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What Drug and Device Companies Need to Know in 2009 With Patent Reform Initiatives and Related Changes in FDA Law


24 Feb 2009, 8:30 AM - 1:00 PM (Central Time)                            
ROUNDTABLE

Continental breakfast and lunch will be provided

Sofitel San Francisco Bay
223 Twin Dolphin Drive
Redwood City, California

On Tuesday, February 24, 2009, King & Spalding will host a complimentary roundtable at the Sofitel San Francisco Bay addressing current patent and regulatory law reform initiatives, their prospects for success, and their implications for pharmaceutical, biotechnology, and medical device companies. The program will include lawyers from the firm’s Intellectual Property, FDA/Healthcare, and Government Advocacy and Public Policy practices.


Agenda

Roundtable discussion topics will include the following:

  • What’s changing in patent law?
    • Highlights of recently proposed patent reform legislation
    • Installation of new leadership at the U.S. Patent and Trademark Office (PTO)
    • PTO agency initiatives for 2009 and beyond
  • What’s changing in food and drug law?
    • New leadership at the U.S. Department of Health and Human Services and the Food and Drug Administration (FDA)
    • Understanding Hatch-Waxman’s historical compromise for innovator and generic products (including essential patent-based competition protections and patent term restoration/extension opportunities)
    • Implications of proposed legislation to create a “follow-on biologics” regulatory pathway
  • Anticipating the discrete and combined effects of patent and FDA law reform on intellectual property prosecution and enforcement
  • Introduction to key decision makers: The new President and Congressional leadership
    • Policy positions of the Obama Administration on patent and FDA law reform
    • Important changes in Congressional leadership
    • Likely schedules for hearings and votes
    • Opportunities for industry involvement
  • Working lunch: Scope of Attorney-Client Privilege (1 hour MCLE Ethics credit)
    • Current law regarding attorney-client privilege communications
    • Realistic expectation of managing privilege based on area of law
    • Interactive audience discussion

Speakers

  • Paul Andre, Partner, Intellectual Property
  • Lisa Kobialka, Partner, Intellectual Property
  • Honorable Lloyd Hand, Senior Counsel, Government Advocacy & Public Policy
  • Christina Markus, Partner, FDA/Healthcare
  • Judy Mohr, Ph.D., Partner, Intellectual Property
  • Christopher Ott, Partner, Government Advocacy & Public Policy
  • Elaine Tseng, Partner, FDA/Healthcare

In-person attendance is limited, so if you have an interest in the Roundtable, please register soon to reserve seats for your organization. You do not have to be a client to attend.

Register to attend by visiting www.kslaw.com/DrugDeviceRoundtable.

Continuing Education Credits: CLE credit will be applied for in California, Georgia, New York, Texas, and Virginia, and a Certificate of Attendance will be provided for attorneys licensed in other states to use to apply for CLE credit. King & Spalding LLP, 1180 Peachtree Street NE, Atlanta, GA, 30309. CA Provider #10947.

PRACTICES
Pharma/Biotech/Med Devices