GSK 'schemed' FDA's drug-device approval pathway to deflect asthma inhaler generics, lawsuit claims

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.

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 the proposed class-action complaint.

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.

GSK declined to comment on the lawsuit.

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.

If competitors had been allowed to reach the market in a timely manner, Dale says he and other wouldn't have been forced to shell out for expensive branded drugs.

The plaintiff seeks an injunction against the “deceptive, unfair, unconscionable, and unlawful business practices” GSK is accused of, plus potential damages.

Dale has brought the lawsuit on his behalf plus that of all others in the U.S. who paid some or all of the purchase price for Ventolin and Arnuity Ellipta.