Pharmaceutical patent law is a niche field with worldwide implications. Building on the concepts learned in a basic patent law course, this course is designed to foster awareness and understanding of the intricacies involved when patent law converges with regulatory law in the pharmaceutical realm to foster innovation while providing the public access to life-saving medicines. This course will focus on the challenges faced by both innovator (brand) and generic pharmaceutical companies and the strategies implemented by such companies in their efforts to retain or capture market share. Topics include an overview of the Hatch-Waxman Act and its practical guidance of the brand and generic drug approval process, Orange Book Listing requirements, pharmaceutical patent drafting, challenging pharmaceutical patents, paragraph IV litigation, settlements, and antitrust concerns.
- Course Number: IP-0148
- Credits: 1
- Course Format: Lecture
- Eligibility: Open to all students.
- Final examination: 100%
- Midterm examination: -
- Class prep. and participation: -
- Research paper: -
- Regular submissions/quizzes: -
- Other (see syllabus): -