Enthalpy Coursework Columbia

Biotechnology Law. A. J. Morrison

The term “biotechnology law” is used here to mean a collection of distinct areas of law that play a prominent role in the biotech industry.  There are many legal disciplines having at least some nexus with this industry, and they include such diverse specialties as corporate law, securities law, real estate law, employment law, tax law and healthcare law. 

          However, this course features the interrelated areas of intellectual property law, regulatory law and contract law, with a particular emphasis on patent law.  Patents and related agreements have become critical resources for universities and research institutes.  Similarly, patents, patent-related agreements and regulatory filings are the sine qua non of biopharmaceutical companies.  This course is designed to arm students with an understanding of these fields so that, during their biotech careers, they can productively work with counsel to manage their organization’s patent portfolio and litigations, negotiate and draft development and license agreements, and oversee regulatory affairs.  Since other courses in the Biotechnology MA Program thoroughly address biotech regulatory affairs, this course addresses only selected regulatory topics germane to patent protection, licensing, generic drugs and biosimilars.  

          The biotech, pharmaceutical and diagnostic sectors will be the course’s industrial focal point.  The course therefore requires familiarity with the science underlying these subjects.

          Lectures will include ample discussion time to reinforce concepts taught and ensure that lingering questions are dealt with immediately and in sufficient detail. 

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