Cipla claims patent laws allow it to make bird-flu drug

Roche has been under growing pressure from several countries and the UN 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 US, 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 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’ll take another company ‘‘two to three years, starting from scratch,’’ to produce it. 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 2006. Asked if he thought Hamied was making an idle boast, Hurley declined to comment.

Cipla, India’s third-largest drugmaker, has copied dozens of Western drugs, including Lipitor and Viagra, and produces raw ingredients for Western drug companies. Its inexpensive HIV drugs, approved by the World Health Organization, are used by 400,000 people worldwide. Hamied said he would sell generic Tamiflu ‘‘at a humanitarian price’’ in developing nations and not aim at the US 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 January 1, 1995, and the Tamiflu patent in India was filed with a ‘‘priority date’’ of February 26, 1995.

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. 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.’’ —NYT