DOSE OF REALITY: STUDY FINDS NEARLY THREE-QUARTERS OF BIG PHARMA’S PATENTS ON TOP-SELLING DRUGS FILED AFTER FDA APPROVAL

Analysis Showcases Egregious Scale of Big Pharma’s Patent Thickets on Blockbuster Products, Including Nearly 1,500 Patent Applications on Just Ten Drugs

A new study, published in JAMA Network, examines Big Pharma’s egregious patent thickets erected around the top 10 best-selling prescription drugs in the U.S. The study found the top 10 brand name drugs in terms of “US net sales revenue in 2021” had a total of 1,429 patents or pending patents. 742 of these, or 52 percent, were issued patents, 218, or 15 percent, were pending patents, and 469, or 33 percent, were abandoned patents.

Of the patents examined in the study, almost three-quarters, or 72 percent, were filed after the U.S. Food and Drug Administration (FDA) initially approved these drugs. The study found that “patent thicket density peaked 13 years after initial FDA approval, at which time these 10 drugs were protected by a median of 42 active patents, 66 percent of which were filed after FDA approval.”

Among patents filed after initial FDA approval, 41 percent were for method of use claims, 27 percent were for formulation claims, 22 percent were for process or synthesis claims and 10 percent were for device claims. Fewer than 20 percent of the patent filings were for chemical composition claims.

The study recommends that more “[s]crutiny of patent applications and of patents filed after FDA approval is needed to facilitate timely generic or biosimilar competition.”

The findings underscore the importance of bipartisan, market-based solutions to hold Big Pharma accountable for egregious abuse of the patent system designed to extend monopolies and keep drug prices high.

 

Read the full study from JAMA Network HERE.

Read more about how Big Pharma’s patent abuse is the root cause behind out-of-control prescription drug prices HERE.

Learn more about market-based solutions to hold Big Pharma accountable and lower prescription drug prices HERE.

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