New Research Shows Drugmakers Increasingly Rely on Patents Disconnected from
Actual Pharmaceutical Innovation to Block and Delay Competition Long After
Initial FDA Approval





 



DOSE OF REALITY: DRUG MAKERS INCREASINGLY UTILIZING DEVICE PATENTS TO EXTEND
EXCLUSIVITY ON BLOCKBUSTER DRUGS

New Research Shows Drugmakers Increasingly Rely on Patents Disconnected from
Actual Pharmaceutical Innovation to Block and Delay Competition Long After
Initial FDA Approval



In case you missed it, a recent study
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published in JAMA Health Forum highlights how Big Pharma has been increasingly
relying on secondary and tertiary patents that are unconnected to the active
pharmaceutical ingredients (API) in top-selling drugs, in order to extend
monopoly pricing.



As coverage
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of the study in Inside Health Policy notes, “[d]rugmakers are systematically
extending monopolies across hundreds of medicines -- from birth control and
migraine treatments to cancer therapies and heart drugs -- by patenting
delivery devices and peripheral technologies that often have little to do with
the drugs themselves.”



The study examined “every small-molecule drug the [U.S. Food & Drug
Administration (FDA)] has approved from 1986 to 2023 and found 331 products
with at least one tertiary patent, defined as a patent on a delivery device or
related technology rather than the drug itself.” Among the 331 analyzed drugs,
drug makers “listed 3,241 patents in the FDA’s Orange Book…more than half – 54
percent – were tertiary patents covering devices or device-related features,
whileonly 4.2 percent were primary patents on the active pharmaceutical
ingredient.”



According to Inside Health Policy, “[a]mong those device patents, nearly 60%
lacked any claim referencing API, a key criterion increasingly used by courts
and the FTC to determine whether a patent is properly listed in the Orange
Book.” And, importantly, the study found that 180 of the drugs examined had
their “patent protection extended beyond all primary and secondary patents due
to tertiary patents, with a median extension of 7.5 years.”


The study builds on previous research which “focused heavily on respiratory
drugs and injectable therapies for diabetes and weight loss.” This study
“identified widespread tertiary patenting across neurology, cardiovascular
disease, oncology, dermatology and genitourinary medicine.”



The new study also builds on a previous analysis
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published in JAMA Network which found that the brand name drug makers
marketing GLP-1 receptor agonists weight loss drugs are increasingly utilizing
device patents to build patent thickets around these products to create and
elongate periods of monopoly pricing power — despite the drugs effectively
being older diabetes medications repackaged for a different indication.


This latest study underscores the importance of bipartisan, market-based
solutions to crack down on Big Pharma’s anti-competitive tactics and reject the
pharmaceutical industry’s debunked rhetoric about innovation, since brand name
drug companies routinely focus more on innovating legal strategies to block
competition, rather than in developing truly novel innovations that improve
clinical value for patients.



Read the full study in JAMA Health Forum HERE
<[link removed]>.



Read coverage of the study in Inside Health Policy HERE
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.



Read more on how Big Pharma has constructed patent thickets on GLP-1 weight
loss drugs that are disconnected from actual innovationHERE
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.



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



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