By Kurt R. Karst —
In the Hatch-Waxman Community there are certain folks who are viewed as “the Founders” or pioneers of the law. There are, of course, the names Representative Henry Waxman and Senator Orrin Hatch, but there were several other Founders. One of them—who was said to have been an honorary Member of Congress leading up to the September 24, 1984 enactment of the Hatch-Waxman Amendments—is Alfred B. Engelberg.
These days, Al (as we have come to know him) is a Trustee for The Engelberg Foundation, a private foundation that supports the Icahn School of Medicine at Mt. Sinai. But forty years ago, Al was the generic drug industry’s patent counsel during the negotiations that led to the Hatch-Waxman Amendments. He originated the idea of patent certifications, new drug exclusivity, and the Bolar exemption. (And by the by, Al, a patent attorney, also brought the earliest successful Paragraph IV patent challenge in the 1980s – see here).
Throughout his illustrious career, Al has been engaged with Hatch-Waxman, even authoring one of the earliest papers providing an account of the law: “Special Patent Provisions for Pharmaceuticals: Have They Outlived Their Usefulness?” In his new book, “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer,” which will be released in January 2025 by Post Hill Press and is available now for pre-order on Amazon, Al provides a first-hand account of the events that led to the enactment of the Hatch-Waxman Amendments and of the many others who have shaped brand-name and generic drug competition over the last fifty years.
From Chapter 1 (My First Generic Drug Client), through Chapter 4 (The Hatch-Waxman Act), to Chapter 12 (My Prescription for the Future), the 208-page “Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer” is definitely worth a read! It provides a perspective on Hatch-Waxman that only a few folks out there (and dwindling) can provide.
