Geoffrey Grant, Ph.D. University of No. Texas Health Science Center –Ft.Worth

1. Geoffrey Grant, Ph.D. University of No. Texas Health Science Center –Ft.Worth

2. The Bayh-Dole Act 1980 and its adjunct legislation. • provides a vehicle for university research • To earn revenues • To attain a degree of accountability • financially • In practical productivity • In economic contribution to the community

3. Technology Transfer & Licensing Royalties Benchmark payments Sponsored Research Funding Equity Holdings Revenues originate from Intellectual Property Chiefly Patents

4. The availability of CASH & the potential for personal and institutional financial gain • Creates potential problems • Conflicts of Interest • Scientific Misconduct • Legal disputes over invention ownership • Legal disputes over infringement • Administration problems • distribution to inventors • Revenues spent to support research • Administrative accountability

5. CASH • How much are we talking about?

6. U.S. University Income ($millions) (AUTM Licensing Survey Data) 144 universities reporting

7. U.S. University Income ($millions) (AUTM Licensing Survey Data) <--------Projected -----------> <----------Actual --------------> Year

8. Invention process • Derived from research in the university or institution • Invention data is recorded in notebooks or on the computer • Disclosed to the institution then a patent filed.

9. Proper documentation determines authenticated inventorship. Kenneth J. Roozen, Ph.D., Executive Director. Medical University South Carolina. Foundation for Research Development “No university patent that I have seen to date could withstand serious interference or infringement litigation, due to the undisciplined quality of data recording, note keeping and witnessing at the laboratory level”

10. Proper documentation eliminates risk. Notebooks are the empirical product of ~ $25 Billion/year of research expenditures chiefly government funding

11. Claiming an invention-claiming ownership of an invention • United States Patent & Trademark Office [USPTO] issues patents • On a “first to develop” or “first to invent” • In all other countries its a a “first to file ” system.

12. Interference litigation • USPTO determines inventorship • when two or more inventors are claiming the same invention. • The inventor determines institutional ownership. • Interference to determine the ‘real inventor’ must be filed within a year after patent is issued • Approximately 2% of applications involve an interference claim. • Lawyers dream with 240,000 patent applications/year. In U.S. by 2005 this projects to about $250 million in university revenues at risk.

13. Legal Declaration of Inventorship • The inventor “swears behind” his discovery • With documentation • Interference litigation • USPTO decides who invented • 5000 cases.year @ ~$10-50,000+/cases • Review of Notebook data and records

14. Notebook Evidence The PTO is looking for documented evidence of three things: • Date of conception • Of every feature claimed in the patent application • Date of actual reduction to practice • Prototype or Utility model • Date of constructive reduction to practice • Patent Filing

15. Intellectual Property • Traditional Laboratory Notebooks • manual time and date stamping • signing & • witnessing • Computer Data Storage • electronic signatures.

16. Problems with Manual Notebooks • May be incomplete, on loose-leaf paper, have gaps and empty pages, non-permanent attachments • Records may be lost or destroyed • Must disclose the invention to an outsider/witness and have them sign documents • Witness may be unreliable or unavailable later. • Patent prosecution [disclosure, filing, examination and issuance can take 3-4 years] • Interference litigation only starts during the next year. • Other litigation starts later.

17. Problems with Notebooks Post-It Notes , Data attached with paper clips Underneath a blank page

18. Problems with Notebooks No Witness Signature Materials and Methods attached with paper clips

19. Problems with Notebooks No Witness Signature Post-It Notes on Blank Page, Data film attached with paper clips

20. Problems with Notebooks No Witness Signature Notes on Blank Page lots of Space open

21. Proper documentation determines authenticated inventorship. • Dr. Ling Chwang. Intellectual Property Attorney • Jackson Walker, L.L.P. • Attorneys and counselors, Richardson, Texas “ Rarely, if ever, have I filed a patent and actually used the raw laboratory notebook data nor have I referred to them during the application preparation.The disclosure paperwork is used.”

22. Actual Practice • Investigators and Researchers routinely use computers in their efforts • Notebooks and computer data are the property of the university • Manual Research Notebooks are often mandated in the laboratory, however protocols are not followed, witnessing is often defective. • Digital signatures and electronic encryption are allowed under Federal law

23. Notebook Recordkeeping If defective allows for an opportunity for F,F & P and other forms of deceit. • Can represent a questionable research practice • Jeopardizes a fraction of $25 billion in research funding • Jeopardizes a fraction of $1 billion in university revenues

24. Electronic NotebooksDigital Authentication of Research Notebooks Method #1 • Working Files Stored on laboratory computer • Copies -backup on university server. • Secure • Read only • Encrypted and Signed electronically • Universal Time and Date stamped Needs lots of Institutional storage capacity.

25. Electronic NotebooksDigital Authentication of Research Notebooks Method #2 • Working copies stored as usual on a PC • Read-Only copies in a separate file on the investigator’s PC and backup copies on a PC in the lab or mentor/professor’s office. • Files digitally signed and the electronic signature emailed, • or saved to a secure, read-only institutional server, • Server time updated using a network time & date stamp United States, the National Institute of Standards and Technology (NIST) http://time-b.timefreq.bldrdoc.gov

26. Electronic NotebooksDigital Authentication of Research Notebooks • Method #2 • Preferred • Simple and secure • Economic use of storage space and capital expense • Authenticates the research data • Time and date validated signatures • Data Tamper-proof

27. Electronic NotebooksDigital Authentication of Research Notebooks PRETTY GOOD PRIVACY -Network Associates, inc . For personal Use FREE SIGNATURE SOFTWARE • PRETTY GOOD PRIVACY • http://www.pgpi.com • http://www.pgpi.org • http://www.pgp.com • Downloads from MIT.edu                   • http://web.mit.edu/network/pgp.html • http://web.mit.edu/network/pgp-form.html

28. Electronic NotebooksDigital Authentication of Research Notebooks How Do You Sign [or Encrypt ] a document ???

29. Electronic NotebooksDigital Authentication of Research Notebooks Signing a document

30. Electronic NotebooksDigital Authentication of Research Notebooks Save a copy to a Independent backup computer or Server Email or Save to a independent Secure Read Only Time & Date Stamped Server

31. Electronic NotebooksDigital Authentication of Research Notebooks Represents a working copy of the Original, dated un-tampered Read Only Stored file Signature verifies and authenticates the Stored data file. Copy date stamped stored elsewhere

32. Electronic NotebooksDigital Authentication of Research Notebooks How Do You VERIFY the signed document ??? What happens if the document, graph or picture has been changed? Even by a single pixel or space ?

33. Digital Authentication preferred • Reliable • Tamper-proof • Authenticates the chronology of documents • Requires NO outside witness • Simple and economical • Paper and Lawyer expense reduction

34. THANK YOU I hope you all can appreciate the economic seriousness of the problem. Manual notebooks are antiquated and that there is a simple digital solution.