How Strategic Patenting and Litigation Delay Access to More Affordable Medicines

This series examines how strategic patenting and serial litigation delay the entry of lower-cost generic and biosimilar drugs, and what can bring more affordable medicines to market sooner.

The United States is a global leader in pharmaceutical innovation, spending $103 billion on R&D in 2024. Patents play a key role in innovation, especially in sectors like pharmaceuticals, which require significant risky investments to bring new drugs to market. Patents allow inventors to recoup these costs through a limited period of exclusivity; in exchange, these inventions become public knowledge, accessible to all. Congress passed the Hatch-Waxman Act in 1984 and the Biologics Price Competition and Innovation Act in 2009 to encourage competition in the market for prescription drugs.

These laws were designed to encourage continued innovation while creating clear pathways for generic and biosimilar competition. Generics now fill 90 percent of all prescriptions in the United States, saving patients, consumers, and taxpayers billions of dollars every year. Yet, over time, brand-name drug companies have become adept at extending their monopoly power beyond the exclusivity originally provided by the law through patent gamesmanship and litigation tactics that delay entry by lower-cost generics and biosimilars.

Patent thickets, product hopping, and serial litigation have created effective barriers to entry that threaten access to more affordable prescription drugs. Low-quality patents with only minor changes from earlier patents are effectively deployed to delay competition and fuel lawsuits against generics and biosimilars.

This series examines these tactics in more detail, discussing their evolution and impact on drug pricing and affordability. These papers also examine the interplay between the patent system and the Food and Drug Administration’s drug approval process to identify opportunities for reform that can reduce strategic exploitation of the process while continuing to reward true innovation. The articles also suggest possible solutions and ways Congress can tackle the challenges of drug pricing affordability.

The Series:

• Clearing the Thicket: Restoring the Market for Lower-Price Drugs
  Strategic patenting delays generic competition, keeping drug prices unnecessarily high for patients, consumers, and taxpayers. This article examines the ETHIC Act, bipartisan legislation introduced in both the House and Senate that would limit some of the delay tactics that keep lower-cost generic and biosimilar alternatives off the shelves.
  
  
• The Process Is the Penalty: How Serial Patent Litigation Delays Low-Cost Drugs
  This article evaluates how the Hatch-Waxman generic drug approval process can be exploited to deter generic entry through serial litigation. The paper provides case studies as well as recommendations for structural reforms to promote a more robust market for generic drugs.
  
  
• How the Terminal Disclaimer Went from Limiting Monopolies to Blocking Generics
  This installment examines how terminal disclaimers evolved from a judicial doctrine to prevent patent term extension into a tool for building patent thickets to delay generic and biosimilar competition.
  
  
• Patent Thickets, Product Hops, and Skinny Labels: Congress Takes on Patent Reform
  This final article surveys pending legislation in the 119th Congress that would address patent thickets, interagency coordination, product hopping, and skinny labeling. Both chambers of Congress and both parties have introduced legislation to address anticompetitive practices and key patent reforms in order to address growing concerns over affordability.