Orange Book Blog

I will have the honor of speaking at American Conference Institute's 6th annual Paragraph IV Disputes conference in New York next month.  I'll be part of a panel discussion entitled, "Of Labels, Patents and Use Codes: The Significance and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges."

The remainder of the agenda includes the following presentations:

• Anticipating and reassessing Paragraph IV challenges in the era of the patent cliff
• Invalidity and non-infringement post-Microsoft: reaffirmation of the ANDA applicant's pre-litigation obligations and assertions
• Throwing down the guantlet: the Paragraph IV notice letter
• New claim construction considerations in Paragraph IV litigation
• Prior art obviousness and obviousness-type double patenting: legal analyses and practical applications for brand names and generics
• And they're off: the start of the Paragraph IV lawsuit–pleadings and other inital considerations
• A view from the bench (with the Honorable Garrett Brown, the Honorable Joel Pisano and the Honorable Tonianne Bongiovanni, all federal judges in the District of New Jersey)
• Reassessing Paragraph IV strategies for method-of-treatment patents in view of recent and pending decisions regarding inducement and divided infringement
• Exclusivities and forfeitures: new developments, controversies and concerns relative to Paragraph IV litigation
• Pay-for-delay update (with Markus Meier, Asst. Director of the Health Care Division, Bureau of Competition, Federal Trade Commission)
• New standards in inequitable conduct post-Therasense: ethical considerations for paragraph IV cases
• New controversies surrounding damages and injunctions relative to at-risk launches
• Parallel proceedings in Paragraph IV disputes: strategies for balancing and streamlining proceedings before the federal courts, PTO and ITC

Additionally, ACI is offering two pre-conference workshops on Monday, April 23rd: "Hatch-Waxman and BPCIA 101–A Primer on IP Basics and Regulatory Fundamentals" and "Working Group Session: The Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation."  Finally, a post-conference session will be offered on Thursday, April 26th: "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Names and Generics."

For more information or to register, please visit the conference website.  For a $200 discount on registration fees, use discount code OBB 200.