American Conference Institute (ACI) will be holding its Pharma/Biotech Patent Boot Camp on June 21-22, 2007 in New York, NY.  The conference will focus on critical intellectual property and regulatory aspects of pharmaceutical and biotechnology patents, including Patent Office practice and claims drafting, FDA
regulation and Hatch-Waxman Act exclusivity, product life cycles, freedom to operate considerations, and pre-commercialization and commercialization of pharmaceutical and biotechnology products.  In particular, ACI's faculty of IP and regulatory counsel will offer presentations on the following topics:

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  The organization and jurisdiction of the FDA and the PTO and their interplay in the approval and patenting of drugs and biologics.
• Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management.
• The critical role of freedom to operate studies in seeking a life sciences patent.
• How the doctrines of accidental and inherent anticipation factor into the drafting of claims for life sciences patents.
• How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs – and now possibly follow-on biological products.
• 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

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 $1,795.  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.