Compliance Requirements under the Bayh-Dole Act

Overview

Compliance with the Bayh-Dole Act is crucial for maintaining the integrity of the research process and maximizing the benefits of federally funded inventions. This section outlines the necessary steps for both the University of Pennsylvania and its inventors to ensure adherence to the Act’s requirements.

Key Compliance Areas

1. Participation Agreement

1. Assignment of Rights: Penn researchers are required to assign their rights to Penn prior to receiving any award.  This is accomplished through the Participation Agreement, which must be signed by all Penn researchers, as well as other employees.  This agreement ensures that the university holds the necessary rights to manage and commercialize the invention in compliance with the Bayh-Dole Act.  Ensuring that all Penn researchers have signed the Participation Agreement before any award is granted is essential for maintaining compliance and protecting the interests of both the researchers and the university.
2. Disclosure of Inventions
   • Timely Reporting: Inventors must disclose any new invention to the University’s Penn Center for Innovation (PCI) promptly.
   • Detailed Documentation: When submitting a disclosure to PCI, you must include a comprehensive written description of the invention, comprising approximately two typed pages, double-spaced.  Additionally, the disclosure document should be fully signed.  This thorough documentation is crucial for PCI to evaluate the invention’s commercial potential and meet the requirement to notify the federal government within 60 days of disclosure. If the disclosure is not properly completed it could be rejected by the federal government, which may put it at risk of not being reported within the required timeframe.
3. Evaluation and Protection of Intellectual Property
   • University Assessment: PCI will work with you to assess the commercial potential of the invention and decide whether to retain rights and pursue patent protection or license as unpatented biological material.
   • Patenting Decisions: If the university elects to retain title, it must file a patent application within one year of election or before any public disclosure, whichever is sooner.

4. Licensing and Commercialization
   • Licensing Strategies: PCI is responsible for finding suitable commercial partners and negotiating licensing agreements that are in line with university policies and federal regulations.
5. Revenue Distribution
   • Revenue Sharing: The Penn Patent Policy contains detailed provisions for distributing revenues received from licensed inventions, including providing a share to the inventors. .
6. Reporting to Federal Agencies
   • Compliance Obligations: The University is responsible for submitting reports to the funding agencies detailing the inventions made, patents filed, and licenses granted.
7. Utilization Reports: The University is responsible for reporting information on how licensed inventions are being brought to practical use by licensees. 

Compliance Checklist

• Before the grant is issued: Ensure that all personnel have signed a Participation Agreement.  Note that if personnel change during the course of a grant, the PI is responsible for ensuring that new researchers or technical personnel have signed a Participation Agreement.
• Immediately upon invention: Document the invention process and note all funding sources.
• Promptly disclose the discovery of a new invention: Disclose the invention to PCI.
• Upon deciding to retain title: PCI must file a provisional or non-provisional patent application within statutory deadlines or indicate the invention is an unpatented biological material.
• During licensing negotiations: PCI will ensure agreements align with federal and university policies.
• Annually: PCI is required to prepare and submit compliance and utilization reports to federal agencies.

Conclusion

Compliance with the Bayh-Dole Act is not only a legal requirement but also a crucial component of the University of Pennsylvania’s commitment to fostering innovation and bringing research discoveries to market. By adhering to these guidelines, the university and its inventors can ensure that federally funded inventions achieve their maximum potential and societal benefit.