2005 Federal Laboratory Consortium Mid-Atlantic Regional Meeting Ethics Issues Terry Lynch Office of Technology Partnerships

Background  Academic institutions have/are undergoing a revolutionary change in focus with respect to local/state economic development and capturing in-house commercialization opportunities derived from education and research missions.  Throughout its 100-year history, NIST researchers have closely collaborated with academic colleagues on an “informal” basis.

Background Background (Continuation)  NIST also has a number of long-standing formal joint research with academic institutions JILA – University of Colorado/NIST (35 yr) Center for Advanced Research in Biotechnology (CARB) – University of Maryland/NIST – 15 yr Hollings Marine Lab. – NOAA/University of South Caroline/College of Charleston/NIST – 5 yr None of the agreements defining these arrangements address IP issues

Background Background (Continuation) The lines between NIST and non-NIST employees in the joint research institutes are frequently invisible to the researchers. The lines between NIST and non-NIST employees in the joint research institutes are frequently invisible to the researchers.  It is not uncommon for academic postdoc’s in the joint research institutes to become NIST employees.  Around 75% of NIST inventions have non-NIST co- inventors; most often without prior IP agreements

“Some ethics-related Issues in the current environment”  New hires - potential for “outside income” that can be enhanced by ones research as a government employee.  Fairness of access When does an academic colleague itself have commercial interests that may be in conflict with the of free and open research? When does the university partner itself have commercial interests that may be in conflict with the of free and open research?

Case Study  University postdoc in a joint NIST/academic research institute has worked interchangeably with NIST staff for a number of years.  Several joint patents have come out of the collaboration. NIST is the filing party. The University has Bayh-Dole rights. The University and NIST each retain their ownership.  The postdoc becomes a NIST employee and continues the ongoing research. Thus, the researcher has the potential to receive “outside income” if the invention is licensed/commercialized.  Due to heavy press coverage of the research; NIST OTP begins to receive inquiries in re the commercial potential of the technology and potential licensing.

Potential Ethic problems  Attempting to head off a potential problem, the Office of Technology Partnerships request a opinion from the DoC Ethics Office:  Is it OK for the researcher to remain the lead inventor for purposes of interacting with the patent attorney and PTO? Yes.  Is it OK for the researcher to continue research as a government employee? No.

Options   Terminate the researcher’s employment   Require that the researcher abandon the research that she/he was hired to do   Put NIST’s ownership of the invention in the public domain to try and preclude the “outside income” potential   Ask the researcher to give up the right to receive a share of royalties from the University   Ask the University to transfer responsibility for royalty sharing with the inventor to NIST in parallel with a transfer of commercialization rights to NIST in return for a share of any royalties.   Terminating employment and stopping the research were immediately eliminated as options (in the case at hand)

Options (Continuation)   Requesting the researcher to give up the right to a share of royalties did not turn out to be a viable option due to: The potential for the appearance of coercion. Possible tax consequences for the researcher. The intrinsic unfairness of the researcher not being able to receive a share of royalties while his/her NIST co-inventor colleagues were able to do so. The University would only go along with this if they retained the potential income being given up by the researcher.

Options (Continuation)   Put NIST’s ownership of the invention in the public domain to try and preclude the “outside income”.   A viable option (especially useful in negotiations with the University), but does not totally eliminate the potential problem, because the University could theoretically still license their ownership.

Options (Continuation)   Ask the University to transfer responsibility for royalty sharing with the inventor to NIST in parallel with a transfer of commercialization rights to NIST in return for a share of any royalties. Preferred option. Received OK from the Ethics office for this resolution. University TT office OK with it. Rejected by the University Counsel’s office   No legal authority to transfer the responsibility to share royalties   NIST’s problem, not the University’s

Current status  University TT office trying to find some way around the University Counsel’s objections  Due to the researcher’s continuing involvement in the research, NIST is running out of time to resolve the problem  NIST will reluctantly go the public domain route and abandon the patents if another viable alternative is not proposed in the very near future.

Contact Information For further information contact: For further information contact: J. Terry Lynch, CRADA & License Officer Office of Technology Partnership (OTP) National Institute of Standards & Technology 100 Bureau Drive, MS 2200 Bldg. 820 Room 209 Gaithersburg, MD Phone: (301) Fax: (301)