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Executive Summary

NIH SEEKING AZT PATENT RECOGNITION FOR NCI's EARLY RESEARCH on the anti-retroviral agent. In a March 18 response to a suit filed by Public Citizen that seeks to invalidate Burroughs Wellcome's Retrovir (AZT) patent, the National Institutes of Health said it believes that "the National Cancer Institute should have been named as co-inventors on these patents." NIH noted that it "has been meeting with Burroughs Wellcome over the past several months" to discuss the firm's AZT patents. However, NIH pointed out that it "is not a party to Public Citizen's lawsuit." In response to the question of whether NIH will file suit against Burroughs Wellcome, an NIH spokesperson said the institute "has not ruled out any possibility." The complaint was filed March 18 in Washington, D.C. federal court by Public Citizen on behalf of two AIDS patients and the People With AIDS Health Group, a New York City-based buyer's club that helps HIV-infected people import drugs for personal use. Along with the company, the U.S. government is named as a defendent in the suit. The complaint maintains that the government "may claim an interest relating to the subject matter of this litigation in that it may assert co-inventorship, or even sole inventorship, in the claims of the AZT patent, which would render the patent invalid or, at a minimum, would provide the U.S., as well as [Burroughs Wellcome], the legal right to exploit the claims of the AZT patent." In a March 19 response to the lawsuit, Burroughs Wellcome said it "has acknowledged many times the highly skilled collaborative efforts of both government and academic scientists in the subsequent development of this drug. Such work, however, does not entitle the collaborators to be named as co-inventors on any patent." At question in the suit is the validity of a "use" patent issued to Burroughs Wellcome in February 1988 that covers AZT as a treatment for AIDS and AIDS-related complex; that patent will expire in the year 2005. The plaintiffs argue that the AZT patent is invalid for a number of reasons, including the fact that the company "did not conceive, develop, or demonstrate the utility of its purported invention and is, therefore, not the inventor," the filing states. The suit also maintains that Burroughs Wellcome " failed to name all of the inventors in its patent application." The plaintiffs also contend that "at the time [Burroughs Wellcome] purported to invent the use of AZT against HIV, the efficacy of using AZT to combat AIDS in particular, and HIV infection in humans generally, had already been demonstrated by individuals other than the [Burroughs Wellcome] employees named on the patent application, and the prior publication of those results therefore rendered [Burroughs Wellcome's] purported invention obvious." The suit adds that "on the day" that the company "purportedly invented" the use of the drug for treating AIDS, "many scientists at NCI, Duke [University] and FDA either knew of, or actually had performed, the AZT treatment upon AIDS patients." In its press release, Burroughs Wellcome maintained that its "scientists were the first to conceive of the use of the chemical AZT for the treatment of HIV infection in humans." Burroughs Wellcome's position is that since government scientists were working with unidentified, coded samples of a compound, they could not have conceived that AZT would be effective in treating HIV infection. The company said that it told NCI that the unidentified drug was active against HIV when the firm sent the sample to them. In its release, the company said its scientists identified AZT as "potentially useful against AIDS" in November 1984. It was not until spring 1985, Burroughs Wellcome said, that researchers from Duke University, FDA and NCI confirmed that the as yet unidentified compound was active against HIV. In a Sept. 20, 1989 letter to "The New York Times, NCI and Duke investigators involved with AZT, including NCI Director Samuel Broder, claimed that the firm "did not develop or provide the first application of the technology for determining whether a drug like AZT can suppress live AIDS virus in human cells." In addition, the investigators asserted that Burroughs Wellcome " was not the first to administer AZT to a human being with AIDS." In addition, the People With AIDS Health Group is seeking a declaration that importation of AZT manufactured by an entity other than Burroughs Wellcome and transfer of such drug to AIDS patients "would not constitute patent infringement." Imported versions of AZT and other AIDS drugs can be bought at lower prices than the U.S.-approved products. Reportedly, Toronto-based ACIC is manufacturing AZT, and another company, Apotex, Inc., is purchasing the AZT and shipping it to other countries ("The Pink Sheet" Jan. 14, T&G-12). The Canadian-made AZT can be purchased through the mail from a business named International Pharmacy that is located in the Bahamas. Apotex and another Canadian company, Novopharm, are challenging Burroughs Wellcome's AZT patents in Canada.

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