By DONALD G. McNEIL Jr. Published: October 14, 2005
A major Indian drug company announced yesterday that it would start making a generic version of Tamiflu, the anti-influenza drug that is in critically short supply in the face of a possible epidemic of avian flu.
"Right or wrong, we're going to commercialize and make oseltamivir," said Dr. Yusuf K. Hamied, chairman of Cipla of Bombay, using the drug's generic name and acknowledging that he might face a fight in the Indian courts with Roche, the Swiss pharmaceutical giant that holds the patent.
Although generic manufacturers cannot legally sell the patented drug in the West, all national patent laws, including those of the United States, allow governments to cancel patents during emergencies and either buy generics or force patent holders to license their formulas to rivals.
A spokeswoman for the Department of Health and Human Services, which has recently ordered 12.3 million doses of Tamiflu from Roche, said she could not comment on the effect of Cipla's announcement. "Preparing the world for a pandemic flu outbreak is a top priority, and we're looking at various options in stockpiling drugs and vaccine," said the spokeswoman, Christina Pearson. "But there are a lot of issues, and it's too early to speculate about this right now."
Roche has been under growing pressure from several countries and the United Nations secretary general, Kofi Annan, to license generic versions of the drug, which eases flu's worst symptoms.
The company, which sells Tamiflu for $60 per treatment in the United States, has repeatedly refused to license the generic version, or even to disclose how much it makes, other than saying it plans to increase production "eightfold." A Roche spokesman, Terry Hurley, said yesterday that the company "fully intends to remain the sole manufacturer of Tamiflu."
Making the drug involves 10 complex steps, he said, and the company believes that it will take another company "two to three years, starting from scratch," to produce it.
Dr. Hamied dismissed that claim, saying that he initially thought it would be too hard but that his scientists had finished reverse- engineering the drug in his laboratories two weeks ago. He said he could have small commercial quantities available as early as January.
Asked if he thought Dr. Hamied was making an idle boast, Mr. Hurley declined to comment.
Cipla, India's third-largest drug maker, has copied dozens of Western drugs, including Lipitor and Viagra, and produces raw ingredients for Western drug companies. Its inexpensive H.I.V. drugs, approved by the World Health Organization, are used by 400,000 people worldwide.
Dr. Hamied said he would sell generic Tamiflu "at a humanitarian price" in developing nations and not aim at the American or European market. "God forbid the avian flu should strike India," he said. "There is no line of defense."
Under Indian patent laws, which were tightened in March, he believes that he can sell the drug in India and in 49 other countries rated "least developed" by the United Nations.
The new law recognizes patents filed by Western companies after Jan. 1, 1995, and the Tamiflu patent in India was filed with a "priority date" of Feb. 26, 1995. Dr. Hamied said he thought the Indian government would be unlikely to fight over a 10-year-old difference of two months, especially if the lives of millions of Indians were at stake.
Scientists in Taiwan and other countries have said they, too, can produce generic Tamiflu, if patent issues are resolved.
Mr. Hurley declined to say whether Roche would fight Cipla in court, but said, "If we determine that there has been an infringement, we'd move to protect our rights and interests."