Orange Book Blog

American Conference Institute is holding a "Hatch-Waxman Boot Camp" conference in San Diego, California on July 18th and 19th, at the Hilton San Diego Resort & Spa.  ACI calls this conference "a primer on IP basics and regulatory fundamentals relative to small molecules and biologics."

Here's the agenda:

• Key agencies overview: Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics
• Identifying and comprehending pre-commercialization concerns relative to small molecules and biologics
• Exploring the link between the FDA approval process and the patenting of drugs and biologics
• IP overview for drugs and biologics: Hatch-Waxman, BPCIA, trade dress, and more
• Paragraph IV disputes and litigation
• How the dynamics of biosimilars and changing the Hatch-Waxman landscape
• Orange book listings, de-listings and related challenges
• Bioequivalence and the "same active ingredient" vis-a-vis patentability
• An in-depth look at 180-day exclusivity
• Comprehending the intracacies of non-patent/regulatory exclusivity
• Assessing patent protections afforded under the 271(e)(1) safe harbor
• Examining pharmaceutical patent extensions: Patent term adjustment and patent term extension

In addition, there is a post-conference Interactive Biosimilars Strategy Session on July 20th.

Orange Book Blog readers can receive a $200 discount by using code OBB 200.  For more information or to register, please visit the conference website.