Ever since a virus contaminated Genzyme's production plant in Allston, Massachusetts close to two years ago, people with Fabry's disease have faced severe shortages of the medicine they need, Fabrazyme (see editorial on page 515). In August 2010, three people with Fabry's petitioned the US National Institutes of Health (NIH) to step in and demand that Genzyme allow other companies to make the enzyme replacement therapy on the basis of the government's so-called 'march-in' rights. The provision of the Bayh-Dole Act allows funding agencies to override exclusivity rights to intellectual property arising from government-funded research when people's lives are at risk.

The NIH denied the request late last year. But, given Genzyme's continuous production delays—the company now says it won't be manufacturing Fabrazyme again until closer to the end of the year—on 5 April the petitioners appealed the original decision.

Such requests have historically failed. But this time could be different. “There's no guarantee that they'll march in, but if not now, when?” asks Dan Vorhaus, a New York–based attorney with the law firm Robinson, Bradshaw & Hinson. “This is almost as bad as you can imagine,” he adds. “If it's not Chernobyl, it's Japan.”

Only three other march-in requests have been made to the NIH since 1997. We review them here.

Stemmed try: In 1997, a small Washington State device manufacturer named CellPro called on the NIH to intervene after a federal court judge ruled that the company's device for sifting stem cells from blood or bone marrow infringed on intellectual property held by Baltimore's Johns Hopkins University and licensed to Baxter Healthcare of Deerfield, Illinois. The NIH, unconvinced that the device offered much clinical benefit over other technologies, declined the request.

No-go on Norvir: In 2004, the Washington, DC–based advocacy group Essential Inventions asked the NIH to rein in the cost of a widely used HIV medicine called Norvir (ritonavir). The drug's manufacturer—Abbott Laboratories of Chicago, which had developed the protease inhibitor with support from a five-year, $3.5 million NIH grant—had increased US retail prices of the medication by up to 400%. The NIH rejected the claim that the price hike made the drug unavailable to the public.

Blocked vision: In another 2004 petition, Essential Inventions also pleaded with the NIH to exercise march-in rights on Pfizer's Xalatan (latanoprost) glaucoma treatment, which was discovered at Columbia University in New York with a grant from the National Eye Institute. Essential Inventions claimed that Xalatan cost up to five times more in the US than abroad, but the NIH held that the use of “march-in was not an appropriate means for controlling prices.”