American Conference
Institute (ACI) will be holding its next Paragraph IV Disputes conference on May
7-8, 2013 in New York, NY. The
conference will allow attendees to:
• Assess how new
PTO proceedings will influence the course of Hatch-Waxman litigation;
• Understand how
new 271(e)(1) controversies under Claussen
and Momenta will affect ANDA filings;
• Decipher the
impact of new obvious considerations in the courts and PTO on primary compound
and composition claims;
• Assess the
implications of new regulatory considerations under FDASIA, the GAIN Act, and
Generic User Fees Act on Paragraph IV proceedings;
• Explore
inducement and divided infringement in the context of Orange Book-listed method
patents;
• Identify new challenges
to market as well as regulatory exclusivities; and
• Examine possible
damages quantifications for launching at risk.
In particular,
ACI's faculty will offer presentations on the following topics:
• Anticipating a Paragraph IV challenge: New
considerations in light of AIA and the patent cliff;
• Asserting invalidity or non-infringement
under Paragraph IV: Exploring the ANDA applicant's pre- litigation obligations
and options;
• Safe harbor or stormy port?: Analyzing how
new 271(e)(1) controversies will impact Paragraph IV disputes;
• Throwing down the gauntlet: The Paragraph IV
notice letter;
• Obviousness in retrospect: Making sense of
prior art, obvious-type double patenting, inherency, and new AIA controversies;
• Let the games begin: The start of the
Paragraph IV lawsuit -- Pleadings and other initial considerations and analyses;
• A view from the Bench;
• Pay-for-delay update -- to be
presented by Markus H. Meier, Assistant Director, Health Care Division Bureau
of Competition, Federal Trade Commission;
• Settlement of Paragraph IV lawsuits: The
industry perspective;
• Parallel and alternate proceedings in
Paragraph IV disputes: Seeking simultaneous or sole redress before the PTO, ITC
and other alternative forums;
• FDA proceedings and regulatory developments
impacting Paragraph IV litigation;
• New exclusivity challenges: Brand names take
notice -- It's not just a concern for generics anymore;
• Examining new rulings in inducement of
infringement and divided infringement and their application to method claims in
Hatch-Waxman litigation;
• New developments in damages theories and injunctions relative to at
risk launches: Legal and economic assessments; and
• Inequitable conduct developments in the courts and at the PTO: Ethical
considerations for Paragraph IV cases.
In addition, two pre-conference workshops will be offered on May 6, 2013. The first, entitled "Hatch-Waxman and BPCIA 101 -- A Primer on IP Basics and Regulatory Fundamentals" will take place from 8:15 to 11:30 am, and the second, entitled "Assessing the Impact of New PTO Procedures Under the AIA on Paragraph IV Litigation" will take place from 12:45 to 4:00 pm. A post-conference session entitled "The Master Class on Settling Paragraph IV Disputes: Drafting and Negotiating Strategies for Brand-Name and Generic -- A Hands-On, Practical Approach" will be offered from 9:00 am to 12:30 pm on May 9, 2013.
The agenda for the Paragraph IV Disputes conference can be found here. More information regarding the workshops and master class 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), $2,995 (conference and one
workshop), $3,595 (conference and two workshops), or $4,195 (conference and all
workshops). Those registering by March
16, 2013 will receive a $400 discount and those registering by April 12, 2013
will receive a $200 discount. Those
interested in registering for the conference can do so here,
by e-mailing [email protected], 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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