Speaking Engagement

CBIs Pharmaceutical Congress on Paragraph IV Disputes

Thursday, October 16, 2008 - Friday, October 17, 2008

04:00 AM BST - 04:00 AM BST

Bruce Wexler will be speaking at CBIs Pharmaceutical Congress on Paragraph IV Disputes Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies. This conference will take place on October 15 - 16, 2008 at Marriott Philadelphia Downtown, Philadelphia, PA. 

Mr. Wexler will cover the Lessons from the Court Examine the Proceedings of a Key Victory on an Important Case segment. When a pharmaceutical company's key product is the subject of paragraph IV dispute, its survival can be contingent on every case detail. This session provides perspectives for major paragraph IV disputes including intense litigation and numerous claims. It details the facts and rulings of the case, and the means by which litigators secured victory. Topics will cover:

  • Challenges in litigating with multiple ANDA filers

  • Evaluation of common arguments

  • Discovery challenges/opportunities/strategies

  • Witnesses as support for the case

Conference overview:

Paragraph IV litigation is reaching an all-time high with almost $85 billion in product sales that potentially could be affected by pending litigation and more than twenty-five drugs going off patent before 2012.  Todays pharmaceutical companies, both brand and generic, have much at stake in this costly, complex and constantly changing area of patent litigation.  CBIs Pharmaceutical Congress on Paragraph IV Disputes brings both sides of the issue together for two days of presentations and panel discussions to discuss litigation strategies, statutory guidelines, current cases and their landmark decisions.  This timely and valuable content is designed to provide you with the information you need to know today for better business decisions tomorrow.

Topics to be discussed include:

  • FTC address on pharmaceutical antitrust

  • In depth analysis of recent court cases and their implications on brand and generic companies

  • Effects of KSR on brand and generic litigation strategies

  • Panel discussion on acceptable settlement strategies for paragraph IV disputes

  • Litigating paragraph IV disputes with multiple ANDA filers

  • Interpreting forfeiture provisions for better business decisions

  • Pre-suit preparedness strategies for paragraph IV disputes

  • Citizen petitions and their impact on generic entry

  • Declaratory judgments

  • At risk launches

For more information or to register for this conference go to https://www.cbinet.com/show_conference.cfm?confCode=PC08088&field=summary

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