American Conference Institute (ACI) will be holding the next session of its Hatch-Waxman Boot Camp conference on June 25-26, 2012 in San Diego, CA.  ACI faculty will help attendees:

• Comprehend how recent biosimilars legislation is changing industry dynamics;
• Understand the interplay of between 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; and
• Recognize how new 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: Federal Court, PTO proceedings & ITC actions;
• 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 Restoration.

A post-conference interactive biosimilars strategy session, entitled "Biosimilars: An In-Depth Look at the Law, Interpreting Regulations, and Anticipated Litigation," will be offered from 9:00 am to 12:00 pm on June 27, 2012.  The workshop will provide an overview of the law governing biosimilars and will then delve into the preparations that should be made in anticipation of litigation.

A post-conference workshop, entitled "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act and the Impact on Hatch-Waxman Litigation," will be offered from 1:00 pm to 4:00 pm on June 27, 2012.  The workshop will provide a clear overview of the numerous sections in the America Invents Act, especially highlighting how it will tie into Hatch-Waxman and when implementation will begin.

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), $2,895 (conference and one workshop), or $3.295 (conference and both workshops).  Those registering by April 27, 2012 will receive a $300 discount and those registering by May 25, 2012 will receive a $200 discount.  Patent Docs readers who reference the discount code "PD 200" will receive $200 off the current price tier when registering.  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.