A federal judge in Pennsylvania is allowing a consolidated litigation to advance against a pharmaceutical company that allegedly helped the maker of Suboxone delay generic versions of the opioid addiction treatment medication from entering the market.
U.S. District Judge Mitchell Goldberg of the Eastern District of Pennsylvania rejected MonoSol Rx’s attempts to have the antitrust case against it tossed on a motion to dismiss. The lawsuit, which was brought by 34 states and Washington, D.C., alleges that the company helped Indivior develop a “product-hopping” scheme that violated the Sherman Act and state statutes against unfair trade.
According to Goldberg, MonoSol did not directly develop Suboxone. The company’s business focused on developing soluble films, and its role in the alleged scheme involved helping Indivior switch from a tablet form of Suboxone to a film form of the medication just before generic drug companies were allowed to enter the market.
Although MonoSol contended that an agreement to develop a new product is pro-competitive, and therefore did not violate antitrust laws, Goldberg rejected that argument.
“When a monopolist combines product improvement with some other conduct, the overall effect of which is to coerce consumers rather than persuade them on the merits, the conduct is anti-competitive under the Sherman Act,” Goldberg said. “The ‘rule of reason’ burden-shifting framework set forth in United States v. Microsoft only requires a plaintiff, at the pleading stage to allege the anti-competitive nature of a defendant’s conduct.”
Indivior had introduced Suboxone in 2002, according to Goldberg. It was developed as an “orphan drug,” which is a federal designation that allows developers a seven-year window to exclusively sell a drug if it has been developed to address a rare disease and revenues are not expected to cover the development costs. However, according to Goldberg, Suboxone tablets earned more than $2 billion by 2010.
As part of the alleged product-hopping scheme, MonoSol allegedly approached Indivior about switching from a tablet form of Suboxone to a film form. The states further alleged MonoSol had advertised on its website that its “PharmaFilm drug technology allows: no generic substitution,” and “PharmaFilm can be an ideal strategy for extending the life of a brand as generic incursion approaches.”
According to Goldberg, the states alleged that beginning in 2006, MonoSol and Indivior began working on a plan to develop a film version that could be introduced on the market by mid-2009. The states contended that the defendants also began aggressively marketing the alleged superiority of the film version, and priced film to be less than the tablets despite expensive production costs.
According to Goldberg, several putative class actions were filed against companies involved with making Suboxone alleging anti-competitive behavior. The cases were later consolidated into a multidistrict litigation in the Eastern District of Pennsylvania.
In its motion to dismiss, MonoSol contended the state could not show that it acted with specific intent to delay the generic market entrance, but Goldberg noted the allegations regarding the company’s internet advertising and its royalty agreement with Indivior, among others.
“Taken collectively, these allegations permit the plausible inference that MonoSol consciously committed to the common scheme of endowing illegal monopoly power to Indivior and benefiting from such monopoly power,” Goldberg said.
Cassandra Adams of Steptoe & Johnson LLP is representing MonoSol and Gwendolyn Cooley of the Wisconsin Attorney General’s Office is a lead attorney for the plaintiffs. Neither attorney immediately returned messages seeking comment. Jones Day attorney Jonathan Berman, who is representing Indivior, declined to comment.
Max Mitchell can be contacted at 215-557-2354 or firstname.lastname@example.org. Follow him on Twitter @MMitchellTLI.