The Center for Business Intelligence (CBI) will be holding its 2nd Annual Pharmaceutical Congress on Paragraph IV Disputes and Settlements on October 22-23, 2009 in Philadelphia, PA. The conference will cover issues relevant to both brand and generic companies during two days of presentations and panel discussions on litigation strategies, statutory guidelines, current cases, and their landmark decisions. CBI's faculty will offer presentations on the following topics:
• State of the industry address -- Identify patent dispute and resolution trends to optimize Paragraph IV strategies;
• Early generic considerations for achieving favorable litigation results;
• Brand preparedness strategies for Paragraph IV certifications;
• Assess the implications of patent reform on pharma and Paragraph IV litigation (panel discussion);
• Understand the FDA's role in Paragraph IV disputes and enforcing Hatch-Waxman regulations;
• Leverage FDA law for Paragraph IV patent strategies;
• Generic perspective;
• Gain insight on biosimilars legislation and what it means for industry;
• Analyze FTC enforcement activity and reverse payment policy initiatives (FTC address);
• Structuring settlements without raising red flags and suffering FTC sanctions (panel discussion);
• Inequitable conduct and exceptional cases -- What does recent case law tell us?
• Differences of opinion on NCEs -- What are the scope and limits?
An additional in-conference workshop entitled: "Mock Litigation -- Develop Paragraph IV Litigation Strategies through Case Law Analysis and Best Practice Utilization" will be offered on October 23, 2009. The in-conference workshop will break attendees into two groups to match their product offering -- brand or generic -- and work through preparatory activities, develop litigation strategies and evaluate current, and/or future changes to the law and market that could affect the current dynamic.
The agenda for the Pharmaceutical Congress on Paragraph IV Disputes and Settlements can be found here (Day 1) and here (Day 2). A brochure for this conference can be requested here.
The registration fee for the conference is $1,995. Attendees registering on or before August 21, 2009 will receive a $300 discount off the registration fee, and attendees registering a group of three individuals will receive a fourth registration for free. Those interested in registering for the conference can do so here.
Patent Docs is a media sponsor of CBI's Pharmaceutical Congress on Paragraph IV Disputes.
Photograph of Independence Hall (above) by Dan Smith, from the Wikipedia Commons under the Creative Commons license.
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