During his remarkable career, Alfred Engelberg ’65 has been a chemical engineer, a trial attorney at the US Department of Justice, a patent lawyer, a philanthropist—and an author. In his new book, Breaking the Medicine Monopolies: Reflections of a Generic Drug Pioneer (Post Hill Press), Engelberg describes his role in the growth of the generic drug industry. As counsel for the Generic Pharmaceutical Industry Association, he was instrumental in shaping the 1984 Drug Price Competition and Patent Term Restoration Act—also known as the Hatch-Waxman Act—which created a regulatory framework for bringing generic drugs to market and challenging the validity of pharmaceutical patents. In 1985, partnering with a generic drug maker, Engelberg founded a venture that brought successful patent challenges against pharmaceutical companies under Hatch-Waxman and opened the way to early market entry for generic versions of important drugs. His pioneering efforts led to more than 10,000 pharmaceutical patent challenges brought by generic drug manufacturers over the last forty years.
In recent years, Engelberg has criticized the patent provisions of Hatch-Waxman, claiming that patent litigation over non-meritorious patents by the United States Patent Office wrongfully delays generic competition and contributes to the soaring costs of prescription medicine. Now 85, Engelberg half-jokingly claims, “Half of the pharmaceutical industry thinks I’m dead and the other half wish I was.” In 1994, he helped found the Engelberg Center on Innovation Law & Policy at NYU Law, which fosters groundbreaking cross-disciplinary research on law and policy, including intellectual property law, that supports innovation. Last year, Engelberg received NYU Law’s Judge Edward Weinfeld Award in recognition of his exceptional contributions to NYU Law and society. Previously, he had been awarded NYU Law’s Vanderbilt Medal.
In this Q&A, Engelberg talks about attending NYU Law’s night school, reflects on the historic Hatch-Waxman Act, and shares some advice for current law school students.
What was the process of working on this book like for you?
I never intended to write this book. It all began as an oral history project to create a record of my life for family and friends. But I eventually realized that my professional life was intertwined with the evolution of competition in the pharmaceutical industry and the events that have led to patients in the United States paying the highest prices in the world for prescription medicines while also consuming more low-cost generic medicines than any other developed country. So I decided to write a book that would educate readers about an important area of public policy by writing a memoir about my role in shaping that policy over five decades. My hope was that it would be more entertaining and easier to understand in that format.
It took me a couple of years to convert the oral historian’s record of 40 hours of conversations about my life into a book. Some days you work many hours and others not at all. But I really enjoyed the process because it gave me time to reflect on how experiences in earlier parts of my life impacted my decision-making later on.
You were in one of the last night school classes at NYU Law. Can you talk about that experience?
I made the decision to go to engineering school when I was 15. I was young and naive. The driving force was that I needed to graduate from college with an education that would lead to a meaningful job. I disliked engineering school, but I loved the work-study program at Drexel University because it exposed me to my future life as an engineer. [That life] didn’t suit me at all. That led me to follow some of my older fraternity brothers to Washington, DC, to work as a patent examiner and attend night law school. My first year, I attended George Washington University. A job with Esso’s patent law department brought me to New York. I chose NYU Law because it had the best night school program.
NYU Law was a great experience because we were getting the same education the full-time students received. I particularly remember studying Evidence with [Professor] Irving Younger. But it was tough going to school every night after working a full day at a responsible job as a patent agent. I didn’t have the time to participate in any of the extracurricular things that full-time students did. On the other hand, I was getting great experience working with patent lawyers every day that was reinforcing what I was learning at night.
What were your ambitions after law school?
There was a point in time, midway through law school—partly because I was exposed to different areas of the law—that I made the decision that I wanted to be a trial lawyer. Esso offered me an enormous starting salary to remain with the company as a lawyer, but I decided to take a large pay cut and join the Justice Department as a trial lawyer in the Civil Division, defending the government in patent infringement cases. I wanted to get hands-on experience in a courtroom before going into private practice. The major law firms did not have intellectual property lawyers. IP lawyers practiced in small boutique firms, and young associates dd not usually get the chance to examine witnesses for several years. I was impatient.
How did you come to be in the position of helping to shape the Hatch-Waxman Act?
[In private practice] I began representing small, family-owned generic businesses in litigation with big pharmaceutical companies beginning in the mid-1970s. In 1980, eight small generic manufacturers formed a trade association to lobby for a faster and less expensive Food and Drug Administration approval process for generic drugs and against an effort by the big pharmaceutical companies to get longer patent life for drug patents. The trade association hired me to represent their interests on Capitol Hill and relied on my expertise in patent law to make sure any legislation limited the extent of new patent benefits granted to the Big Pharma companies. But there was a caveat. Getting the abbreviated generic drug approval process was their top priority and they would give up whatever was necessary on the patent side to achieve that goal.
