Dose of Reality: Breaking Down Big Pharma’s Year of Bad Behavior in 2025: Part III: Big Pharma’s Anti-Competitive Tactics That Keep Prices High
Exploring Big Pharma’s Egregious Abuse of the Patent System Designed to Extend Monopoly Pricing Power
With each new year comes a time-honored tradition for Big Pharma: Hiking prices on hundreds of brand name prescription drugs in the first weeks of January.
As Big Pharma’s next expected round of price hikes approaches, let’s review how Big Pharma games the system to block competition, extend monopolies and keep prices high, including enabling repeated price hikes on top-selling products.
In the first installment of our year-end series, we reviewed Big Pharma’s egregious pricing practices in 2025, including continuing to hike prices faster than the rate of inflation and bringing new drugs to market with skyrocketing launch prices.
In the second installment of our series, we looked at Big Pharma’s harmful marketing tactics and staggering investments in direct-to-consumer (DTC) advertising.
Today, we’ll explore new data from 2025 on the staggering cost of Big Pharma’s anti-competitive abuse of the U.S. patent system.
Get a Dose of Reality on Big Pharma’s year of extending monopolies and keeping prices high:
A CASE STUDY IN BIG PHARMA’S PATENT GREED: MERCK’S KEYTRUDA
Big Pharma Giant’s Patent Abuse Scheme for Keytruda Will Extend Monopoly Pricing, Undermine Competition from More Affordable Alternatives
In January, pharmaceutical giant Merck indicated that it would expedite an anti-competitive product hopping strategy designed to extend exclusivity and monopoly pricing on its blockbuster cancer drug, Keytruda.
At the J.P. Morgan Healthcare Conference in January, Merck CEO Rob Davis said the brand name drug company “was planning to offset Keytruda’s loss of exclusivity by moving up plans to file for approval and launch a subcutaneous version of Keytruda by the end of 2025.”
Keytruda, which generated nearly $29 billion in revenue for the Big Pharma giant in 2024, is already patent-protected in the U.S. until 2028. To further extend monopoly pricing and undermine competition from more affordable alternatives beyond 2028, Merck first announced it would seek the new formulation and accompanying added patents in 2022.
According to STAT News coverage of Merck’s progress in pursuing the Keytruda reformulation, “the new under-the-skin, or subcutaneous, formulation of Keytruda could represent a major way of holding on to a larger share of Keytruda’s $25 billion in annual sales than would otherwise occur when the medicine’s U.S. patent expires in 2028.”
Merck’s strategy is a case study of Big Pharma’s patent abuse. Big Pharma companies file new patents for changes such as intake method or dosage on existing products that don’t represent truly new innovations or improve clinical benefits for patients. This enables Big Pharma to add to patent thickets designed to block competition from more affordable alternatives, keep drug prices high and boost profits.
Big Pharma Giant Closer to Further Extending Monopoly Pricing on Top Money-Making Oncology Drug After Already Delaying Competition by Years, Gaming the Patent System
In October, Big Pharma giant Merck announced that it surpassed a major milestone – the brand name drug maker’s latest scheme to further delay competition and maintain monopoly pricing on blockbuster cancer drug Keytruda — securing approval from the U.S. Food and Drug Administration (FDA) for a new, subcutaneous version of the drug.
As coverage from The New York Times noted, as patent exclusivity on the current version of Keytruda approaches the end of its life, already significantly extended by patent abuse, Merck is following “a well-worn playbook…by develop[ing] a new version of the drug, given as a shot under the skin,” that will “keep Keytruda revenue flowing.”
The company expects “up to 40 percent of Keytruda users” to shift to the new version of the drug, called Keytruda Qlex, according to The New York Times. “Merck’s new shot will most likely slow the adoption of cheaper copycat infusions, keeping prices higher for longer at the expense of Americans.”
Merck’s strategy is an example of product hopping, one of Big Pharma’s preferred patent abuse tactics for delaying competition from more affordable alternatives and keeping prices higher on their blockbuster drugs for longer.
BIG PHARMA TARGETS PATENTS AROUND BLOCKBUSTER GLP-1 DRUGS
Novo Nordisk Alone Has Filed 320 Patents on Single Active Ingredient Behind Blockbuster Brand Name Drugs for Diabetes and Weight Loss
In April, a report from the Initiative for Medicine, Access and Knowledge (I-MAK) highlighted how Big Pharma giants Novo Nordisk and Eli Lilly are gaming the U.S. patent system to extend monopolies and keep prices high on blockbuster GLP-1 drugs like Ozempic, Wegovy and Mounjaro.
