American Conference
Institute (ACI) will be holding its 11th Maximizing Pharmaceutical Patent
Lifecycles conference on October 6-7, 2010 in New York, NY.  The conference will allow attendees to:

• Understand how
the introduction of biosimilars has profoundly altered pharmaceutical patent
life cycle strategies;
• Appreciate the
relationship between life cycle management, brand optimization and new product
development;
• See how the
Federal Circuit is paving the way for Patent Reform;
• Determine when
and how secondary patents — for both small and large molecules should be
pursued;
• Comprehend how
the clear delineation between written description and enablement is influencing
claims drafting strategies for drugs and biologics via Ariad v. Lilly;
• Assess how the
Court's determination in Bilski
regarding methods claims may affect areas such as personalized medicine and
other new pharmacological technologies;
• Examine the
impact of Caraco on skinny labeling,
carve-outs and Orange Book listing determinations;
• Identify
circumstances under which exclusivity is forfeited; and
• Navigate the
boundaries of the safe harbor.

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

• The remaking of the patent
endgame;
• Patent reform revisited:  Pondering its impact on the
pharmaceutical industry;
• Understanding the particulars,
peculiarities and politics of biosimilars and their impact on pharmaceutical
patent life cycle management;
• Of biosimilar applications (BPCIA) and
ANDAs (Hatch-Waxman);
• New patent term adjustment and patent
term extension decisions and their significance for small and large molecules;
• Obviousness continued:  How KSR
and its progeny are impacting the patent life of drug and biological products;
• Ariad
v. Lilly:  The reaffirmation of
written description and enablement and their collective role in patent life
cycle management — presented in part by Orange Book Blog author Aaron
Barkoff;
• Biliski,
Prometheus and Myriad:  Understanding
the madness over methods claims in the pharmaceutical industry;
• Eye on the CAFC and district
courts:  Life cycle lessons derived
from Paragraph IV litigation;
• FTC keynote:  Competition considerations for
pharmaceutical patent life cycle management — presented by Markus H. Meier,
Assistant Director of the Health Care Division for the Bureau of Competition of
the Federal Trade Commission;
• New controversies and
concerns associated with Orange Book listing and labeling strategies;
• Exclusivity:  Modes, methods, forfeitures and relinquishments;
• FDA keynote:  Update on FDA activities relative to
pharmaceutical patent life cycles for small and large molecules — Elizabeth
Dickinson, Associate Chief Counsel for the Office of the Chief Counsel of the
U.S. Food and Drug Administration; and
•
Learning to navigate the new limits and boundaries of the safe harbor.

Two pre-conference
workshops will be offered on October 5, 2010.  The first, entitled "Hatch-Waxman and BPCIA 101 — A Primer
on IP Basics and Regulatory Fundamentals" will offer presentations on the
following topics:

• Understanding
pre-commercialization concerns relative to small molecules and biologics;
• The nature of the
approval process for drugs and biologics: 
What every pharmaceutical patent attorney should know; and
• Patent and IP
overview for drugs and biologics: 
Hatch-Waxman, trade dress, and more.

A second
pre-conference workshop on "Pharmaceutical Patent Life Cycle Strategies
for the EU and Emerging Markets" will also be offered on October 5, 2010.

A post-conference
workshop, entitled "The Master Class on Patent Term Adjustment and Patent
Term Extensions for Pharmaceutical and Biological Patents," will be held
on October 8, 2010.  This post-conference
workshop will provide practical advice as well as tips and techniques for PTA
and PTE, take attendees through the intricacies of the four major ways of
getting more time on their patents, and provide the tools that attendees need
to accomplish this goal.

The agenda for the
Maximizing Pharmaceutical Patent Lifecycles 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
fees are $2,295 (conference only), $2,895 (conference plus one workshop),
$3,295 (conference plus two workshops), or $3,495 (conference plus all three
workshops).  Those registering by
September 9, 2010 will receive a $200 discount (for all but the conference plus
three workshops), and those registering on or before August 6, 2010 will
receive a $300 workshop (for all but the conference plus three workshops).  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 Maximizing Pharmaceutical Patent
Lifecycles conference.