The Bayh-Dole Act, enacted in 1980, gives NIH certain "march-in" rights to compel drug patent-holders to grant licenses to other manufacturers under certain circumstances. Recently, three Fabry disease patients have been petitioning NIH to exercise its Bayh-Dole march-in rights to demand that Genzyme allow other firms to make Fabrazyme — currently the only effective treatment for the disease — after contamination problems interrupted production at Genzyme's only manufacturing facility in 2009, which caused a shortage of the drug. But NIH has refused the patients' latest petition, according to the Genomics Law Report's John Conley, despite the fact that they face severe rationing, and that new patients can't obtain any Fabrazyme at all. NIH says that granting licenses to other manufacturers alone won't adequately address the problem, because no competitor would be able to get a drug to market before Genzyme's manufacturing problems are projected to be solved (which is sometime in 2011). On the surface, Conley says, NIH's reasoning make sense. But questions at to whether the agency is sending a message to rights-holders that they can do whatever they want, regardless of their duty to provide products that improve human health. Conley also makes the Myriad connection — if Judge Robert Sweet's decision is reversed on appeal and Myriad regains its gene patents, the firm will likely continue to refuse to license them. "In that scenario, the current concerns about the cost of Myriad's tests and patients' inability to get second opinions would continue, and the issue would be even more politicized than it is now," he says. With Myriad's case still unresolved, Conley suggests it's unlikely NIH will be marching in on anything anytime soon.
NIH 'Refuses to March'
Jan 19, 2011