NEWS OF THE WEEK
AIDS DRUGS: Suit seeks to overturn AZT patent ents, another possible outA suit filed last week in Washcome, also could lead to sale ington, D.C., seeks to strip by others. Burroughs Wellcome of its The U.S. government is curU.S. patents giving it exclurently listed as a defendant in sive rights to produce and the case, but the plaintiffs market AZT (zidovudine) as hope it will join their side. Inan AIDS therapy. AZT is the deed, NIH officials seem genonly drug approved in the erally to agree with them. In a U.S. for t h e t r e a t m e n t of letter in the New York Times AIDS. on Sept. 28, 1989, National The plaintiffs in the suit are Cancer Institute director Samtwo men who test positive for uel Broder and coworkers said human immunodeficiency viof AZT, "There are few drugs rus (HIV) and the People With now approved in this country AIDS Health Group. They are that owe more to governbeing represented pro bono ment-sponsored research," atby Public Citizen, a public intributing the key developt e r e s t g r o u p f o u n d e d by ments to "the staff of NCI Ralph Nader. working with staff at Duke The suit claims the patents University." Davis: government's position is this was a mistake are invalid because Burroughs Moreover, NIH acting diWellcome "did not conceive, develop, or demonstrate the utility" sight," it says, is the basis of the "use" rector William F. Raub said last week of AZT, and because it failed to name patent that it received in 1988 and its that NIH has been meeting with Burall the inventors and give other im- subsequent continuation patents. The roughs Wellcome to discuss the patents, and believes NCI researchers portant information about the drug's chemical itself is unpatented. development in its patent applicaAt the heart of the case is the price "should have been named as cointion. The suit alleges that scientists at of AZT, which has been the subject ventors." the National Institutes of Health, as- of controversy for years. If other Michael H. Davis, a professor of sisted by researchers at Duke Univer- companies were allowed to provide law at Hofstra and Cleveland State sity, played the key role in inventing AZT, it could be available for much University law schools who is assistthe therapy. less "than the monopoly price being ing the plaintiffs, says, "I think the Burroughs Wellcome president charged by Burroughs Wellcome," government's position is this was a and chief executive officer Philip R. says Brian Wolfman, an attorney mistake.... As a direct result of what they know to be the AZT scandal, Tracy responds that the firm "has ad- with Public Citizen. Derek Hodel, executive director of they have completely renovated their dressed these erroneous claims many times in the past and remains confi- People With AIDS Health Group, procedures and opened an office of dent of its patent position. . . . The says the retail cost of AZT is about technology management within NIH idea that our company would engage $3000 a year for a typical dose of 500 to make sure other drugs don't esin illegal activities to obtain patent milligrams a day. "We believe at the cape." rights is both offensive and wrong." outset it could be half of that." Total The same day the lawsuit was The company's claim to the patent U.S. sales of AZT in 1990 were $175 filed, Burroughs Wellcome reduced rights seems to rest heavily on the million, with world sales of $287 mil- the price of AZT to about $2200 per year, attributing the reduction to exfact that it provided samples of the lion. The complaint seeks to declare the pected growth in patient population drug to NIH in 1985 for testing as a potential antiretroviral agent. The AZT patents invalid, which would and recent production economies. company contends that its scientists make it possible for other suppliers The company says this represents a were the first to conceive of the to produce and market the drug. De- total price reduction of 70% since drug's potential use for treatment of termination that the government the drug was first marketed. HIV infection. "This creative in- deserves co-ownership of the patStu Borman 4
March 25, 1991 C&EN
