Big Pharma giant Merck recently surpassed a major milestone in 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.





 



DOSE OF REALITY: MERCK SURPASSES MILESTONE IN PRODUCT-HOPPING STRATEGY TO
BLOCK COMPETITION, KEEP PRICES HIGH ON BLOCKBUSTER CANCER DRUG KEYTRUDA

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



Big Pharma giant Merck recently surpassed a major milestone in 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
<[link removed]>
from The New York Times notes, 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.



“Merck is just the latest in a long line of drug companies that have
introduced new versions of their medicines that allow them to keep charging
high prices even as their original patents expire,” The New York Times notes.
This strategy is known as “a product ‘hop,’ [where] a company rides out its
monopoly on the original drug, and then, a few years before competition reaches
the market, the drugmaker ‘hops’ to a new version that remains protected by
patents.”



Executives from Merck have touted
<[link removed]>
the new version of Keytruda as “a meaningful advance,” and Merck’s CEO even
claimed <[link removed]> that the new
subcutaneous version of the drug is an “invention.” However, as the Initiative
for Medicines, Access & Knowledge (I-MAK) recently explained, Keytruda Qlex is
created by “combining Keytruda’s known immune PD-1 checkpoint inhibitor
(pembrolizumab) with a form of the enzyme hyaluronidase… [h]yaluronidase, and
variations of it, is a well-understood ingredient that companies have long used
to enable subcutaneous delivery of biologic drugs.” In fact, other Big Pharma
companies, including Bristol-Myers Squibb and Roche, have used it to create
injectable versions of their blockbuster products as well.



So, the truth is, there is little actual innovation associated with Merck’s
new version of Keytruda — the change in delivery method and its timing is about
extending monopoly pricing power, keeping prices high for patients, and
maximizing Merck’s profits.



Two Clear Examples of Big Pharma’s Patent Abuse Playbook: Humira & Keytruda



In addition to Merck’s Keytruda, The New York Times cites another example of
Big Pharma’s use of “product hopping” in the form of AbbVie’s blockbuster
autoimmune drug Humira.



While Humira finally faced its first competition in the U.S. starting in 2023,
over the course of its more than 20 years on the market, AbbVie applied for
more than300 patents
<[link removed]>
on Humira, securing more than half of them. 94 percent of the patents filed on
Humira came after the drug was initially approved by the FDA. This strategy
helped block competition for years and generated almost$200 billion
<[link removed]>
for AbbVie. In 2022, the drug brought in moremoney
<[link removed]>
for the company, $21 billion, than all 32 teams in the NFLcombined
<[link removed]>
, $19 billion.



AbbVie’s Humira is an example that Merck seems to be following with Keytruda.



According to research
<[link removed]>
from I-MAK, Merck has filed for 129 patent applications on Keytruda – more
than half of which were filed after the drug’s initial approval by the FDA. The
Big Pharma company has been granted 53 patents on this one drug alone, and
I-MAK estimates that Americans will spend at least $137 billion on Keytruda
while the drug faces no competition due to its extended exclusivity that
already totals more than eight years — without reflecting the added impact of
the Big Pharma giant’s new patent strategy.



In addition to the impact of Merck’s strategy to further block competition on
Keytruda, this week, the nonpartisan Congressional Budget Office (CBO)released
<[link removed]>
a revised estimate on the impact of The Optimizing Research Progress Hope And
New (ORPHAN) Cures Act, a Big Pharma-backed policy that will help drug
manufacturers keep prices high on blockbuster brand name drugs at the expense
of seniors and taxpayers. While Merck’s Keytruda was left out of CBO’s original
estimate, in its revised analysis, with Keytruda included the CBO estimates
that the impact of this Big Pharma-backed policy nearly doubled, from $4.9
billion to $8.8 billion. Now armed with more accurate information on the policy
than when it was passed in a larger legislative package, lawmakers should
repeal the Big Pharma blockbuster bailout that will help brand name drug
companies keep prices high on top money-makers like Keytruda.



Read more on Merck’s product hopping playbook on Keytruda in The New York Times
HERE
<[link removed]>.


Read more on the CBO’s updated analysis of the ORPHAN Cures Act with Keytruda
includedHERE
<[link removed]>
.



Read more on Big Pharma’s patent abuse HERE
<[link removed]>
.



Learn more about bipartisan, market-based solutions to hold Big Pharma
accountableHERE <[link removed]>.



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