Yale University Patent Policy Acknowledgement & Agreement (PPAA) Brown Bag Series – July 29, 2009 Kim Mickey Research Compliance Officer Office of Research Administration Phone: Allison Goldsnider Intellectual Property Associate Office of Cooperative Research Phone: Fax: Tina Muzzy Intellectual Property Compliance Associate Office of Cooperative Research Phone: Fax:

2 Yale University’s Patent Policy The entire Patent Policy can be found at: 1.Encouragement of Patents. In the course of teaching, research, and other intellectual and administrative activity by faculty, staff, fellows, students, and other individuals in the University community, discoveries or inventions both patentable and practical occur. Encouragement of such inventions in appropriate ways is both supportive of the public interest and consistent with the advancement of knowledge for its own sake, the primary purpose of teaching and research in a university 2. Purpose of Patent Policy. The purposes of this University Patent Policy are (1) to help assure, in the public interest, that the patentability (or other means of exploitation) and practicality of inventions will be evaluated by qualified persons, and that the income from inventions will be used to support further research or other desirable University activities; and (2) to define remuneration to the inventor or inventors (hereinafter the "Inventor") and the University as long as the invention is productive of royalties

3 Yale University's Patent Policy 9. Governmental Rights in Certain Inventions. Current governmental regulations permit educational institutions to retain rights and title to patentable inventions which results from federally funded experimental, developmental and research work. Retention of rights by University is contingent upon the fulfilling of a number of obligations on the part of the University and of the Inventor(s) and these obligations must be discharged in order to protect the interests of all parties. Though the University may retain rights and title to such patentable inventions, the federal government retains a royalty free license and places certain other restrictions upon the ultimate disposition of the patents(s)…….Incumbent upon members of the University community who apply for and receive federal funding to support research or who use federal monies in the conduct of their research is the requirement for written agreement that they will promptly disclose patentable inventions to the University and will execute all instruments necessary to protect the rights of the government and/or the University.

4 Bayh-Dole Act 1980

5 The Bayh-Dole Act is the United States legislation way of dealing with intellectual property arising from federal government-funded research Among other things, it gave US universities, small businesses and non- profits intellectual property control of their inventions and other intellectual property that resulted from such funding The most important change of Bayh-Dole is that it reversed the presumption of title. Bayh-Dole permits a university, small business, or non-profit institution to elect to pursue ownership of an invention in preference to the government The government retains a non-exclusive license to practice the invention throughout the world The government retains rights

6 How does Bayh-Dole relate to Yale? Yale University is a non profit organization Yale University heavily relies on United States government funding for its ongoing research Yale University & the United States Government retain rights of the invention Yale University is required to report all government funded inventions to the government within 60 days of disclosure to Yale

7 What does the Patent Policy Acknowledgment & Agreement (PPAA) state? I understand that Yale University has a Patent Policy that applies to inventions made under University auspices. I also understand that Yale's funding agreements with third parties, including the United States Government, impose certain obligations with respect to rights in inventions. In order to facilitate compliance with the terms of those agreements and applicable Federal regulations, I agree as follows: – I will abide by the Yale University Patent Policy, including any amendments to it adopted from time to time, and I will execute any assignments or other documents necessary to comply with its terms. – If in the course of research conducted under University auspices, as defined by the Patent Policy, I make any invention (whether or not patentable), I will provide to the Yale Office of Cooperative Research a written disclosure of the invention and I will cooperate with that Office in the preparation of any patent applications. – I do not have any consulting or other agreement with any third person or organization which grants rights that are in conflict with this agreement, nor will I knowingly enter into any such agreement.

8 Who has to sign the PPAA? According to Yale University’s Patent Policy, “In the course of teaching, research, and other intellectual and administrative activity by faculty, staff, fellows, students, and other individuals in the University community, discoveries or inventions both patentable and practical occur….” = entire Yale community

9 ORA’s Assessment of the PPAA Objective: Determine if the Patent Policy Acknowledgement & Agreement (PPAA) form was being signed in accordance with Yale Policy and federal regulations

