PHA-Exchange> Indian Company to Make Generic Version of Flu Drug Tamiflu

[Claudio]

From: "Vern Weitzel" <vern.weitzel at undp.org>
> > http://www.nytimes.com/2005/10/14/health/14virus.html

> > 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 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."