Part 2 – Hatch-Waxman and BPCIA Fundamentals: Understanding Follow-On Products and the Rules for Generic Entry

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Drugs Overview of Hatch-Waxman and reforms 30-month stay; patent extensions; ANDA filer exclusivity (180 day) Comparing the NDA, 505(b)(2), and ANDA (Abbreviated New Drug Application) drug approval routes Reviewing fundamentals of applications Exploring the ANDA Paragraph IV Certification, and response to Notice Letters Examining ANDA Standards for approval and the concepts of sameness and bioequivalence…

Part 1 – Patents and Related IP Protections and Mechanisms

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Patent Protection for Drugs and Biologics Summarizing the patenting process for drugs and biologics Strategies for building patent protection for drugs and biologics Applying for and achieving extension of patent term for time spent in the drug approval process Patent Term Extension (“PTE”) Patent Term Adjustment (“PTA”) Reviewing the 271(e)(1) “safe harbor” provision Distinguishing the…