Novo Nordisk has filed 320 U.S. patent applications, with 154 being granted for semaglutide, the same active ingredient in Ozempic, Rybelsus and Wegovy. The report found that “the main compound patent for semaglutide as used in the three drugs was set to expire in March 2026, it said, but regulatory extensions have lengthened Novo’s exclusivity until December 2031.” I-MAK estimates that this five-year period will grant Novo Nordisk an additional $166 billion.
The report also found, “Eli Lilly has filed 53 U.S. patent applications and been granted 16 patents,” on its two blockbuster GLP-1 products, Mounjaro and Zepbound, which also rely on the same active ingredient.
And while gaming the patent system to block competition and extend monopolies, these Big Pharma giants are also prioritizing profits over research and development (R&D). For example, Novo Nordisk has spent 41 percent more on dividends and buybacks than R&D, according to the report.
BIG PHARMA’S PATENT TACTICS KEEP PRICES HIGH AND BLOCK COMPETITION FROM MORE AFFORDABLE ALTERNATIVES
Analysis Underscores How Anti-Competitive Tactics Like Patent Thicketing Keep U.S. Drug Prices High
In June, the Initiative for Medicines, Access and Knowledge (I-MAK) released the latest installment of the organization’s “Overpatented, Overpriced” series, analyzing Big Pharma’s egregious abuse of the U.S. patent system and how these anti-competitive strategies keep prescription drug prices high.
This report from I-MAK highlights blockbuster brand name drugs Eliquis, Ozempic, Rybelsus and Wegovy as particular case studies in how Big Pharma games the system to extend monopoly pricing.
Bristol Myers Squibb & Pfizer: The report details how Bristol Myers Squibb (BMS) and Pfizer recently secured a patent term extension (PTE) on blood-thinner Eliquis, securing patent exclusivity for an additional four years to 2026, 24 years after the first patent was filed on the blockbuster drug in 2002.
During these four years of delayed competition, Eliquis is projected to generate $39.1 billion in U.S. revenue for its Big Pharma manufacturers. Pfizer and BMS are set to rake in an additional $11.6 billion in U.S. sales in the 16-month gap before the anticipated first generic launches in April of 2028. As a result of this anti-competitive gamesmanship of the U.S. patent system, BMS and Pfizer will collect approximately $50 billion in U.S. revenue from this high-priced brand name drug that would otherwise be subject to generic competition.
Patent Abuse Blocked Competition From More Affordable Alternatives for Periods Ranging from Seven Months to More Than One Year
In August, 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.
The analysis included a review of delayed generic competition to imatinib (Gleevec), glatiramer (Copaxone), celecoxib (Celebrex) and bimatoprost (Lumigan). These brand name products all began facing competition from more affordable alternatives between 2014 and 2018.
“The study found that extended market exclusivity periods ranged from seven months for celecoxib to 13 months for glatiramer, significantly delaying generic entry and driving up costs,” according to a summary published in The American Journal of Managed Care (AJMC). “Over the two years following generic competition, the absence of these extensions would have reduced US drug spending by an estimated $3.5 billion—including $1.9 billion (95% CI, $1.3–$2.5 billion) in commercial insurance and $1.6 billion (95% CI, $1.1–$2.1 billion) in Medicare Part D.”
Big Pharma has a long history of price-gouging American patients through tactics designed to game the U.S. patent system and block competition from more affordable alternatives — enabling pharmaceutical manufacturers to maintain monopolies over their biggest money-makers. Big Pharma companies often file many, even dozens or hundreds, of patents on a single medication, a practice known as patent thicketing, to extend exclusivity and block competition from more affordable options, for months, years or even decades.
As policymakers return to Washington in 2026, they should take note of the pharmaceutical industry’s continued egregious pricing practices and work to advance bipartisan, market-based solutions to hold Big Pharma accountable.
Read our first blog in this series on Big Pharma’s egregious price hikes and increasing launch prices HERE.
Read our second blog in this series on Big Pharma’s massive spending on direct-to-consumer advertising HERE.
Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.
And stay tuned for the start of Big Pharma’s annual tradition of welcoming the new year with egregious price hikes on hundreds of brand name prescription drugs.
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