American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on July 18-19, 2011 in San Diego, CA. ACI faculty will help attendees:
• Understand the interplay of the PTO and FDA in the patenting of drugs and biologics;
• Learn about the essentials of the FDA approval process and its link to biopharmaceutical patents;
• Develop an in-depth and practical knowledge of Hatch-Waxman protocols, including: Orange Book listings, bioequivalency, exclusivities, the 30-month stay, and the safe harbor;
• Navigate the intricacies of patent term adjustment and patent term extension;
• Comprehend how recent biosimilars legislation is changing industry dynamics; and
• Recognize how pre-commercialization concerns relative to CMS approval and Medicare/Medicaid formulary selection are influencing the patenting and approval of drugs and biological products.
In particular, ACI's faculty will offer presentations on the following topics:
• 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 are 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 intricacies of non-patent/regulatory exclusivity;
• Assessing patent protections afforded under the safe harbor; and
• Examining pharmaceutical patent extensions: Patent Term Adjustment and Patent Term Extension.
A post-conference workshop, entitled "Biosimilars: The Law, Interpreting Regulations, and Anticipated Litigation," will be offered from 9:00 am to 12:00 pm on July 20, 2011. The workshop will provide an overview of the law governing biosimilars, delve into the preparations that should be made in anticipation of litigation, and run through what the first biosimilars litigation could possibly look like.
The agenda for the Hatch-Waxman Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, detailed descriptions of conference sessions, list of speakers, and registration form can be obtained here.
The registration fee for the conference is $2,295 (conference alone) or $2,895 (conference and workshop). Those registering by May 20, 2011 will receive a $300 discount and those registering by June 17, 2011 will receive a $200 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media partner of ACI's Hatch-Waxman Boot Camp conference.
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