Responding to controversy over the steep price hike of a popular AIDS drug, the US National Institutes of Health (NIH) is assessing whether an obscure law gives the agency the right to 'march in' and force the drug's patent holder to license its patent to generics manufacturers.

The US government and pharmaceutical industry face mounting global pressure to provide affordable AIDS drugs. The US has long insisted that its aid money fund expensive patented medications, but in a surprise policy shift in May, the government announced it would allow cheap generics that clear an expedited review process. Five companies also agreed last year to slash antiretroviral drug prices in 16 Caribbean and African countries. Jamaica in May became the first country to benefit from that deal.

Meanwhile, last year's 400% price increase for the eight-year-old drug Norvir, made by Illinois-based Abbott Laboratories, hit the NIH radar after letters poured in from activists, politicians and physician groups, says Mark Rohrbaugh, head of the NIH's technology transfer office. Norvir is a protease inhibitor that has become integral for boosting the activity of other AIDS drugs.

The NIH held a public forum on the issue when Essential Inventions, a Washington-based advocacy group, urged the NIH to use the 1980 Bayh-Dole Act to intervene against Abbott. At issue is a provision of the act that says the government can “march in” if government-funded innovations are not made “available to the public on reasonable terms.” The NIH gave Abbott nearly $3.5 million for preclinical work on Norvir.

Rohrbaugh and other NIH officials plan to prepare recommendations on whether the agency should intervene on Bayh-Dole grounds, but Rohrbaugh declines to say when.

Abbott executives counter that the argument does not apply because Norvir is available in 60 countries. “There is no legal basis for march-in rights,” says John Leonard, Abbott's vice-president for development of global pharmaceutical research and development. Leonard says the price hike better reflects Norvir's real contribution to fighting AIDS. “[Essential Inventions] has tried to twist the Bayh-Dole Act's words into a vehicle to impose price controls,” says Leonard, adding that, at $8.57 per day, Norvir costs less than other AIDS drugs. Bristol-Myers Squibb's protease inhibitor Reyataz costs $22 a day and GlaxoSmithKline's Lexiva is priced at $32.