On Tuesday April 28, 2020, KEI submitted comments to the National Institutes of Health (NIH) regarding the “Prospective Grant of an Exclusive Patent License: AAV Mediated Exendin-4 Gene Transfer to Salivary Glands To Protect Subjects From Diabetes or Obesity” (85 FR 20508) to Kriya Therapeutics, Inc.
Little is known publicly about Kriya Therapeutics, a startup with offices in Palo Alto California and Durham North Carolina. Shankar Ramaswamy,the CEO and a Co-Founder, has worked for the company seven months. Fraser Wright, the Scientific Co-Founder, is a professor at Stanford, was a co-founder of Spark Therapeutics where he worked on Luxturna, and previously worked at the Children’s Hospital of Philadelphia.
The technology to be licensed on an exclusive basis concerns a gene therapy,involving the use of an adeno-associated viral vector to deliver exendin-4 to the salivary gland as a treatment for diabetes and obesity.
The invention was successful in preclinical studies and if it were to come to market, could help regulate blood sugar in patients with diabetes and promote weight loss in individuals suffering from obesity, conditions affecting large numbers of people worldwide.
KEI’s comments began by focusing on the analysis required by the Bayh-Dole Act to justify the grant of exclusive rights in a license, and if exclusive rights are granted, the scope, such as the geographic area for exclusivity, and the terrm of the exclusivity. In recent years, the NIH has favored worldwide exclusivity, term of patent exclusivity, and no specific restrictions on pricing. KEI addressed these and other issues, such as transparency. In the event that the NIH does grant an exclusive license, KEI requested seven specific public interest safeguards.
The full comments are available here: KEI NIH Comments License Kriya Therapeutics 28April2020
(For more KEI comments on NIH licenses, see: https://www.keionline.org/nih-licenses)