California Western -- Robert Bohrer
Courses Taught - Robert A. Bohrer

  Biotechnology Seminar          FDA Law          Torts II


BIOTECHNOLOGY SEMINAR (SWR, 3 units)
The biotechnology industry is now booming and patent, business, regulatory and health-care lawyers are providing advice and guidance essential to the industry’s growth.  This course surveys the role of the lawyer in the commercialization of biotechnology.  It follows the “life cycle” of the technology, from basic research at universities and not-for-profit foundations through transfer to the private sector and ultimately into the marketplace.  In doing so, attention is focused on the legal protection of biotechnology inventions through trade secret and patent, the regulation of the biotechnology industry by the FDA, EPA, USDA and NIH, “technology transfer” from not-for-profit institutions via licensing agreements and the creation of for-profit affiliates, venture capital agreements, corporate formation and financing of biotechnology companies.  The course requirements are an independently researched scholarly writing paper on an aspect of biotechnology law (patents, licensing, financing, regulation or reimbursement) and a short, informal oral report and paper analyzing a publicly traded biotech company from a lawyer’s perspective.   back to top
  
FDA LAW (SWR, 3 units)
This course is a "case study" approach to learning about the way in which the Food and Drug Administration regulates the development of new drugs, biologics (such as vaccines and injectable protein drugs), medical devices, and food additives.  Particular emphasis will be placed on the statute, regulations, and FDA materials intended to assist FDA "users" in interpreting the FDA's authority and procedures.  Students will write a paper for swr credit which examines a current problem involving the FDA and in which the students propose a solution or evaluate alternative solutions.   back to top
  
TORTS II (3 units)
Continued examination of civil liability for harm arising out of some or all of the following tort areas:  negligence, including special duties (such as owners and occupiers, third party liability and governmental entities), nonfeasance and duty arising out of contract, wrongful death and birth; strict liability, including vicarious liability, abnormally dangerous activity, and products liability; nuisance; defamation; invasion of privacy; misrepresentation; economic torts.   back to top


 Full course descriptions are available in PDF format on the J.D. Curriculum page.

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