In case you missed it, a recent analysis found Big Pharma promptly admitted
more than 40 patents on brand name prescription drugs were shams after the most
recent round of challenges from the Federal Trade Commission (FTC),
highlighting the scale of Big Pharma’s patent thickets on top money-makers.





 

September 26, 2025



TOPLINE



In case you missed it, a recent analysis
<[link removed]>
found Big Pharma promptly admitted more than 40 patents on brand name
prescription drugs were shams after the most recent round of challenges from
the Federal Trade Commission (FTC), highlighting the scale of Big Pharma’s
patent thickets on top money-makers.



The FTC issued its latest series of challenges
<[link removed]>
to the validity of prescription drug patents in the U.S. Food and Drug
Administration’s (FDA) Orange Book in May. According to ananalysis
<[link removed]>
from Competition Dynamics, Inc, published in Law360, Big Pharma companies
responded by delisting 41 unique patents — essentially admitting that dozens of
the challenged patents were so baseless they weren’t even worth an attempted
defense.



Among the delistings were patents on blockbuster GLP-1 drugs—like Novo
Nordisk’s Ozempic and Saxenda and AstraZeneca’s Bydureon—and COPD inhalers like
AstraZeneca’s Symbicort, GSK’s Anoro Ellipta and Incruse Ellipta and Boehringer
Ingelheim’s Striverdi Respimat.



To stop Big Pharma from gaming the system to keep drug prices high, Congress
must advance bipartisan, market-based solutions, like The Affordable
Prescriptions for Patients Act (S. 1041), and additional solutions to foster
greater competition in the market. Read moreHERE
<[link removed]>
.



QUOTES OF THE WEEK



“This common-sense legislation will allow companies working to bring
lower-cost generics to market clarity from the FDA on whether or not their drug
is qualitatively and quantitatively the same as the list of drugs. What this
means is that Americans and their companies can face less hurdles when they’re
bringing a generic drug to market… Generic medicines are safe, effective and
often far cheaper than our branded counterparts. Increased access to these
medications will save Americans money at the pharmacy and also promote their
health and well-being.”



U.S. Representative Neal Dunn (R-FL-02)
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DATA POINTS YOU SHOULD KNOW



$3.1 Trillion



The amount of savings to the healthcare system from generic and biosimilars
over the last decade, according to awhite paper
<[link removed]>
from the Association for Accessible Medicines.



TWEETS OF THE WEEK



@HHSGov <[link removed]>: “Direct-to-consumer
drug ads can push people to take drugs they don’t actually need. Americans
often end up harmed instead of helped—that’s why @POTUS and @SecKennedy are
taking action.”



@RepGregLandsman <[link removed]>:
“We have to get the cost of Rx drugs down…here’s one way: Let doctors swap in
safe, lower-cost, similar versions of medicines like insulin, arthritis drugs,
and cancer treatments so folks can get the care they need for less - which is
what our new bipartisan bill does.[link removed]
<[link removed]>”



ROAD TO RECOVERY



Inside Health Policy: CSRxP: Lawmakers Advance Solution To Foster Greater Rx
Competition
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On Wednesday, the U.S. House Committee on Energy and Commerce held a markup on
bipartisan legislation that would increase transparency in generic drug
applications (H.R.1843). This bipartisan, market-based solution, sponsored by
U.S. Representatives Neal Dunn (R-FL-02) and Kevin Mullin (D-CA-15), would
reform Q1/Q2 sameness requirements from the U.S. Food and Drug Administration
(FDA) that Big Pharma abuses to extend exclusivity, promoting a more efficient
and streamlined generic drug approval process.



The Wall Street Journal: How The FDA Is Taking Aim At The Surreal World Of TV
Drug Ads
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The surreal world of TV pharmaceutical ads, where people with terrible
diseases tend to be young, beautiful and living life to the fullest—sometimes
with animated monsters—has been parodied on late night sketch comedy shows. But
the drug industry’s biggest critic may turn out to be government regulators
inside the Food and Drug Administration. The FDA is cracking down on
direct-to-consumer ads on the directive of President Trump.



RealClearHealth: Opinion: Republicans Should Lead The Charge To Stop Big
Pharma’s Patent Games
<[link removed]>



When Congress passed the Hatch-Waxman Act in 1984, it was a model of smart
policymaking. The law struck a careful balance, maintaining patent protections
to reward pharmaceutical innovators for undertaking the risks of drug
development, while ensuring that once patents expired, lower-cost generics
could quickly reach the market. The framework it established worked for
decades, fueling innovation and saving American patients billions. But that
framework has been hijacked by Big Pharma’s newest innovation: serial patent
litigation. A new white paper from the Association for Accessible Medicines and
the Biosimilars Council details how.



PHARMA’S POOR PROGNOSIS



The New York Times: A New Shot For Cancer Is Convenient, But Poised To Keep
Prices High
<[link removed]>



The cancer medication Keytruda is the world’s best-selling drug. But with
lower-priced competition set to arrive as soon as 2028, Keytruda’s
manufacturer, Merck, is on the brink of losing tens of billions of dollars in
sales. To keep Keytruda revenue flowing, Merck followed a well-worn playbook.
It developed a new version of the drug, given as a shot under the skin, which
the Food and Drug Administration approved on Friday. The company is talking up
the new version as quicker and easier for patients than the original therapy,
which is given through tubes as an intravenous infusion.



Fox News: Watch: Parody Drug Ad Spotlights RFK’s Crackdown On Misleading
Pharmaceutical Marketing
<[link removed]>



Shortly after announcing a strategy to go after deceptive direct-to-consumer
advertising by the pharmaceutical industry, Robert F. Kennedy Jr. and the
Department of Health and Human Services released a parody video of a drug
advertisement, a pointed way of emphasizing the fact that the United States is
largely unique in allowing drug ads. "Tired of endless drug ads promising quick
fixes but leaving you sicker than you were before? That can change today. Ask
your doctor about MAHA," the parody commercial begins, referring to Kennedy's
"Make America Healthy Again" initiative. "MAHA may cause healthier living,
fewer chronic diseases and lower drug costs," the video's narrator continues.
"Some Americans reported more time spent with family instead of at the
pharmacy. Other side effects may include healthier children, a stronger nation,
more transparency in healthcare, honest advertising and accountability from Big
Pharma."



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