William Mitchell Law Review evaluates impact of the Hatch-Waxman Act

The latest issue of the William Mitchell Law Review was sought out before it even hit the presses. Volume 40, Issue 4 covers the 30th Anniversary of the Hatch-Waxman Act, exploring the legislation’s success, shortcomings, and influence on new legislation, with authors ranging from the bill’s namesake, U.S. Sen. Orrin Hatch, to national leaders in intellectual property law.

The Hatch-Waxman Act

William Mitchell Law ReviewWidely known as the Hatch-Waxman Act, the Drug Price Competition and Patent Term Restoration Act of 1984 established a system for drug regulation that protects the rights of brand-name companies to pioneer new drugs, while creating a successful generic-drug industry that allows consumers to access cost-saving generic drugs.

“Our goal was to draw attention to the fact that the Hatch-Waxman Act has been successful, but also to explore questions and gaps that exist in the law,” said Fred Struve ’14. “What are the benefits of the act? Has it created any side effects that need to be addressed? What new legislation can improve the purpose of the act?”

Struve served as the executive editor on Issue 4, working to bring the issue to publication for more than a year. The recent alumnus of William Mitchell chose the topic out of his deep interest in intellectual property law and economics, and he drew on his experience with international patent law to produce the issue.

“The Hatch-Waxman Act has broken the mold, creating a fair balance between the intellectual property rights of brand companies and the needs of patients and consumers. That’s why it has been successful,” he said.

Producing a valuable resource

Issue 4 finishes out the 40th anniversary year of the William Mitchell Law Review. The print edition of the issue was just released in June, and several organizations that normally do not subscribe to the Law Review have already ordered copies. Some of the articles have already been cited, even before Issue 4 went to print.

Editor-in-Chief Jevon Bindman said the issue is already gaining traction on patent law blogs, and Struve said that is likely to be the case going forward.

For Struve, the greatest honor in producing this edition was successfully recruiting nationally respected writers on the topic. Published in advance of the Sept. 24, 1984 anniversary of the Hatch-Waxman Act, the authors for Issue 4 include:

  • Sen. Orrin Hatch, Utah
  • Robert Armitage, consultant in IP strategy and policy and former senior vice president and general counsel at Eli Lilly and Company
  • Kurt Karst, director at Hyman, Phelps & McNamara in Washington, D.C. and primary author of the FDA Law Blog (
  • Shashank Upadhye, partner in the Chicago office of Seyfarth Shaw and author of the industry-leading treatise Generic Pharmaceutical Patent and FDA Law
  • Lars P. Taavola, attorney at Robins, Kaplan, Miller & Ciresi
  • Brian P. Wallenfelt ’13, attorney at Merchant & Gould
  • Kristina M. Lybecker, associate professor of economics at Colorado College and a contributor at,

“William Mitchell has a great reputation, especially when it comes to intellectual property law. Through our faculty, we also have a national reach,” said Struve. “We’re very honored to feature these authors.”

Issue 4 also features an article by J. Travis Laster, vice chancellor, Court of Chancery of Delaware, who takes an in-depth look at the issue of standard of review for litigation of corporate decision-making, and an article by Professor Mike Steenson, who examines presumed damages in Minnesota defamation law.

Creating unique opportunities for law students

The William Mitchell Law Review is unique in that the editorial staff starts each volume from scratch. Instead of bidding on prewritten articles from an online database, the editors personally contact leaders in the field to request new writing, based on what each issue hopes to accomplish.

“It’s a rigorous process,” said Struve.

Struve emigrated from Denmark before attending William Mitchell College of Law. He never imagined that he would have the opportunity to collaborate with a member of Congress during law school – an experience he got from William Mitchell. He said that’s just one way he benefited from his time on the student-run Law Review.

“The Law Review is a great resource for students here,” said Struve. “It gives them a chance to hone their writing skills and master citations, and sets them up for legal writing post-graduation.”

Issue 4 is available for print order and can be found in electronic format on the William Mitchell Law Review website.

William Mitchell Law Review Volume 40