American Conference
Institute (ACI) will be holding a conference on Follow-on Biologics on June
21-22, 2010 in New York, NY.  ACI
faculty will help attendees:

• Prepare for
follow-on patent litigation and understand what mechanisms are and will be in
place for resolving patent disputes;
• Analyze the
impact of the 12-year exclusivity period on the financial viability of
development of follow-ons;
• Develop methods
for demonstrating or disproving similarity "in terms of safety, purity and
potency of the product";
• Determine what
safety data and technical level of support bio applicants will have to provide
in order to get approval of follow-ons;
• Examine and learn
from the global development of biosimiliars;
• Maximize the biologic
patent lifecycle and protect the value of intellectual property for biologics;
• Investigate
alternative approval methods for biosimilars including BLA applications and
FD&C 505(b)2 applications; and
• Evaluate the
impact of follow-ons on existing and future licensing agreements and strategic
alliances.

In particular,
ACI's faculty will offer presentations on the following topics:

• Overview, status
and history of biosimiliars legislation in the U.S.:  The inside story;
• Practical
implications for the biosimilars market under the new regime;
• Current FDA
position and initiatives regarding follow-on biologics;
• Defining
biosimilars:  Proving (or
disproving) interchangeability and biosimilarity — to be presented in part by Patent Docs author Kevin Noonan;
• An overview of
dispute resolution mechanisms under PHS § 351;
• Developing
procedures and strategies in preparation of follow-on litigation;
• Maximizing the
biologic patent lifecycle and protecting the value of IP for biologics in light
of new legislation:  Written
description, enablement, the doctrine of equivalents and more;
• FTC
spotlight:  Addressing the
antitrust concerns resulting from follow-on legislation;
• Lessons learned
from the development of biosimilars on the international stage;
• Understanding
proposed clinical trials requirements and overcoming safety concerns associated
with follow-ons;
• Developing
alternative pathways for getting biosimilars on the market;
• Renegotiating and
reworking licensing agreements with companies and universities in anticipation
of follow-on biologics; and
• Overcoming
challenges to marketing, branding, and promotion of biosimilars.

A post-conference
workshop, entitled "Applying Patent Term Adjustments and Patent Term
Extensions to Biosimilars to Optimize the Biologic Patent Lifecycle," will
be offered from 9:00 am to 12:00 pm on June 23, 2010.  The workshop will take attendees through the intricacies of
the major ways of getting an extension on biologics patents, and provide
attendees with the tools needed to accomplish this goal in a time of changing
rules and regulations.

A complete brochure
for this conference, including an agenda, list of speakers, and registration
form can be obtained here.

The registration
fee for this conference is $2,195 (conference alone) or $2,795 (conference and
workshop).  Those registering by
May 28, 2010 will receive a $300 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 ACI's Follow-on Biologics conference.