KEI Comments on NIH Exclusive License to Panacea for Gene Therapy

On Friday July 9, 2021, Knowledge Ecology International submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Delivery of a Corrective Glucose-6-Phosphatase-Alpha Gene to Treat Glycogen Storage Disease Type 1a (GSD-Ia) in Humans” (86 FR 33321) to Panacea Opportunity, Ltd. The technology to be licensed concerns the delivery of a corrective gene in order to treat glycogen storage disease type 1a (GSD-Ia). GSD-Ia is a rare inherited disorder that occurs in approximately 1 in 100,000 births.

Considering the rarity of the indication, the resultant treatment will qualify for seven years of orphan exclusivity, as well as another twelve years for exclusive rights in the registration test data. Further, because GSD-Ia affects infants, Panacea will also qualify for a rare pediatric disease priority review voucher, a transferable asset that has recently been sold for $100 million. An exclusive license by the NIH must only provide the incentives reasonably necessary to bring a technology to market, according to 35 U.S.C. § 209. These valuable incentives for which the treatment would qualify must be considered when negotiating the license, and the terms should reflect this with reduced scope of duration, geographic applicability, or other terms.

KEI also notes that the firm to receive the exclusive license has no apparent website, and appears to be related to Panacea Opportunity Fund I, L.P., whose principal, James Zuie-chin Huang, is affiliated with a large number of firms and investment funds, including Ziopharm Oncology, Inc., a company the NIH sought to provide an exclusive license in January 2021.

A PDF of KEI’s full comments is available here: KEI-Comments-Exclusive-NIH-License-Panacea-9July2021