The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices.
The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.
It’s the first time the FTC has tried the tactic, said Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning.
“We are using all the tools we have to bring down drug prices and reduce barriers to generic competition,” she said in an interview.
President Joe Biden has instructed his Federal Trade Commission to be more aggressive in reining in the pharmaceutical industry. Under its chairperson, Lina Khan, the agency is aggressively testing the limits of its powers in pursuit of that goal.
The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. Drugmakers list them in the FDA’s “Orange Book,” which can afford the products greater protection from generic competition.
Many of the medicines delivered by the devices are decades old, years off patent. But manufacturers have long tweaked the delivery methods, patenting the changes, in ways that sometimes make the drugs more convenient to administer.
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They might, for example, change the propellant in an inhaler or add a counter that tells a patient how many doses are left. A …
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The Federal Trade Commission has challenged the validity of over 100 drug product patents, focusing on devices used to deliver medicines, like inhalers and autoinjectors, in an effort to increase competition and potentially lower some prices.
The FTC says drugmakers illegitimately use the patents to prevent competitors from offering cheaper generic alternatives.
It’s the first time the FTC has tried the tactic, said Hannah Garden-Monheit, director of the FTC’s Office of Policy Planning.
“We are using all the tools we have to bring down drug prices and reduce barriers to generic competition,” she said in an interview.
President Joe Biden has instructed his Federal Trade Commission to be more aggressive in reining in the pharmaceutical industry. Under its chairperson, Lina Khan, the agency is aggressively testing the limits of its powers in pursuit of that goal.
The targeted patents cover devices that propel medicines for asthma and emphysema into the lungs or inject epinephrine to treat a severe allergic attack. Drugmakers list them in the FDA’s “Orange Book,” which can afford the products greater protection from generic competition.
Many of the medicines delivered by the devices are decades old, years off patent. But manufacturers have long tweaked the delivery methods, patenting the changes, in ways that sometimes make the drugs more convenient to administer.
Email Sign-Up
Subscribe to KFF Health News’ free Morning Briefing.
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