American Conference
Institute (ACI) will be holding its 4th Annual Paragraph IV Disputes conference
on April 27-28, 2010 in New York, NY. 
The conference will allow attendees to:

• Identify patents
for small molecules and small proteins that may be ripe for a Paragraph IV
challenge;
• Recognize an ANDA
applicant's initial obligations and reevaluate Orange Book tactics;
• Incorporate post-KSR obviousness considerations into
Paragraph IV litigation strategies;
• Develop a plan of
action for Notice Letter delivery and Post-Notice Letter deliberations;
• Master techniques
for drafting the initial Paragraph IV pleadings;
• Understand the
criteria for 180-day exclusivity and the circumstances under which it may be
forfeited;
• Appreciate the
significance of generic versus generic actions for brand names and generics;
• Navigate the
intricacies of litigation with multiple ANDA filers;
• Spearhead
discovery dilemmas, optimize the use of experts, and perfect Markman timing; and
• Weigh the options
over an at risk launch.

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

• Pre-suit due
diligence strategies in anticipation of the Paragraph IV challenge;
• Assessing the
ANDA applicant's initial obligations;
• New takes on
obviousness:  Pre-suit
considerations for brand-names and generics;
• Throwing down the
gauntlet:  The Paragraph IV notice
letter — delivery and receipt;
• Let the games
begin:  The start of the Paragraph
IV law suit — Pleadings and considerations;
• Exploring
exclusivity and forfeiture dilemmas relative to Paragraph IV litigation;
• A view from the
bench on Paragraph IV litigation;
• A closer look at
generic versus generic law suits;
• Litigating with
multiple ANDA filers:  Brand name
and generic perspectives;
• FTC keynote:  Pay for delay settlements;
• Recent decisions
impacting Paragraph IV challenges and motion practice;
• Discovery
strategies and pre-trial maneuvering tactics for brand names and generics; and
• Assessing danger
and mitigating liabilities associated with injunctions and "at risk
launches."

Two additional
workshops will be offered before and after the conference.  A pre-conference workshop, entitled
"Hatch- Waxman Boot Camp — A Primer on IP Basics and Regulatory Fundamentals,"
will be offered on April 26, 2010. 
During this workshop, ACI's faculty will offer presentations on the
following topics:

• A guide to the
essentials of the FDA approval process for drugs and biologics for life
sciences patent lawyers;
• Patent and IP
overview for drugs and biologics: 
Hatch-Waxman, trade dress, and more;
• Patent and
non-patent exclusivity;
• Bioequivalence
and the "same active ingredient" vis-à-vis patentability; and
• Exploring
pharmaceutical patent extensions: 
Patent Term Adjustment and Patent Term Restoration.

In addition, a
post-conference workshop, entitled "The Master Class on Settling Paragraph
IV Disputes:  Brand-Name and
Generic Perspectives," will be offered from 9:00 am to 12:30 pm on April
29, 2010.  In this workshop, ACI
faculty will explore the best practices for reaching and finalizing settlements
that the parties and the FTC can live with.

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

The registration
fee for the conference is $2,195 (conference alone), $3,090 (conference and
pre-conference workshop), $2,795 (conference and post-conference workshop),
$3,590 (conference and both workshops), or $1,395 (pre-conference workshop
alone).  Those registering by
February 19, 2010 will receive a $300 discount, and those registering before
March 26, 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 the Paragraph IV Disputes conference.