2026

U.S. consumers suffer from high drug prices. A lack of generic competition is one reason why. Congress enacted balanced landmark legislation in 1984 to promote competition and innovation. In the past few years, however, the U.S. Court of Appeals for the Federal Circuit has issued two significant rulings that threaten this balance by allowing brand companies to block generics even when they specifically avoid patents.

This Essay first introduces the pharmaceutical regulatory regime, emphasizing the importance of generic competition and the carefully calibrated balance between competition and innovation. It then discusses the Federal Circuit’s recent decisions in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. and Amarin v. Hikma, which sharply limited the skinny label pathway. It concludes by highlighting the advantages skinny labels provide as compared to other (litigation-focused) ways generics enter the market.

The text of the Twenty-Second Amendment seems clear that a president cannot be elected to a third term: “No person shall be elected to the office of the President more than twice.” This Essay looks further to the history surrounding the Twenty-Second Amendment, an exercise sometimes employed by judges, particularly those who favor the constitutional interpretive method of originalism. History shows that a president cannot be elected to a third term on the theory that the previous terms were nonconsecutive.