KEI Comments on NIH Exclusive License to Australian firm SubRed

On Monday April 26, 2021, Knowledge Ecology International submitted comments regarding the “Prospective Grant of an Exclusive Patent License: N-butyldeoxynojirimycin To Treat Smith-Lemli Opitz Syndrome (SLOS) and Diseases That Exhibit a Similar NPC-Like Cellular Phenotype” (86 FR 18545) by the National Institutes of Health (NIH) National Institute of Child Health and Human Development (NICHD). The technology is to be licensed to SubRed Pty Ltd, a firm located in Victoria, Australia.

In response to an inquiry by KEI regarding the license, the NIH tech transfer contact stated that the NIH was not in any concurrent negotiations to waive the domestic manufacturing requirement (35 USC 204) (in other words, the proposed licensee was not currently seeking such a waiver). Per the Bayh-Dole Act, one of the requirements of granting an exclusive license is that licensees “substantially” manufacture the invention in the United States. The NIH should factor this in while negotiating terms of any exclusive license to a foreign firm. Furthermore, as SubRed is not based in the US, it is crucial that the NIH ensure license terms that will protect US patients from paying higher prices than other high income countries, for any resultant treatment. Any medical technology using the patented invention should be available in the United States at a price that does not exceed the median price in the seven largest economies by GDP that have at least 50 percent of the GNI per capita as the United States, using the World Bank Atlas method.

The technology to be licensed is to “treat Smith-Lemli Opitz Syndrome (SLOS) and diseases that exhibit a similar NPC-like cellular phenotype.” SLOS is a rare hereditary disease, which makes clinical trials challenging (as noted by the NIH in response to KEI’s questions), but also highlights the need for the NIH to ensure license terms that provide for affordable access to any resultant treatment for this vulnerable patient population. The NIH must ensure patients are not held hostage by high prices.

A PDF of KEI’s full comments is available here: KEI-Comments-NIH-License-SubRed-26April2021


Claire Cassedy