For nearly forty years, the Hatch-Waxman system for expediting approval of generic drugs has brought increased levels of competition to the pharmaceutical markets, lowering drug prices for all consumers. On its face, the Hatch-Waxman Act has enjoyed extraordinary success. Today, nearly 90% of prescriptions are filled with generic pharmaceuticals, with around 80% of all brand-name pharmaceuticals having a generic competitor. Despite this success, anecdotal evidence in recent years suggests new forms of strategic behaviors designed to block generic entry are on the rise.

From highly publicized congressional hearings to high profile press articles and outrage from various presidential candidates on the topic, the rising price of pharmaceuticals has led to public outcry. For example, Turing CEO Martin Shkreli and his company riveted the nation after increasing the price of a drug from $13.50 per tablet to $750 per tablet, an action that eventually led to congressional hearings on the topic. Additionally, pharmaceutical manufacturers’ tactics relating to specialty pharmacies and price increases have drawn notice from federal prosecutors, further underscoring the rise of new forms of strategic, anticompetitive behaviors.

It is not difficult to understand the motivation behind such behaviors. If a brand-name pharmaceutical manufacturer can delay generic entry for a blockbuster drug—even by just a mere month or two—it stands to earn hundreds of millions of dollars in additional revenue. With a significant amount of dollars at stake, brand-name manufacturers have a powerful incentive to keep searching for new methods of delaying generic competition into the market. From society’s standpoint, this is directly contrary to what one would prefer: instead of brand-name manufacturers using their resources in search of new pathways for treating disease, they instead search for new pathways of blocking competition. Thus, in order to keep the generic system on track, it is critical to expose the various avenues of generic delay.

Part I of this Note briefly describes the generic entry process as prescribed by the Hatch-Waxman Act. Part II details four well-known tactics used by brand-name manufacturers to block or delay the entry of generic competition, highlighting how the tactics are successful. Part III concludes by examining the nature of the various problems and arguing that the first step towards ending the different forms of anticompetitive behavior is through increased disclosure requirements.