American Conference Institute (ACI) will be holding its next Paragraph IV Disputes conference on May 3-4, 2011 in New York, NY. The conference will allow attendees to:
• Decipher the proposed revision to the standard of invalidity under Microsoft v. i4i;
• Assess the evolving state of the law on double patenting type obviousness;
• Analyze the significance of the Supreme Court's grant of certiorari in Global Tech v. SEB to Paragraph IV related inducement of infringement actions;
• Explore new damages quantification criteria in view of Plavix, Protonix, and Prilosec; and
• Comprehend the legal and ethical considerations surrounding a possible shift in the standard of inequitable conduct.
In particular, ACI's faculty will offer presentations on the following topics:
• Pre-suit due diligence strategies: Anticipating of the Paragraph IV challenges to small molecule and small protein patents;
• "Invalid or will not be infringed": Re-Assessing the ANDA applicant's pre-litigation considerations and obligations under Paragraph IV vis-à-vis Microsoft v. i4i;
• New standards and controversies in double patenting type obviousness: Repercussions for Paragraph IV challenges;
• Throwing down the gauntlet: The Paragraph IV notice letter;
• Let the games begin: The start of the Paragraph IV law suit -- Pleadings and considerations;
• Forfeiture of exclusivity dilemmas relative to Paragraph IV litigation;
• A view from the Bench on Paragraph IV litigation;
• Mastering regulatory maneuvers essential to PIV litigation;
• Comprehending the new found significance of inducement actions in Paragraph IV litigation;
• FTC keynote: Pay for delay settlements;
• Damages and injunctions: Exploring the consequences and conundrums of launching at risk;
• Alleging and defending against inequitable conduct in a Paragraph IV case: Legal and ethical considerations; and
• Discovery strategies and other pre-trial maneuvering tactics for brand names and generics.
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 May 2, 2011. During this workshop, ACI's faculty will offer presentations on the following topics:
• The FDA approval process for drugs and biologics: A guide for life sciences patent lawyers;
• IP overview for drugs and biologics: Hatch-Waxman, BPCIA, trade dress, and more;
• Patent and non-patent exclusivity;
• Bioequivalence and the "same active ingredient" vis-à-vis patentability; and
• Exploring Patent Term Adjustment and Patent Term Extensions and understanding their applicability to drugs and biologics.
In addition, a post-conference workshop, entitled "The Master Class on Settling Paragraph IV Disputes: Drafting and negotiating strategies for brand-names and generics -- A hands-on, practical approach," will be offered from 9:00 am to 12:30 pm on May 5, 2011. 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 $2,395 (conference alone), $3,290 (conference and pre-conference workshop), $2,995 (conference and post-conference workshop), $3,795 (conference and both workshops), $1,395 (pre-conference workshop alone), or $795 (post conference workshop alone). Those registering by March 4, 2011 will receive a $400 discount (except for the workshops alone) and those registering by April 8, 2011 will receive a $200 discount (except for the workshops alone). 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.
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