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Spring 2015
5367 Biotechnology & the Law - EVANS- 19040

Professor(s): Barbara Evans (FACULTY)

Credits: 3

Course Areas: Health Law 
Intellectual Property and Information Law

Time: 2:30p-4:00p  TTH  Location: 240  BLB

Course Outline: Note: The Biotechnology and Law course taught by Professor Barbara Evans also counts as an EENR course. This course will count towards EENR LLM credits for all UHLC students.

This course provides a practice-oriented survey of the laws and regulations affecting innovation and commercialization of advanced biotechnologies, including agricultural products that rely on recombinant DNA technology (GMO foods, "biopharming"), genetic tests and advanced medical technologies. It can be taken as an elective by students interested in controversies with genetically modified food and advanced biomedical technologies, or as a way to gain practical knowledge if you wish to pursue a career in Houston's growing life sciences and biotechnology industries. It explores the role of major agencies like the NIH, EPA, FDA, USDA, and others in managing environmental and human-safety risks; First Amendment constraints on regulation; and the limits of litigation as a tool to protect the public. The second major topic is regulation by FDA and under the CLIA clinical laboratory regulations--both are extremely hot topics right now as major regulatory changes are in the works--and strategic choices among business models that affect clients' overall regulatory burdens. The third major topic is ownership, control, and pricing of data and biospecimens, which are critical resources for biotechnology innovation and for measuring impacts on health and environment. The final topic is a set of concerns relating to protection and commercialization of biotech IP. This course does not duplicate your IP courses, but explores a group of important topics affecting the application of IP principles to the life sciences industries.

Course Syllabus: Syllabus updated 2/17/15

Course Notes:   A course packet will be made available to you from the professor.

EXAM: A short in-class graded MIDTERM (30% of grade) and a TAKE HOME FINAL (70% of grade).

Prerequisites:  No science background is required. This course does not duplicate Genetics and Law. Students are free to take either or both courses in either order.

First Day Assignments: Read: (1) in Topol book: Introduction, pages v - xi; (2) Joshua Sharfstein, JAMA Viewpoint, (3) James P. Evans and Michael Watson, JAMA Viewpoint.

Final Exam Schedule: Take-home Exam      

This course will have:

Satisfies Skills Course Requirement: No
Satisfies Senior Upper Level Writing Requirement: No

Experiential Course Type:

Bar Course:

Course Materials (11/4/2014 1:01:47 PM)

Book(s) Required