American Conference Institute (ACI) will be holding a West Coast edition of its Paragraph IV Disputes conference on December 8-9, 2010 in San Francisco, CA. The conference will allow attendees to:
• Identify patents for small molecules and small proteins that may be ripe for a Paragraph IV challenge;
• Recognize an ANDA applicant's initial obligations and reevaluate Orange Book tactics;
• Incorporate post-KSR obviousness considerations into Paragraph IV litigation strategies;
• Comprehend the procedural and substantive requirements for the contents and delivery of the Notice Letter;
• Develop a plan to use the 45 day post-Notice Letter receipt period more effectively and know when it makes sense to file suit;
• Master techniques for drafting the initial Paragraph IV pleadings and factor in considerations relative to venue, jurisdiction, local rules, and cost;
• Understand the criteria for 180-day exclusivity and the circumstances under which it may be forfeited;
• Appreciate the significance of generic versus generic actions for brand names and generics;
• Navigate the intricacies of litigation with multiple ANDA filers;
• Spearhead discovery dilemmas, optimize the use of experts, and perfect Markman timing;
• Analyze the CAFC's latest findings on declaratory judgments, inequitable conduct, preliminary injunctions, and Rule 11 sanctions vis-a-vis Paragraph IV cases; and
• Weigh the options over an at risk launch.
In particular, ACI's faculty will offer presentations on the following topics:
• 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 versus generic law suits;
• Litigating with multiple ANDA filers: Brand name and generic perspectives;
• FTC keynote: Pay for delay settlements;
• Recent decisions impacting Paragraph IV challenges and motion practice;
• Discovery strategies and pre-trial maneuvering tactics for brand names and generics; and
• Assessing danger and mitigating liabilities associated with injunctions and "at risk launches."
Two additional workshops will be offered before and after the conference. A pre-conference workshop, entitled "Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals," will be offered from 10:00 am to 5:00 pm on December 7, 2010. During this workshop, ACI's faculty will offer presentations on the following topics:
• A guide to the essentials of the FDA approval process for drugs and biologics for life sciences patent lawyers;
• Patent and IP overview for drugs and biologics: Hatch-Waxman, trade dress, and more;
• Patent and non-patent exclusivity;
• Bioequivalence and the "same active ingredient" vis-à-vis patentability; and
• Exploring pharmaceutical patent extensions: Patent Term Adjustment and Patent Term Restoration.
In addition, a post-conference workshop, entitled "The Master Class on Settling Paragraph IV Disputes: Brand-Name and Generic Perspectives," will be offered from 9:00 am to 12:30 pm on December 10, 2010. In this workshop, ACI faculty will explore the best practices for reaching and finalizing settlements that the parties and the FTC can live with.
The agenda for the Paragraph IV Disputes conference 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 is $2,295 (conference alone), $3,195 (conference and pre-conference workshop), $2,895 (conference and post-conference workshop), $3,595 (conference and both workshops), or $1,395 (pre-conference workshop alone). Those registering by November 12, 2010 will receive a $200 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of the Paragraph IV Disputes conference.
Comments