American Conference Institute's

Paragraph IV Disputes Master Symposium

The Advanced Forum for Brand Name and Generic Counsel on the Intricacies of Pre-suit Considerations, Law Suit Commencement, Motion Practice and Final Adjudication in Hatch-Waxman Litigation

Thursday, October 03 to Friday, October 04, 2013
Millennium Knickerbocker Hotel, Chicago, IL

Building on the precedent and tradition of its renowned and industry-leading Paragraph IV Disputes conference, ACI proudly brings you the next installment in our Hatch-Waxman Series — the Paragraph IV Disputes Master Symposium.

With the help and input of ACI’s Hatch-Waxman Advisory Board, we have designed this conference as a true symposium. This is a brand name and generic think tank where the leading legal minds in this area will meet to exchange information and insights. 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 — leading counsel from well-known brand name and generic companies and firms — 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. They will join together to discuss and provide insights on:

  • Paragraph IV assertions of invalidity and non infringement in view of 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 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

We are also very pleased to have the participation of several esteemed Federal Jurists from the Districts of Northern Illinois, Eastern Texas, and New Jersey. Their presence will provide you with the opportunity to learn firsthand how the bench analyzes your theories of the case.

Further enhance your experience at this symposium by attending our Master Class and/or Boot Camp on critical Hatch-Waxman competencies that go straight to the crux of a Paragraph IV challenge:

  • Hatch-Waxman and BPCIA Master Class — Perfecting Your IP and Regulatory IQ of Small and Large Molecules will supplement and enhance your knowledge of the intellectual property and regulatory framework governing the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act of 2009 (BPCIA).
  • Post-Grant Review and Inter Partes Review Boot Camp: Essential Considerations for Brand Names and Generics Regarding the Use of These PTO Procedures in Paragraph IV Scenarios will provide a critical step-by-step guide on how new PTO procedures under The America Invents Act (AIA) such as Post-Grant Review and Inter-Partes Review in relation to Paragraph IV.

You must acquire and master the necessary skills to rise to the challenges of this costly and ruthless endgame. Register now by calling 1-888-224-2480, faxing your registration form to 1-888-927-1563 or logging onto www.AmericanConference/PIVDisputesChicago.