The Federal Trade Commission on Thursday issued what amounted to a warning to pharmaceutical companies about the legality of a widespread patenting strategy that experts say has helped keep inhaler costs high for patients with asthma and lung problems.
In a policy statement unanimously endorsed by the agency’s commissioners, the F.T.C. said it “intends to scrutinize” whether companies are illegally engaging in an unfair method of competition when they exploit a regulatory loophole that can delay rivals from entering the market.
The policy statement did not single out any particular products. But an F.T.C. official who was not authorized to discuss the agency’s findings said that the agency’s staff had identified dozens of patents on inhalers that appear to be being used in violation of federal law.
“This seems to be a real problem, and one that could really be contributing to unaffordable medicines and drug products,” Lina Khan, the F.T.C. chair, said at a public meeting on Thursday.
At issue is a maneuver in which drug companies patent different aspects of their products and list those patents in a federal registry known as the Orange Book. The listing can be worth hundreds of millions of dollars for a company because it deters rivals from introducing competing generic products. Under certain circumstances, a listing automatically bars federal regulators for over two years from approving a competitor’s generic product.
Only certain types of drug patents — such as those protecting a medication itself or a method of using it — are allowed to be listed in the Orange Book. But that hasn’t stopped companies from listing their patents on inhalers, injector pens and other devices. Those patents sometimes don’t mention the medication they’re delivering. Some are far removed from the world of drug development, like patents for a container, a rubber strap and a dose counter that keeps track of the number of puffs that a patient has left.
In its policy statement, the F.T.C. said it would examine whether companies are listing certain patents in the Orange Book that aren’t allowed to be there, at the expense of generic competition.
The tactic is a type of “patent gamesmanship” that “seems to be delaying generic competition, keeping prices high for patients,” said Dr. William Feldman, a researcher at Brigham and Women’s Hospital in Boston who began studying the phenomenon after seeing his patients with asthma and lung problems struggling with high out-of-pocket costs for their inhalers.
Any regulatory crackdown on patents improperly listed in the Orange Book would not have an immediate impact on the prices of inhaler products, though it could help accelerate the availability of lower-priced generics.
The medicines used to treat asthma and the common lung condition known as chronic obstructive pulmonary disease are generally decades old and have long since lost patent protection. Some can be bought separately for pennies. But drug makers have kept revenue flowing by introducing new patent-protected inhalers to deliver the drugs.
For example, Boehringer Ingelheim generates hundreds of millions of dollars annually from an inhaler product known as Combivent Respimat introduced in 2011. It combines two drugs first approved in the 1980s, and the patents listed in the Orange Book protecting it cover only aspects of the inhaler device. The inhaler costs hundreds of dollars and faces no generic competition.
Boehringer Ingelheim declined to comment.