The National Institute of Standards and Technology (NIST), a part of the US Department of Commerce, proposed a slate of detrimental changes to regulations in the Bayh-Dole Act governing “Rights to Federally Funded Inventions and Licensing of Government Owned Invention.” The public was given the opportunity to comment on the proposed changes, and by the close of the comment period on April 5, 2021 NIST had received over 81,000 comments on the issue. The proposed changes cover a variety of areas that impact policies concerning access to medicines and drug pricing, including patients’ rights to challenge the government’s grant of a taxpayer-funded invention to a company via exclusive license.

The Union for Affordable Cancer Treatment filed comments opposing several of the proposals, including:

  1. The proposal to modify 37 C.F.R. § 401.6 to exclude prices as a standalone ground for march-in requests; and
  2. The proposal to modify 37 C.F.R. § 404.11 to eliminate the standing of patients to challenge an exclusive license.

UACT’s comments also highlights notable statistics on government rights in patented inventions for cancer patients. For example, from 2010 to 2020 the USPTO issued 146,358 patents that included the word “cancer” in the patent. Of these patents, 20,717 declared either an assignment to the United States of America on the patent or declared in a separate field that the U.S. government had rights in the patent, pursuant to a funding agreement.

A PDF of UACT’s comments available here: UACT_Comments_NIST_5April2021

The full docket of comments received by NIST on this issue is available here: