Brand Name Drug Companies Prevent Competition from More Affordable Alternatives by Gaming the Patent System and Deploying Tactics Like Product Hopping

In case you missed it, STAT News covered a new academic analysis published in Health Affairs that found manufacturers of brand name inhalers used to treat asthma and chronic obstructive pulmonary disease engage in anti-competitive tactics to keep more affordable generic competition from entering the market.

According to the analysis, manufacturers are guilty of “combining old ingredients into new inhalers; shifting ingredients from one inhaler to another; and adding new patent and exclusive rights bestowed by regulators after approvals.”

Specifically, the study “examined 62 inhalers approved by the Food and Drug Administration between 1986 and 2020, and found 53 — or 85 percent — were brand-name products with an average of 16 years of patent protection. Yet only one inhaler contained an active ingredient with a new mechanism of action, while more than half of the patents were on devices, not any of the ingredients.”

Among the more egregious examples, one branded product was granted extended market exclusivity 28 years after the drug’s initial approval.

Researchers also point to GlaxoSmithKline, who extended one inhaler’s exclusivity 35 years by product hopping or simply placing the same active ingredient into a new device.

Authors of the report also referenced previous research showing, “inhalers represented approximately five percent of total net retail spending on prescription drugs in the U.S., suggesting that out-of-pocket spending may lead to poor patient adherence and health outcomes.”

They include, “what the researchers call a ‘notorious example,’” in which, “Boehringer Ingelheim released a new version of its Combivent inhaler in 2011 with 25 patents, all of which were for the device rather than the drug ingredients. The company now has a total of 34 years of monopoly beginning with the initial approval in 1996 and running through 2030, when the last patent on a chlorofluorocarbons-free version expires.”

The analysis endorses market-based solutions to bring more affordable alternatives to the market and crack down on Big Pharma’s egregious anti-competitive practices, including U.S. Patent and Trademark Office (USPTO) reforms targeting extraneous patents that extend monopolies without benefitting the public.

Read STAT News’ coverage of the analysis, “Drugmakers use monopoly tactics to thwart lower-cost generic competition for inhalers, analysis finds” HERE.

Read the entire analysis, “Patents And Regulatory Exclusivities On Inhalers For Asthma And COPD, 1986–2020,” in Health Affairs HERE.

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

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