The idea of writing a biotechnology law book for scientists was Patrick Fitzgerald’s long before it was mine. I met Patrick in 2015 when he was completing his tenure as science publisher at Columbia University Press. At the time, I hadn’t written a word of my manuscript. That didn’t matter, since publishing a book like mine was already a goal of his. He quickly embraced this project and shepherded me through the proposal, contract, and drafting stages with zeal. I’m indebted to Patrick for his support. Without it, I would not have written this book.
This book covers three complex fields: patent law, regulatory law, and contract law. Attempting a project of this scope would have been unthinkable without rigorous review by experts in these fields. I was most fortunate, then, to have colleagues who were kind enough to critique my draft chapters and knowledgeable enough to do so brilliantly. I’m especially grateful to the following people: Jeffrey Alan Hovden, Esq., partner, Robins Kaplan LLP, for his insights into patent law generally, and patent litigation in particular; Jules T. Mitchel, MBA, Ph.D., president, Target Health Inc., for his insights into the FDA’s drug approval pathways; Michael W. Johnson, Esq., partner, Willkie Farr & Gallagher LLP, for his insights into regulatory law generally, and ANDA and biosimilar litigation in particular; and Stephen M. Goodman, Esq., partner, Pryor Cashman, and cofounder, Mid Atlantic Bio Angels, for his insights into contract law generally, and biotech contracts in particular. For their thoughtful critiques of my draft manuscript, I also extend my heartfelt thanks to the two anonymous peer reviewers retained by Columbia University Press.
Since this project’s inception, I’ve been buoyed by the encouragement and advice of those in the biotech community—from students to clients and from academics to start-up founders. I thank them for this. In particular, I thank Eric M. Vieira, Ph.D., director of Strategic Collaborations, Columbia University, Fu Foundation School of Engineering and Applied Science, for his feedback on my early draft chapters and his invaluable tactical guidance.
The cover design gives this book soul, and the figures let it speak in a way that words alone never could. This is all thanks to the unparalleled artistic talents of Melinda Beck.
I wish to express my sincere thanks to the many people at Columbia University Press—particularly Miranda Martin, Brian Smith, and Ryan Groendyk—whose professionalism and good cheer paved the way to publication.
I’m blessed to have a constellation of family and friends who have always been quick to show their excitement and unconditional optimism for this project.
To write a book is to change one’s life—to let the venture fill each day and inhabit its obsessions. My life and days and obsessions are my wife’s as much as they’re mine. For the past four years, Chiping has met this venture—our venture—with boundless patience, humor, and love. She’s joined me in braving its trials and savoring its joys. For this I’m eternally grateful.