Exploring Big Pharma’s Egregious Abuse of the Patent System Designed to Extend
Monopoly Pricing Power





 



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
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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
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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
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, is already patent-protected in the U.S. until 2028. To further extend
monopoly pricing and undermine competition from more affordable alternatives
beyond 2028, Merckfirst announced
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it would seek the new formulation and accompanying added patents in 2022.



According to STAT News coverage
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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
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– 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
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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
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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 latestinstallment
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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
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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 asummary
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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 pricesHERE
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.



Read our second blog in this series on Big Pharma’s massive spending on
direct-to-consumer advertisingHERE
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.



Learn more about market-based solutions to hold Big Pharma accountable and
lower prescription drug pricesHERE <[link removed]>.



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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