Drug Patents Do Not Cause High Drug Prices

Key Takeaways
 

• The “patent thicket” and “evergreening” allegations about drug patents are conventional wisdom in Washington, D.C., but the facts do not support this policy rhetoric.
• USPTO and FDA data contradict the narrative that drug innovators obtain huge numbers of patents to block generic drug competition and keep drug prices high.
• Bills introduced in Congress, such as the ETHIC Act, are not evidence-based policymaking because they are based on unreliable data and false claims that drug patents cause high drug prices.

Introduction

Americans have long debated whether the prices of prescription drugs are too high.^[1] In recent years, this debate took a turn into new territory when activists and politicians began blaming the patent system for high drug prices.^[2] The Initiative for Medicines, Access, and Knowledge (I-MAK) was formed in 2006, for instance, to argue that a “root cause of the high cost of medicines” is “unjust patent monopolies.”^[3]

Some academics now claim that patents are the sole cause of high drug prices. They often rely on numbers of drug patents listed by I-MAK in its annually published pamphlets.^[4]

It’s common to hear that drug innovators create “patent thickets” (obtaining numerous patents on a single drug) and engage in the practice of “evergreening” (artificially extending exclusive patent terms by stacking terms of follow-on patents). The argument goes that patent thickets and evergreening tactics block generic drug companies from competing with “brand drugs” and thus keep prices higher without this competition in prescription drugs. I-MAK’s numbers are often the fountainhead of these claims. In a letter to Senator Elizabeth Warren, for example, activists and academics argued that drug prices “are high primarily because brand-name drug companies use government-granted exclusivities, such as patents, to prevent competition and charge high prices,” and they cite for support academic articles that restate without question I-MAK’s numbers of patents.^[5]

Congress and agencies have acted on the basis of these patent thicket and evergreening arguments: numerous bills have been introduced in Congress to restrict or eliminate patent rights in new drugs or to impose costly new regulatory burdens on drug innovators.^[6] This includes the ETHIC Act,^[7] which has considerable support from generic drug trade associations and policy organizations. The Federal Trade Commission (FTC) has also accused drug innovators of creating improper thickets of drug patent listings with the U.S. Food and Drug Administration (FDA).^[8] Adopting the numbers of patents and arguments of I-MAK and other activists, the FTC has alleged systemic abuses of patents by drug innovators in blocking generic drug competition, keeping prescription drug prices high, and harming patients.^[9]

The principle of evidence-based policymaking, just as much as evidence-based medicine, requires evidence that an illness or harm exists, and that a proposed cure not only redresses this harm, but the cure is not worse than the disease. With this in mind, there are serious concerns about the “patent thicket” and “evergreening” allegations that are the foundation of the argument that patents stifle competition and raise prescription drug prices. Data from official, public institutions, such as the FDA and the U.S. Patent and Trademark Office (USPTO), have exposed the ubiquitous I-MAK numbers of patents on prescription drugs to be rife with serious data questions and methodological flaws that call into question their veracity.^[10] FDA data on rates of prescriptions for generic drugs, as well as numerous studies by many empirical scholars over the past decade on the total years of market exclusivity of prescription drugs. contradict the allegations of patent thickets and evergreening tactics in the drug price policy debates.^[11]

Moreover, the claims that drug innovators are stifling competition and harming patients contradict the historical and economic evidence on the key role of property rights in new inventions as a driver of healthcare innovation and economic growth. In the healthcare revolution of the last 100 years, patents have spurred the invention and commercial development of new drugs that have benefited patients and contributed to longer and higher-quality lifespans for everyone worldwide. Property rights in inventions (patents) contribute to prosperous innovation economies and flourishing societies, as confirmed by the similar historical and economic evidence on the key role of property rights in successful market-based economies with higher standards of living for all people.^[12]

In sum, the claim that drug patents cause high drug prices is ubiquitous in the drug price policy debates, but this ubiquity does not correlate with reliable data or proven harms that make it true. This white paper first describes how property rights in inventions (patents) are a key factor in innovation and economic growth, especially in spurring innovations in new drugs and other healthcare treatments to the benefit of all patients. Thus, the evidentiary burden rests on activists and academics who propose systemic “reforms” that restrict patent rights for drug innovators and impose additional costs on all healthcare innovators. Second, it reviews USPTO and FDA data and summarizes numerous empirical studies that consistently contradict allegations by I-MAK and other activists of patent thickets and evergreening by drug innovators. Dug innovators in fact have far less than the 20-year exclusive right secured to inventors by the Patent Act. Third, it explains how systemic changes to the patent system only for drug innovators violates the principle of technology neutrality that has been an essential feature of the U.S. patent system as a successful property rights regime in incentivizing the creation and distributing of new drugs in the healthcare market to the benefit of patients.

