KEI Comments Regarding the NIST Special Publication 1234 Draft Green Paper on Return on Public Investment

KEI filed comments on the NIST Draft Green paper on the return from investment on federally funded R&D (See: https://www.keionline.org/29518). We expect the comment period to be extended, but filed this on January 9, 2018, as an initial submission.

KEI-comments-NIST-SP-1234-ROI-9Jan2018

This is the table of contents for our submission.

  • Introduction: 1
  • Government Use License (Royalty-Free Right in Inventions): 3
    • Intended Action 1.: 4
    • Consequence of Intended Action 1: 5

  • March-in Rights: 6
    • Intended Action 2.: 6
    • Consequence of Intended Action 2: 7

  • Commentary: 8
    • What is a “Compelling National Issue”?: 8
    • The Policy and Objective of the Bayh-Dole Act as Described in the Statute: 8
    • The Bayh-Dole Act Statutory Standards for March-in Rights: 9
    • Available to the Public on Reasonable Terms: 10
    • The Culture of Private Benefit from Public Funded Research: 11

  • Increasing Interest in the Use of Royalty-free or March-in Rights in Federally-funded Biomedical Inventions: 11
    • Table 1: Examples of march-in and royalty-free cases: 12
    • Two potential march-in or royalty-free rights cases: 14
    • CRISPR and CAR T: 14
    • Relationship Between Royalty-free and March-in rights and 35 USC § 1498.: 15

  • The Views of Senators Birch Bayh and Robert Dole: 16
    • Bayh’s Views Shifted with Client’s Interests: 17
    • Dole was a Spokesperson for Viagra, Employed by Pfizer and Representing other Corporate Clients: 19