The National Institutes of Health has denied four petitions to exercise its “march-in” rights under the Bayh-Dole Act. I wrote a number of stories on the fourth, the Fabrazyme petition. On Oct. 25, 2012, a fifth was filed.  

The Bayh-Dole Act provides nonprofit institutions and small businesses with the opportunity to acquire patent rights to certain inventions arising out of government-sponsored research and development in order to encourage the commercialization of new technologies through cooperative ventures. It also allows any responsible individual to request “march-in rights” that empower the federal agency funding the research to “march in” and issue patent licenses on its own when the holder of a patent that resulted from the research is not “reasonably” satisfying U.S. health or safety needs.  

The Fabrazyme petition was prompted by the disruption due to manufacturing problems of the supply of the only Food and Drug Administration approved drug for Fabry patients.  

I remember the attorney who filed the petition, C. Allen Black, reacting with amazement to NIH’s explanation for denying the petition, that an alternative drug would require FDA approval, which would take too long. “Aren’t FDA and NIH both part of the Department of Health and Human Services?,” he asked me. “Can’t they work together on this?”  

The fifth petition is for the AIDS drug Norvir, complaining about its high costs, which was the same drug and complaint cited in the second “march-in” petition in 2004 and which NIH denied.  

NIH’s response is due at in 60 days, on Dec. 25.