American Conference
Institute (ACI) will be holding its Hatch-Waxman Boot Camp conference on July
19-20, 2010 in Boston, MA.  ACI
faculty will help attendees:

• Understand the
interplay of 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, including: Orange
Book listings, bioequivalency, exclusivities, the 30-month stay, and the safe
harbor;
• Navigate the
intricacies of patent term adjustment and patent term restoration;
• Comprehend how
the introduction of biosimilars will change industry dynamics; and
• Recognize how
pre-commercialization concerns relative to CMS approval and Medicare/Medicaid
formulary selection are influencing the patenting and approval of drugs and
biological products.

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;
• Identifying and
comprehending pre-commercialization concerns relative to small molecules and
biologics;
• Exploring the
link between the FDA approval process and the patenting of drugs and biologics;
• Patent and IP
overview for drugs and biologics: 
Hatch-Waxman, trade dress, and more;
• How the dynamics
of follow-on biologics will change the Hatch-Waxman landscape;
• Orange Book
listings, de–listings, and related challenges;
• Bioequivalence
and the "same active ingredient" vis-a-vis patentability;
• A 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.

Two post-conference
workshops will be offered on July 21, 2010.  The first, entitled "Follow–On Biologics: The Master
Class," will be offered from 9:00 am to 12:00 pm, and will take attendees
through every facet of this exciting and challenging new area.  The second workshop, entitled
"Practical Considerations Surrounding Pre-Lawsuit Paragraph IV Diligence
from Both a Brand and Generic Perspective," will delve into the practical
side of the A to Z pre-lawsuit diligence necessary leading up to and including
filing of the Paragraph IV lawsuit including, obviousness and non-obviousness
searching, notice Letter preparation, brand response, offers of confidentiality,
and venue.

A complete brochure
for this conference, including an agenda, list of speakers, and registration
form can be obtained here.

The registration
fee for this conference is $2,195 (conference alone), $2,795 (conference and
one workshop), or $3,195 (conference and two workshops).  Those registering by June 11, 2010 will
receive a $200 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.