Study: Inhaler manufacturers use patents, exclusivity to shut out generic competition

Regulatory NewsRegulatory News | 19 May 2022 |  By 

Brand-name inhaler manufacturers have successfully used patent hops, cross-listed patents, and other nonpatent regulatory exclusivities to keep generic manufacturers out of the US inhaler market over the last 35 years, according to an analysis published in Health Affairs.

The result has been higher costs for patients and a lack of innovation, according to the study’s lead author William B. Feldman of Brigham and Women’s Hospital and Harvard Medical School, both in Boston. “Our study shows how brand-name inhaler manufacturers have taken advantage of the current patent and regulatory system to extend periods of market exclusivity,” Feldman said in an interview with Regulatory Focus. “It also shows how the current system rewards not just true innovation but also incremental changes to existing products with little or no added clinical benefit. At the end of the day, the gamesmanship by brand-name inhaler manufacturers harms our patients with asthma and [chronic obstructive pulmonary disease] who cannot afford their medications, and it contributes to higher premiums for all of us.”  

The researchers created a novel database of all patents and regulatory exclusivities granted to inhalers approved by the US Food and Drug Administration (FDA) from 1986-2020 and analyzed the impact on generic competition. During the 35-year study period, FDA approved 62 inhalers for asthma and chronic obstructive pulmonary disease (COPD), of which 53 were brand-name products and 9 were generics. During the study period, only one inhaler entered the market with an ingredient with a new mechanism of action. 
Through both patents and statutory exclusivities, manufacturers received more than 15 years of protection from competition, on average, with only one of the 53 brand-name products analyzed facing competition from an interchangeable generic before the expiration of its patents and exclusivities.

Since inhalers are drug-device combination products, manufacturers can patent both components. Manufacturers may receive pre- and post-approval patents, as well as nonpatent exclusivities related to new chemical entities, new combinations, new products, and new dosage forms. Manufacturers also can take advantage of other moves to protect their market exclusivity, including cross-listing patents to cover more than one product. In this analysis, manufacturers listed the same patent on four or more products in 36 cases.

Device hopping is another strategy to protect market exclusivity in which manufacturers place the same active ingredient into a new device with new patents and exclusivities. Manufacturers used this approach with 15 different originator inhalers, resulting in 19 follow-on branded inhaler products. The average time from approval of originators to expiration of patents on follow-on inhalers was 28 years, according to the analysis.  

The researchers outlined several areas for potential reform, both by regulators at FDA and by Congress. FDA could prohibit brand-name manufacturers from listing device patents in the Orange Book and prevent manufacturers from adding patents to the Orange Book after approval unless the patents protect alterations associated with “real clinical benefit.” Additionally, when manufacturers seek to list patents on new versions of drug-device combinations, FDA could require that they show superiority of the new version in a clinical trial (RELATED: FDA looks to overhaul Orange Book, seeks input on patent listings, Regulatory Focus 29 May 2020).

The researchers also suggested that Congress consider new legislation to restrict manufacturers to just one patent or exclusivity for FDA to consider when approving generics. “Such an approach would raise other complicating factors, such as whether it aligns with international trade agreements, but it would effectively thin out the expansive patent thickets that now protect brand-name drug-device combinations,” the researchers wrote.

While the patent practices on inhalers and other drug-device combinations outside the US were outside the scope of this analysis, Feldman said he and his colleagues are planning a comparative analysis of the US versus other countries.

Health Affairs study


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