When patents for name-brand drugs expire and generic versions are allowed to enter the market, drug prices fall for consumers. But this class action alleges that GlaxoSmithKline, PLC (GSK) has managed to keeps its exclusivity and high prices with schemes to avoid competition for its inhalers. The complaint claims that the company has managed to obtain thirty-five years of “uninterrupted patent and regulatory protection” for its Flovent and Arnuity Ellipta inhalers and sixty years of it for its Ventolin inhalers, through a process called “device hopping.”
The class for this action is all persons or entities in the US and its territories who bought or paid for some or all of the purchase price for Ventolin and Arnuity Ellipta inhalers, for consumption by themselves, their families, or their members, employees, insureds, participants, or beneficiaries, not for resale, between January 1, 1986 and the time the anticompetitive effects of GSK’s unlawful behavior end.
Inhalers contain prescription drugs inside a delivery device that administers the medicine. They are considered drug-device combinations and are the primary way of treating asthma and chronic obstructive pulmonary disease (COPD).
Inhalers are expensive; the complaint alleges they comprise five percent of the country’s net retail spending on prescription drugs.
Because they are complex products, the Food and Drug Administration (FDA) have special regulatory requirements before it will approve generic versions, the complaint alleges, in that “the FDA is prohibited from approving the generic version of that product until the patent protection [of the brand-name original] expires or is challenged and overturned.”
The patent protection period is twenty years and can be extended, the complaint says, “under unique regulations governing pharmaceutical patents.” One method of doing this, the complaint alleges, is a process known as “device hopping.” The complaint alleges, “Device hopping works by retiring a branded inhaler but placing the same active ingredients into a new ‘follow on’ branded inhaler with new patent and regulatory protection periods.”
The complaint contends that this works because “a generic version of a reference brand-name inhaler may only be approved for that specific brand-name inhaler” and not for the follow-on version.
This is why, the complaint contends, GSK has managed to have a thirty-five-year period of exclusivity for its Flovent and Arnuity Ellipta inhalers and a sixty-year period of exclusivity for its Ventolin inhalers.
The complaint alleges that GSK has “used its unlawfully[-]obtained market exclusivity to charge artificially[-]inflated prices for inhalers.”
The counts include violations of the federal antitrust Sherman Act and state antitrust statutes, as well as unjust enrichment.
Article Type: LawsuitTopic: Consumer
Most Recent Case Event
Flovent, Arnuity Ellipta, Ventolin Inhalers Patents Antitrust Complaint
May 20, 2022
When patents for name-brand drugs expire and generic versions are allowed to enter the market, drug prices fall for consumers. But this class action alleges that GlaxoSmithKline, PLC (GSK) has managed to keeps its exclusivity and high prices with schemes to avoid competition for its inhalers. The complaint claims that the company has managed to obtain thirty-five years of “uninterrupted patent and regulatory protection” for its Flovent and Arnuity Ellipta inhalers and sixty years of it for its Ventolin inhalers, through a process called “device hopping.”
Flovent, Arnuity Ellipta, Ventolin Inhalers Patents Antitrust ComplaintCase Event History
Flovent, Arnuity Ellipta, Ventolin Inhalers Patents Antitrust Complaint
May 20, 2022
When patents for name-brand drugs expire and generic versions are allowed to enter the market, drug prices fall for consumers. But this class action alleges that GlaxoSmithKline, PLC (GSK) has managed to keeps its exclusivity and high prices with schemes to avoid competition for its inhalers. The complaint claims that the company has managed to obtain thirty-five years of “uninterrupted patent and regulatory protection” for its Flovent and Arnuity Ellipta inhalers and sixty years of it for its Ventolin inhalers, through a process called “device hopping.”
Flovent, Arnuity Ellipta, Ventolin Inhalers Patents Antitrust Complaint