GSK Lawsuit: Angling to block generics of Ventolin and Arnuity Ellipta, GSK for decades has “schemed” the FDA drug-device approval system to shield its asthma inhalers with patents and regulatory exclusivity, according to a proposed class-action complaint.

GSK’s perpetual asthma inhaler updates have kept generics makers chasing a moving target for more than half a century, and it’s patients who are being forced to foot the bill, a new lawsuit filed in a Missouri federal court contends.

The company used a ploy known as “device hopping,” in which a branded inhaler is retired and succeeded by a follow-on inhaler with the same active ingredients. The new product then gets a new patent and regulatory protection periods, court documents filed Friday claim.

“[GSK] knowingly and intentionally engaged in an anticompetitive scheme designed to block and delay entry of competing inhalers,” argues plaintiff Elliot Conrad Dale, a Jackson County, Missouri, man who paid part of the purchase price for Ventolin and Arnuity Ellipta during the period when GSK was allegedly running its schemes.

Dale argues the company’s strategy allowed it to fabricate more than 60 years of uninterrupted patent and regulatory protection for its Ventolin inhaler line and more than 35 years of protection for its Flovent and Arnuity Ellipta devices.

With its extended exclusivity, GSK charged “artificially inflated prices for inhalers,” the suit says. The high cost of inhalers is recognized as a “significant public health concern” in the U.S., where decades-old devices represent some 5% of total net retail spending on prescription drugs, the lawsuit adds.

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