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 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 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, while only 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 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.
Read coverage of the study in Inside Health Policy HERE.
Read more on how Big Pharma has constructed patent thickets on GLP-1 weight loss drugs that are disconnected from actual innovation HERE.
Learn more about market-based solutions to hold Big Pharma accountable and lower drug prices HERE.
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