Federal District Court finds brand-name manufacturer’s alleged regulatory delay tactics a valid theory of attempted monopolization
In a recent decision denying the defendant’s motion to dismiss, Judge Mitchell Goldberg of the Eastern District of Pennsylvania allowed the manufacturer of a generic version of Suboxone to proceed upon an interesting theory of attempted monopolization by the brand-name manufacturer Indivior (formerly, Reckitt). Amneal, the generic manufacturer, alleges that Indivior purposefully delayed what was supposed to be a joint effort to develop a combined risk management strategy for all versions of Suboxone.
Suboxone was the first treatment for opioid dependence that can be prescribed for use in a patient’s home. The FDA conditioned the 2002 approval of Suboxone on Indivior’s completion of a “comprehensive risk management program, or “RiskMAP”—a precursor to what is now known as a REMS, or “Risk Evaluation and Mitigation Strategy.” The FDA can require a drug manufacturer to complete a REMS to demonstrate and ensure that a drug’s benefits outweigh its risks. In the case of Suboxone, the RiskMAP was designed to avoid abuse of Suboxone and mitigate other risks posed by the drug.
If the FDA requires a REMS for a brand name drug, any subsequent generic manufacturer must join with the brand manufacturer to create a “single, shared” REMS—known as an SSRS. The goal of the SSRS mechanism is to avoid burdening the healthcare system with multiple REMS programs. Notably, a generic manufacturer’s ANDA will not be approved until the SSRS process has been completed or waived. In 2012, the FDA issued a letter to the sponsors of pending ANDAs for generic Suboxone, indicating that it would require completion of an SSRS and instructing the sponsors to contact Indivior to that end. Amneal alleges that it attempted to collaborate with Indivior in the SSRS process but that Indivior gave the generic sponsors the run-around, dragging its feet and inventing excuses to delay development of the SSRS. After months of these delays, the generic sponsors requested, and the FDA granted, waiver of the SSRS requirement, approving a separate REMS in February 2013. On the same day, the FDA approved Amneal’s ANDA.
Amneal brings Sherman Act claims relating to the delay in approval of its ANDA allegedly caused by Indivior’s tactics. Additionally, Amneal accuses Indivior of “product hopping” (by switching the delivery mechanism for Suboxone from tablets to film) and of filing a sham citizen petition with the FDA (requesting that the agency impose new conditions on generic Suboxone that had never applied to the branded version), which caused further delay. (We previously discussed related product hopping allegations in this case here.)
In putative class action concerning the same conduct, the Court dismissed claims based on Indivior’s alleged delay of the SSRS process, finding that that under the Supreme Court’s “duty to deal” caselaw (discussed previously on this blog in the pharmaceutical context), Indivior had no duty to work with its generic competitors. But in Amneal’s case, the Court allowed the allegations related to the SSRS-delay to stand, because Amneal made an argument that the class plaintiffs did not: it alleged that, even if the SSRS-delay allegations are not actionable standing alone, they are part of a larger anticompetitive scheme—a “tapestry” of conduct that includes multiple actions designed to maintain Indivior’s monopoly, including the product hopping and the sham petition. Judge Goldberg accepted this argument, citing cases that, in his view, establish that “in certain circumstances, a plaintiff can allege a series of actions that when taken together make out antitrust liability even though some of the individual actions, when viewed independently, are not all actionable.” Such a situation is to be distinguished, he said, from one in which “every aspect of the conduct alleged . . . fails under the antitrust laws” (emphasis added). Here, Amneal has a viable product-hopping claim, so its “overarching scheme” theory, including the SSRS-delay allegations, remains in the case.
The decision is notable in at least two respects. First, it explores yet another wrinkle of the increasingly complex antitrust dynamics in the ANDA context. Second, it suggests that, assuming there is a sufficiently-pled “hook” for antitrust liability, some courts may allow ancillary allegations to proceed, allowing plaintiffs to weave a “tapestry” of anticompetitive conduct together even though the allegations may not be independently actionable. We will continue to monitor this case and report on developments.