American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on June 9-10, 2014 in Chicago, IL.  ACI faculty will help attendees:

• Understand the interplay of between the PTO and FDA in the patenting of drugs and biologics;
• Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents;
• Develop an in-depth and practical knowledge of Hatch-Waxman protocols;
• Navigate the intricacies of patent term adjustment and patent term extension; and
• Comprehend how the BPCIA biosimilars pathway for large molecules will compare to the Hatch-Waxman schematic for small molecule.

In particular, ACI's faculty will offer presentations on the following topics:

• Key agencies overview:  Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics;
• Exploring the link between the FDA approval process and the patenting of drugs and biologics;
• IP overview for drugs and biologics:  Hatch-Waxman, BPCIA, trade dress, and more;
• ANDA litigation 101: Paragraph IV disputes primer;
• Orange Book listings, de–listings, and related challenges;
• Bioequivalence and the "same active ingredient" vis-a-vis patentability;
• An in-depth look at 180-day exclusivity;
• Comprehending the intricacies of non-patent/regulatory exclusivity;
• Assessing patent protections afforded under the safe harbor; and
• Examining pharmaceutical patent extensions:  Patent Term Adjustment and Patent Term Restoration.

A post-conference interactive biosimilars strategy session, entitled "Biosimilars 101:  Interpreting the Law, Appreciating the Science, Anticipating Regulations and Preparing for Litigation," will be offered from 9:00 am to 12:00 pm on June 11, 2014.

The agenda for the Hatch-Waxman Boot Camp conference can be found here.  A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.

The registration fee for the conference is $2,295 (conference alone) or $2,895 (conference and workshop).  Those registering by May 9, 2014 will receive a $300 discount.  Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.

Patent Docs is a media partner of ACI's Hatch-Waxman Boot Camp conference.