ranbaxy did not reveal the price at which the company would be willing to supply Cipro to the US but Tempest said it would be "attractive". Two months' supply of Cipro equivalents in India costs just $20, around one-thirtieth of the US price.
Other Indian firms are also eager to step into the breach, and several, including Ranbaxy, have tentative US Food and Drug Administration approval to supply the active ingredient in Cipro to US generic firms once Bayer's patent expires.
Cipla Ltd and Dr Reddy's Laboratories Ltd both said they could supply large quantities.
Shares in Ranbaxy ended up 2.4 percent on Wednesday while Cipla gained five percent and Dr Reddy's 3.6 percent.
Indian law only allows patenting of processes by which drugs are made. As a result, companies can make drugs like Cipro that are under patent in the West, providing they use a process that is different from the original. |
