FDLI Conference – Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy

June 7, 2011

The Food and Drug Law Institute (“FDLI”) will host an intensive one-day, must-attend conference on June 24, 2011, at the Westin City Center in Washington, DC, titled “Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy.”  The conference will cover myriad Hatch-Waxman issues, including 180-Day Exclusivity, New Drug Application Exclusivities and Patent Term Extensions, Patent Certification/Litigation, and Regulatory Strategies and Conundrums, and boasts a virtual who’s who of presenters from the Hatch-Waxman legal community.  Among other presenters are FDA’s Elizabeth H. Dickinson, Associate Chief Counsel for Drugs, Office of the Commissioner, Caroline Holland, Chief Counsel and Staff Director, Subcommittee on Antitrust, Competition Policy, and Consumer Rights, Judiciary Committee, U.S. Senate, and C. Scott Hemphill, Professor of Law, Columbia Law School.

According to the program description:

The constant array of lawsuits, petitions, and administrative challenges regarding 180-day exclusivity, patent listings, and patent-term extensions have addressed important issues during the last year, resolving some but further complicating others.  This program will provide an in-depth analysis of these ongoing issues.  The Program will also address antitrust considerations associated with Hatch-Waxman patent and administrative challenges and the interplay between Hatch-Waxman and the newly authorized biosimilars approval pathway.

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst, a member of the conference planning committee, is a speaker on the 180-Day Exclusivity panel.  Others on that panel moderated by David G. Adams, Partner, Chairman, FDA Group, Venable LLP, are Ms. Dickinson, Mr. Hemphill, and Michael D. Shumsky, Partner, Kirkland & Ellis LLP.

You can register for the event on FDLI’s website here, or by contacting FDLI’s Customer Service at (202) 371-1420.  We look forward to seeing you at the conference.