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  • The Orange Book blog team are a group of attorneys with McAndrews, Held and Malloy, which is a full-service IP firm representing both brands and generics in various aspects of IP law. This blog does not provide legal advice. If you are seeking legal advice, please contact the author directly.

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March 16, 2012

ACI "Paragraph IV Disputes" Conference, New York, April 24-25

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.

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