Bayh-Dole Act confidentiality provisions timeline

For a general timeline of the Bayh-Dole Act, see this page.

Bayh-Dole Act Section 202 legislative timeline

1980. December 12. Section 202(c)(5) was enacted by Public Law 96-517, 94 Stat. 3021. As reflected by the use of the term “may”, this section gave Federal agency discretion to treat as confidential the periodic reporting submitted by contractors or their licensees.

202(c)(5)

The right of the Federal agency to require periodic reporting on the utilization or efforts at obtaining utilization that are being made by the contractor or his licensees or assignees: Provided, That any such information may be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code.

1984. November 8. Section 202(c)(5) was amended by Public Law 98-620, 98 Stat. 3366. The term “may” was struck and replaced with the term “shall”, making confidentiality mandatory.

202(c)(5)

The right of the Federal agency to require periodic reporting on the utilization or efforts at obtaining utilization that are being made by the contractor or his licensees or assignees: Provided, That any such information may as well as any information on utilization or efforts at obtaining utilization obtained as part of a proceeding under section 203 of this chapter shall be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code.

The only additional change regarding F202(c)(5) were minor editorial changes, in 2002.

Bayh-Dole Act Section 209 legislative timeline

1980. December 12. Section 209 was enacted by Public Law 96-517, 94 Stat. 3024 and 94 Stat. 3025. As reflected by the use of the term “may”, this section gave Federal agency discretion to treat as confidential the periodic reporting submitted by licensees.

209(a)

(a) No Federal agency shall grant any license under a patent or patent application on a federally owned invention unless the person requesting the license has supplied the agency with a plan for development and/or marketing of the invention, except that any such plan may be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code.

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209(f)(1)

(1) periodic reporting on the utilization or efforts at obtaining utilization that are being made by the licensee with particular reference to the plan submitted: Provided, That any such information may be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code;

1999. September 22. the Public Citizen Health Research group filed five FOIA requests seeking information related to NIH licenses.

2000. June 22. Public Citizen Health Research group filed a FOIA seeking “records concerning the percentage of sales that NIH received as royalties from a) intramural research and b) inventions arising out of CRADAs.

2000. July 31. Public Citizen files lawsuit against the NIH pursuant to 5 USC Section 552(a)4)(B) to compel the Defendant to release information relating to its September 29, 1999 and June 22, 2000, FOIA requests. Pharmaceutical company Johnson & Johnson joined the litigation as an Intervenor-Defendant.

2000. October 26. Maria Freire, representing the NIH, formally denies the Public Citizen Health Research group FOIA requests filed on September 29, 1999 and June 22, 2000, under FOIA exemptions 4 and 5.

2000. November 1. Section 209 was amended by Public Law 106-404, 114 Stat. 1744. The term “may” was struck and replaced with the term “shall”, making confidentiality mandatory.

209(a)(f)

(a)(f) No Federal agency shall grant any license under a patent or patent application on a federally owned invention unless the person requesting the license has supplied the agency with a plan for development and/or marketing of the invention, except that any such plan may shall be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code

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209(f)(1)(d)(2)

(d) (2) requiring periodic reporting on the utilization or efforts at obtaining utilization of the invention, and utilization efforts, that are being made by the licensee with particular reference to the plan submitted: Provided, but only to the extent necessary to enable the Federal agency to determine whether the terms of the license are being complied with, except T that any such information report may shall be treated by the Federal agency as commercial and financial information obtained from a person and privileged and confidential and not subject to disclosure under section 552 of title 5 of the United States Code;

2002. March 12. Public Citizen v. NIH et al. was decided in favor of the NIH. A copy of the 30 page decision by District Court Judge Colleen Kollar-Kotelly is available here.

(There have since been additional minor edits to the text of 209 for style, but these are the changes that were relevant to transparency).