Hatch-Waxman Boot Camp

ACI Hatch-Waxman Series Presents…

Hatch-Waxman Boot Camp

A Primer on IP Basics and Regulatory Fundamentals Relative to Small Molecules and Biologics for Brand Names, Generics and Biopharmas

Monday, May 24 to Tuesday, May 25, 2010
ACI, The Nation’s Premier Provider of Life Sciences Intellectual Property Conferences, is pleased to bring the first installment of its renowned Hatch-Waxman Series to San Diego.
Understand the interplay of IP and FDA regulation relative to pharma/biotech patents vis-à-vis Hatch-Waxman and a proposed FOB scenario.
A thorough understanding of Hatch-Waxman is absolutely essential to anyone working in the biopharmaceutical industry. This knowledge sets the foundation for the protection of small molecules and small proteins and provides the tools to comprehend an IP and regulatory framework for what lies beyond the realm of traditional pharmaceuticals. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to the FDA approval process. Anyone who works in the life sciences industry — or who even remotely deals with its IP — must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
You cannot afford to be left in the dark regarding the interconnection of IP law and FDA regulation in these industries.
Garner the winning edge — boost your life sciences IP and regulatory IQ.
ACI’s Hatch-Waxman Boot Camp has been designed to give counsel and advisors to brand name and generic drug companies — and biopharmas — critical insights into commercialization and the pre-approval process, and also provide an in-depth review of Hatch-Waxman and other IP basics relative to small molecules and biologics. This conference will lay the necessary foundation for you to comprehend thoroughly the dynamics of the relationship between patent life cycles for pharmaceutical and biopharmaceutical products and business development plans.
Master the intricacies of the patent and regulatory framework for drugs and biologics.
A faculty of top-notch IP and regulatory counsel — all having a wealth of experience through working for brand names and generics as well as biopharmas — will share their knowledge on:

  • The organization and jurisdiction of the FDA and the PTO and their interplay in the patenting of drugs and biologics
  • How the approval process for drugs and biologics is connected to the patenting of these products
  • Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management
  • How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs — and how follow-on biological products may add a new dimension to this schematic
  • The relationship between patent and non-patent exclusivity
  • The importance of patenting bioequivalence characteristics in certain drug products
  • The ‘ins and outs’ of patent term extension under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791

Also, i n response to your requests, we have added a special Master Class on Follow-On Biologics which will lead you through every IP and regulatory consideration in this complex and impending area.

Attend this conference and learn to navigate your way through the IP and regulatory mazes that play such a crucial role in your practice areas. Register now by calling 1-888-224-2480, faxing your registration form to 1-877-927-1563, or registering online at www.AmericanConference.com/HWBootCamp



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