American Conference Institute (ACI) will be holding its fall session of the Pharma/Biotech Patent Boot Camp on September 18-19, 2007 in San Francisco, CA.  The conference will focus on the interplay of the Patent and Trademark Office (PTO) and Food and Drug Administration (FDA) in the patenting of drugs and biologics as well as on coordinating patent filings with FDA strategies; developing practical knowledge concerning Hatch-Waxman protocols, including Orange Book listings, exclusivities, bioequivalency, the 30-month stay, and the safe harbor; determining when and how to undertake a freedom to operate analysis; navigating patent term adjustment and patent term restoration regulations; drafting strong claims; and avoiding pitfalls associated with licensing agreements.  In particular, ACI's faculty of IP and regulatory counsel will offer presentations on the following topics:

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  Key agencies: Understanding the jurisdiction and interplay of the FDA and PTO in the patenting of drugs and biologics;
• Life sciences patents: What is patentable?
• Tests for patentability in the life sciences;
• Perfecting claims in life sciences patent applications;
• Pre-patent considerations relative to product development, commercialization and life cycle management;
• Freedom to operate: Analysis and opinions for pharma and biotech patents;
• Finding safe harbors for life sciences IP: Assessing protections and identifying infringing activities relative to third-party patents;
• The nature of the approval process for drugs and biologics:  What every life sciences patent attorney should know;
• Patent and IP overview for drugs and biologics:  Hatch-Waxman, trade dress, and more;
• Patent and non-patent exclusivity;
• Bioequivalence and the "same active ingredient" vis-à-vis patentability;
• Exploring pharmaceutical patent extensions:  Patent term adjustment and patent term restoration;
• Transactional considerations:  The essentials of life sciences licensing

The agenda for the Pharma/Biotech Patent Boot Camp can be found here and a list of conference speakers can be found here.  A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.

The registration fee for the conference is $1,995 (or $1,795 for those registering before July 20, 2007).  Those interested in registering for the conference can do so here or by calling 1-888-224-2480.

Patent Docs is a media sponsor of ACI's Pharma/Biotech Patent Boot Camp.