ANDA Litigation and The America Invents Act

About the Course: This session is critical for understanding how The America Invents Act will impact ANDA Litigation. This course begins with a thorough review of provisions relating to Abbreviated New Drug Applications. Topics illuminated include restoration of patent term; requirements for filing ANDA applications (e.g. in terms of active ingredients and bioequivalency); and, Paragraph IV certifications. The seminar continues by providing insight as to how aspects of the AIA will affect ANDA. These discussion points include inter-partes review; post-grant review; supplemental examination; derivation proceedings; defenses; and, patent prosecution issues. The program concludes by delving into an analysis of recent litigation that intersects with the AIA and ANDA. The following are among the issues discussed during this webinar: What are the incentives for filing for ANDA? How will interferences by impacted by the AIA? Does the AIA raise or lower the bar for the issue of obviousness? How can potential obvious challenges be drafted around? How does the AIA affect prior use defenses? What is the status of the best mode requirement under the AIA? What should you know about the intersection of prophetic experiment and the written description requirement? What are the standards for pursuing post-grant review? What role does lead compound analysis play in ANDA and patent challenges under the AIA? What are the fee schedules like in terms of filing for inter-partes review and supplemental examinations? The following are among the recent cases that are reviewed in detail: Pfizer v. Apotex Otsuka Pharma v. Sandoz University of Rochester v. Pfizer Ariad v. Eli Lilly Caraco Pharma Labs., Ltd v. Novo Nordisk A/S Course Leader: Robert D. Katz, Partner, Eaton Van Winkle Robert D. Katz received his BA degree in chemistry from Columbia University and his JD degree from Case Western Reserve University, where he was an Editor of the Law Review. He is admitted to the New York and Illinois State Bars; the US District Courts for the Southern and Eastern Districts of New York and the Northern District of Illinois (Trial Bar) and the US Courts of Appeals for the Second, Fifth, Seventh, Ninth and Federal Circuits. He is a registered patent attorney. Mr. Katz is a member of the American Intellectual Property Law Association and the New York Intellectual Property Law Association. He has lectured on intellectual property law at Stern Graduate School of Business at New York University and Columbia University School of Business. His practice involves biotech, nanotech, advanced materials, chemical, and pharmaceutical patent solicitation and litigation, trademark, unfair competition and copyright litigation and counseling. He was recently inducted into the prestigious Conner Inn of Court in New York City.
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