American Conference Institute (ACI) will be holding its 12th Annual Paragraph IV Disputes conference on April 23-24, 2018 in New York, NY. ACI faculty will provide insights into:
• Understanding the correlation between Paragraph IV filings and the speed of ANDA approvals
• Reviewing recent Federal Circuit rulings and District Court interpretations of TC Heartland, and their impact on venue
• Exploring Oil States vs. Greene's Energy Group and the constitutionality of IPR proceedings
• Examining the impact of the Sovereign immunity defense and the status of a Congressional response
• The interplay between the new FDA leadership and Hatch-Waxman litigation
• Recent PTAB decisions and appeals in the pharmaceutical practice group
• Deciphering recent Federal Circuit opinions addressing obviousness in the ANDA setting
• Reviewing the state of the law on induced infringement for Hatch-Waxman cases
• Evaluating typical ethical predicaments that may arise in Paragraph IV litigation
The conference will offer presentations on the following topics:
• Paragraph IV Litigation Year in Review: Present Developments and Future Forecasts
• The Evolving Principles of Venue and Jurisdiction in the Aftermath of TC Heartland
• IPR Update: Oil States, SAS and the Future of IPRs: An Assessment of Challenges to Inter Partes Review Presently before the Supreme Court
• IPR Update: The Question of Sovereign Immunity: A Legitimate Means of Pharmaceutical Patent Protection?
• The Distinctive Roles of The Magistrate Judge and Local Counsel in Paragraph IV Proceedings
• View From the Bench: The Federal Judges Speak on Paragraph IV Litigation
• The Impact of New FDA Leadership on Hatch-Waxman Practice
• PTAB Update: Wins, Losses and Appeals
• Fireside Chat with the PTAB: Thoughts on Practice, Procedure, IPRs and Other Meanderings in the World of Pharmaceutical Patent Validity Challenges
• Obviousness Update for PIV Litigation: Matters of Inherency, Anticipation and Secondary Considerations
• FTC Keynote: Antitrust Developments Concerning Brands & Generics
• The Devil in the Label Details: A New Test for Induced Infringement
• Ethics: Case Studies in Ethical Developments Influencing Paragraph IV Practice
In addition, two post-conference workshops will be offered on April 25, 2018. The first, entitled "Jurisdiction and Venue Selection Master Class" will be offered from 8:30 am to 12:00 pm, and the second, entitled "Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator" will be offered from 1:00 to 4:30 pm.
The agenda for the Paragraph IV Disputes conference can be found here. More information regarding the workshops can be found here and here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference alone is $2,395 (or a special $1,795 in-house rate for pharmaceutical & biotech organizations), or $3,495 for the conference and both workshops. Patent Docs readers are entitled to a 10% discount off of registration using discount code P10-999-PTD18. Those interested in registering for the conference can do so here, by e-mailing [email protected], or by calling 1-888-224-2480.
Patent Docs is a media partner of ACI's 12th Annual Paragraph IV Disputes Conference.
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