To: Selected Deans, Directors, and Department ChairpersonsCOLUMBIA UNIVERSITY INTERDEPARTMENTAL MEMORANDUM OFFICE OF PROJECTS AND GRANTS 351 ENGINEERING TERRACE December 22, l995 OPG:9612
Some members of Congress and certain federal agencies have noted the rapid growth of the university-based technology activities and fear that the volume and complexity of those activities may lead to a lapse in compliance and abuse of delegated authority. To guard against the latter, the National Institutes of Health (NIH) issued a document last November entitled "Developing Sponsored Research Agreements: Considerations for Recipients of NIH Grants and Contracts." It is designed to help clarify the rights and responsibilities of all parties. To test university compliance, especially the school's adherence to reporting requirements for NIH funded inventions, NIH has decided to launch a limited set of site visits to commence later in the fall.
NIH expects the university community to be cognizant of all reporting obligations. In the site visits, NIH will certainly look at a number of compliance issues. Among the issues of concern to NIH are: acknowledgment of federal support; utilization of license revenue; and providing the confirmatory license to the federal funding agency, once the university has elected title. NIH is particularly interested in "employee agreements." At issue is the federal requirement that each university must make sure that is employees disclose to the university all inventions made with federal funding and sign all papers necessary to file patent applications on those inventions. The university is responsible for subsequently disclosing those inventions to the government. While the requirement for "written agreements" is clearly stated in the rules, 401. l 4.(f)(2), the method of obtaining them and enforcement measures are not prescribed. It is important, however, that the university's approach to these requirements be clear, and consistently followed.
This federal invention reporting issue has gained visibility because a Congressional oversight committee has called upon NIH to demonstrate that NIH is protecting the government's interest in these inventions. The government has certain rights to federally funded university inventions, whether or not the university elects title and proceeds with patenting and licensing the invention. NIH seems to believe that employee agreements obligating prompt disclosure of inventions and providing the government with a confirmatory license to federally assisted patents are key elements in protecting those government rights.
The only agency immediately concerned here is NIH, but all federal science agencies are subject to the same Department of Commerce rules on rights to inventions and it is thought they will all be checking for university compliance with these rules in the near future.
Checklist of Major Institutional Responsibilities for compliance with the Bayh-Dole Act.
based on government-wide rules - 52 FR 85523:
Employee Agreements - 401.14(f)(2)
Invention Disclosure - 401.14(c)(1)
Election of Title - 401.14(c)(2)
Filing of Patent Application - 401.14(c)(3)
Utilization Report - 401.14(h)
Non-Election of Title - 401.14(d)(1)
Foreign Filings - 401.14(c)(3)
Flowdown of Requirements - 401.14(g)
Acknowledgment of Government Support - 401.14(f)(4)
Preference for U.S. Industry and Small Business - 401.14(i)
March-In Rights - 401.14(j)
Special University Provisions - 401.14(k)
Decision to Discontinue Patent Prosecution - 401.14(f)(3)
Utilization of License Revenue - 401.14(k)(3)
Columbia recently initiated employee agreements on the assignment of inventions to Columbia to accord with this act. You are reminded that these were to be signed and forwarded to your department or other unit, in order to be able to submit proposals after November 1, 1995.
James P. Lewis
Executive Director for
Research Administration
cc: Science and Technology Policy Committee Members