DOSE OF REALITY: HEALTH AFFAIRS SCHOLAR ANALYSIS FINDS BIG PHARMA’S PATENT ABUSE GROWING IN SCALE, KEEPING PRESCRIPTION DRUG PRICES HIGH

New Report Demonstrates How Brand Name Drug Companies Wield Litigation Around Patent Estates to Block Competition and Extend Monopoly Pricing

In case you missed it, an analysis authored by researchers affiliated with the University of Alabama School of Law and published in Health Affairs Scholar, highlights how Big Pharma continues to game the U.S. patent system to block competition from more affordable alternatives, enabling brand name drug manufacturers to maintain monopolies over their biggest money-makers and keep prices high.

The analysis explains that while the Hatch–Waxman Act of 1984 was designed to accelerate generic drug entry, brand-name manufacturers are increasingly exploiting its framework to delay or deter competition. As the authors note, “a core tenet of the U.S. legal system is that parties should get only one opportunity to litigate and appeal a case,” yet expanding patent estates are being used in ways that undermine that principle.

According to the study, the number of patents listed per drug has tripled since 1980, dramatically expanding the size of patent thickets surrounding brand name products. Nearly half of the Food and Drug Administration-listed (FDA) patents are now derivative “continuation” patents, additional patents layered onto existing ones that can be used to prolong exclusivity and block competition from more affordable alternatives, like generics and biosimilars. Each round of Hatch–Waxman litigation costs generic manufacturers an average of $6.2 million, increasing financial risk and discouraging timely market entry.

As the study explains, these tactics “create procedural delays and increase legal costs,” meaning generic manufacturers “may choose to stay off the U.S. market or settle in ways that undermine patients’ timely access to affordable generics.” Importantly, the authors make clear that manufacturers can block competition regardless of whether they ultimately win the litigation.

Sean Tu, lead author of the analysis, told BioSpace, “If we stop competition, that’s a win for brand companies, right? That means that we’re going to have higher drug prices for longer periods of time…How do I get less competitors? I make it riskier. I make it more expensive. I force them to come on the market later.”

As the authors conclude in Health Affairs Scholar, “Preventing this type of gamesmanship is essential to ensuring timely access to generics and biosimilars, driving down drug prices, and ultimately improving patient access and health outcomes.”

This latest analysis builds on mounting evidence that Big Pharma’s egregious abuse of the patent system is the root cause of out-of-control prescription drug prices. Whether through patent thickets, product hopping, or other anti-competitive tactics designed to extend monopolies, brand name drug companies continue to game the system to block competition from generics and biosimilars.

BIG PHARMA’S ANTI-COMPETITIVE TACTICS THAT KEEP PRICES HIGH

• Patent Abuse On Just Four Blockbuster Drugs Cost $3.5 Billion in Two Years: In August 2025, a study published in JAMA Health Forum found that lost competition due to Big Pharma’s patent thickets on just four widely prescribed brand name drugs cost patients, taxpayers and the U.S. health care system more than $3.5 billion in excess spending over two years.
• Big Pharma’s Patent Thickets On Just Five Drugs Cost Over $16 Billion In a Single Year: A January 2023 report from Matrix Global Advisors, “Patent Thickets and Lost Drug Savings,” quantified the one-year cost of lost savings on five brand name drugs around which Big Pharma has built especially egregious patent thickets. The five drugs were AbbVie’s autoimmune drug Humira and oncology drug Imbruvica, Regeneron’s ophthalmology drug Eylea, Amgen’s autoimmune drug Enbrel and Bristol Myers Squibb’s oncology drug Opdivo.
• Targeting Blockbuster Products for Patent Abuse: A May 2022 study published in the Journal of the American Medical Association (JAMA) Health Forum revealed how brand name drug companies target their most profitable products for reformulation to extend monopolies and prohibit generic competition from entering the market.
• Big Pharma Increasingly Utilizing Secondary Patents to Extend Monopoly Pricing: A January 2026 study published in JAMA Health Forum highlights how Big Pharma has been increasingly relying on secondary and tertiary patents that are unconnected to the active pharmaceutical ingredients (API) in top-selling drugs to extend monopoly pricing. Among 331 analyzed drugs, manufacturers “listed 3,241 patents in the FDA’s Orange Book…more than half – 54 percent – were tertiary patents covering devices or device-related features, while only 4.2 percent were primary patents on the active pharmaceutical ingredient.”
• Delayed Generic And Biosimilar Competition Costs U.S. Health System Hundreds Of Billions In Excess Spending: An analysis from the Association for Accessible Medicines estimated that accelerating access to generic and biosimilar drugs could generate $422.9 billion in savings by reducing prices through competition.

Restoring competition requires bipartisan, market-based solutions to crack down on patent abuse and hold Big Pharma accountable to lower drug prices. Learn more HERE.

Read the full research article from Health Affairs Scholar HERE.