KEI and UACT Comments to NIH on License in AAV Vectors to Generation Bio and Spark Therapeutics

On Friday October 11, 2019, Knowledge Ecology International and the Union for Affordable Cancer Treatment (UACT) submitted comments to the Federal Register notice (84 FR 51171) for the “Prospective Grant of Exclusive Patent License: Capsid-Free AAV Vectors, Compositions, and Methods for Vector Production and Gene Delivery.” The FR notice outlined the National Institutes of Health (NIH), National Heart, Lung and Blood Institute’s (NHLBI) intent to award an exclusive patent license to Generation Bio Co. (based in Cambridge, MA), and a co-exclusive license to Generation Bio and Spark Therapeutics (based in Philadelphia, PA). The licenses were to the same invention, but in different fields of use.

Generation Bio was founded by Robert Kotin, who was one of the NIH inventors of the technology to be licensed. From representations on its website, it appears that Generation Bio has been presenting this technology as an asset that the company already owns.

Spark Therapeutics is the company that developed Luxturna, a gene therapy that treats a type of blindness, for a price of $425,000 per eye.

The exclusive field to be granted to Generation Bio was described as, “Electroporation-mediated delivery of DNA-based vectors to express therapeutic molecules for the treatment or prevention of human diseases,” while the co-exclusive field of use to be granted to both Generation Bio and Spark Therapeutics was described as, ” The treatment or prevention of cancer by administration of DNA-based vectors (with the exception of electroporation mediation) to express therapeutic molecules.”

KEI and UACT’s comments note several grounds for objecting to the licenses including:

  1. Concerns about the timing of the license and selection of Generation Bio as licensee;
  2. KEI’s correspondence with the NIH concerning the prospective licenses indicates that the NIH has not faithfully applied the criteria in 35 U.S.C. § 209 and 37 C.F.R. § 404, and, in particular, that it has not properly considered the reasonableness and necessity of granting an exclusive license in a platform technology for expansive fields of use;
  3. The NIH has withheld information about the license on the basis of inapplicable confidentiality provisions; and
  4. 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 KEI and UACT’s full comments is available here: KEI_UACT_Comments_NIH_ License_Capsid_Free_AAV_Vectors_11Oct2019