drug company "did not conceive, develop or demonstrate" the use of AZT as an anti-AIDS drug and, therefore, "is not the inventor."
William Raub, acting director of the National Institutes of Health (NIH), yesterday said that while the agency was not party to the suit, National Cancer Institute researchers "should have been named as co-inventors on these patents."
"In the diplomatic language of patent law, those are fighting words," said a congressional staff member.
Raub's comment was NIH's first public questioning of Burroughs Wellcome's claims of exclusivity, said people who have followed the controversy since the patents were awarded.
Phillip R. Tracy, president of Burroughs Wellcome, said the suit's allegations were "offensive and wrong." He said the British-owned company first conceived of the use of AZT as an anti-AIDS drug.
The purpose of the suit is to lower the price of AZT, the only federally approved drug known to inhibit the virus that causes AIDS.
But the suit also is expected to refocus national attention on drug pricing and the government's role in allowing some companies to monopolize that practice.
"What this litigation is most about is ultimately indicting the goverment for its complicity with industry," said Jean McGuire of the Harvard School of Public Health and former director of the AIDS Action Council in Washington. ''The government has created a situation that has got it and the taxpayers paying industry out of our pockets."
AZT now costs about $2,800 a year for HIV-infected patients with AIDS symptoms, said Kathy Bartlett, spokeswoman for Burroughs Wellcome.
That is much lower than its original price - about $10,000 a year - but still too high for many AIDS patients, said Derek Hodel, executive director of the People With AIDS Health Group, of New York. He said the government, through Medicaid payments, spent millions of dollars a year to help poor patients get AZT.
"The price of AZT is killing us," Hodel said.
Advocates for people with AIDS have been protesting the price charged by Burroughs Wellcome for AZT for three years.
The impetus for the lawsuit came from a Cleveland State University student during a discussion in a patent law class in September 1989. The subject was a letter that appeared in that month's New York Times.
The letter, signed by five medical professionals from the National Cancer Institute and Duke, disputed Burroughs Wellcome claims that it had discovered
AZT's use as an anti-AIDS drug with limited federal cooperation.
Michael Harris, a professor of patent law at Cleveland State, discussed the letter in class. One student - Harris can't remember who - suggested that if the letter were accurate, the patents were invalid.