It has been only a little over a year since Congress passed into law a structured pathway for abbreviated approval of “follow-on biologics”. The follow-on biologics law, which was included as a subtitle of the Patient Protection and Affordable Care Act signed into law on March 23, 2010, is conceptually similar to what is commonly known as the Hatch Waxman Act. Just as Hatch Waxman created an abbreviated pathway for the approval of generic small molecule drugs, the follow-on biologics law creates an abbreviated pathway for generic biologics.

While conceptually similar to Hatch Waxman, the follow-on biologics law differs in a number of respects, reflecting the very different nature of biologics versus small molecules.

This audio conference presentation explores the mechanics of the follow-on legislation and how the branded industry should be preparing for the generic challenges to their branded biologics.

This audio conference covers:

• Drugs and biologics distinguished
• Requirements for Follow-on Biologic (FOB) application
• Non-interchangeable vs. interchangeable FOBs
• FOB exclusivity
• Litigation procedures under the FOB law

About the speaker:

Patricia Carson, Partner, Kaye Scholer LLP has extensive patent litigation experience across a broad range of technologies, including pharmaceutical and biotechnology, and has served as trial counsel for numerous healthcare industry clients including Pfizer, Wyeth, Roche, Genentech, Elan and Ariad. Her landmark victory in Wyeth v. Kappos successfully challenged the U.S. Patent and Trademark Office’s interpretation of the statute designed to compensate patent holders for loss of patent term – resulting not only in significant additional patent term being awarded to her clients’ patents, but also to countless other patents throughout the entire pharmaceutical industry.

She has been recognized by numerous publications, including Corporate Counsel, The National Law Journal and Super Lawyers, as a leading patent lawyer for the pharmaceutical and biotechnology industry. Last year, Intellectual Asset Management (IAM) Magazine identified her as one of the “World’s Leading Life Sciences Patent Litigators.”

Who should attend?

• Chief IP Counsel
• General Counsel
• Marketing
• Regulatory Affairs