Indian Company to Make Generic Version of Flu Drug Tamiflu
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 possi-
ble epidemic of avian flu.
"Right or wrong, we're going to commercialize and make osel-
tamivir," 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 pharma-
ceutical 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 an-
nouncement. "Preparing the world for a pandemic flu outbreak is
a top priority, and we're looking at various options in stock-
piling drugs and vaccine," said the spokeswoman, Christina Pear-
son. "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 ge-
neric versions of the drug, which eases flu's worst symptoms.
The company, which sells Tamiflu for US$ 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 say-
ing it plans to increase production "eightfold." A Roche spokes-
man, Terry Hurley, said yesterday that the company "fully in-
tends to remain the sole manufacturer of Tamiflu."
Making the drug involves 10 complex steps, he said, and the com-
pany 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 fin-
ished 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 be-
lieves that he can sell the drug in India and in 49 other coun-
tries 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 in-
fringement, we'd move to protect our rights and interests."