MPTX 516: Medical Products and the Law

Instructors: Kellie Ann Moore, JD
Fred Weissman, Pharm D, JD School of Pharmacy (coordinator)
Monica Thompson, JD
Carol Schneider, LLD, partner, Lyons and Lyons

Course weight: 3 units
Placement: September 13 - December 6 2001, Thursday evenings
Next class offering: Fall 2002

Latest agenda (may be from previous class)

Introduction and Purposes:

Laws governing medical products are the beginning point for regulations that identify how research, development and marketing of such products should be pursued. Almost every activity in the chain of product-development activities will have legal implications and liabilities. This course will explore the history of laws related to medical product development, commercialization and clinical use, and will consider relevant legal cases whose decisions have been important in establishing precedents and guiding interpretations of legal theory over the last two decades.

The course is core to a new Master’s program in Regulatory Science and optional for other students in USC graduate programs. Graduates from this program will be expected to demonstrate a solid knowledge of the legal framework governing regulatory activities. They will understand the legal consequences of improper behavior or inadequate oversight. At the end of this course, students should have acquired the following knowledge- and skill-sets:

- Students will know how to file a patent disclosure, provisional patent and final patent in the US and internationally
- Students will be able to understand the significance of patent claims language, and understand the implications of patent term; students will understand the mechanisms for extending patent terms for products with lengthy regulatory paths.
- Students will understand the legal framework underlying liability suits, including theories of negligence, breach of warranty and strict liability
- Students will understand the legal implications of non-compliance with FDA and FTC regulations
- Students will understand the rights of individuals as clinical subjects; they will be able to differentiate concepts of malpractice, assault and battery, and negligence in the clinical setting
- Students will have a basic understanding of contract law as it pertains to employment and to the establishment of relationships with customers and vendors.

Much of the course will be presented using the case-study method, with relevant examples from recent court cases. The course will be team-taught by a consortium of individuals with different skill-sets.

Course Requirements and Grades:

At the end of the course students should be able to demonstrate a competent knowledge of the subject matter as appraised by an end-of-term examination. However, students also will work in a group to present a short case study based on an assigned legal case. The students will work as a team to present the case study, then discuss the salient issues addressed by the case, the effect of its decision on the regulatory process or environment, and the implications for practice. The oral presentation will be followed by a short ( 4-page maximum) report.

Examination: 60%
Case study (class presentation): 20%
Report: 20%

The presentation in class will be marked by both the class members and the instructors using the appended evaluation sheet. The written submission will be evaluated on the basis of:

- Clarity of presentation
- Correct identification of regulatory issues
- Judgment regarding implications for regulatory and other aspects of practice
- Appropriate use of source materials collected as a reference list

Course Sessions
Lecture sessions will be grouped in blocks of 3-4 hours. Each block, numbered below, will include the presentation of a case study and an exploration of the concepts underlying the central question of issue using relevant text materials and journal articles.

1. Intellectual Property:

Writing and filing patents
Interpreting patent claims
Using regulatory activities to justify extension of patent terms (Drug Price Competition and Patent Term Restoration Act)
Different rules in different constituencies

2. Patents as competitive tools:

Infringement
Invalidation
Sale and licensing
Implications for generic drug development