DOSE OF REALITY: BIG PHARMA’S QUICK DELISTING OF MORE THAN 40 SHAM PATENTS HIGHLIGHTS SCALE OF PATENT THICKETS ON TOP MONEY-MAKERS
Analysis Finds Brand Name Drug Companies Declined to Even Attempt a Defense of Dozens of Patents Recently Challenged by the FTC
In case you missed it, a new 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).
The FTC issued its latest series of challenges to the validity of prescription drug patents in the U.S. Food and Drug Administration’s (FDA) Orange Book in May. According to an analysis 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.
On paper, the Orange Book is meant to serve as a resource listing all the patents that brand name drug manufacturers have secured for FDA-approved products. However, in practice, brand name drug companies effectively game the Orange Book to make it more challenging for potential competitors to introduce alternative products to brand name drugs.
The quick delisting of so many patents this year underscores just how many patents brand name drug companies file on the same product to block would-be competitors from entering the market — regardless of whether any actual innovation has occurred.
A recent study published in JAMA Health Forum recently found lost competition due to Big Pharma’s patent thickets on just four widely prescribed brand name drugs cost patients, taxpayers and the U.S. health care system more than $3.5 billion over two years due to lost competition.
A January 2023 report from Matrix Global Advisors found Big Pharma’s patent thickets on just five brand name drugs, including AbbVie’s autoimmune drug Humira and oncology drug Imbruvica, Regeneron’s ophthalmology drug Eylea, Amgen’s autoimmune drug Enbrel and Bristol Myers Squibb’s oncology drug Opdivo, cost patients, taxpayers and the U.S. health care system more than $16 billion in a single year.
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 the full analysis published in Law360 HERE.
Read more on the cost of Big Pharma’s patent abuse HERE.
Read more on bipartisan, market-based solutions to foster greater competition HERE.
Read more on bipartisan, market-based solutions to hold Big Pharma accountable HERE.
###
