ACI Maximizing Pharmaceutical Patent Lifecycles Conference

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.