Patent Thickets to Boost Obesity Medicine Prices

Are patent thickets boosting the prices of obesity medicine prices and putting these important medical advances out of reach for everyone but the wealthy and well insured? A new paper in JAMA this week suggests this is true – at least in part. Rasha Alhiary and colleagues explain:

“Manufacturers have secured long periods of market exclusivity on these products, in part by listing numerous device patents with the FDA, creating large patent thickets (ie, many patents directed toward the same product). These patent listings can delay competition by precluding the FDA from approving generic versions for marketing until the patents expire or face successful challenge, which can be time-consuming and costly.”

Alhiary et al examined patent litigation to prevent competition for GLP-1 medicines and found that most of the patents cited (57%) have nothing to do with the actual drugs. They are all about the devices (the pens) used to deliver them.

This is what a patent thicket is all about. Generate a dizzying array of patents in the hope that one or more of them will keep competition out of the market.

FTC and Legislators
Targeting Patent Thickets

Health policy advocates say patent thickets amount to patent abuse that prevents competition. They prevent wider access to innovative drugs by keeping prices high. So the FTC and U.S. legislators are pursuing strategies to limit this tactic. They want to clear out some of these thickets and promote competition.

FTC has challenged more than 100 patents for drug products. They have focused on patents for devices that deliver the medicine. An example would be the injection pens in which Novo Nordisk and Lilly sell their GLP-1 medicines. “We are using all the tools we have to bring down drug prices and reduce barriers to generic competition,” said FTC’s Hannah Garden-Monheit.

In the same vein, Republicans and Democrats are working together on legislation to prevent these abuses. They introduced a bill in the Senate and the House last month for this purpose. Senator Mike Braun (R-IN) describes the reasoning:

“Protecting intellectual property is one of the things that makes the American economy so innovative, but often there are loopholes that allow the pharmaceutical industry to delay competition. Market competition is essential for keeping prices low, and this bill will go a long way to fixing one of those problems,”

High Prices Denying Access

This matters. Competition is essential for keeping drug prices reasonable. William Feldman, senior author of the paper in JAMA, explains:

“The number one way to bring down prices of brand name prescription drugs in the United States is robust, generic competition. If these products were cheaper, we absolutely would not see the fights with payers and patients about coverage of the products because payers would have an easy time covering them.”

Right now almost all of the people who might benefit from advanced treatments for obesity cannot get them. High prices are a key barrier. This must change.

Click here for the paper in JAMA and here for reporting on it. For more on patent thickets and patent abuse, click here, here, and here.

Thickets, painting by Ivan Shishkin / WikiArt

Subscribe by email to follow the accumulating evidence and observations that shape our view of health, obesity, and policy.

February 9, 2024