Bayh-Dole Compliance for Tech Transfer: Q&A Part One
With the recent regulation changes in Bayh-Dole compliance, quite a few questions have been brought to us by clients as we work with them to assure that they remain compliant with disclosures, both pre and post May 14, 2018. At the AUTM Compliance Course in October, I led a presentation, alongside NIH and other agencies that included NIST, NSF, DOE, USDA, NASA and the Army,about the implementation of the new Bayh-Dole reporting requirements. What quickly became apparent is that how these agencies want institutions to comply is far from uniform. In addition, not all agencies use Edison for reporting (NASA and some DOD sponsors do not). In those instances, it is necessary to read the contract to determine the compliance reporting contact and review the reporting requirements. This lack of agreement across agencies on implementation guidelines presents an ongoing challenge for institutions as they strive to stay current with reporting on all of their federally funded research.
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The next few articles on our Borman & Company Tech Transfer Compliance Central blog will address questions that our clients have brought to us in response to the new regulations.
1) If you report an invention after the 60-day deadline, can the Government take title?
Yes, the Government can come in at any time and take title if compliance is not completed. Most agencies require that you report invention disclosures within 60 days of receipt, or as soon as you become aware of federal funding thereafter. Regardless of when the disclosure is reported, it is critical to elect title upon the filing of the first U.S. filing (which is considered to be the provisional filing as of May 14, 2018). It is always better to report late than not at all.
2) What happens if you are late in submitting utilization reports?
While we are not aware of any instances in which the Government has asserted rights to an invention based on missing utilization reports, it is possible that they could do so in the future. Government agencies (and Congress) want to collect data on the licensing and commercialization activities for federally funded inventions. Just recently NIH has targeted some institutions with a large number of outstanding utilization notifications. The notification includes a deadline for remediating notifications within a short period of time, with a warning of loss of grant funding if compliance reporting is not completed.
3) If disclosure is rejected for lack of description, does that delay the 60-day reporting requirement?
Yes, if a disclosure is rejected for lack of description it will delay the 60-day reporting requirement. Often it takes time to gather the appropriate disclosure documents. If this is the case, it is best to elect title if you have filed, enter the patent filings, and complete all other compliance while you work on clearing the disclosure rejection. Keep in mind that if you have not filed a patent application and you need to waive the invention, it cannot be waived until the disclosure is accepted.
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To date, government agencies have refrained from asserting title to inventions as a result of non-compliance. However, in just the past two years we’ve seen a spike in interest by a variety of Non-Governmental Advocacy Groups (NGOs) in how institutions comply with the Bayh-Dole regulations. This increased scrutiny from outside of the research institution, in combination with the new regulatory changes, makes it even more important that tech transfer offices pay close attention to Bayh-Dole Compliance.
If there is still confusion around this group of questions or you have additional questions that I can help with, drop me a line at Borman & Company. We’ll be happy to respond to you directly and share the topic in an upcoming Q&A blog post.