KEI Comments to the NIH on Exclusive License of AAV Technology to Children’s Medical Research Institute in Australia

Knowledge Ecology International (KEI) submitted comments on Wednesday July 14, 2021 to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: Adeno-Associated Virus Polynucleotides, Polypeptides and Virions” (86 FR 34246). The rights to technology are currently co-owned by the US government, Sydney Children’s Hospital Network, and the Children’s Medical Research Institute (CMRI). This exclusive license is intended to consolidate the rights with CMRI, with the express intention of expediting development, commercialization, and marketing. The exclusive license to CMRI will be sublicensable.

The technology to be licensed concerns “a “fossilized” AAV-derived endogenous viral element (referred to as mAAV-EVE) within the germline of an ancient lineage of Australian marsupials” and “may provide the basis for recombinant AAV vectors with unique biological properties.”

As noted in the Federal Register, CMRI is based in Westmead NSW, Australia. 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 refused to tell KEI if there were talks with CMRI about a waiver of the U.S. manufacturing requirement.

CMRI is not based in the US and intends to sublicense the technology. The NIH should include license terms that protect US patients from paying higher prices than other high income countries. In our comments, KEI suggests a provision in the license that requires that any medical technology using the patented invention 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.

A PDF of KEI’s full comments is available here: KEI-Comments-NIH-License-CMRI-Australia-14July2021