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Fish at the Podium,
Fish Forum
10/28/2010
Pharmaceutical Intellectual Property Summit 2010
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Pharmaceutical Intellectual Property Summit
Thursday, October 28, 2010 11:30 am - 5:00 pm Reception 5:00 pm - 6:30 pm
In cooperation with: FDA Keynote
Keynote addressSpeaker: Howard Sklamberg, Director, Office of Enforcement, Food and Drug Administration (invited)Please join us for an interactive discussion on changes to the FDA's enforcement policy directed to inspections, recalls, off-label marketing, Park doctrine criminal prosecutions, and additional compliance issues of interest to the biologics, pharma, and medical device community. Following the luncheon keynote, we will have a series of in-house counsel panels led by principals from Fish & Richardson’s biotechnology and pharmaceutical practice. Confirmed in-house counsel panelists include: • Nicholas Boivin, Director, Intellectual Property Counsel, Cubist Pharmaceuticals • Charles Caruso, International Patent Counsel, Merck & Co., Inc. • Reza Green, Chief Patent Counsel, Novo Nordisk, Inc.
Panel Topics
Defending Qui Tam and Fraud Claims - Current Strategies and Developments Who you gonna call? Best practices for keeping government investigators away from your pharmaceutical and medical device businesses and what to do if those measures fail.
Biosimilars: Now That the Dust Has (Somewhat) Settled Managing patent-related problems created by the biosimilars legislation, anticipating how biosimilars might game the system, and retooling license agreements for your in-licensed patents.
You Know It Is Coming: Preparing for the Paragraph IV Letter How a branded company can prepare prior to receipt of a Paragraph IV letter, from the perspective of both inside and outside counsel.
Protecting Your Brand Name: Obtaining PTO and FDA Approval Update on obtaining FDA approval of pharma trademarks, tips for how to pick good marks, and the interplay between FDA-approval and registration at the U.S. Patent and Trademark Office
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