The American Conference Institute (ACI) will be presenting its 3rd Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA as part of its VIRTUAL proficiency series on October 10-26, 2023. The course provides a primer on IP basics and regulatory fundamentals relating to small molecules and biologics for practitioners representing brand name, generic, and biopharma drugs.
The three week virtual course is set out in three topic areas. Week 1 (sessions on October 10th and 12th) will set forth the regulatory foundation of pharmaceutical patent protection and regulatory approval. These sessions will discuss the interplay of the FDA and PTO; pre-commercialization concerns; the links between the drug approval process at FDA and patenting before the USPTO; and discuss the intricacies of the Orange Book.
Week 2 (October 17th and 19th) explore the Hatch-Waxman and BPCIA regulatory frameworks, including the Hatch-Waxman landscape; Paragraph IV dispute and litigation; biosimilars, the BPCIA and aBLA; participation in the "patent dance" set out in the BPCIA statutory regime; and the Purple Book, the biologics/biosimilar counterpart of the Orange Book, as well as the distinctions between the two.
Week 3 (October 24th and 26th) will focus on bioequivalence, exclusivity, extensions, and exceptions. These sessions will discuss bioequivalcency, interchangeability, and the distinctions between the two; the 180-day exclusivity provided to first generic filers under Hatch-Waxman; non-patent/regulatory exclusivities; exploring the safe harbor for research under 35 U.S.C. § 271(e)(1); and obtaining patent term extensions.
Instructors include Li Feng/Finnegan, Henderson, Farabow, Garrett, and Dunner; Rachel L. Pernic Waldron/Rakoczy Molino Mazzoci Siwik; David B. Abramowitz/Locke Lord; Michael A. Davitz/Leason Ellis; Daniel Klein/Groombridge, Wu, Baughman & Stone; Frederick Ball/Duane Morris; Dov Grossman/Williams & Connolly; Keeto Sabharwal/Husch Blackwell; Daniel P. Margolis/Allen & Overy; Bryan Vogel/Robins Kaplan; April Weisbruch/McDermott Will & Emery; Kyle Musgrove/Parker Poe Adams & Bernstein; Gary Vernon/Hogan Lovells; Mureen Rurka/Winston & Strawn; Christina Markus/King & Spaulding; Jordan Markham/Steptoe & Johnson; Christopher Noyes/WilmerHale; Brian Burgess/Goodwin Proctor; Lara E. FitzSimmons/ Rakoczy Molino Mazzoci Siwik; David Ffazier/Latham & Watkins; Rob Vrna/Young Conaway Stargatt & Taylor; Fabian Koenigbauer/Ice Miller; and Matthew Murphy/Axinn, Veltrop & Harkrider.
The brochure, agenda, and registration information can be found here. The registration fee for the program, including all modules, is $1,795 if registration and payment is received by September 22, 2023 and $1,895 if registration and payment is received by October 10th. ACI can be contacted by e-mail at [email protected] and by telephone at 1-888-224-2480.
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