Three people affected by shortages in Genzyme's drug for Fabry disease failed to convince the National Institutes of Health (NIH) to use 'march-in rights' to break manufacturing patents held by the Cambridge, Massachusetts–based biotech and grant a new license to third parties to deal with the problem. The enzyme replacement therapy Fabrazyme (agalsidase β; rh α-galactosidase A) is the only treatment available for individuals with this disorder, and ongoing manufacturing problems at Genzyme's plants (Nat. Biotechnol. 27, 681, 2009) have curtailed supplies for over a year. March-in right is granted to the government under the Bayh-Dole Act to issue a new license or revoke an existing patent in cases where a federally funded invention has not been adequately developed. Two of the drug's patents, owned by Mt. Sinai Hospital School of Medicine in New York, are based on inventions funded by NIH and exclusively licensed to Genzyme. But in December, NIH declined to hold a hearing on the issue, stating that a march-in proceeding would not increase the supply of Fabrazyme in the short term. Given that Genzyme expects to return patients to normal dosing during the first half of 2011, the real interest of the petitioners may lie more in inducing the biotech to lower the price of Fabrazyme, which costs hundreds of thousands of dollars per patient per year. That strategy succeeded for Knowledge Ecology International (KEI), a nongovernmental organization dealing with intellectual property issues related to public health, based in Washington, DC. KEI obtained a march-in hearing on the antiviral drug ritanovir in 2004. Although they lost the case, “Abbott Labs did make concessions,” says KEI director James Love, who assisted the Fabrazyme plaintiffs. “But these Fabry's patients will never have their day in court and won't be able to push Genzyme.” The plaintiffs are appealing the decision. Opening up the Mt. Sinai patent license could spur development of a biosimilar, which would put price pressure on Fabrazyme. But in the 30 years since Bayh-Dole was enacted, NIH has never asserted march-in rights. “It's often perceived that one of the missions of the NIH is to keep the biotech community as happy as possible, so innovation continues,” says Love. But when taxpayers put up the money for research, not industry, “patent law protection is not relevant,” he contends.