Akron Law student takes first place in national legal writing competition

Left to right: Akron Law Associate Professor Emily Michiko Morris, third-year law student Ying Wang and Assistant Professor George Horvath.

University of Akron School of Law 3L Ying Wang is the first-place winner in the 2022-23 American Association of Patent Judges Honorable Frederick E. McKelvey Writing Competition for her essay, “The FTC Should Be Delegated to Establish a Prenotification and Review Process to Regulate Reverse Payment Settlements.”

The essay will be published in the Journal of the Patent and Trademark Office Society, and Wang will receive a plaque and $1,000. The competition is open to students pursuing study in any field that impacts technology. Wang was advised by Assistant Professor George Horvath and Associate Professor Emily Michiko Morris, who is the David L. Brennan Endowed Chair and associate director of the Center for Intellectual Property Law & Technology.

The essay originated as a note for the Akron Law Review.

“I was preparing the law review note and Professor Horvath was advising me since I was taking his Food and Drug Administration (FDA) Law course,” Wang said. “I was also preparing for the patent law moot court competition, which is where I had a chance to talk with Professor Morris, who is an expert in this area. She recommended I consider submitting my note to the competition.”

As Wang explained the topic of her note, in 1984 Congress enacted the Drug Price Competition and Patent Term Restoration Act (more popularly known as the Hatch-Waxman Act), which established a new regulatory pathway and various incentives to encourage generic drug manufacturers to bring products to market. The legislation accomplished the goal, but it also incentivized litigation in a way that resulted in unintended consequences.

“Typically, a patent infringer pays damages to the patent owner to settle a patent-infringement case,” Wang said.

However, the Hatch-Waxman Act significantly changed the typical allocation of risk in infringement cases involving pharmaceutical patents, and it became increasingly common for drug patent holders to pay generic drug companies to settle these infringement cases. Critics began to view these settlements as, effectively, payments not to produce a competing generic drug for a certain period of time, which is clearly not in the best interest of consumers.

“This type of settlement therefore has created significant antitrust concerns and received considerable attention from economists and legal scholars,” Wang writes in the essay. “On the other hand, branded drug manufacturers may be justified in their ownership of the patent which entitles them to enjoyment of lawful exclusive rights. As such, reverse payment settlement represents a question at the intersection of patent law and antitrust law.”

The question wound its way to the Supreme Court. In 2013, in FTC v. Actavis, the Court rejected the idea that these reverse payment settlements were either per se illegal or per se legal and instead laid out a rule of reason framework for trial courts to analyze the settlements on a case- by-case basis. However, rather than deterring reverse payment settlements the Court’s decision only served to make them more complex. Subsequent legislative efforts to deter the payments have failed to advance in Congress.

Wang’s essay goes on to propose a solution: legislation to have Congress delegate to the Federal Trade Commission (FTC) an authority to establish a prenotification and review process along the line of the premerger notifications that companies are required to file with the FTC and the Antitrust Division of the Justice Department for certain acquisitions. The intended result would be less litigation overall and fewer anticompetitive reverse payment settlements.

“There has been a lot of ink spilled on this particular issue, mostly about whether these reverse payment settlements are per se antitrust violations or per se legal, so there’s really no middle ground,” Michiko Morris said. “Most of the student notes I’ve seen just rehash what others have already said. Even some of the academics writing on this topic really don’t present anything new. That’s why I thought Ying’s approach was really interesting and very realistic. It’s not one that I’d seen in the many articles that I’ve read on this subject.”

“As someone who focuses on the FDA and not on the intellectual property and antitrust issues, my involvement in this was more limited,“ said Horvath, who holds a medical degree. “But this was a really fun paper to work on. It takes an incredibly complicated set of topics combining FDA law, patent law and antitrust law and presents it in an accessible way, and then works toward a solution.”

Michiko Morris noted that Wang had not actually taken the patent law course until the fall 2023 semester, nor has she taken a course Michiko Morris teaches that deals with the Hatch-Waxman Act and related biopharmaceutical legislation, “so her expertise on this topic really is self-taught.”

Wang, however, brought a formidable science background to the task. She has a Ph.D. in genetics from the University of Cologne and did cancer research for three years as a postdoctoral fellow at Baylor College of Medicine before deciding to embark on a legal career at The University of Akron.

“I feel very fortunate to have the input and support from Professor Horvath and Professor Morris, who are such experts in this area. Their comments made me much more confident in what I was writing,” she said.

Wang is on track to graduate from Akron Law in May 2024. She is currently working part-time as a law clerk at the Cleveland-based intellectual property law firm Tarolli, Sundheim, Covell & Tummino LLP.