Orange Book Blog

FTC Roundtable, "Competition Issues Involving Follow-On Biologic Drugs," Washington, November 21

The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington.  Speakers include industry leaders, government officials, outside counsel and others.

The agenda includes the following presentations:

• Welcoming remarks, FTC Commissioner Pamela Jones Harbour
• Opening remarks, Rachel Behrman, FDA: "How Do Biologic Drugs Differ from Small Molecule Drugs?"
• "Likely Market Effects of Follow-On Biologic Drug Competition," a panel discussion moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Likely Competitive Effects of Reference Product Regulatory Exclusivity," moderated by Michael Wroblewski and Christopher Garmon, FTC
• "Biotechnology Patent Issues," moderated by Suzanne Michel and Suzanne Drennon, FTC
• "Likely Competitive Effects of Follow-On Biologic Regulatory Incentives," moderated by Michael Wroblewski and Elizabeth Jex, FTC
• "Patent Dispute Resolution Processes," moderated by Michael Wroblewski and Suzanne Drennon, FTC

In advance of the roundtable, over a dozen organizations have submitted comments to the FTC, including BIO, GPhA, and PhRMA.

A live webcast of the event will be offered.  For more information, please visit the FTC website.

ACI "Paragraph IV On Trial" Conference, New York, November 19-20

American Conference Institute is presenting its first-ever "Paragraph IV On Trial" Conference, November 19-20 in New York.  This is a unique conference, with the format of a mock trial in a Hatch-Waxman case.

ACI states:  "Structured as an actual trial based on an ANDA filing involving a compound and a formulation patent, our experienced faculty of patent litigators will conduct live demonstrations of direct and cross examinations, as you witness an entire, detailed, Paragraph IV trial, beginning with the banging of the gavel and concluding with closing statements."

After each direct and cross examination, a panel of judges and in-house counsel will provide commentary.

For more information or to register, please visit the conference website.

Orange Book Blog readers can save $200 by using registration code "S".