I’m an attorney. Six years ago, I joined the faculty of Columbia University’s Department of Biological Sciences. I can explain.
At the time, teaching law to scientists was unorthodox. Doing so for an entire semester was even more so. Yet, the department wanted to take this step by offering a graduate biotech law course through its M.A. in Biotechnology program. They presented me with the honor of designing and teaching it. How could I say no? I had long known that law is indispensible to the biotech industry. I also believed that it should be part of every scientist’s education.
The contours of biotechnology law are not clear to most. So, to design the course, I first had to define that term. In a sense, defining biotechnology law is akin to taking a Rorschach test. Everyone does it differently, and how one does it reveals much about their own professional outlook.
My own outlook, of course, came from decades of representing biotech companies, universities, research institutes, and investors. My work for them centered on patents, transactions, and, tangentially at least, regulatory matters. It was through the prism of this experience that I defined biotechnology law to include patent, regulatory, and contract law. This was a sweeping definition. As such, it raised the question of exactly what I would cover within these three legal fields. I again turned to my own experience for the answer.
As a core part of my law practice, I had fielded countless questions from clients. Many were abstract. What makes an invention patentable? How is a patent a negative right? How does patent prosecution work, and how long does it take? When is a patent infringed, and what types of infringement exist? How can patent infringement be avoided? What is a patent opinion, and what are its risks and benefits? What are the requirements for getting a small-molecule drug approved? What about a biologic drug? How does regulatory exclusivity work, and how does it relate to patent protection? How does generic drug approval work, and what is ANDA litigation? What is a biosimilar, and what is the patent dance? What are the features of a confidentiality agreement? How does a patent license work? What is the difference between an exclusive and nonexclusive license? What does the grant clause do? What does a drug development agreement accomplish? What might its core provisions be? The list goes on.
The answer to each question was a concise explanation of just one or two points of law. Together, though, they made up the fundamentals of patent, regulatory, and contract law—or at least the fundamentals that I wished my clients had understood before discussing their cases with me. My course was to be for science students. What better template for its content, then, than the answers to questions my clients had actually asked over the years?
While designing the course, I also searched for an appropriate textbook. I found none and had to rely instead on detailed lecture notes, slides, and a semester’s worth of class time. In the end, of course, my students learned the material.
Yet, what of the far larger group of those who need to learn this subject but haven’t the time, ability, or inclination to take a semester-long course? What of those who, like my clients, seek a better grasp—or simply a grasp—of biotechnology law so that they can derive more from their time with counsel? What of the start-up founder filing her first patent application, or the regulatory specialist foreign to patent law yet needing to comprehend ANDA litigation? What about the in-house patent liaison grappling with the field-of-use provision in a patent license, or the private equity investor unfamiliar with the basics of patent opinions?
Those in this group—start-up founders, regulatory specialists, patent liaisons, investors, and other scientifically trained nonattorneys—need a biotechnology law book written just for them. They need a book that is at once practical, clear, concise, and suitable for independent use.
This book is my humble attempt to provide just that.