10 Applicable Requirements Yale University Patent Policy – 1.Encouragement of Patents. In the course of teaching, research, and other intellectual and administrative activity by faculty, staff, fellows, students, and other individuals in the University community, discoveries or inventions both patentable and practical occur... – 9. Governmental Rights in Certain Inventions …Incumbent upon members of the University community who apply for and receive federal funding to support research or who use federal monies in the conduct of their research is the requirement for written agreement that they will promptly disclose patentable inventions to the University and will execute all instruments necessary to protect the rights of the government and/or the University. Federal regulations (37 CFR Part 401): The contractor agrees to require, by written agreement, its employees, other than clerical and nontechnical employees to disclose promptly in writing to personnel identified as responsible for the administration of patent matters and in a format suggested by the contractor NIH Grants Policy Statement (NIHGPS): The PI (employee) must sign an agreement to abide by the terms of the Bayh-Dole Act and the NIHGPS as they relate to intellectual property rights.

11 Applicable Requirements Faculty Handbook In conjunction with any application for external funding support, a faculty member must submit a written agreement confirming his or her acceptance of the University Patent and Copyright Policies Proposal Summary and Certification form (Section X) signed by PI: In accordance with Yale University’s Patent Policy, all personnel on this project including postdocs, students and visiting scientists will have signed the University’s Patent Acknowledgment and Agreement prior to initiation of this project

12 SECTION X - CERTIFICATIONS Principal Investigator/Co-Principal Investigator: We certify that the information contained on this Proposal Summary & Certification Form is true, accurate and complete as of this date. Any false, fictitious or fraudulent statements or claims may subject PI and/or Co-PI to criminal, civil, or administrative penalties. We accept responsibility for the scientific and administrative conduct of the project and will provide the required progress reports if a sponsored agreement is awarded as a result of the application. We have completed all required Yale University faculty training, including Sponsored Projects Financial Administration for Faculty ( * Conflict of Interest (COI): By signing below, I/we have determined that all individuals responsible for the design, conduct or reporting of this research (listed in Section VII) have read and understand Yale's policy on Conflict of Interest and Conflict of Commitment, have made all required disclosures, and have disclosed any changes necessitated by this proposal. I/we further agree to comply with any conditions or restrictions imposed by Yale to manage, reduce or eliminate conflicts of interest. * Intellectual Property: In accordance with Yale University’s Patent Policy, all personnel on this project including postdocs, students and visiting scientists, will have signed the University’s Patent Acknowledgement Agreement prior to initiation of this project. *Debarment: by signing below the Principal Investigator/Co-Principal Investigator certify that neither the PI nor anyone proposed to work on this project are, to the best of my/our knowledge, excluded from participation in the federally funded activities as a result of government-wide suspension or debarment. * Health and Safety: I/we are aware of the potential environmental health and safety issues and hazards identified in this proposal, will share this information with staff and students, and will obtain applicable training, authorizations and equipment necessary to perform this work safely. * Export Controls: I/we have read and understand Yale’s Guidelines on Export Controls and I/we will work with the GCA to ensure this project complies with the United States export control laws and regulations.

13 Data Review/Analysis Identified all active federal awards 1,845 active federal awards 65 were selected as the sample Reviewed each award to determine if the Proposal Summary and Certification form (Pro-Sum) was signed by the PI

14 Data Review/Analysis 112 individuals were selected for review. Visited OCR staff to determine if PPAA’s were on file. Interviewed 10 departments to identify departmental process for collection and maintenance of PPAAs.

15 Summary of Findings 1,366 PIs with active awards Data review identified that the Pro-Sum certification was signed by the PI verifying that the PPAA was signed, however less than half of the PPAAs were found on file in OCR.

16 Summary of Findings Not all business offices are fully aware of the University’s Patent Policy or federal requirements relating to PPAAs and do not have a process for the collection or maintenance of the signed documents.

17 Streamlining the PPAA process Starting in July 2009: – Using TMS to assign PPAA requirement to Yale community – Rollout to be done in two phases – One time only requirement

18 Streamlining the PPAA process Phase I: All individuals (excluding clerical and non- technical) paid from a federally funded sponsored award (including federally funded subawards) will be rolled out in July/early August Phase II: All other members of the Yale community will be required to agree to the PPAA at time of their annual TMS assessment. Providing Phase I is completed effectively Phase II should start in September.

19 Streamlining the PPAA process Goal: All new hires will be required to complete the PPAA requirement via TMS along with any other required training based on employment. YALE UNIVERSITY REMAINS COMPLIANT!

20