ACI Maximizing Pharmaceutical Patent Lifecycles Conference

American Conference Institute (ACI) will be holding its 10th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 7-8, 2009 in New York, NY.  The conference will allow attendees to:

• See how a new global legal paradigm for pharmaceutical patent life cycles is being shaped by forces in the U.S. and abroad;
• Understand the interplay between Patent Reform and Follow-on Biologics legislation and how these pending laws will dramatically alter pharmaceutical patent life cycle strategies;
• Determine when secondary patents should be pursued in light of KSR's progeny and Kubin;
• Learn to properly calculate PTA via Wyeth v. Dudas and avoid A and B period overlap dilemmas;
• Examine how Bilski may affect pharmaceutical method claims;
• Incorporate precedents from leading Paragraph IV cases involving declaratory judgments, inequitable conduct and double patenting into your life cycle strategies;
• Assess the impact of skinny labeling and carve-outs on Orange Book listing determinations;
• Decipher the FDA's new interpretations of pre- and post- MMA exclusivity and make sense of new rulings on forfeiture determinations;
• Navigate the new boundaries of the safe harbor as set by Proveris; and
• Explore pharmaceutical patent life cycle strategies for emerging markets.

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

• The endgame re-invented:  Preparing for an emerging pharmaceutical patent paradigm;
• Patent reform and the pharmaceutical industry:  Anticipating and adapting to change;
• Follow–on biologics:  Understanding the role of patents in health care reform and related consequences for life cycle strategies;
• Wyeth v. Dudas:  Revisiting patent term adjustment calculations;
• Overcoming obviousness:  An analysis of the post-KSR treatment of primary and secondary patents and finding new ways to extend patent life;
• In re Bilski:  Exploring its implications for pharmaceutical method claims;
• Eye on the Federal Circuit and District Courts:  Life cycle lessons derived from Paragraph IV litigation;
• Promoting competition in the pharmaceutical industry;
• The European Commission pharmaceutical sector inquiry - Main findings and policy recommendations;
• Rethinking life cycle strategies for established and emerging international markets:  Focus on Europe and Asia;
• A new look at Orange Book listings, delistings and related challenges;
• Update on FDA activities relative to pharmaceutical patent life cycles;
• Exclusivity:  Modes, methods and new interpretations; and
• Re-exploring the safe harbor:  Learning to navigate the potential limits and boundaries of Proveris.

A pre-conference workshop, entitled "Hatch-Waxman Boot Camp -- A Primer on IP Basics and Regulatory Fundamentals" will be held on October 6, 2009.  This workshop will offer presentations on the following topics:

• Understanding 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;
• 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.

Two additional master classes will be offered on October 9, 2009.  One of the master classes, entitled "New Strategies for Obtaining Pharmaceutical Patent Extensions in a Post-KSR World," will focus on brand name drugs, and the other master class, entitled "Updated Drafting Guidelines for Paragraph IV Certifications and Notice Letters," will focus on generic drugs.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles conference can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be obtained here.

The registration fees are $2,195 (conference only), $3,090 (conference plus workshop), $2,695 (conference plus one master class), $3,590 (conference plus workshop and both master classes), and $1,395 (workshop alone).  Those registering on or before September 21, 2009 will receive a $200 discount (for all but the workshop alone), and those registering on or before August 7, 2009 will receive a $300 workshop (for all but the workshop alone).  ACI will also provide a $200 discount off the standard price to all Patent Docs readers who reference the discount code "The Media Partner Discount" when registering.  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.