American Conference Institute’s 4th Annual “Paragraph IV Disputes" conference will take place in New York City on April 27–28.
I am looking forward to speaking at the conference in a session entitled “Recent Decisions Impacting Paragraph IV Challenges and Motion Practice”. My presentation will be about recent judicial decisions concerning declaratory judgment jurisdiction and method-of-treatment patents.
A highlight of the conference will be a panel discussion with the Honorable Garrett E. Brown, Jr., U.S. District Judge; Honorable Joel A. Pisano, U.S. District Judge; and Honorable Tonianne Bongiovanni, U.S. Magistrate Judge. All three have very active paragraph IV litigation dockets in the District of New Jersey. Another highlight will be an FTC presentation on “pay for delay” settlements, by Markus H. Meier, Assistant Director of the Health Care Division, Bureau of Competition, Federal Trade Commission. Mr. Meier will provide an update on FTC's activities to end such settlements.
Other presentations include:
- Pre-suit due diligence strategies in anticipation of the paragraph IV challenge
- Assessing the ANDA applicant’s initial obligations
- New takes on obviousness: pre-suit considerations for brand names and generics
- Throwing down the gauntlet: the paragraph IV notice letter — delivery and receipt
- Let the games begin: the start of the paragraph IV law suit — pleadings and considerations
- Exploring exclusivity and forfeiture dilemmas relative to paragraph IV litigation
- A closer look at generic v. generic lawsuits
- Discovery strategies and pre-trial maneuvering tactics for brand names and generics
- Assessing danger and mitigating liabilities associated with injunctions and “at-risk launches”
In addition, a pre-conference workshop is offered on Monday, April 26, entitled “Hatch-Waxman Boot Camp — A Primer on IP Basics and Regulatory Fundamentals” and a post conference workshop is offered on Thursday, April 29, entitled “Master Class on Settling Paragraph IV Disputes: Brand-Name and Generic Perspectives”.
Orange Book Blog readers may receive a substantial discount on registration fees with the “media partner discount”.
For more information or to register, please visit the conference website.