American Conference Institute’s 8th Annual


Paragraph IV Disputes

Monday, April 28, 2014 – Tuesday, April 29, 2014

The Conrad New York, New York, NY


Master the litigation strategies that your company needs to successfully scale the legal intricacies of this next crag of the patent cliff.

It is estimated that the industry will experience patent losses approaching $150 billion within the next three years.* This will undoubtedly test the balance of power created by the Hatch-Waxman Act and lead to dramatic new litigation challenges for brand names and generics.

Come to this conference and meet with the leading legal minds in this area as you acquire the skills needed for the new era of extreme Hatch-Waxman litigation.

Now in its eighth iteration, American Conference Institute’s (ACI’s) Paragraph IV Disputes conference is the only event which helps both brand name and generic pharmaceutical companies make sense of changing industry dynamics precipitated by the patent cliff and other factors such as patent reform, regulatory shifts and recent and pending case law. This is the conference that not only sets the standards for Paragraph IV litigation, but also serves as the annual meeting place for the “who’s who” of pharmaceutical patent litigation.

With the help and input of ACI’s Hatch-Waxman Advisory Board, we have designed this conference as a true symposium.  At this gathering, there will be in-depth discussions and practical take-aways that will prepare you for this new era of extreme Hatch-Waxman litigation. Critical sessions will address all facets of Paragraph IV litigation from pre-litigation concerns to the commencement of suit through final adjudication. Most importantly, our faculty will delve deeply into the re-shaping of these elements by an evolving legal, regulatory, and procedural schematic and the harsh economic realities of the patent cliff.

Meet with our faculty of leading counsel from well-known companies and lawyers from firms who represent both brand name and generic interests as they join together to discuss and provide insights on:

·         Paragraph IV assertions of invalidity and non infringement in view of changes to the U.S. patent system under the AIA

·         PTO proceedings as  a parallel or alternate path in a Paragraph IV challenge

·         New obviousness challenges based on evolving case law and patent reform

·         Pleading strategies and dispositive motion practice vis-à-vis local patent rules

·         New safe harbor considerations relative to pre-market and post-market activities

·         Provisions under FDASIA and GDUFA which may impact regulatory matters before the FDA relative to Hatch-Waxman litigation

·         New challenges to regulatory and market exclusivities

·         The latest on patent settlement agreement drafting in view of Watson

·         Claim construction and Markman strategies in light of continuing intra-circuit discord

·         Evolving theories of law in divided infringement and inducement that are influencing method of treatment claims

·         Damages and at risk launches in view of Protonix

·         Inequitable conduct challenges post- Therasense and post-AIA

Our prior delegates say it best:

·         “ACI’s Paragraph IV Disputes (NYC) is the premiere conference in our industry – the place to see and be seen and to rub shoulders with all colleagues, clients and the major players in Hatch- Waxman litigation.” (2013 attendee)

·         “Overall good information and discussed issues of relevance for the present and speakers projected thoughts on future trends which [was] informative and useful.” (2013 attendee)
“A tremendous amount of valuable information.  The speakers were knowledgeable, dynamic, and engaging.”  (2013 attendee)

·         “Great panels, great program, great ACI team.  Conference gets better every year.”  (2013 attendee)

·         “Great conference, very educational.”  (2013 attendee)

·         “This outstanding program has become even better!  It is an invaluable resource for anyone who practices in this complex demanding field, with a timely, comprehensive agenda and impressive presenters who are at the top of the profession.” (2012 attendee)

·         “Useful and informative.” (2012 attendee)

·         “Excellent.”  (2012 attendee)

·         “It is a very interesting conference.  Best when attorneys for generics and branded comment on an issue to get opposing views.” (2012 attendee)

·         “Always an informative, up-to-date, relevant and cogent conference.” (2012 attendee)

·         “Very good conference!  Presenters that discussed as a team [were] very effective.” (2011 attendee)

·         “Exceptional.  Incredibly talented speakers.  Presenters know their stuff cold … and are real experts.  [These are] the people who are making law.”  (2012 attendee)

·         “Really great program – very timely and topical.  All of the speakers have been superb.”  (2011 attendee) 

You must acquire and master the necessary skills to rise to the challenges of this costly and ruthless endgame Past iterations of this event have sold out; register now to ensure your place at this unique and important event.  Call 1-888-224-2480, fax your registration form to 1-877-927-1563 or log onto 

Full conference details are on the way shortly.  If you are interested in speaking at this event, contact Lisa Piccolo at [email protected].  For information on sponsoring or exhibiting at this event, contact Esther Fleischhacker a [email protected]