New lawsuit accuses GSK of 'device hopping' to block generic inhaler competition
Despite inhalers being on the market for decades, many patients still can’t afford them. A new lawsuit filed in Missouri federal court puts the blame on GSK.
Last week, plaintiff Elliot Conrad Dale — who’s paid for GSK’s Ventolin and Arnuity Ellipta inhalers — filed a class-action lawsuit against the pharma giant, accusing it of scheming to block generic versions of its brand-name inhalers.
Dale alleged that GSK engaged in “device hopping,” or in other words, retiring a branded inhaler while placing the same active ingredients in a follow-on inhaler with new patent protections. Generics that were previously approved for an earlier version of a branded inhaler are not approved for these follow-on versions.
“Thus, device hopping prevents generics from ever having an unprotected brand name inhaler to reference for a generic,” the complaint states.
Plaintiffs allege that through this scheme, GSK enjoyed 60 years of uninterrupted patent and regulatory protection for its Ventolin inhaler line, and 35 years for its Flovent and Arnuity Ellipta inhaler line.
Currently, inhalers account for about 5% of total net retail spending on prescription drugs in the US, according to the complaint.
The class-action suit seeks an injunction that would bar GSK from “engaging in the deceptive, unfair, unconscionable, and unlawful business practices alleged in this Complaint,” as well as compensatory damages to the plaintiff and proposed class.
A GSK spokesperson declined to comment, but said the company would “thoroughly review the complaint.”
Just last week, new research published in Health Affairs accused follow-on inhaler products (including ones from GSK) of blocking competition from cheaper generics.
Researchers pointed out that GSK received 35 years of protection from competition after the FDA approval of its fluticasone inhalers through the successive release of new inhaler devices containing fluticasone: Flovent (approved in 1996), Flovent Rotadisk (1997), Flovent Diskus (2000), Flovent HFA (2004), and most recently Arnuity Ellipta (2014).
“Brand-name manufacturers have secured long periods of market exclusivity by patenting the delivery devices of their products – even when the active ingredients are off-patent – and by moving active ingredients from one device to the next (which we refer to as ‘device hopping’),” author William Feldman told Endpoints News at the time.
The news comes as GSK looks to stand out from the pack in severe asthma, winning approval for a 40 mg prefilled syringe of Nucala for certain kids between 6 and 11 years old back in January. That means they can take the drug at home, rather than going to the doctor’s office every four weeks.