The negotiations over the patent provisions were conducted by Representative Henry Waxman and his counsel in discussions with lawyers and executives representing [Pharmaceutical Research and Manufacturers of America (PhRMA)], the Pharma lobby, and me. My years of experience as a patent examiner, patent agent, and litigator gave me a big advantage and eventually convinced the congressman and his staff to rely more on my proposals for what PhRMA needed than [on] what they were demanding. My book provides the details about those negotiations. For 40 years, people have been writing articles about the intent of the law. I wanted to set the record straight about who was in the room, what the discussions were about, and how the language used in the statute reflected those discussions.
At a symposium celebrating the 40th anniversary of Hatch-Waxman last fall, Congressman Waxman publicly stated that I should have been made an honorary congressman for my work. I was very grateful for his recognition and proud of what I had accomplished.
You’re also a prominent critic of the failings of the law. Why?
I’ve been a critic for a long time. Hatch-Waxman was extremely successful in creating a robust generic drug industry. Before the law was enacted, less than 20 percent of all prescriptions were filled with a generic drug. Today, it’s over 90 percent. But the 10 percent market share enjoyed by newer brand name drugs accounts for 84 percent of drug spending.
Part of the problem is that the monopolies over new drugs last too long and the prices charged—while the monopolies exist—are much too high. Hatch-Waxman and the Patent Office are partly to blame for the fact that monopolies last too long. The Patent Office issues far too many secondary patents of little merit that prolong a monopoly over a drug after the basic patent claiming the active ingredient of the drug expires. Hatch-Waxman allows litigation over these secondary patents to delay legitimate completion that would lead to lower drug prices. A separate law governing generic competition for biologic drugs, drugs made from living organisms, is even worse in allowing belated secondary patents to delay competition.
Some people are shocked that I would be so critical of a law that I was instrumental in helping to get enacted. My view is that nothing lasts forever. If a law fails to accomplish its intended goals, it should be fixed. That doesn’t make me a failure. It’s not surprising that skilled lawyers can figure out over time how to “game” a law to produce unintended consequences that are in their clients’ interests. It’s their job.
Things are clearly in flux in Washington these days, but what do you envision are the chances that the cost of consumer drugs will be addressed on a federal level?
It’s very uncertain because we have a new administration. In the first Trump Administration, the president talked about “pharmaceutical companies getting away with murder” and promised to bring down drug prices. But it never happened. Now he is talking about 25 percent tariffs on imported drugs, which would increase prices. The powerful pharmacy lobby is also unhappy with Medicare drug price negotiations and wants a Republican administration to repeal the law that authorized negotiations. On the other hand, lowering drug prices is a populist issue supported by Trump’s base. We will just have to wait and see what happens.
What has the Engelberg Center on Innovation, Law, and Policy meant to you?
The Hatch-Waxman Act was the result of a negotiation between two industries supervised by Congress. I thought that was wrong. The public should have been represented. More questions should have been asked about the impact of the legislation on consumers. I thought that we needed more expertise at the academic level to play that role. Law schools had a deep bench on constitutional law, antitrust law, and other fields but not much on intellectual property law. When I first got involved with NYU Law as an alumnus in 1993, I discussed my concerns with then-dean John Sexton [Benjamin F. Butler Professor of Law], and he embraced the idea of creating a center on innovation law. It would not have happened without him.
The center, led by our excellent IP faculty, is doing a lot of scholarly work, holding many conferences, and providing expert advance to congressional committees. I’m very proud to have my name associated with the center and to know that long after I am gone, it will continue to make important contributions to society.
What piece of advice would you have given yourself in 1965? And what would you tell law school students today?
I was always looking for a competitive edge. The big questions for me despite all the experience I had by the time I graduated from law school were: “What do I need to learn? What do I need to know that will give me the confidence to perform at the highest level?” That is why I chose the Justice Department rather than a law firm as my starting point.
Today, I think there may be too much emphasis on getting the best paying job from the most prestigious law firm. Perhaps that may be the best way to learn what practicing law is all about. But I would urge students to think a bit more about the larger questions: “What is it that I want to do with my life? What am I really good at? What can I improve so that when the best shot comes along, I’m prepared to take it?”
You have to be lucky, too. I certainly was. But I was also ready when the opportunity presented itself and was able to see an opportunity that many others lacked the experience to appreciate. I’m grateful for that because I’ve had a phenomenally interesting and rewarding life.
Posted February 25, 2025