American Conference
Institute (ACI) will be holding its 2nd Annual Paragraph IV on Trial conference
on November 12-13, 2009 in New York, NY.
At this conference, Hatch-Waxman litigators experienced in representing
both generic and innovator drug manufacturers will immerse attendees in a live,
two-day, interactive mock trial of a Paragraph IV case based on a real-life
fact pattern derived from an ANDA filing.
The mock trial, Newark Branded
Pharmaceuticals v. Flatiron Generic Pharmaceuticals, will allow attendees
to hone advocacy and litigation skills in:
• Communicating
with the judge in a clear and concise manner while presenting complex technical
and scientific information to the court;
• Developing a
cohesive and scientifically-supported theory to address issues raised by
infringement, validity, and inequitable conduct claims during trial;
• Addressing prior
art and discrepancies in the patented product's prosecution history in a manner
that supports the theory of your case; and
• Handling expert
and fact witnesses on the stand during direct and cross examination when
testifying about sensitive product and company details.
The conference is
structured as an actual trial based on an ANDA filing involving Newark's formulation patents for "biploxy" and "esbiploxy," during which ACI's faculty will conduct live
demonstrations of direct and cross examinations. ACI's faculty will also delve into the key issues at stake
during trial, including:
• Infringement —
how to lay the proper foundation through your expert in order to build your
case;
• Obviousness and
anticipation — tactics for handling prior art testimony and addressing
arguments of validity and invalidity;
• Secondary
considerations — strategies for effectively presenting technical experts and
communicating complex, scientific and technical information to the court; and
• Inequitable
conduct — dealing with testifying patent law experts and complicated
prosecution records during trial.
Two additional
master classes will be offered on November 11, 2009. The first, entitled "Pre-Trial Preparation: Filing Strategies, Witness Selection, Motions
and Claim Construction," will be held from 9:00 am to noon, and the
second, entitled "Reverse Settlement Payments: Negotiating and Finalizing Settlements That Won't Raise
Antitrust Concerns," will be held from 1:00 to 4:00 pm. During the first master class, patent
litigators experienced in representing both brand name and generic
manufacturers will discuss proven strategies for preparing for a Paragraph IV case. In the second master class, Hatch-Waxman
and antitrust litigators will provide attendees with the best practices for
negotiating and finalizing settlements that both parties and the FTC can live with.
The agenda for the
Paragraph IV on Trial conference and master classes can be found here. A complete brochure for this
conference, including an agenda, list of speakers, mock trial fact pattern, and
registration form can be downloaded here.
The registration
fee for the conference is $2,195 (conference alone), $2,795 (conference and one
master class), or $3,395 (conference and both master classes). Those registering on or before
September 18, 2009 will receive a $300 discount off the registration fee and
those registering on or before October 23, 2009 will receive a $200 discount
off the registration fee. 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 sponsor of ACI's Paragraph IV on Trial conference.

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