5367 Biotechnology & the Law - EVANS- 20388
Barbara Evans (FACULTY)
Course Areas: Health Law
Intellectual Property and Information Law
Time: 4:00p-5:30p MWLocation: BLB-209
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 genetics. 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 challenge lax regulatory oversight. The second major topic is regulation by FDA and under the clinical lab regulations, 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 such as bioprospecting, collaborative research and development agreements, and the Bayh-Dole amendments; and issues affecting the business strategy for commercializing IP after the recent Myriad and Prometheus decisions.
Course Syllabus: Syllabus revised 1/10/2014
Course Notes: There will be no textbook for this class. A course packet will be made available to you from the professor.
Prerequisites: No 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: FIRST DAY'S ASSIGNMENT: For the first day, come prepared to discuss the following two readings: Reading 1A, which is an excerpt from Katharine van Tassel's article that provides background on the Food and Drug Administration's approach to regulating genetically modified foods; Reading 1B - International Dairy Foods Ass'n v. Amestoy, discussing First Amendment issues with laws requiring disclosure of biotechnology-related modifications of food products.
Final Exam Schedule: 05/05 4-7pm
This course will have:
Exam: 70 min. Midterm (30%) and 1 hr, 50-min. Final (70%).
Satisfies Skills Course Requirement: No
Satisfies Senior Writing Requirement: No