The Center for Business Intelligence (CBI) will be holding its 3rd Annual Life Sciences Congress on Paragraph IV Disputes concerning Emerging Regulatory and Pre-Litigation Strategies for Prosecuting and Defending PIV Suits on October 18-19, 2010 in Alexandria, VA. The conference will offer presentations on the following topics:
• Generic vs. generic suits;
• FTC investigations and pay for delays;
• FDA forfeiture provisions;
• Use codes and section VIII carve outs;
• Pre-litigation strategy and development
• Inequitable conduct, at risk launches, and damages;
• Anti-trust and PIV counterclaims; and
• PIV settlements keynote panel.
In particular, CBI faculty will offer presentations on the following topics:
• Overview on recent biologics legislation -- How to make it work for branded and generic companies;
• Generics attacking their own -- An examination of inter-generic legal and regulatory strategies (Keynote Address);
• FTC Address -- Pharmaceutical pay-for-delay -- The FTC view;
• FDA forfeiture provisions and review of strategic developments;
• What global pharmaceutical professionals should know about Indian patent law?
• Challenges of patent extensions, patent listings and de-listings in Paragraph IV litigation;
• Pre-litigation strategy, analysis and preparation for PIV disputes (panel discussion);
• Branded strategy -- Portfolio and lifecycle management for PIV;
• Use codes and carve outs -- Methods of use and label indications;
• Hear from the Judge -- The do's and don'ts in the courtroom -- Hon. Joseph J. Farnan, Jr., United States District Court for the District of Delaware
• At risk launches -- Preliminary injunction and damages considerations; and
• Inequitable conduct -- How to prevent and how to prevail.
Two pre-conference workshops will be held on October 18, 2010. The first workshop, entitled "A Paragraph IV Boot Camp -- What to Expect and How to Prevail" will address the following key questions:
• How can the team prepare for a PIV case?
• What outcomes should be expected in various PIV scenarios?
• What novel strategies can be implemented for defending PIV cases?
• How can the team obtain strategic intelligence for prosecuting or defending PIV cases?
The second workshop, entitled "How to Align the FDA Approval Process with PIV Strategy" will address the following key questions:
• How can patent attorneys leverage the FDA approval process?
• What are the key regulatory issues we should be concerned with?
• How can FDA issues influence PIV strategy?
A complete agenda for the Congress on Paragraph IV Disputes can be found here (Day One), here (Day Two), and here (Pre-Conference Workshops). A brochure for this conference can be requested here.
Pricing for the conference can be obtained here. Those interested in registering for the conference can do so here, by calling 1-800-817-8601, or by email at [email protected].
Patent Docs is a media partner of the Congress on Paragraph IV Disputes.
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