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.
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