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Genzyme, U.S. Department of Health and Human Services metabolic news

August 9, 2010 7:00 AM UTC

Three Fabry's disease patients petitioned HHS to exercise march-in powers under the federal Bayh-Dole Act for an open license to patents covering Genzyme's Fabrazyme agalsidase beta. The Bayh-Dole Act allows the government to make federally-funded inventions available to the public under certain circumstances, including when "action is necessary to alleviate health or safety needs which are not reasonably satisfied by the contractor, assignee, or their licensees." The petitioners argue that as Fabrazyme was discovered using grant funding from the National Institutes of Health and that Genzyme's manufacturing issues have caused a shortage leading to rationing of the drug, that HHS has the authority to grant an open license under Bayh-Dole. The petitioners call for a 5% royalty to Genzyme on the sales of any agalsidase beta products made under the open license. ...