2012: NIH case: exclusive rights in regulatory test data are absolute, even where there are drug shortages
In August 2, 2010, the National Institutes of Health (NIH) was asked to grant an open license to permit manufacture of Fabrazyme, a drug used to treat Fabry disease (more on the march-in case here: https://www.keionline.org/fabrazyme). On December 1, 2010, Francis S. Collins, Director of the NIH issued a determination in the case, rejecting the petition for the NIH to exercise its march-in rights, citing as support for the denial that granting march-in rights would not overcome other barriers, including the exclusive rights in test data.