Pharmaceutical Patent Litigation/ Hatch Waxman (LAW-795BC-001)
Sanya Sukduang, Jonathan Davies
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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. The course will use letter grades.
Textbooks and Other Materials
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First Class Readings
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