Read the full report at the Center for the Protection of Intellectual Property.

1. See, e.g., Consumer Group Decries Rise in Drug Prices, LOS ANGELES TIMES (Mar. 16, 1995) (“Prices of the 20 top selling prescription drugs are rising faster than inflation, despite drug company promises to slow the increases, a consumer group charged Wednesday.”); E. RICHARD BROWN, ROCKEFELLER MEDICINE MEN: MEDICINE AND CAPITALISM IN AMERICA 1 (1979) (“The crisis in today’s health care system is deeply rooted in the interwoven history of modern medicine and corporate capitalism. The system’s most obvious problems are cost, inflation, and inaccessibility of medical care in the United States.”). ↑
2. See, e.g., Arti K. Rai & Rebecca S. Eisenberg, Bayh-Dole Reform and the Progress of Biomedicine, 66 L. & CONTEM. PROBS. 289, 301 (2003) (“[P]atents on the many discoveries that enable product development are more likely to add to a product’s costs than to enhance its profitability.”). ↑
3. I-MAK, Drug Pricing Crisis, https://www.i-mak.org/health-equity/#pricing (accessed Sep. 1, 2025). ↑
4. See, e.g., Doni Bloomfield & Aaron S. Kesselheim, Biden can lower drug prices without Congress doing anything, WASH. POST (Jan. 5, 2021) (“Drugs are costly because brand-name medications are patent-protected monopolies.”); Hannah Brennan, Amy Kapczynski, Christine H. Monahan & Zain Rizvi, A Prescription for Excessive Drug Pricing: Leveraging Government Patent Use for Health, 18 YALE J.L. & TECH. 275, 284 (2016) (“Drug prices in the United States are among the highest in the world . . . . [T]hey result from . . . [o]ur patent system . . . [and its] grant of a monopoly [that] allows the manufacturer to charge any price . . . .”); Amy Kapczynski & Aaron S. Kesselheim, ‘Government Patent Use’: A Legal Approach to Reducing Drug Spending, 33 HEALTH AFFAIRS 791, 791 (2015) (claiming that “new medicines . . . are expensive not because they are expensive to manufacture but because they are protected by patents”). ↑
5. Letter to Senator Elizabeth Warren from Amy Kapczynski, Aaron S. Kesselheim, et al., at 1 (Apr. 20, 2022), https://tinyurl.com/yt62wt4t. ↑
6. See Eliminating Thickets to Increase Competition Act (ETHIC Act), S. 2276 (July 15, 2025); Preserve Access to Affordable Generics and Biosimilars Act, S. 1096 (Mar. 25, 2025); Interagency Patent Coordination and Improvement Act of 2025, S. 1097 (Mar. 24, 2025); Drug Competition Enhancement Act, S. 1040 (Mar. 13, 2025); Affordable Prescriptions for Patients Act, S. 1041 (Mar. 13, 2025); Stopping Pharma’s Ripoffs and Drug Savings For All Act, H.R. 890 (Jan. 31, 2025). ↑
7. See Eliminating Thickets to Increase Competition Act (ETHIC Act), S. 2276 (July 15, 2025). ↑
8. See FTC Challenges More Than 100 Patents as Improperly Listed in the FDA’s Orange Book (Nov. 7, 2023), https://www.ftc.gov/news-events/news/press-releases/2023/11/ftc-challen… orange-book. ↑
9. See id. (“Delays in generic competition, even if brief, can reduce patient access to more affordable alternatives and increase costs across the entire health care system.”). ↑
10. See Drug Patent and Exclusivity Study (June 2024), https://www.uspto.gov/initiatives/fda-collaboration/drug-patent-and exclusivity-study-available [hereafter, “USPTO Study”]. ↑
11. See infra notes 33-38 (detailing numerous studies of market exclusivity periods of drugs). ↑
12. See generally Stephen Haber, Patents and the Wealth of Nations, 23 GEO. MASON L. REV. 811 (2016); see also Jonathan M. Barnett, Patent Tigers: The New Geography of Global Innovation, 2 CRITERION J. INNOVATION 429 (2017). ↑