KEI Comment to NIST on Bayh-Dole Rights and Cases of Mixed Patent Landscapes

KEI submitted comments to the National Institute of Standards and Technology (NIST) in response to the Request for Information regarding the “Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights” (88 FR 85593) concerning Bayh-Dole rights and the issue of products with mixed patent landscapes. KEI highlights in our comments that the draft guidance must address the common cases in which patent landscapes for a product have some Bayh-Dole rights but not on all patents.

KEI’s comments presents the following issues related to patent landscapes and the consideration of Bayh-Dole rights:

  • Failures to disclose
    • Non-standard disclosures on patent applications
    • Certificates of Correction
  • Non-disclosures
  • Non-standard rights
  • Complex patent landscapes
  • Biologic drugs, vaccine and cell and gene therapies
  • March-in rights can be used with other federal rights in patents
  • The federal government’s Section 202 and 209 royalty-free license
    • Pros and cons of zero royalty licenses
  • The federal government’s right to use any patented invention using 28 U.S.C. 1498
  • Using all three rights to address complex patent landscapes or to avoid injunction or stays
    • March-in case royalties are set by the funding agency rather than a court
    • The 1498 government use right when used with the Section 202/209 licenses
    • Using the march-in, Section 202/209 and 1498 licenses together
  • ANNEX: Daniel B. Ravicher’s April 29, 2004 Analysis of Patents Relevant to the Ritonavir March-in Petition

The full PDF of KEI’s comments and accompanying attachment are available below:

Note: NIST’s RFI follows a nearly year-long interagency review of the march-in guidance, which was announced in tandem with the NIH’s rejection of the Xtandi march-in petition in March 2023. KEI submitted a series of comments on several different important topics for NIST to consider as they finalize the guidance.