PATENT ISSUES

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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
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UVAPF Organizational Chart
Licensing Department Alan Bentley,
M.S. Christopher Harris, Ph.D. Todd Huffman,
Ph.D. Marie Kerbeshian, Ph.D. Miette Michie,
M.S. Veena Rao-Mirmira, Ph.D., MBA Senior
Paralegal Cathy Good Secretary Kelli Megill
Board of Directors Chairman of the Board Erik
Hewlett, M.D.
Patent Department Patent Counsel,
Biotech Rodney Sparks, J.D., Ph.D. Patent
Counsel, EngineeringRobert Decker, J.D. Senior
Paralegal Sue Ann Carr Legal Assistant Shawn
Harris
CEO Executive Director Robert S. MacWright,
J.D., Ph.D.
Business Department CFO Business Manager Jeff
Wilk, M.B.A. Business Manager Lynn Pillow
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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)

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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

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Issues Pertinent to Managing Inventors
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

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Issues Pertinent to Managing Inventors
Expectations REMEDIES

• Educate Inventors in the Licensing and Patenting
  Process
• Keep Inventors in the Loop
• Maintain a Good Relationship With the Inventors

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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

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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.)

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Protecting the TechnologyNontraditional
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

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Protecting the TechnologyNontraditional
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.

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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

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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)

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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

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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

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Contact Information
Rodney L. Sparks, J.D., Ph.D. Direct
434-243-6103 Main 434-924-2175 E-mail
rodney_at_uvapf.org www.uvapf.org