Hatch-Waxman Boot Camp

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