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Summer 2014
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Pharm Patent Litigation under Hatch Waxman (LAW-795BC-001)
Sukduang, Davies

Meets: 09:00 AM - 05:00 PM (FS) - Room 445

Enrolled: 12 / Limit: 15


Meets 6/20-21 9AM-5PM


This course provides a detailed look into a very complex area of patent litigation. This course will explore the origins of Hatch-Waxman and address various issues that arise litigating these cases, including FDA Orange Book patent listing and delisting, the interplay between patent law and FDA law as it pertains to branded drug exclusivity, settling Hatch-Waxman lawsuits, and the newly enacted counterpart to Hatch-Waxman, the Biologics Price, Competition, and Innovation Act for biological drugs.

Textbooks and Other Materials

The textbook information on this page was provided by the instructor. Students should use this information when considering purchases from the AU Campus Store or other vendors. Students may check here to determine if books are currently available for purchase at the AU Campus Store.

First Class Readings

Not available at this time.


The syllabus is available in the following format(s):