Patent Issues Facing Universities - Patent Foundation

							       PATENT ISSUES
FACING UNIVERSITIES
          LES Winter Meeting- 2006

              Presented by:
     Rodney L. Sparks, J.D., Ph.D.
       In-House Patent Counsel
University of Virginia Patent Foundation
       UVAPF Organizational Chart
Licensing Department              Board of Directors
                                  Chairman of the Board             Patent Department
      Alan Bentley, M.S.             Erik Hewlett, M.D.
                                                                     Patent Counsel, Biotech:
   Christopher Harris, Ph.D.                                        Rodney Sparks, J.D., Ph.D.
     Todd Huffman, Ph.D.
                                                                   Patent Counsel, Engineering:
                                                                       Robert Decker, J.D.
   Marie Kerbeshian, Ph.D.
                                CEO & Executive Director
     Miette Michie, M.S.        Robert S. MacWright, J.D., Ph.D.        Senior Paralegal:
                                                                          Sue Ann Carr
Veena Rao-Mirmira, Ph.D., MBA
                                                                         Legal Assistant:
                                                                          Shawn Harris
      Senior Paralegal:
        Cathy Good               Business Department
                                 CFO & Business Manager:
         Secretary:                 Jeff Wilk, M.B.A.
         Kelli Megill
                                    Business Manager:
                                       Lynn Pillow
   Outline- University Patent Issues
• Educating Academic Inventors and
  Managing Their Expectations
• Protecting the Technology
  • Undisclosed Disclosure
  •Nontraditional Prior Art
  •Failure to Comply with Government
  Reporting (Bayh-Dole)
  • Infringement - Experimental Use Exemption
  and Statutory Experimental Use Safe Harbor of
  §271(e)(1)
   What Motivates Inventors?

• Most faculty still live by the phrase
  “Publish or Perish”
• Promotions, tenure, and prestige are still
  primarily based on grant support and
  publishing
• Universities have little control over faculty
  regarding timely submission of invention
  disclosures
       Issues Pertinent to Managing
          Inventor’s Expectations
        for Patenting and Licensing
• Poor disclosures (no detail, lack of support for
  claims, lack of ENABLEMENT)
• Improper Inventorship
• Lack of cooperation
• Invention previously disclosed (prior to
  invention disclosure submitted for
  consideration)
• Inventor is uneducated in the processes of
  licensing and patenting
 Issues Pertinent to Managing
    Inventor’s Expectations:
         REMEDIES

• Educate Inventors in the Licensing
  and Patenting Process
• Keep Inventors in the Loop
• Maintain a Good Relationship With
  the Inventors
     Protecting the Technology
Once an invention is disclosed publicly-
    intellectual property could be lost
      (some grace periods exist)

Types of Disclosure-
• Traditional Publication by Inventor Before
  Disclosure (i.e., journal; submitted manuscripts
  are generally treated with confidentiality)

• Nontraditional Publication
    Protecting the Technology
Nontraditional Publication-
• Presentations
• Theses and Dissertations
• Posters
• Abstracts
• Conversations
• Websites (early online publication of
  abstracts and journal articles)
• Federal Grant Applications (NIH, SBIR,
  etc.)
      Protecting the Technology:
      Nontraditional Publication
• Presentations- (visual aids are “transitory”, but
  accompanying handouts are publications; Regents
  of the Univ. of CA v. Howmedica, Inc.; MIT v.
  Fortia)

• Theses and Dissertations- are generally indexed
  and thus available; student may disclose all or part
  of an invention before the manuscript is prepared
  and an invention disclosure is submitted

• Posters- troublesome area; could be interpreted as
  a publication, as could copies made available or
  photographs taken of the details
       Protecting the Technology:
       Nontraditional Publication
• Abstract- redact if possible

• Conversation- not really a printed publication

• Website - early online publication of abstracts and
  journal articles

• Grant Applications- upon funding, abstract may
  publish; Freedom Of Information Act allows access
  to funded federal applications; E.I. du Pont de
  Nemours and Co. v. Cetus Corp.
      Protecting the Technology
• Failure to Comply with Government
  Reporting (Bayh-Dole)
  –There are complicated reporting issues
   pertaining to invention disclosures, patent
   applications, and patents which were
   developed using federal funds
  –Failure to comply may cause the government
   to confiscate the technology (Campbell
   Plastics)
• Remedy- COMPLY
      Protecting the Technology
• Infringement (university liability)
  – Experimental Use Exemption
     • Extremely limited (Madey v. Duke
       demonstrates that universities can
       infringe)
  – Statutory Experimental Use Safe Harbor
    of §271(e)(1)
     • Limited, but there is a safe harbor
       pertaining to experimentation related to
       FDA submission (Merck v. Integra)
     Take Away Suggestions

• Educate Inventors in the Licensing
  and Patenting Process
  – Encourage disclosure
  – Encourage participation
• Keep Inventors in the Loop
• Maintain a Good Relationship With
  the Inventors
          DISCLAIMER

• None of the aforementioned problems
  occur at the University of Virginia
• This presentation is based on actual
  hearsay and secondhand information
  from other universities
    Contact Information

Rodney L. Sparks, J.D., Ph.D.
    Direct: 434-243-6103
    Main: 434-924-2175
  E-mail: rodney@uvapf.org
       www.uvapf.org