American Conference Institute (ACI) will be holding its 9th Annual Maximizing Pharmaceutical Patent Lifecycles conference on October 15-16, 2008 in New York.  At the conference, ACI's faculty will offer presentations on the following topics:

• Clarifying the evolving meaning of 'patent life cycle' for the pharmaceutical business;
• Constructing, adjusting, and executing a pharmaceutical patent life cycle management plan;
• View for the FTC;
• Navigating the complexity of structuring patent settlement options between brand name and generic pharmaceutical patent cases;
• Eye on the bench: Identifying judicial trends in pharmaceutical patent cases;
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Mastering the intricacies of the 180-day generic market exclusivity;
• Penetrating the complexitites of non-patent/FDA exclusivities;
• Plotting a course into safe harbor for branded pharma;
• View from the FDA;
• Slicing through the complex spectrum of declaratory judgment actions in pharmaceutical patent cases; and
• Factoring the role, challenges, and impact of Orange Book listings and de-listings in patent portfolio management.

Attendees can also elect to attend a branded or generic master class on October 17, 2008.  The branded master class, entitled: "Overpowering the challenges in increasing the pharmaceutical patent life cycle through patent extensions," will address the following topics:

• Defining the benchmarks in the drug’s development;
• Determining eligibility for patent term extension;
• Mastering the regulatory review period determinations;
• Calculating the patent term restoration;
• Adjusting the patent term because of delays, glitches, and obstacles in prosecuting patents at the USPTO;
• Calculating the effect of patent term extensions outside the U.S.;
• Obtaining extensions through FDA Pediatric Exclusivity and Orphan Drug Exclusivity;
• Measuring the import of second-generation patents; and
• Incorporating non-US filing strategies into the life cycle plan for pharmaceutical patents.

The generic master class, entitled: "Adding value to Paragraph IV certifications and notice letters," will address the following topics:

• Defining the four types of patent certifications;
• Clarifying the obligations of the ANDA applicant;
• Probing the impact of the declaratory judgment and counter claim provisions;
• Applying the 30-month stay effectively;
• Incorporating the benefits, costs, and impact of the 180-day exclusivity;
• When will forfeiture of exclusivity be triggered?
• Forecasting consequences of inadequate notice letters;
• When should disclosure of technical information about the ANDA and proposed generic product occur?
• Identifying exceptional cases where attorney's fees may be awarded; and
• Illuminating the procedural and substantive requirements of Paragraph IV letters.

The agenda for the Maximizing Pharmaceutical Patent Lifecycles Conference conference can be found here.  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 alone is $1,895 (the registration fee for the branded or generic master classes has not yet been set).  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 sponsor of ACI's Maximizing Pharmaceutical Patent Lifecycles Conference conference.