American Conference Institute (ACI) will be holding its 6th Annual Paragraph IV Disputes master symposium on October 2-3, 2018 in Chicago, IL. ACI faculty will help attendees in:
• Understanding the connection between drug pricing and drug patents;
• Examining how different jurisdictions are interpreting the TC Heartland decision for pharmaceutical patent infringement filings;
• Analyzing the significance of the Federal Circuit's Allegan Inc. v. Teva Pharmaceuticals decision holding that the defense of tribal sovereign immunity does not apply to IPR proceedings;
• Assessing the latest decisions on § 101 and their implications for branded pharmaceuticals;
• Reviewing the state of the law on induced infringement and its repercussions for Hatch-Waxman;
• Identifying triggering events for the on-sale bar under the Helsinn and Medicines Co. decisions;
• Understanding how Paragraph IV litigation costs have been affected by multiple filers;
• Exploring how the PTAB has changed its operations since SAS;
• Examining the continued evolution of the obviousness-type double patenting doctrine; and
• Evaluating typical ethical predicaments that may arise in Paragraph IV litigation.
The conference will offer presentations on the following topics:
• Examining the Nexus Between Pricing and Patents in the Hatch-Waxman Landscape
• The Future of Venue and Jurisdiction: Examining the Latest Interpretations and Applications of TC Heartland
• Brand and Generic Perspectives on the Latest FDA Initiatives in the Hatch-Waxman Space
• A Question of Sovereignty: A Retrospect on Invoking Tribal and State Sovereign Immunity as a Means of Patent Protection
• Assessing the Latest Use of § 101 Challenges to Method of Use Patents in a Paragraph IV Setting
• Evolving Tests for Induced Infringement Relative to Method of Use Patents: Implications for Labels, Carve-Outs and Proof of Actual Inducement
• Legal and Business Perspectives on the On-Sale Bar: Examining the Continued Aftermath of Helsinn
• The Distinctive Role of the Magistrate Judge and Local Counsel in Paragraph IV Proceedings
• A Chat With the Chiefs: Perspectives from Chief Judges Castillo and Linares on the Latest Paragraph IV Litigation Challenges
• Developing Effective Strategies for ANDA Litigation Management: Budgeting, Cost-Containment Strategies and Other Practical Considerations Based on Recent Trends
• Assessing the Implications of the Supreme Court's Recent Decision in SAS and Its Impact on PTAB Practice
• PTAB Pharmaceutical Patent Invalidity Round-Up: Update on Wins, Losses, Appeals and the Latest Estoppel Considerations and Concerns
• The PTAB Live: A Hatch-Waxman Practitioner's Guide to Practice, Procedure, IPRs and More in the World of Pharmaceutical Patent Validity Challenges
• Obviousness Update: Addressing Matters of Obviousness-Type Double Patenting, Inherency, Anticipation and Secondary Considerations in the World of Paragraph IV Litigation
• Antitrust Developments Concerning Brand Name, Generic and Hybrid Interests
• Assessing the True Measure of Damages in an At-Risk Launch
• Identifying and Avoiding Common Ethical Dilemmas in Paragraph IV Practice
In addition, two pre-conference workshops will be offered on October 1, 2018. The first, entitled "Biosimilar Litigation Boot Camp for the Hatch-Waxman Litigator" will be offered from 9:00 am to 12:00 pm. This pre-conference workshop will be presented by Patent Docs author Kevin Noonan. The second, entitled "Parallel Proceedings Master Class: Strategies for Balancing and Streamlining Simultaneous Proceedings Before the Federal Courts, PTO & ITC in Pharmaceutical Patent" will be offered from 1:00 to 4:00 pm.
The agenda for the Paragraph IV Disputes master symposium can be found 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 Paragraph IV Disputes Master Symposium.
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