KEI Comments to the NIH on Exclusive License to Opsis Therapeutics for Retinal Cell Therapies

On October 18, 2019, Knowledge Ecology International (KEI) submitted comments to the Federal Register Notice for the “Prospective Grant of an Exclusive Patent License: Compositions, Devices and Processes for Production and Delivery of Cell Grafts of Manufactured Retinal Pigment Epithelium Cell(s) Alone, or in Combination With Photoreceptor Cells, and on a Biodegradable Support Scaffold Transplanted Subretinally for Intra-Ocular Ophthalmic Treatment of Conditions of Degeneration, Dysfunction or Terminal Injury of Retinal Pigment Epithelium and/or Photoreceptors in Humans” (84 FR 52889). The license is proposed to be granted on an exclusive, worldwide basis to Opsis Therapeutics, LLC and its affiliate FUJIFILM Cellular Dynamics, Inc, and includes six separate inventions developed by the National Institutes of Health (NIH) National Eye Institute (NEI).

The six inventions concern technologies that “relate to development of compositions, devices and processes for production and delivery of RPE-containing tissue graft therapies for treating a range of retinal function disorders, including retinal degenerative conditions in humans[,]” through the development, production and commercialization of allogeneic cell grafts.

KEI objects to the proposed license for the following reasons:

  1. KEI correspondence with the National Institutes of Health (NIH) concerning the prospective license indicates that the NIH has not faithfully applied the criteria in 35 U.S.C. § 209 and 37 C.F.R. § 404.7;
  2. The NIH has not been completely transparent about the license, impeding the public’s right to comment under 35 U.S.C. § 209(e); and
  3. The NIH apparently has not sought the antitrust advice of the U.S. Attorney General regarding the license, as required by 40 U.S.C. § 559.

A PDF of the full comments is available here: KEI_Comments_NIH_Exclusive_License_OpsisTherapeutics_18Oct2019